Changes to the documentation required for supplying medical devices in Australia

Manufacturers of medical devices which are already approved for supply in the United States have not been able to rely upon that approval or documentation when going through conformity assessment procedures or applying for inclusion on the Australian Register of Therapeutic Goods (ARTG) – until now.

As part of its review of the Australian Regulatory Guidance for Medical Devices (May 2011) (2011 ARGMD), the Therapeutic Goods Administration (TGA) has issued new guidance material in relation to updated sections of the 2011 ARGMD, which makes it clear that it will now accept, amongst other things, certain documentation from the United States Food and Drug Administration (FDA) as part of the application process for manufacturers wanting to supply a new medical device in Australia.

The review of the Australian Regulatory Guidance for Medical Devices

The 2011 ARGMD, which among other things, explains how to obtain approval to supply a medical device in Australia, has been under review following a recommendation of the Expert Panel Review of Medicines and Medical Devices in November 2014.  Although the 2011 ARGMD remains under review, certain sections have been updated to address and incorporate the recommendations of the Expert Panel.  The TGA has also begun to release guidance about these changes. 

The Australian Government accepted one of the Expert Panel's recommendations for the better utilisation of existing marketing approvals of a medical device where the device has been:

• conformity assessed by a body that has been designated to undertake conformity assessments by a comparable overseas designating authority; or
• approved by a comparable overseas national regulatory authority.

(Note that the TGA will retain responsibility for market authorisation of therapeutic goods in Australia, and will continue to assess applications for conformity assessment certificates for some devices and for the inclusion of medical devices in ARTG.)

The November 2018 "Use of market authorisation evidence from comparable overseas regulators / assessment bodies for medical devices (including IVDs)" (New Guidance Material) now explains how specific overseas assessments and approvals can be used by applicants:

• to seek an abridged assessment of an application for a TGA conformity assessment certificate, or
• as part of the documentation required to be provided with applications for inclusion of medical devices (including IVDs) in the ARTG.

2011 ARGMD

Previously,  the TGA would only accept documentary evidence from Australia, the European Union (EU) and/or the European Free Trade Association (EFTA) conformity bodies or regulators in support of abridgment of an application for a TGA conformity assessment or an application for inclusion of a medical device in the ARTG.  The underlying reason for this, as noted in the 2011 ARGMD, was the similarity between the European regulatory scheme and the Australian system in relation to classification of a medical device.

The TGA accepts certificates from the EU and/or the EFTA because of two international agreements:

• the Agreement on mutual recognition in relation to conformity assessment, certificates and markings between the European Community (EC) and Australia (24 April 1998) (ECMRA); and
• the Agreement on mutual recognition in relation to conformity assessment, certificates and markings between Australia and the Republic of Iceland, the Principality of Liechtenstein and the Kingdom of Norway (29 April 1999) (EFTA-MRA).

Both the ECMRA and EFTA-MRA recognise the competence of designated conformity assessment bodies in the relevant countries to undertake conformity assessment of medical devices to Australian regulatory requirements.  This means that devices imported under the ECMRA or/and EFTA-MRA can be placed on the Australian market without further assessment by the TGA.  It is also beneficial for Australian manufacturers, as products for export to the EC market can be assessed for compliance with European requirements at the same time as they are assessed against Australian regulatory requirements.

On the other hand, the 2011 ARGMD made it clear that documents or approval from the US FDA would not be accepted as evidence of compliance of a medical device for supply in Australia "because the US system does not align with the Australian regulatory framework".

New Guidance Material – acceptance of FDA documentation

Under the New Guidance Material, the TGA has broadened the scope of documentation that it will consider in relation to requests for abridgement of TGA conformity assessments or as the documentation in support of applications to include medical devices in the ARTG. 

The most significant change is that, depending on the category and classification of the medical device in question, the TGA will now accept:

• decisions of the FDA, including De Novo Decision Summaries and 510(k) Summaries (or pre-market notifications); and
• Medical Device Single Audit Program (MDSAP) Certificates (or pre-market approval).

The New Guidance Material does make it clear, however, that the TGA will continue to assess the comparability of US FDA 510ks and De Novo approvals when used to support applications for Class IIb implantable medical devices to ensure these approvals are appropriately aligned with Australian regulatory requirements.  The New Guidance Materials suggest that applications for ARTG inclusion of Class IIb implantable devices are likely to be subjected to an application audit, even if supported by evidence of an FDA assessment.

Further, the New Guidance Material makes it clear the documentation should be issued by an overseas regulator or assessment body for the same medical device that the manufacturer is applying for in Australia, including the same design, the same intended purpose, and intended for the same indications.

What these changes will mean for manufacturers of medical devices

The New Guidance Material supports the TGA's stated objective of "avoiding unnecessary regulatory duplication, burden and cost" on manufacturers by harmonising the regulation of medical devices with other overseas regulatory bodies as much as possible.

These changes will allow manufacturers to use a broader scope of overseas certification documentation, which should increase the efficiency, and lower the cost, of supplying a medical device in Australia.  Greater international cohesion on the regulation of medical devices may also assist Australian manufacturers of medical devices to expand their supply in the international market by easing the regulatory process.

Manufacturers should, however, remember that greater international cohesion on the regulation of medical devices does not mean that all documentation between jurisdictions is transferable.  Caution should be taken by suppliers of medical devices in Australia as to which specific documents from overseas regulators may be used in Australia.