Therapeutic Goods (Medical Devices) Amendment (Australian Manufacturers) Regulation 2014

Administered by Department of Health, Disability and Ageing

Legislation au F2014L01465 Regulations Not in force Legislative Instrument

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EXPLANATORY STATEMENT

 

 

Select Legislative Instrument No. 159, 2014

 

Therapeutic Goods Act 1989

 

Therapeutic Goods (Medical Devices) Amendment (Australian Manufacturers) Regulation 2014

 

The object of the Therapeutic Goods Act 1989 (the Act) is to establish and maintain a national system of controls for the quality, safety, efficacy/performance and timely availability of therapeutic goods that are used in Australia or exported from Australia. The Therapeutic Goods Administration (the TGA), which is part of the Department of Health, is responsible for administering the Act.

 

Subsection 63(1) of the Act provides that the Governor-General may make regulations, not inconsistent with the Act, prescribing matters required or permitted to be prescribed by the Act or necessary or convenient to be prescribed for carrying out or giving effect to the Act.

 

Under section 41EA of the Act and subregulation 4.1(1) of the Therapeutic Goods (Medical Devices) Regulations 2002 (the Principal Regulations), a valid application for marketing approval cannot be made for a medical device that is manufactured in Australia unless the manufacturer of the device has applied to the Therapeutic Goods Administration (the TGA) for, and been issued, a conformity assessment certificate.

 

This contrasts with devices manufactured overseas, for which a TGA conformity assessment certificate is only needed before an application for marketing approval can be made if the device is of a type described in paragraphs 4.1(2)(a)-(e) of the Principal Regulations. These are higher risk products, such as devices (other than in vitro diagnostic medical devices) containing tissues, cells or substances of microbial or recombinant origin, and Class 4 in vitro diagnostic medical devices.

 

Conformity assessment certificates signify a range of matters about the manufacture of the medical devices to which they relate, e.g. that they comply with minimum requirements for performance and safety, and that relevant manufacturing standards are being observed in the manufacturing process.

 

Sponsors of all medical devices, wherever manufactured, must certify that their devices comply with these requirements when they apply for marketing approval, and must also certify that either they have information to substantiate that compliance or are able to obtain it from the manufacturer.

 

Overseas manufacturers (other than those manufacturing higher risk devices mentioned in paragraphs 4.1(2)(a)-(e) of the Principal Regulations, for which a conformity assessment certificate is mandatory) have the option of applying to the TGA for a conformity assessment certificate.  They also have the option of using the services of a private conformity assessment body to assess their manufacturing processes and validate that they comply with relevant regulatory requirements.

 

These bodies are approved and supervised by regulators in other countries, including in particular in Europe, and an assessment by such a body of a manufacturer’s processes and the devices being manufactured is expected to deliver the same outcome as an assessment by the TGA in terms of examining and verifying the manufacturer’s compliance with manufacturing standards, and safety and performance requirements for the devices in question.

 

The Therapeutic Goods (Medical Devices) Amendment (Australian Manufacturers) Regulation 2014 (the Regulation) amends the Principal Regulations to place Australian manufacturers on the same footing as overseas manufacturers in this regard in relation to conformity assessment certificates for medical devices other than those higher risk devices noted above. 

 

This allows Australian manufacturers also to use private conformity assessment bodies for all medical devices other than a higher risk device of a kind referred to in paragraphs 4.1(2)(a)‑(e) of the Principal Regulations.

 

This measure provides Australian medical device manufacturers with greater flexibility in relation to demonstrating compliance with conformity assessment requirements, as well as providing for flow-on benefits such as a reduction in administrative costs associated with the issuing of conformity assessment certificates.

 

The Regulation also includes a small number of minor, consequential amendments.

 

Details of the Regulation are set out in the Attachment. 

 

The Act does not specify conditions that would need to be met before the power to make the Regulation may be exercised.

 

The Regulation is a legislative instrument for the purposes of the Legislative Instruments Act 2003.

 

The Regulation commences on 5 November 2014.

 

Consultation

 

The TGA released a public consultation paper in January 2013 on a proposal to allow third party conformity assessment for Australian medical device manufacturers, inviting submissions. A request for further public input was also invited in May 2013.  Responses to both rounds of consultation were received from a range of industry stakeholders, healthcare professionals and consumer representative organisations. 

 

In both instances, industry stakeholders were supportive of the proposal, and consumer and professional representatives and medical device procurers, expressed some concern about the reduction in direct TGA oversight of manufacturers.

 

 

Authority:  Subsection 63(1) of the              Therapeutic Goods Act 1989

ATTACHMENT

 

Details of the proposed Therapeutic Goods (Medical Devices) Amendment (Australian Manufacturers) Regulation 2014

 

Section 1 – Name of Regulation

This section provides for the regulation to be referred to as the Therapeutic Goods (Medical Devices) Amendment (Australian Manufacturers) Regulation 2014.

 

Section 2 – Commencement

This section provides for the regulation to commence on 5 November 2014.

 

Section 3 – Authority

This section provides that the regulation is made under the Therapeutic Goods Act 1989 (the Act).

 

Section 4 – Schedule(s)

This section provides that each instrument that is specified in a Schedule to the regulation is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to the regulation has effect according to its terms.

 

 

Schedule 1 – Amendments of the Therapeutic Goods (Medical Devices) Regulations 2002

 

Therapeutic Goods (Medical Devices) Regulations 2002

 

Items 1 and 2 – Regulation 3.5 (heading) and subregulation 3.5(1)

These items make a minor, consequential change to subregulation 3.5(1), and introduce a new heading for regulation 3.5, of the Principal Regulations.

 

Subregulation 3.5(1) allows a power or function of the Secretary in relation to assessing whether an overseas manufacturer has correctly applied relevant manufacturing standards (known as ‘conformity assessment procedures’) in their production processes to be exercised by a body or authority (including a private conformity assessment body) that the Secretary is satisfied has appropriate expertise to do so.

 

These powers and functions include, for example, assessing whether a device manufacturer has implemented a quality management system for the design, production, packaging, labelling and final inspection of its devices.

 

Item 2 removes the reference in subregulation 3.5(1) to overseas manufacture, with the effect that Australian manufacturers can also use the services private conformity assessment bodies to conduct such assessments.

 

Item 1 introduces a new heading for regulation 3.5(1) to reflect the removal of the reference to medical devices manufactured outside Australia.

 

Item 3 – Subregulation 4.1

This item repeals subregulation 4.1(1) of the Principal Regulations, thus removing the current requirement in that provision for all Australian medical device manufacturers to have applied for, and been issued, a conformity assessment certificate before marketing approval can be sought for their devices.

 

The effect of this item, taken together with the amendment made by item 6, is to place Australian medical device manufacturers on the same footing as overseas manufacturers – i.e. device manufacturers, whether based in Australia or overseas, will only need a conformity assessment certificate issued by the TGA if they are engaged in the manufacture of certain kinds of medical devices (listed in paragraphs 4.1(2)(a)-(e)).

 

Item 4 – Subregulation 4.1(2)

This item makes a minor formatting change to subregulation 4.1(2) as a consequence of the amendments made by items 3 and 7.

 

Item 5 – Subregulation 4.1(2)

This item makes a minor formatting change to subregulation 4.1(2) as a consequence of the amendment made by item 7.

 

Item 6 – Subregulation 4.1(2)

Currently under subregulation 4.1(2) of the Principal Regulations, a conformity assessment certificate must have been issued by the TGA before marketing approval can be sought for certain kinds of medical devices that are manufactured overseas – e.g. medical devices (other than in vitro diagnostic medical devices) containing non-viable tissues of animal origin.

 

Item 6 removes the reference to overseas manufacture from subregulation 4.1(2), with the effect that subregulation 4.1(2) applies to require any medical device manufacturer engaged in the production of one of these kinds of devices to obtain a conformity assessment certificate, whether they are based overseas or in Australia.

 

Item 7 – Subregulation 4.1(3)

Item 7 repeals subregulation 4.1(3), principally as a consequence of the repeal of subregulation 4.1(1).

 

Subregulation 4.1(3) exempts specified kinds of medical devices from the requirement in subregulations 4.1(1) and (2) to obtain a conformity assessment certificate. With the repeal of subregulation 4.1(1), subregulation 4.1(3) is no longer necessary.

 

In addition, some of the kinds of devices in subregulation 4.1(3) do not require a conformity assessment certificate in any event, as they are devices which, under the Act, are not required to be included in the Australian Register of Therapeutic Goods (the Register) – e.g. devices approved under section 41HB of the Act for use solely in clinical trials.

 

Item 8 – Subparagraph 5.3(1)(j)(viii)

Item 8 replaces current subparagraph 5.3(1)(j)(viii) of the Principal Regulations with a new subparagraph of that number, incorporating a minor, consequential change to reflect the amendments introduced by item 2 above.   

 

Subparagraph 5.3(1)(j)(viii) currently requires the Secretary to audit an application for the inclusion in the Register of an in vitro diagnostic medical device manufactured overseas in specified circumstances.  Those circumstances are where the device is one in relation to which the Secretary is not satisfied, under subregulation 3.5 of the Principal Regulations, that a private conformity assessment body has the expertise and authority to assess the suitability of the manufacturing processes of the overseas manufacturer of the device.    

 

As item 2 amends subregulation 3.5 to remove any distinction between medical devices manufactured in Australia or overseas in relation to the Secretary’s ability to authorise a private body to assess manufacturing processes, there is a need to also amend subparagraph 5.3(1)(j)(viii) to the same end.


Statement of Compatibility with Human Rights

Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011

 

Therapeutic Goods (Medical Devices) Amendment (Australian Manufacturers) Regulation 2014

This legislative instrument is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.

Overview of the Legislative Instrument

The Therapeutic Goods (Medical Devices) Amendment (Australian Manufacturers) Regulation 2014 (the Amendment Regulation) is made under subsection 63(1) of the Therapeutic Goods Act 1989 (the Act). Under section 41EA of the Therapeutic Goods Act 1989 and subregulation 4.1(1) of the Therapeutic Goods (Medical Devices) Regulations 2002 (the Principal Regulations), an application for marketing approval cannot be made for a medical device manufactured in Australia unless the manufacturer has applied to the Therapeutic Goods Administration (TGA) for, and been issued, a conformity assessment certificate.  This contrasts with devices manufactured overseas, for which a TGA conformity assessment certificate is only required before an application can be made for marketing approval if the device involved is of a higher risk type described in paragraphs 4.1(2)(a)-(e) of the Principal Regulations.

 

Conformity assessment certificates signify a range of matters about the manufacture of the devices to which they relate, e.g. that they comply with minimum requirements for performance and safety, and that relevant manufacturing standards are being observed in the manufacturing process. Sponsors of devices must certify that their devices comply with these requirements when applying for marketing approval, and conformity assessment certificates substantiate that compliance for manufacturers required to obtain them. Overseas manufacturers, however, are able to use the services of private conformity assessment bodies to verify such matters.

 

The purpose of the Amendment Regulation is to amend the Principal Regulations to place Australian manufacturers on the same footing as overseas manufacturers in regard to the need for conformity assessment certificates for medical devices other than those higher risk devices mentioned above, providing Australian manufacturers with greater flexibility in relation to demonstrating compliance with conformity assessment compliance and benefits such as a reduction in associated administrative costs.     

 

Human rights implications

As the Amendment Regulation does not introduce any changes to the Principal Regulations other than to implement the measure outlined above, it does not engage any of the applicable rights or freedoms.

Conclusion

This legislative instrument is compatible with human rights as it does not raise any human rights issues.

Fiona Nash

Assistant Minister for Health

Overview

The Therapeutic Goods (Medical Devices) Amendment (Australian Manufacturers) Regulation 2014, made under the Therapeutic Goods Act 1989, aims to address the disparity between Australian and overseas medical device manufacturers in terms of conformity assessment requirements. The Therapeutic Goods Administration (TGA) is responsible for administering the Act, which establishes and maintains a national system of controls for the quality, safety, efficacy/performance, and timely availability of therapeutic goods in Australia or exported from Australia. The Act empowers the Governor-General to make regulations, not inconsistent with the Act, prescribing matters required or permitted to be prescribed by the Act or necessary or convenient to be prescribed for carrying out or giving effect to the Act. This amendment allows Australian medical device manufacturers to use private conformity assessment bodies for all medical devices, except higher-risk devices, thus providing them with greater flexibility in demonstrating compliance with conformity assessment requirements. The Regulation also reduces administrative costs associated with issuing conformity assessment certificates. The Therapeutic Goods (Medical Devices) Amendment (Australian Manufacturers) Regulation 2014 was introduced to provide a more streamlined and consistent process for medical device manufacturers in Australia and overseas.

Scope and Application

The Therapeutic Goods Act 1989, administered by the Therapeutic Goods Administration (TGA) within the Department of Health, aims to ensure the quality, safety, efficacy, and timely availability of therapeutic goods used or exported from Australia. The Act allows for the creation of regulations to enforce its provisions, including the Therapeutic Goods (Medical Devices) Regulations 2002. The Therapeutic Goods (Medical Devices) Amendment (Australian Manufacturers) Regulation 2014 amends these regulations to align the requirements for conformity assessment certificates for medical devices with those for overseas manufacturers. Specifically, it removes the mandatory requirement for Australian manufacturers of non-higher-risk devices to obtain a TGA conformity assessment certificate before marketing approval can be sought. Instead, Australian manufacturers can now also use private conformity assessment bodies to verify compliance with manufacturing standards and safety requirements, similar to overseas manufacturers. This change provides Australian medical device manufacturers with greater flexibility and reduces administrative costs associated with conformity assessment certificates. The Regulation applies to medical device manufacturers in Australia and came into effect on 5 November 2014. It does not introduce any exclusions, exemptions, or thresholds beyond those already specified in the Principal Regulations for higher-risk devices.

Key Provisions

The Therapeutic Goods (Medical Devices) Amendment (Australian Manufacturers) Regulation 2014 amends the Therapeutic Goods (Medical Devices) Regulations 2002, primarily by aligning the requirements for Australian medical device manufacturers with those for overseas manufacturers. Section 41EA of the Therapeutic Goods Act 1989 and subregulation 4.1(1) of the Therapeutic Goods (Medical Devices) Regulations 2002 previously required Australian manufacturers to obtain a conformity assessment certificate before marketing approval could be sought. This contrasted with overseas manufacturers, who only needed a conformity assessment certificate for higher risk devices as outlined in paragraphs 4.1(2)(a)-(e) of the Principal Regulations. The Amendment Regulation removes the requirement for Australian manufacturers to obtain a conformity assessment certificate for medical devices other than those higher risk devices, placing them on the same footing as overseas manufacturers. This change allows Australian manufacturers greater flexibility in demonstrating compliance with conformity assessment requirements and reduces associated administrative costs. The obligations imposed by the Amendment Regulation include the requirement for all medical device manufacturers, whether Australian or overseas, to certify that their devices comply with the relevant requirements when applying for marketing approval. This certification must be substantiated by either information from the manufacturer or the ability to obtain such information. For Australian manufacturers of higher risk devices, a conformity assessment certificate is still necessary, aligning them with the requirements for overseas manufacturers of the same types of devices. Additionally, overseas manufacturers have the option to use private conformity assessment bodies to verify compliance with regulatory requirements, a practice now extended to Australian manufacturers. Breach of the requirements under the Therapeutic Goods Act 1989 and the Therapeutic Goods (Medical Devices) Regulations 2002 can lead to various civil or criminal consequences, depending on the nature and severity of the breach. Penalties for non-compliance can include fines, imprisonment, or both. The maximum penalties vary based on the specific offence, but they can be substantial, reflecting the importance of ensuring the quality, safety, efficacy/performance, and timely availability of therapeutic goods in Australia. For example, offences involving the supply of therapeutic goods that do not comply with the Act can result in significant fines and imprisonment. The Therapeutic Goods Administration (TGA) is responsible for enforcing these provisions and takes a rigorous approach to ensuring compliance. The Amendment Regulation also includes minor, consequential amendments to the Principal Regulations to reflect the changes made by the primary amendment. For instance, subregulation 4.1(1) of the Principal Regulations is repealed, and subregulation 4.1(2) is amended to remove references to overseas manufacture, ensuring consistency across the regulations. Additionally, subparagraph 5.3(1)(j)(viii) is amended to align with the changes in subregulation 3.5, ensuring that the regulatory framework is coherent and reflects the new requirements for conformity assessment certificates.

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