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1998-1999-2000-2001
THE
PARLIAMENT OF THE COMMONWEALTH OF
AUSTRALIA
HOUSE OF
REPRESENTATIVES
THERAPEUTIC GOODS
AMENDMENT (MEDICAL DEVICES) BILL 2001
THERAPEUTIC GOODS (CHARGES)
AMENDMENT BILL 2001
EXPLANATORY
MEMORANDUM
(Circulated
by authority of the Parliamentary Secretary to the Minister for
Health and Aged Care, Senator the Hon Grant
Tambling)
ISBN: 0642 46832X
THERAPEUTIC GOODS AMENDMENT (MEDICAL DEVICES) BILL
2001
THERAPEUTIC GOODS (CHARGES) AMENDMENT BILL
2001
OUTLINE
The Bill introduces a new medical device regulatory system which is
internationally accepted best practice, harmonising Australia's requirements for
quality, safety and performance with the recommendations of the medical devices
Global Harmonisation Task Force, which are based on those of the European
Community.
The new devices regulatory system has several key features.
It provides for specified criteria for safety and performance (the 'essential
principles') with which devices must conform; increased use of internationally
recognised standards for devices as a means of demonstrating that a device
conforms with the essential principles; a risk based classification of medical
devices; conformity assessment procedures to ensure devices meet the essential
principles for safety and performance; and increased emphasis on post-market
activities.
The essential principles provide the measures for safety and
performance of all devices and will be set out in the regulations.
The
classification rules require devices to be classified according to the degree of
risk involved in using the device, based on the degree of invasiveness in the
human body, duration of use, location of use and whether or not the device is
powered. Devices are currently classified as either 'registrable' or 'listable'.
The new classification system has several levels of classification which will
allow a more appropriate level of regulation to be applied to each class of
device proportional to the level of risk posed by its use. It will also be
better able to identify and manage risks associated with new and emerging
technologies. Details of the classification rules will be set out in the
regulations.
The conformity assessment procedures will allow more
rigorous pre-market assessment of devices. All manufacturers of all medical
devices will be required to meet manufacturing standards and all manufacturers,
except those manufacturing the lowest risk devices, will be audited and have
their systems certified. The level of assessment will be commensurate with the
level and nature of risks posed by the device to the patient or user, ranging
from manufacturer self assessment for low risk devices through to full
Therapeutic Goods Administration (TGA) assessment with respect to high risk
devices (which are to be identified in the regulations). Under the new system
there will be increased scrutiny of high risk devices, which are often highly
invasive in nature. A conformity assessment certificate, issued by the TGA,
will be required before such devices can be marketed in Australia.
Detail of the conformity assessment procedures will be set out in the
regulations. Under the new system there is more flexibility as to how devices
are assessed as well as a requirement that documentation be held and made
available as evidence to verify conformity with the essential principles.
Post market monitoring will include TGA checking evidence of conformity,
periodic inspections of manufacturer's quality systems and technical
documentation, including documentation held by a sponsor, and specific
requirements for manufacturers and sponsors to report, within specified
timeframes, adverse events involving their medical devices. Australia will also
have increased involvement in the international post market vigilance system and
this should reduce the likelihood of repeated adverse events as well as
influence the development of new medical devices.
The new harmonised
system for medical devices will retain major elements of the current
legislation, in particular, the requirement for medical devices to be entered on
the Australian Register of Therapeutic Goods (the Register). As medical devices
will no longer be 'registered' or 'listed' but rather will be 'included in the
Register', a new part of the Register has been created for this purpose. As a
consequence, the Therapeutic Goods (Charges) Act 1989 has been
amended to provide for annual charges to be imposed in respect of medical
devices 'included in the Register'. Provision has been made for exemptions
from inclusion in the Register along similar lines to the current legislation
and devices may still be recalled and Register entries cancelled in much the
same way as they currently are. Provision has also been made for suspending
medical devices from the Register where this is seen as more appropriate in the
circumstances.
The Bill also makes provision for applications for
'inclusion' of medical devices in the Register to be made under the new devices
electronic application lodgement system. This will allow automatic entry of
devices onto the Register once the evidence of conformity has been prepared and
a proper application is lodged. However, an important feature is the provision
for some applications to be selected for checking prior to entry of devices onto
the Register.
The Bill inserts a new part into the Therapeutic Goods
Act 1989 (the Act) to provide for the creation of the new devices scheme but
a large number of the current administrative provisions of the Act will continue
to be used for the new scheme. The Act has been restructured into separate
chapters and part numbers have been renumbered as a consequence. There is a
separate chapter (Chapter 4) for regulation of medical devices and a separate
chapter for medicines and other therapeutic goods that are not medical devices
(Chapter 3). The remaining chapters deal with matters common to all therapeutic
goods.
Transitional arrangements for the new system allow five years for
devices currently on the Register to meet the new requirements. There is also
provision for a two year transition period for some specified new devices.
These will be specified in the Regulations and will include devices not
previously manufactured to a certified quality system and some complementary
therapy devices that are currently excluded from regulation. At the end of the
transition period, provision has been made in Schedule 2 for further amendments
to the Act as a 'clean up' of provisions which will no longer be required once
the new scheme has been fully implemented.
Financial Impact
Statement
The amendments to the Act have no significant financial
impact.
THERAPEUTIC GOODS AMENDMENT (MEDICAL DEVICES) BILL
2001
NOTES ON CLAUSES
Clause 1: states that the short title of the legislation is the
Therapeutic Goods Amendment (Medical Devices) Act 2001.
Clause 2:
sets out the commencement date for the changes set out in the Schedules.
Schedule 1 commences on the day to be fixed by Proclamation or 6 months after
Royal Assent, whichever occurs first. Schedule 2 commences on the
5th anniversary of the day on which Schedule 1
commences.
Clause 3: has the effect of stating that the
Therapeutic Goods Act 1989 (the Act) will be amended in the manner specified in
the Schedules.
Item 1: repeals the current heading of Part 1 and inserts a new
heading which allows for the Act to be divided into Chapters.
Items 2
to 27 amend the definitions contained in subsection 3(1) of the Act and
insert some additional definitions.
Items 3, 6, 8, 9, 10, 12, 18, 21,
22, 23, 24, 25 & 27: insert a number of signpost definitions to certain
words and expressions that are defined, or the meaning of which can be
ascertained, elsewhere in the Act or Regulations. These are: application audit
assessment fee, composite pack, conformity assessment fee, conformity assessment
procedures, conformity assessment standard, essential principles, kind,
manufacturer, medical device, medical device classification, medical device
standard, refurbishment, system or procedure pack.
Items 5, 14, 15,
16, 19, & 26: make amendments to allow for renumbering required as a
result of restructuring the Act.
Other changes to definitions in
subsection 3(1):
Item 2: inserts a definition of
“accessory” (one intended by its manufacturer to be used in
conjunction with a medical device to enable the device to be used for its
intended purpose).
Item 4: inserts a definition of
“assessment fee” (a conformity assessment fee or an application
audit assessment fee).
Item 7: inserts a revised definition of
“conformity assessment certificate”. It has a different meaning for
the purposes of Chapter 3 and Chapter 4. The existing definition is retained
for the purpose of Chapter 3. For the purpose of Chapter 4 it means a
certificate issued under section 41EE.
Item 11: inserts a
definition of “device number” (any combination of numbers, symbols
and letters assigned to the device under section 41FL).
Item 13:
inserts a definition of “exempt device” (one exempted by the
regulations from the requirement under Division 3 of Part 4-11 to be included in
the Australian Register of Therapeutic Goods (the Register)).
Item
17: explains that “included in the Register” means included in
the Register under Chapter 4. It is an additional means of entry onto the
Register, distinct from registration or listing.
Item 20: amends
the definition of “manufacture” so that it does not apply to medical
devices. There is a new definition of ‘manufacturer’ in Chapter 4
which applies to medical devices.
Item 28: amends the definition
of “therapeutic goods” to make it clear that medical devices are
therapeutic goods.
Item 29: amends subsection 3(6) to insert a
reference to an annual charge for medical devices ‘included in the
Register’.
Item 30: inserts an explanation of
“efficacy” (performance as intended by the manufacturer) in relation
to devices.
Items 31 & 34: amends references to Parts of the
Act to allow for renumbering.
Item 32: makes it clear that medical
devices included in the Register are also covered by arrangements under section
6A.
Item 33: inserts new subsection 7(4) to clarify that a
declaration under section 7 that particular goods or classes of goods are not
therapeutic goods also means the goods are not medical devices.
Item
35: amends paragraph 7B(1)(c) to make it clear that a kit of therapeutic
goods under Chapter 3 cannot be a system or procedure pack of medical devices
that is regulated under Chapter 4.
Item 36: amends
paragraph 7B(2)(b) to make it clear that a composite pack of medicinal
therapeutic goods must not contain any medical devices.
Item 37:
as part of the restructuring of the Act, this provision inserts a new Chapter 2
(incorporating new sections 9A to 9E) which establishes the Australian Register
of Therapeutic Goods and provides for inspection and variation of the Register.
Section 9A: largely replicates repealed section 17. It provides
that, in addition to parts for registered and listed goods, the Register will
have a part for medical devices included in the Register under Chapter 4. The
Register may set out which goods are to be included in each part of the
Register, how goods can be transferred between parts, and how goods can be
assigned a different registration, listing, or device number. The Minister may
publish a Gazette notice requiring specified goods to be included in the part
for listed goods but the notice ceases to have effect if the regulations are
amended to require any of those goods to be included in the Register as listed
or registered goods.
Section 9B: provides for the cancellation of
registrations and listings of medical devices. Under the transitional
arrangements set out in section 15A, the registration or listing will be
cancelled either 2 or 5 years after commencement of Chapter 4, or on the date
the inclusion in the Register under Chapter 4 is effective, whichever occurs
first.
Sections 9C, 9D & 9E replace repealed sections 32 & 33.
Section 9C: provides that the Register is not open for public
inspection but a person in relation to whom therapeutic goods are entered on the
Register may make a written request for a copy of the entry in the Register in
relation to those goods and the Secretary must provide a copy or, if the person
requests, provide the copy on a data processing device or by electronic
transmission.
Section 9D: provides for variations to entries in
the Register. Depending on the circumstances some variations are obligatory. In
other cases, the Secretary has a discretion whether or not to vary an
entry.
Subsection 9D(4): provides for moving of entries to the
part of the Register for registered or listed goods where the goods are declared
not to be medical devices but are entered on the Register as
such.
Subsection 9D(5): inserts a definition of “product
information “ for the purposes of section 9D.
Section 9E:
requires the Secretary to publish a list of therapeutic goods in the
Register at least once every 12 months.
Item 38: is a transitional
provision providing that the first publication of lists of goods after the
amendment of the Act must not take place later than 12 months after the last
publication of the list under repealed section 33.
Item 39: as
part of the restructuring of the Act, this provision repeals the heading of Part
2 and inserts a new Chapter 3 heading dealing with therapeutic goods that are
not medical devices.
Item 40: provides for the change of title for
the entity now known as “Standards Australia International
Limited”.
Item 41: inserts a new section 10A, which provides
that a standard under section 10 does not apply to a medical device unless Part
3-2 applies to the device. Part 3-2 only applies to devices where section 15A
provides for it to apply (ie during the transition period).
Item
42: provides for the new heading - Part 3-2 covering registration and
listing.
Item 43: inserts new section 15A setting out the
transitional arrangements for application of the existing provisions of the Act
to medical devices during specified periods.
Subsection 15A(1):
provides that Part 3-2 (registration and listing of therapeutic goods) does not
apply to a medical device unless section 15A specifically provides that it does.
Subsection 15A(2): clarifies that Part 3-2 applies to a device if
it was registered or listed goods before Section 15A commenced, unless the
registration or listing is cancelled.
Subsection 15A(3): makes it
clear that Part 3-2 applies to a medical device if an application was made under
Part 3 for the registration or listing of therapeutic goods that included the
medical device before the commencement of section 15A and immediately before
that commencement, the application had not been finally determined or withdrawn.
Part 3-2 ceases to apply to the device if the goods have been registered goods
or listed goods and the registration or listing is
cancelled.
Subsection 15A(4): defines “finally
determined” for the purposes of paragraph 15A(3)(b).
Subsections
15A(5), (6), (7) and (8) set out other circumstances when Part 3-2 applies
to a medical device. Provision is made for some new medical devices (specified
in the regulations) to be the subject of an application for registration or
listing for up to 2 years after commencement of section 15A. Existing exempt
goods are also to be dealt with under Part 3-2 for 2 years after commencement.
Part 3-2 continues to apply to existing approvals and authorisations under
section 19 and new approvals and authorisations under section 19 for 2 years
after commencement.
Item 44: makes it clear that subsection 16(2)
(gazetted therapeutic goods group) does not apply to medical
devices.
Item 45: repeals existing section 17 which established
the Register, as the Register is now established under Chapter 2.
Item
46: is a savings provision which clarifies that any therapeutic goods that
were included in the Register immediately before these amendments are taken to
be included in the Register after their commencement.
Item 47:
provides that regulations providing for the payment of evaluation fees by
instalments may provide that such fees cannot be paid by instalment if certain
other fees are unpaid.
Items 48, 49, 50, 51, 52 & 53:
provide for renumbering as a consequence of the Act being restructured, in
sections 25, 26 and 26A.
Item 54: repeals sections 32 and 33
which deal with inspections and variations of the Register because these matters
are now provided for in section 9C and 9D.
Item 55: is a savings
provision that explains how requests for inspection or variation of the Register
that were made before these amendments commenced and were not dealt with, are to
be handled.
Item 56: to allow for the restructuring of the Act
this provision repeals the heading of Part 4 of the Act and substitutes the new
heading, “Part 3-3 – Manufacturing of therapeutic
goods”.
Item 57: inserts new section 33A which sets out when
Part 3-3 (manufacturing of therapeutic goods) applies to a medical device. Part
3-3 only applies where Part 3-2 (registration and listing) applies to the
device.
Item 58: renumbers existing section 42 as section 41A so
that there are enough 'vacant' section numbers to accommodate the new Chapter
4.
Item 59: inserts the new “Chapter 4 – Medical
devices” into the Act (incorporating new sections 41B to 41MQ).
This Chapter establishes the framework for the new harmonised regulatory
regime. It will apply to all therapeutic goods that are medical devices (except
those for which there are transitional arrangements in place for up to 5 years
following commencement of Chapter 4).
Part 4-1
Introduction
Part 4-1 provides an overview of the Chapter,
definitions and application provisions.
Section 41B: outlines the
purpose of Chapter 4 – to set out particular requirements for medical
devices, establish administrative processes mainly aimed at ensuring those
requirements are met and provides for enforcement through offences, to ensure
that medical devices are safe and perform satisfactorily.
Section 41BA: provides that the essential principles (about
the safety and performance characteristics of medical devices) and the
conformity assessment procedures (mainly about the application of quality
management systems) are the requirements for medical devices.
Section
41BB: summarises the administrative processes under Chapter 4.
Section 41BC: explains that the offences provisions in Part 4-11
are designed to ensure that the requirements for medical devices are complied
with and the administrative processes under Chapter 4 are
followed.
Section 41BD: defines what is a medical device. The
definition emphasises the importance of the manufacturer’s intended
purpose in determining whether something is a medical device. The amendment
clarifies that accessories to medical devices are medical devices in their own
right. Subsection (3) provides that the Secretary may publish an order in the
Gazette declaring articles not to be medical devices. They may still be
therapeutic goods to which the requirements under Chapter 3
apply.
Section 41BE: explains when a medical device is taken to be
of the same kind as another medical device. This definition allows different
types of medical devices to be grouped or dealt with separately by defined
characteristics depending on the level of risk associated with the use of the
device. For example, a range of low risk Class I products may be included in
the Register as one ‘kind’ of medical device whereas a high risk
Class III device may be included in the Register separately as a unique kind of
device. The regulations will prescribe the relevant characteristics for this
purpose.
Section 41BF: explains what a system or procedure pack is
and clarifies that it is a medical device.
Section 41BG: a
'manufacturer' is the person responsible for the design, production, packaging
and labelling of the device and under whose name the device is supplied. The
responsibility is mainly about applying an appropriate conformity assessment
procedure as specified in the Regulations. A manufacturer includes someone
carrying out specified activities in relation to ready-made products which are
to be supplied under the person’s own name but not someone (such as a
professional user) customising for an individual patient, a device supplied by
another person.
Section 41BH: explains what compliance with the
essential principles means. A device which complies with a medical device
standard is taken to comply with the essential principle or principles to which
that standard specifies that it relates.
Section 41BI: sets out
when a conformity assessment procedure is taken not to have been applied to a
medical device. Compliance with a conformity assessment standard when applying
a quality management system in the manufacture of a device will enable a
manufacturer to show application of a conformity assessment procedure but only
to the extent that the standard specifies that it relates to that
procedure.
Section 41BJ: sets out when Chapter 4 applies to
medical devices covered by the transitional arrangements in Part 3-2. A further
transitional arrangement is provided where an exemption under section 34
(manufacturing) applied before commencement of Chapter 4. In this case
specified provisions of Chapter 4 do not apply until 2 years after commencement
of Chapter 4.
Section 41BK: provides that Chapter 2 of the
Criminal Code, setting out the general principles of criminal responsibility,
applies to all offences against Chapter 4.
Section 41C: explains that the essential principles set out the
requirements relating to the safety and performance characteristics of medical
devices and that compliance with applicable medical device standards, whilst not
compulsory, is one way to establish compliance with the essential
principles.
Section 41CA: provides that the regulations may set
out requirements (essential principles) for medical
devices.
Subsection 41CB(1): provides that the Minister may
publish an order in the Gazette determining medical device standards for kinds
of medical devices and provides that the devices that comply with the standard
are to be taken to comply with those parts of the essential principles specified
in the standard.
Subsection 41CB(2): provides that the medical
device standard takes effect on the day the order is published or on a later day
specified in the order.
Subsection 41CB(3): provides that medical
device standards are disallowable instruments.
Section 41CC: sets
out the matters by reference to which a medical device standard may be
established. These may include: the safety or performance characteristics of
the devices, a monograph in the British, European or US Pharmacopoeia: a
monograph approved by the Minister for the purposes of subsection (1); a
monograph modified in a manner specified in the order; a standard published by a
standards organisation (defined in subsection (2)), or such other matters as the
Minister thinks fit.
Section 41CD: explains how inconsistencies
between medical device standards are to be dealt with and how standards are to
be applied in relation to a device consisting of component parts. In subsection
(1) a more specific standard applying only to some devices prevails over a more
general standard applying to a kind of device. In subsection (2) a standard
applying to a combination of component parts prevails over any standard applying
to particular component parts.
Section 41D: explains that Part 4-3 deals with conformity
assessment procedures which set out the requirements relating to the application
of quality management systems for medical devices and other requirements imposed
on manufacturers. To show compliance with applicable conformity assessment
standards is one way to establish that part of the conformity assessment
procedures have been applied to medical devices.
Section 41DA:
provides that the regulations may specify requirements (conformity assessment
procedures) relating to the obligations of manufacturers of medical devices. The
procedures may apply to one or more medical device classifications or apply
differently to different medical device classifications, different kinds of
medical devices or different manufacturers.
Subsection 41DA(4):
sets out certain matters that the conformity assessment procedures may relate
to.
Section 41DB: provides that the regulations may specify
medical device classifications applying to medical devices or kinds of medical
devices and also specify matters in relation to classifications of medical
devices or kinds of medical devices. A medical device classification allows the
manufacturer to select an appropriate conformity assessment procedure and is
also used for determining what constitutes a kind of medical device for the
purpose of inclusion in the Register. The regulations will set out the
classifications based on levels of risk, the principles for applying the
classification rules and the rules for classifying devices.
Section
41DC: provides that the Minister may, by order in the Gazette, determine a
conformity assessment standard for specified quality management systems and the
standard may be limited to particular kinds of medical devices. The order takes
effect on the day of publication or later day specified in the order and is a
disallowable instrument. Compliance with a standard is treated as application
of the parts of the conformity assessment procedures specified in the
standard.
Section 41DD: sets out by reference the matters to which
a section 41DC order may be specified.
Section 41DE: sets out
how inconsistencies between conformity assessment standards are to be resolved.
A conformity assessment standard applying to particular kinds of medical devices
prevails over one applying generally to quality management systems.
Section 41E: explains what Part 4-4 is about: the Secretary can
issue a conformity assessment certificate in respect of a manufacturer of
medical devices indicating that the relevant quality management systems have
been applied; that the device complies with the essential principles; that other
certification requirements of the conformity assessment procedures have been
met. The conformity assessment certificate may be limited to some only of the
manufacturer’s medical devices.
Section 41EA: the
regulations may prescribe that conformity assessment certificates are required
by certain kinds of manufacturers or in respect of certain kinds of medical
devices before devices can be included in the Register. This provision enables
particular high risk devices, such as those that are highly invasive or sourced
from animal tissues, to be fully assessed by the TGA before they are marketed in
Australia. High risk devices can be targeted for examination by being
identified in the regulations as devices in respect of which a TGA conformity
assessment certificate must be issued. Prescription in the regulations in this
manner provides for administrative flexibility in the scrutiny of devices by
allowing changing technologies and high risk devices to be
accommodated.
Section 41EB: sets out the requirements for making
an application for a conformity assessment certificate. An application will not
be effective if the prescribed application fee is not paid or the application
contains false or misleading information. It also provides that the Secretary
may require an applicant to allow an authorised person to inspect the premises
(including premises outside Australia) and equipment, processes and facilities
that are being or will be used to manufacture the medical devices and any other
kind of medical devices on those premises.
Section 41EC: sets out
what the Secretary must consider in determining an application for a conformity
assessment certificate.
Section 41ED: sets out the timeframe for
considering applications involving examination of the design of medical devices.
A decision must be made within the period prescribed in the regulations.
Neither the Commonwealth, Secretary nor a delegate of the Secretary is liable
for any loss, damage or injury if the application is not decided within the
timeframe.
Section 41EE: sets out the procedure to be followed
after a decision has been made on the application for conformity assessment
certificate and, where a decision has been made to issue a certificate, what a
certificate must specify.
Section 41EF: sets out how the
commencement and duration of a certificate can be determined.
Section
41EG: sets out the situations in which an application for a conformity
assessment certificate will lapse. These include a failure to provide requested
information or samples, provision of false or misleading information, and
failure to allow an inspection or to pay outstanding assessment
fees.
Section 41EH: if a period has been prescribed for
making a decision on applications for conformity assessment certificates
involving examination of the design of medical devices and the decision has not
been notified to the applicant at the end of that period, at any time before the
decision is notified, an applicant can give the Secretary notice that the
application is to be treated as having been refused.
Such a notice has
effect as if the Secretary had decided not to issue the conformity assessment
certificate and the Minister had reviewed the decision and confirmed the
Secretary’s decision on the day notice was given to the
Secretary
Section 41EI: provides a maximum penalty of 60 penalty
units for knowingly making a statement that is false or misleading in a material
particular in connection with an application for a conformity assessment
certificate. This penalty is less than the penalty for making false or
misleading statements in an application for entry onto the Register (s41FE). In
the former case, the risk is much less of the false or misleading information
resulting in a successful application. TGA has a greater opportunity to assess
information about conformity assessment than it does in respect of information
submitted via the electronic lodgement process with respect to applications for
entry onto the Register. The latter applications are, to some extent,
predicated on self-evaluation.
Section 41EJ: sets out the
conditions to which the issue of a conformity assessment certificate is
automatically subject. These include: inspection of premises (including
overseas premises) and medical devices, taking samples of devices, carrying out
tests on the devices and procuring documents including documents relating to the
manufacturer’s quality management system (subsection (1)); review to
determine whether the conformity assessment procedures relating to specified
matters have been applied to the kinds of medical devices covered by the
certificate (subsection (2)); the person in respect of whom the certificate is
issued notifying the Secretary of planned substantial changes to quality
management systems, product range or product design (subsection (3)); and, the
applicant paying a fee (prescribed in the regulations) for review (subsection
(4)). The level of fees may vary for different kinds of manufacturers and
medical devices (subsection (5)).
Entry and inspection of premises under
a condition on the manufacturer's conformity assessment certificate will be
conducted by authorised persons in accordance with Part 6-2 (previously Part 5A)
of the Act. This power is necessary to check compliance with the requirements
of the Act and regulations and to determine whether any offences have been
committed which might seriously endanger public health. A similar power already
exists in subsection 40(4) of the Act.
Other conditions: the Secretary
may, in respect of kinds of medical devices or the manufacturer’s quality
management system, impose additional conditions on a certificate when it is
issued (section 41EK) and after it has been issued. The latter conditions may be
imposed on the Secretary’s initiative or at the request of the applicant.
The Secretary may also vary or remove conditions (section 41EL).
A
condition imposed or varied under section 41EL takes effect, if it is necessary
to prevent imminent risk of death, serious illness or injury, on the day the
notice is given or otherwise not earlier than 20 working days after the notice
is given.
Section 41EM: gives the Secretary power to suspend a
certificate, for not more than 6 months, if he or she is satisfied that it is
likely that there are grounds for revoking the certificate under section 41ET.
The suspension may be in respect of some only of the medical devices covered by
the certificate.
Section 41EN: unless a suspension is to prevent
imminent risk of death, serious illness or injury, a person must be given notice
of a proposed suspension and a reasonable opportunity to make a submission to
the Secretary about it.
Section 41EO: sets out when a suspension
takes effect and the duration of a suspension. If a person can show that he has
taken steps to remove the grounds for a revocation of the certificate, the
Secretary can extend the suspension for one further period not exceeding 6
months (subsection (3)).
Section 41EP: provides that the Secretary
must revoke a suspension when the grounds for suspension no longer apply and
there are no other grounds for suspending. It also gives the Secretary a
discretion to revoke a suspension of his own initiative or on application by the
manufacturer or the person who applied for the certificate. Notice of the
decision on the revocation must be given within 20 working days.
Section 41ER: provides for automatic revocation of a certificate
where the certificate has been suspended and the period applying to the
suspension expires before the suspension is revoked under section
41EP.
Section 41ES: provides that the Secretary may revoke a
certificate if the manufacturer requests its revocation.
Section
41ET: sets out the situations under which the Secretary may revoke a
conformity assessment certificate after having first given notice of the
proposed revocation. These are: if conformity assessment procedures have not
been applied to medical devices of a kind to which the certificate applies; if
the manufacturer refused or failed to comply with a condition to which the
certificate is subject; if the Secretary gives a section 41JA notice requiring
certain information or documents and the recipient does not comply within an
additional 10 working days of the date specified in the section 41JA notice; if
the manufacturer no longer manufactures any of the kind of medical devices to
which the certificate relates. Subsection (2) in effect, accords the person
natural justice in that he or she must be given a reasonable opportunity to make
submissions on a proposed revocation and the Secretary must take the response
into account before making a decision about revocation.
Section
41EU: provides for a revocation to be limited to some of the kinds of
medical devices or to some medical devices of the kinds to which the certificate
applies in appropriate circumstances, and for the certificate to be varied
accordingly.
Section 41EV: the revocation or variation of a
conformity assessment certificate must be gazetted.
Section 41EW:
sets out when revocations or variations of conformity assessment certificates
take effect - on the day of notification where the revocation or variation
results from expiry of a suspension period or is requested by the manufacturer,
otherwise on a later day specified in the notice.
Section 41F: explains that under Part 4-5 kinds of medical devices
can be included in the Register if they meet requirements. The inclusion is
subject to certain conditions.
Section 41FA: explains that kinds
of medical devices are included in the Register automatically after a proper
application has been made unless the application is selected for
checking.
Section 41FB: is a diagram explaining the application
process for inclusion of devices in the Register.
Section 41FC:
sets out what is considered to be an effective application for including a kind
of medical device in the Register. The application must be in the approved form,
with the prescribed application fee and, where required by the regulations, a
valid conformity assessment certificate, and must not contain false or
misleading information. Provision is also made for an application to be made
using an electronic lodgement process.
Section 41FD: sets out
matters an applicant must certify when making an application. The applicant must
certify the intended purpose for the device and that the device meets the
requirements of the Act and regulations including the essential principles and
conformity assessment procedures. The applicant must have available sufficient
information to substantiate compliance with the requirements or have procedures
in place to ensure that such information can be obtained from the manufacturer
within the prescribed period. These procedures are to include a written
agreement with the manufacturer which covers the matters set out in the
regulations.
Section 41FE: provides that a person commits an
offence if the person makes a statement (either orally, in a document or in any
other way) that is in connection with an application for including a kind of
medical device on the Register under Chapter 4 or certification or purported
certification under section 41FD and the person knows that the statement is
false or misleading in a material particular. The penalty of 400 penalty units
is provided for because use of an electronic lodgement process for applications
means that the ability for TGA to check the veracity of the information in the
application is significantly reduced. Deception which results in the improper
inclusion of devices on the Register or certification of a faulty or dangerous
medical device could pose a significant threat to public health and safety. The
penalty is significantly higher than the Criminal Code 60 penalty unit maximum
fine for the ‘false or misleading statement’ offence. However, the
focus of the Criminal Code offence is loss of revenue. The 400 penalty unit
fine is also in line with the penalty for deception in registering therapeutic
goods under section 22A of the Act.
Section 41FF: provides that if
an applicant makes an effective application and certifies those matters required
by section 41FD, the kind of device must be included in the Register unless the
application has been selected for audit under section 41FH. The applicant is
issued with a certificate which specifies the date inclusion in the Register
commences. The applicant must be notified within 20 working days if an
application is unsuccessful (section 41FG).
Section 41FH: provides
that those applications of a kind prescribed in the regulations must always be
selected for auditing. All other applications may be audited at the Secretary's
discretion. Applicants must be notified of the selection within 20 working
days.
Section 41FI: sets out what may be considered in auditing an
application. The application may be checked to see whether it is in the approved
form and whether the matters certified by the applicant under section 41FD are
correct. If the Secretary is satisfied on all aspects of the audit the goods
must be included in the Register; if not satisfied, the goods must not be
included in the Register.
Section 41FJ: sets out the procedure
following an audit: the Secretary must notify the applicant of the decision
within 20 days after it is made; if the kind of device is not to be included in
the Register, reasons for the decision must be provided; and, if it is to be
included, and all outstanding assessment fees have been paid, include the
kind of the device in the Register and give the applicant a certificate of
inclusion.
Section 41FK: applications selected for audit lapse if
the applicant does not provide such information that will allow the audit of the
application, does not provide a reasonable number of samples of the kind of
medical device as required, fails to provide information required under section
41JA, if information given by or on behalf of the applicant is false or
misleading or if all assessment fees have not been paid within the period
specified in the regulations.
Section 41FL: requires the
Secretary to assign a unique device number to a kind of medical device included
in the Register.
Section 41FM: the inclusion of a kind of medical
device in the Register commences on the day specified in the certificate of
inclusion and has effect until the kind of device is suspended or
cancelled.
Section 41FN: sets out conditions to which the
inclusion of a kind of medical device on the Register is automatically subject.
These include to: allow entry and inspection; deliver samples on request; not
advertise devices for purposes inconsistent with their intended purpose; and,
have available sufficient information or be able (within the prescribed period)
to obtain access to information from the manufacturer to: substantiate
compliance with the essential principles, show that the conformity assessment
procedures have been applied to the kind of medical device or identify changes
to the device, product range or quality management system. The sponsor has an
ongoing obligation to provide the Secretary with such information on request and
to provide information on adverse effects, as well as provide specified
information to the manufacturer. The regulations may prescribe the amount,
standard or kind of information or evidence to be required (subsection
(4)).
Entry and inspection of premises under this condition on the
sponsor's inclusion of a device in the Register will be conducted by authorised
persons in accordance with Part 6-2 (previously Part 5A) of the Act. This power
is necessary to check compliance with the requirements of the Act and
regulations and to determine whether any offences have been committed which
might seriously endanger public health. A similar power already exists in
subsection 28(5) of the Act.
Section 41FO: apart from those
conditions imposed automatically, the Secretary may impose additional conditions
on the inclusion of a kind of device in the Register which relate to:
manufacture of devices of that kind; custody, intended purpose, supply, disposal
or destruction of devices of that kind; keeping of records, including records
relating to the tracking and location of devices after their supply; and,
matters relating to the essential principles or such other matters as the
Secretary thinks fit.
Section 41FP: after inclusion of a kind of
medical device in the Register, the Secretary may, at the request of the person
in relation to whom the kind of medical device is included in the Register or at
the Secretary’s own initiative, by written notice impose new conditions or
vary or remove existing conditions. If the new condition or variation is
necessary to prevent imminent risk of death, serious illness or serious injury,
the notice takes effect on the day it is given to the person. Otherwise it
takes effect on the day specified in the notice which cannot be earlier than 20
days after the notice has been given to the person.
Part 4-6
Suspension & cancellation from the Register
Section 41G:
explains that this part is about the suspension and cancellation of medical
devices that have been included in the Register.
Section 41GA: the
Secretary may suspend (for a specified period not exceeding 6 months) a kind of
medical device included in the Register if the Secretary is satisfied that there
is a potential risk of death, serious illness or serious injury from continuing
supply of the kind of device and it is likely that, within the period of
suspension, the person will be able to take the necessary action to ensure that
those potential risks are removed. Suspension may be used when there is early
scientific evidence to demonstrate a correlation between the supply of a kind of
medical device and a risk of death, serious illness or serious injury, but
causality has not been determined. The Secretary may also suspend a kind of
device from the Register if he or she is satisfied that there are grounds for
cancelling the entry of the kind of device from the Register (other than under
41GL(a) (cancellation for imminent risk of death, serious illness or serious
injury), 41GL(d) (person has requested cancellation), or section 41GM
(cancellation for non-compliance with a request to provide information for the
purpose of ascertaining whether the device should have been on the Register)).
The suspension may be limited to some medical devices only of the kind.
As soon as possible after the suspension, the Secretary must publish in the
Gazette a notice setting out the particulars of the
suspension.
Section 41GB: if suspension is being considered
because there are likely grounds for a cancellation after notice under section
41GN, the Secretary must inform the person of the proposed suspension and the
reasons for it and give the person an opportunity to respond. The Secretary
must take the person’s response into account before
suspending.
Section 41GC: a suspension made because it is
necessary to prevent a potential risk of death, serious illness or serious
injury takes effect on the day the notice is given. In any other case, not
earlier than 20 working days after the notice is given. A suspension has effect
until revoked or until the end of the period specified in the notice or until
the expiration of any extension to the period of
suspension.
Subsection 41GC(3): if a person can show he or she has
taken steps to remove the grounds for cancelling the entry, the Secretary may
extend the period of suspension for one further period not exceeding 6 months
and publish a notice of the extension in the Gazette.
Section
41GD: provides that the Secretary must revoke a suspension when the grounds
for suspension no longer apply and there are no other grounds for suspending.
The Secretary has a discretion to revoke a suspension of his own initiative or
on application by the person in relation to whom the kind of medical device is
included in the Register. Notice of the revocation must be given to the person
within 20 working days and be notified in the Gazette as soon as practicable.
If the Secretary decides not to revoke a suspension, he must (within 20
working days) give notice of the decision, including reasons for
it.
Section 41GE: if a period has been prescribed for considering
applications for revocation of a suspension and the decision has not been made
at the end of that period, at any time before the decision is made an applicant
can give the Secretary notice that the application is to be treated as having
been refused. Such a notice has effect as if the Secretary had decided not to
revoke the suspension and the Minister had reviewed the decision and confirmed
the Secretary's decision on the day notice was given to the
Secretary.
Section 41GF: provides the Secretary with a discretion
to suspend a kind of device, or some devices of that kind, from the Register
where a relevant conformity assessment certificate has been suspended under Part
4-4. Notice of the suspension is to be published in the Gazette and is
effective from the day on which notice is given to the person until revocation
of the notice (section 41GG). If the suspension of the conformity assessment
certificate ceases to have effect and there are no other grounds for suspension,
the suspension of the Register entry must be revoked and the person notified
within 20 working days. A notice of the revocation must also be published in
the Gazette (section 41GH).
Section 41GI: makes it clear that
suspension has the effect of treating devices as not being included in the
Register whilst the suspension has effect. However, suspended devices are still
treated as being included with respect to the conditions of entry on the
Register, the provisions dealing with suspension and the Secretary's powers to
obtain information.
Section 41GJ: makes it clear that the
Register entry may still be cancelled despite its being
suspended.
Sections 41GK to 41GN set out ways in which an entry may be
cancelled from the Register - automatically, immediately or after
notice.
Section 41GK: provides for the automatic cancellation of
an entry from the Register where a period of suspension expires (and the
suspension has not been revoked) or a conformity assessment certificate relevant
to the entry has been revoked.
Section 41GL: provides the
Secretary with a discretion to cancel immediately an entry in a number of
circumstances including where: there is an imminent risk of death, serious
illness or serious injury if supply of the devices continues, the entry covers a
product which is no longer a medical device or therapeutic goods, the person
requests cancellation, there has been a false or misleading statement leading to
the entry, the annual charges are unpaid, there has been non-compliance with a
direction or requirement relating to the Advertising Code, and where there is a
serious breach of the advertising regulations.
Cancellation may be used
when there is scientific evidence to demonstrate both a correlation between the
supply of a kind of medical device and a risk of death, serious illness or
serious injury, and causality has been determined.
Section 41GM:
provides for cancellation of an entry where the Secretary has requested
information under section 41JA for the purpose of ascertaining whether the kind
of device should have been included in the Register or is still being supplied
in Australia, and the information has not been provided within 10 working days
of the time specified in the section 41JA notice or the information confirms the
devices are no longer being supplied.
Section 41GN: provides for
cancellation of an entry after notice of the proposed cancellation where: the
devices have changed kind, there is a failure to comply with conditions of entry
on the Register or a section 41JA notice requesting information (other than
notices covered under section 41GM), adverse events are not reported, the safety
or performance of the device is unacceptable, or a certification under section
41FD is found to be incorrect. The person is to be given a reasonable
opportunity to respond to the notice before a decision is made on the
cancellation.
Section 41GO: provides that the cancellation of the
entry from the Register is to be limited to some medical devices of a kind
covered by the entry where the grounds for cancellation apply to some only of
that kind and the Register entry is to be varied accordingly. Details of the
cancellation are to be published in the Gazette (section
41GP).
Section 41GQ: provides that the cancellation is effective
on the date notice is given where the cancellation is automatic or immediate
and, in other cases, on the date specified in the notice, which must be at least
20 working days after notice is given.
Part 4-7 - Exemptions from
inclusion in the Register
Section 41H: explains that this Part
is about three types of exemptions from inclusion in the Register - by
regulation, by approval of the Secretary and by authorisation of particular
medical practitioners.
Section 41HA: provides for regulations to
be made exempting medical devices or specified kinds of medical devices from the
requirement that they be included in the Register. Exemption may be subject to
prescribed conditions or in respect of prescribed classes of persons.
Section 41HB: provides for the Secretary to approve applications
from a person to import, export or supply devices not included in the Register
for use in the treatment of another person or for use for experimental purposes.
The approval may be subject to conditions specified by the Secretary as well as
conditions prescribed in the regulations. Conditions may also be prescribed for
use of a device for experimental purposes by a person who is not the person to
whom the approval has been granted (subsection (7)). Applications must include
such information about the device as is required by the Secretary and, where the
device is to be used for experimental purposes, be in writing and accompanied by
the prescribed fee (subsections (4) & (5)).
Section 41HC:
provides for the Secretary to authorise medical practitioners (but only
those specified in regulations made under subsection (4)) to supply specified
kinds of devices for use in treating a specified class of recipients. The
authority may be given subject to conditions. Subsection (4) makes it clear that
only medical practitioners with ethics committee approval may be authorised
unless the regulations prescribe exceptional circumstances when this requirement
does not apply. The regulations may also prescribe circumstances in which
devices may be supplied under an authority.
Part 4-8 - Obtaining
information
Section 41J: explains that the Secretary may seek
information or documents relating to various matters involving administration of
the Act.
Section 41JA: provides that the Secretary's power to
issue a notice requiring information relating to compliance with the
requirements of the Act and other matters extends to persons who are applicants
for, or holders of, a conformity assessment certificate and to those who are
applicants for a device to be, or in whose name a device is, included in the
Register. The power to require information extends to persons who previously had
a device included in the Register in their name during the period set out in
subsection (2). The notice must specify the day and form in which the
information is to be provided, and the specified day must be at least 10 working
days from the date notice is given (section 41JB(1)).
Section
41JB: makes it an offence to fail to comply with a notice under section 41JA
or to give information that is false or misleading in response to such a
notice.
Section 41JC: provides that a person cannot refuse to
respond to a request for information on the grounds of self-incrimination but
any information given in response to such a notice cannot be used in criminal
proceedings against the person, except proceedings relating to section
41JB(4).
Sections 41JD to 41JI: enable the Secretary to require
information that will assist the Secretary to establish whether the use and
handling of medical devices covered by exemptions meet acceptable standards,
including regulatory requirements of the Act and
regulations.
Subsection 41JD: provides that where devices are
exempted from inclusion in the Register under section 41HA of the Act, the
Secretary may, by notice in writing, require the sponsor of the devices to
provide specified information or documents relating to the supply and handling
of those devices, monitoring of the supply, the results of the supply and any
other prescribed matter.
Subsection 41JD(2): provides that where
devices are exempted under section 41HA in accordance with the regulations, the
Secretary may require the medical practitioner who signed a statement in
accordance with those regulations, to provide information relating to the
condition of the patient, the supply and handling of the device, the monitoring
and results of the supply and any other prescribed matter.
Subsection
41JE(1): enables the Secretary, by notice in writing, to require the person
to whom an approval is granted under section 41HB to give the Secretary
information relating to the supply, handling, monitoring of the supply, results
of the supply of the devices and any other prescribed matter.
Subsection 41JE(2): provides that where an approval is granted
under section 41HB to a particular person for experimental use, but another
person uses the devices for the purposes of carrying out or conducting the
experiment, the Secretary may require, by notice in writing, that other person
to provide information about the use of the devices and any other prescribed
matter.
Section 41JF: enables the Secretary to require, by notice
in writing, a medical practitioner to whom an authority has been granted to
supply specified unapproved devices under section 41HC, information relating to
the supply, handling, monitoring of the supply, results of the supply of the
devices and any other prescribed matter.
All notices under sections 41JD,
41JE, and 41JF must specify a reasonable period (which must be at least 10
working days) within which the information must be provided.
Sections
41JG & 41JH: make it an offence to fail to comply with a notice under
section 41JD, 41JE, or 41JF or, in relation to such a notice, to give
information that is false or misleading or omit any matter without which the
information is misleading.
Section 41JI: also makes it an offence
to knowingly produce a false or misleading document in response to a notice
under section 41JD, 41JE, or 41JF. No offence is committed if the false or
misleading document is accompanied by a written statement stating that the
document is, to the knowledge of the person signing the statement, false or
misleading in a material particular and that material particular is identified
in the statement.
Section 41JJ: provides that a person cannot
refuse to respond to a request for information on the grounds of
self-incrimination but any information given in response to such a notice cannot
be used in criminal proceedings against the person, except proceedings relating
to section 41JH or 41JI.
Part 4-9 - Public notification and recovery
of devices
Section 41K: explains that this Part is about the
recovery and public notification of medical devices which do not comply with the
requirements of the Act.
Subsection 41KA(1): provides that the
requirements set out in subsection (2) may be imposed on various specified
persons where devices (including in some cases those to which exemptions apply)
have been supplied which do not comply with the essential principles, where the
conformity assessment procedures have not been applied, where the device is not
included in the Register nor the subject of an exemption from inclusion, and
where a device has been suspended or cancelled from the Register.
Subsection 41KA(2): the requirements are recovery of distributed
devices (except those which have been administered or applied to a patient) and
public notification in a specified manner and period. One or both requirements
may be imposed. Recovery may be limited to only those devices to which the
circumstances in subsection (1) apply (subsection (3)).
Section
41KB: a notice setting out any requirements imposed under section 41KA is to
be published in the Gazette.
Section 41KC: creates an offence for
failure to comply with the requirements imposed under section
41KA.
Section 41KD: provides that the Secretary may still suspend
or cancel an entry on the Register despite the imposition of a requirement under
section 41KA.
Part 4-10 - Assessment fees
Section 41L:
explains that this Part is about two types of assessment fee, those for
considering an application for a conformity assessment certificate, and those
for auditing particular applications for entry on the
Register.
Section 41LA: creates an obligation to pay assessment
fees in accordance with the regulations. These fees are payable in accordance
with the requirements set out in the regulations.
The regulations may
specify a conformity assessment fee for consideration of an application for a
conformity assessment certificate and these fees may be prescribed at different
levels in relation to different kinds of manufacturers or devices and in respect
of different parts of the conformity assessment procedures that need to be
considered in relation to an application (subsections (1) and (2)).
The
regulations may also specify an application audit assessment fee for auditing of
an application for inclusion of a kind of device in the Register. Application
audit assessment fees are only payable in respect of audits of applications of a
type which are prescribed in the regulations (under paragraph 41FH(1)(a)) as
ones which the Secretary must always select for auditing). No assessment fee is
payable in respect of applications that the Secretary has a discretion to audit
(under paragraph 41FH(1)(b)). Application audit assessment fees may also be
prescribed at different levels but are only payable in respect of considering
whether the application is in the approved form and whether the matters
certified by an applicant under section 41FD are correct (subsections (4) and
(5)).
Section 41LB: specifies that assessment fees are
due for payment on the day and in the manner specified in the
regulations.
Section 41LC: provides for the payment of assessment
fees by instalments in accordance with the regulations. The regulations may
provide that assessment fees cannot be paid by instalment if certain other fees
are unpaid.
Section 41LD: provides that assessment fees may be
recovered as a debt due to the Commonwealth.
Section 41LE:
provides for the reduction of a conformity assessment fee where a decision on an
application for a conformity assessment certificate is not made within the
period prescribed in the regulations. This provision only applies where
consideration of the application involves the examination of the design of
medical devices. The applicant in such cases is not required to pay more than
3/4 of the conformity assessment fee before the decision is made on the
application. The remaining fee is payable on notification of the decision to
the applicant but if the decision is not notified within the prescribed period
the remaining fee does not become payable.
Part 4-11 - Offences
relating to medical devices
Section 41M: explains that Part
4-11 contains offences that are aimed at ensuring that the essential principles
are complied with; the conformity assessment procedures have been applied to
kinds of medical devices; and, that administrative processes established by
Parts 4-4 to 4-9 are followed.
Section 41MA: makes it an offence
for a person to import into, supply for use in, export from Australia a medical
device if the medical device does not conform with the essential principles and
the Secretary has not consented to the importation, supply or exportation.
Imported devices need not comply with labelling requirements until the time of
supply in Australia. Devices which are exported are exempt from Australian
labelling requirements. Subsection 41MA(5) provides that the Secretary must not
consent to the exportation of a device that does not comply with the essential
principles unless there are exceptional circumstances that justify giving
consent.
Section 41MA imposes a maximum penalty of 240 penalty units,
recognising the significant threat to public health and safety where there are
dealings in medical devices which do not meet the fundamental safety and
performance requirements prescribed in the essential
principles.
Section 41MB: provides that no offence will be
committed where it can be shown that the device complies with a medical device
standard. However, the standard must be relevant to the part or parts of the
essential principles which have not been met (the standard must specify the
relevant part or parts of the essential principles which will be met by
application of the standard).
Subsection 41MC(1): provides that
the Secretary's consent to import into, supply in or export from Australia a
medical device may be given unconditionally or subject to conditions, or in
respect of particular medical devices or kinds of medical
devices.
Subsection 41MC(2): makes it an offence for a person to
do, or fail to do, an act that constitutes a breach of a condition of the
Secretary's consent.
Section 41MD: provides that devices which do
not comply with the essential principles and whose non-compliance has not been
consented to by the Secretary, may be treated as prohibited imports or
prohibited exports under the Customs Act 1901.
Section
41ME: makes it an offence for manufacturers to supply or export a medical
device to which the conformity assessment procedures have not been applied.
Similar offences are provided in section 41MF where a sponsor supplies or
exports under these circumstances. However, no offence will be committed where
it can be shown that the quality management system applied to the device
complied with a relevant conformity assessment standard, and the standard itself
specified that it can be used for the purpose of showing application of the
conformity assessment procedures in question (s41MG).
The maximum
penalty for an offence under s41ME or s41MF is 240 penalty units, which is the
same penalty as for an offence under section 41MA. This is because the
consequences flowing from a breach of s41MA, 41ME or 41MF are similar. Breach
of these requirements constitute a significant threat to public health and
safety.
Section 41MH: provides that a person commits an offence if
the person has manufactured a medical device and the person makes a statement in
or in connection with a declaration about application of the conformity
assessment procedures to the device and the statement is false or misleading in
a material particular.
As for the similar offence in section 41FE, the
penalty of 400 penalty units is provided for because deception which results in
the improper declaration and certification of a faulty or dangerous medical
device could pose a significant threat to public health and safety. It is
significantly higher than the Criminal Code 60 penalty unit maximum fine for the
'false or misleading statement' offence. However, the focus of the Criminal
Code offence is loss of revenue rather than public safety. This penalty is also
in line with the penalty for deception in registering therapeutic goods under
section 22A of the Act.
Section 41MI: makes it an offence if a
person imports into, exports from, manufactures or supplies in Australia a
medical device that is not entered in the Register in the person's name or is
not an exempt device or one which is the subject of an approval under section
41HB or an authority under section 41HC. If the defendant proves that he or she
was not the sponsor of the device at the time of the importation, exportation,
manufacture or supply, the defendant has not committed this
offence.
Section 41MI imposes a legal burden on a defendant to prove that
he or she is not a sponsor of the particular device. An evidential burden would
not address the problems experienced by the Therapeutic Goods Administration
prior to 1996 which led to an amendment to section 20 of the Act. The
imposition of a legal burden on the defendant under section 41MI in relation to
devices brings this provision into line with the existing section 20 offence
(which will continue to apply to medicines and other therapeutic goods).
Prosecutions in relation to offences regarding illegal supply of therapeutic
goods should all be dealt with in a similar manner.
This offence
recognises the gravity of any unlawful actions that may be taken by those
persons who are subject to regulation. It is a key provision because if devices
are supplied without being entered on the Register they have not been subject to
any TGA scrutiny, thus potentially jeopardising public health. Without being
able to establish who the sponsor is, charges cannot be laid under the Act. It
is difficult for the Crown to prove a person is a sponsor or to show, among
other things, that there is no agency relationship, a fact peculiarly within the
knowledge of the sponsor. This is the reason for placing the legal burden on
the defendant. The initiation of prosecutions for unapproved supply of devices
is a crucial part of the new devices scheme. There is a need for strong
deterrents against illegal (and potentially dangerous) supply and a real
prospect of being caught and of successful prosecution for those breaking the
law. Section 13.4 of the Criminal Code recognises this need to have a reversal
of the legal burden in some situations and section 41MI is an example of such a
situation.
Section 41MJ: allows the Secretary to have devices
which are prohibited devices under section 41MI made prohibited imports or
prohibited exports under the Customs Act 1901.
Section
41MK: creates an offence for wholesale supply of devices not entered in the
Register, exempt or subject of an approval under section 41HB or an authority
under section 41HC.
Section 41ML: creates an offence for
misrepresenting the status of devices in relation to the Register and for a
sponsor advertising devices for a purpose other than that for which they were
accepted for inclusion in the Register.
Section 41MM: creates an
offence for making a claim that supply can be arranged of devices that are not
included in the Register or exempt devices.
Section 41MN: creates
an offence for breaching a condition of inclusion in the Register, a condition
of a conformity assessment certificate, a condition of an exemption under
section 41HA or a condition of an approval for special and experimental uses
under section 41HB.
Subsection 41MO(1): creates an offence for
medical practitioners granted authority under section 41HC, supplying a medical
device in breach of that authority or in breach of any conditions or regulations
to which the authority is subject.
Subsection 41MO(2): creates an
offence for persons granted approvals under section 41HB to use a device in a
way that is not in accordance with the approval.
Section 41MP:
creates an offence for a person in relation to whom a device is included in
the Register failing to provide (within the prescribed period) specified
information about adverse events relating to the device when the person becomes
aware of such information. Subsection (2) specifies the relevant kinds of
information which must be provided to the Secretary. It will not be a defence
that the person has already notified information relating to the same matter.
For example, there is an obligation to notify separate adverse incidents
relating to the same device, not just the first of such incidents of which the
person becomes aware.
A penalty of 400 penalty units is provided because
of the high risk to public health and safety if sponsors of devices do not bring
to the TGA's notice information they have which may indicate that a device is
dangerous and may cause serious harm or death to a patient or user. Reporting
of adverse events and deficiencies of medical devices is a key part of TGA's
post-market surveillance strategy designed to ensure ongoing safety and
performance of devices after they have been included on the
Register.
Section 41MQ: It is an offence to fail to comply with a
notice from the Secretary to provide information about adverse events of the
kind specified in section 41MP(2), the notice being given where an application
for including a device in the Register is withdrawn or lapses. It is also an
offence to provide false or misleading information in response to such a notice.
As for section 41MP, the penalty is 400 penalty units, recognising the gravity
of the consequences in having potentially defective or sub-standard devices
available to the public.
Further amendments to the
Act:
Items 60, 61 & 62: as part of the restructuring of
the Act, repeal the headings of Parts 4A, 4B and 4C and replace them with the
revised headings as part of new Chapter 5, which deals with advertising,
counterfeit therapeutic goods and product tampering.
Item 63:
makes it clear that the Secretary’s powers of suspension
and revocation under Chapter 4 are not affected by the operation of section
42V.
Item 64: as part of the restructuring of the Act, repeals the
heading of Part 5 and replaces it with the new heading, “Chapter 6 –
Administration.”
Items 65 and 66: make it clear that the
person in relation to whom a device is included in the Register is responsible
for the annual charge.
Item 67: extends the operation of section
44 (time for payment of charges) to an annual charge for inclusion of a device
in the Register.
Items 68 and 69: make it clear that an annual
charge is payable for inclusion of a device in the Register.
Item
70: makes it clear that the day on which an annual charge for inclusion in
the Register is due, can be varied.
Item 71: makes it clear that
amounts equal to amounts received for annual charges for inclusion in the
Register must be transferred to the Consolidated Revenue Fund.
Items
72, 77, 78 & 79: as part of the restructuring of the Act, amend the
numbering of Parts 5A, 5B, 5C and 6 of the Act.
Item 73: makes it
clear that the power of an authorised person to enter premises extends to the
premises of a person granted approval to import into, export from and supply in
Australia medical devices for special and experimental purposes and to medical
practitioners authorised to supply medical devices for use in the treatment of
humans or a specified class of humans.
Items 74 & 75: extends
the operation of section 46A (power to search premises) to premises of persons
in relation to whom goods are included in the Register.
Item 76:
extends the type of premises that can be searched to those in respect of which a
conformity assessment certificate has been issued.
Items 80:
repeals the old and inserts a new, section 53 to make it clear that the
Department may retain an application and any material submitted with an
application relating to the inclusion of a kind of medical device in the
Register or a conformity assessment certificate.
Item 81: sets out
certain matters in relation to devices that are indictable offences: the making
of false statements in connection with the inclusion of medical devices in the
Register, or in relation to certification for inclusion of devices in the
Register; failure to notify adverse events within the prescribed period; and,
where an application for inclusion of a device in the Register is withdrawn or
lapses, failure to respond to a notice seeking information of adverse events or
the making of false or misleading statements in response to such a
notice.
Item 82: judicial notice of the British Pharmacopoeia and
the British Pharmacopoeia (Veterinary) is not to be taken in respect of
proceedings under Chapter 4 (which applies to medical devices).
Items
83, 84, 85, 86, & 88: expand the matters in respect of which the
Secretary may issue certificates certifying certain matters. Those additional
matters are: that particular medical devices are not exempt devices; that there
was no authority in effect allowing a person to import, export or supply medical
devices for special or experimental purposes or to allow a medical practitioner
to supply specified devices for use in the treatment of humans or a specified
class; that particular devices were or were not of a kind included in the
Register; that particular devices were suspended from the Register; that the
inclusion of particular devices in the Register has been cancelled; that a
conformity assessment certificate has been issued relating to a particular kind
of medical device; that a conformity assessment certificate has been suspended;
and, that the conformity assessment certificate is subject to conditions
including those specified in the certificate.
Item 87: as part of
the restructuring of the Act, amends a reference to a Part of the Act.
Item 89: amends a reference to the paragraph numbers in section
56A to provide for additional matters that can be certified.
Item
90: extends the operation of subsection 56A(4) (certificates about consents
to import, export or supply substandard products) to consents concerning medical
devices under section 41MA.
Item 91: expands the matters that
can be delegated to include the Secretary’s powers to approve a person to
import, export or supply kinds of medical devices for use in the treatment of
another person.
Item 92: expands the matters that the regulations
can deal with to include the circumstances in which delegates may grant
approvals to import, export or supply medical devices for the treatment in the
use of another person.
Item 93: under subsection 41HC(1) the
Secretary can authorise a specified medical practitioner to supply specified
kinds of medical devices for use in the treatment of a specified class of
recipients. The Secretary can only delegate this power to specified persons
who are registered or eligible for registration in a State or internal Territory
as a medical or dental practitioner.
Item 93 also has the effect of
expanding the regulation making power in subsection 57(7) to provide that the
regulations may prescribe the circumstances in which, and the requirements
subject to which, delegates may grant authorities under subsection
41HC(1).
Items 94, 95 & 96: have the effect of bringing
certain decisions made under the Act within the review scheme set out in section
60 by providing that they are “initial decisions”. “Initial
decisions” can be reviewed by the Minister. A person, dissatisfied with a
decision on review, can make application for a further review by the
Administrative Appeals Tribunal. The decisions that can be reviewed are
decisions made in relation to: a declaration that a particular thing is not a
medical device for the purposes of the Act; inspection of the Register and
variations to the Register; registration and listing of therapeutic goods;
manufacturing of therapeutic goods; conformity assessment certificates;
including medical devices on the Register (certain decisions about the auditing
of applications are not reviewable); exempting medical devices from
inclusion in the Register; obtaining information; public notification and
recovery of medical devices; and, refusing to grant or imposing conditions on a
grant of consent for the purposes of dealing with devices which do not comply
with the essential principles.
Item 97: clarifies that proposals
to: suspend or revoke a conformity assessment certificate (sections 41EM and
41ET); to suspend a kind of medical device from the Register (Section 41GA);
and, to cancel the entry of a kind of medical device on the Register (section
41GN); are not reviewable as 'initial decisions'.
Items 98, 99 &
100: bring a decision of the Secretary about whether or not to issue a
conformity assessment certificate within the scheme for handling “new
information”. Some separate provision for devices is made in relation to
consideration of “new information” because the language describing
the fees is different. The items provide essentially for the same
decision-making procedures as for other therapeutic goods.
Item
101: allow for renumbering as part of the restructuring of the Act and
inserts a reference to Part 4-4 - conformity assessment
certificates.
Items 102, 103, 104, 105, 106, &108: expand the
types of information (specifically to include certain information about devices)
that the Secretary may release to organisations (including overseas regulatory
organisations). This includes information relating to the issue of, imposition
of conditions on, or revocation of conformity assessment certificates; decisions
on the inclusion or cancellation of kinds of medical devices in the Register;
and approvals issued in relation to the use of therapeutic goods for special and
experimental purposes; medical devices exempted from inclusion in the Register;
and, authorities given to medical practitioners for the use of medical devices
not included in the Register.
Item 107: makes provision for
renumbering as part of the restructuring of the Act.
Item 109:
inserts additional matters for which the regulations may provide. These are
time periods within which: decisions to revoke suspensions of conformity
assessment certificates must be made; decisions on applications for the issuing
of conformity assessment certificates are to be made when the design of medical
devices has to be examined; and, decisions to revoke suspension of entries on
the Register are to be made.
Item 110: amendment to expand the
regulation-making power to provide for the transfer of a device included in the
Register.
Items 111, 112 & 113: as part of the restructuring
of the Act, make amendments to a heading and to references to Parts of the Act.
Items 1, 2, 3 & 5: repeal the definitions of “gazetted
therapeutic devices group”, “grouped therapeutic goods”,
“listable devices” and "therapeutic devices". These definitions
will no longer be required after the end of the transitional period, as they
relate to 'therapeutic devices' which will no longer exist at that time. At the
end of 5 years after the new medical devices scheme comes into operation, all
therapeutic goods coming within the definition of 'medical devices' will be
regulated under Chapter 4.
Item 4: replaces the definition of
'medicine' so that it no longer refers to the definition of therapeutic devices
because that definition will be removed from the Act in 5 years
time.
Items 6, 10, 13, 14, 18, 19: repeal various references to
'therapeutic devices' in the Act.
Item 7: repeals the note
following the heading to Chapter 3 (dealing with the application of Chapter 3 to
medical devices that are registered or listed) because the new devices scheme
providing for the inclusion of medical devices in the Register will have been
fully implemented and all medical devices will be regulated under Chapter 4 at
this time.
Item 8: amends section 10A to reflect the fact that
Part 3-2 will no longer apply to medical devices.
Item 9: repeals
section 15A (transitional arrangements) and inserts a new provision indicating
that Chapter 3 does not apply to medical devices.
Item 11: repeals
subsection 16(3) because there will no longer be gazetted therapeutic
devices.
Item 12: the effect of the repeal and replacement of the
paragraphs 20(2)(a) and (b) is to remove the reference to devices that are
listed goods because this concept will be obsolete 5 years after the
commencement of Schedule 1.
Item 15: removes a reference to
'therapeutic devices' in paragraph 25A(2)(a) by replacing the
paragraph.
Item 16: repeals section 25B (which deals with the
registration of therapeutic devices to which a conformity assessment certificate
applies) as all medical devices will be regulated under Chapter 4 rather than
Chapter 3.
Items 17 & 20: repeal section 26AA (which deals
with the listing of therapeutic devices to which a conformity assessment
applies) and removes the reference in section 26 to section 26AA because Chapter
3 will no longer apply to medical devices after 5 years.
Item 21:
repeals the note under Chapter 4 heading (which provides that Chapter 3 will
apply to already registered or listed medical devices) because, 5 years after
the commencement of Chapter 4, this note will be no longer be required because
the Chapter 4 provisions will then apply to all medical devices.
Item
22: repeals section 41BJ as it is a transitional provision which will no
longer have application after 5 years.
Item 23: omits a reference
to the definition of 'therapeutic device' in subsection 60(1) because that
definition will no longer be operative.
THERAPEUTIC GOODS (CHARGES) AMENDMENT BILL
2001
NOTES ON CLAUSES
Clause 1: states that the short title of the legislation is
the Therapeutic Goods (Charges) Amendment Act 2001.
Clause
2: sets out the commencement date for the changes set out in the Schedule.
Schedule 1 commences on the day on which Schedule 1 to the Therapeutic
Devices Amendment (Medical Devices) Act 2001 commences.
Clause
3: has the effect of stating that the Therapeutic Goods (Charges) Act
1989 (“the Act”) will be amended in the manner specified in the
Schedule.
Schedule 1 – Amendment of the Therapeutic Goods
(Charges) Act 1989
Item 1: amends the long title of the
Act to reflect the fact that medical devices are now
included in the Register.
Item 2: clarifies that, if a kind of
medical device, or medical devices of a particular kind, have been suspended
from the Register under Chapter 4 of the Therapeutic Goods Act 1989, they
are still taken to be included in the Register for the purposes of the
application of the Therapeutic Goods (Charges) Act.
Item 3:
inserts a new provision relating to the inclusion of kinds of medical devices in
the Register. The new provision reflects the existing provision relating to
therapeutic goods and provides that annual charges for the inclusion of kinds of
medical devices in the Register are payable when the charges take effect at any
time during a financial year.
Items 4 & 6: amend references to
Parts of the Therapeutic Goods Act 1989, made as a result of the
restructuring of that Act.
Item 5: relates to the inclusion of
kinds of medical devices in the Register and reflects the existing provision
relating to therapeutic goods. The effect of the provision is that where medical
devices are included in the Register in the exercise of a function or power
conferred on the Secretary by a corresponding State law, charges apply as if the
device had been included in the Register under Chapter 4 of the Therapeutic
Goods Act 1989.
Item 7: clarifies that the reference to
“goods” in the regulation-making power to prescribe different
charges for different classes of goods includes medical devices.
Items
8 & 9: clarify that the regulation-making power to exempt persons whose
turnover of goods is of low volume and low value from the payment of annual
charges applies also to the inclusion of kinds of medical devices in the
Register under Chapter 4 of the Therapeutic Goods Act
1989.