Consultation: Conformity Assessment Procedures for Medical Devices | Proposed Amendments

In Australia, medical devices are regulated by the Therapeutic Goods Administration (TGA). The TGA considers how the medical device is meant to be used and the possible risks to individuals or public health. Since all medical devices carry some risk, the TGA uses scientific and clinical expertise to make sure the benefits outweigh the risks.

The TGA has been systematically reviewing the way medical devices are regulated. This has been guided by An Action Plan for Medical Devices which is a three-part strategy to strengthen Australia’s regulatory system while continuing to be patient focused and have greater transparency. The Australian Government is also committed to improve how medical devices are regulated by internationally aligning our regulatory framework (wherever possible) and to participate in the Medical Devices Single Audit Program (MDSAP). This consultation is part of the ongoing reform program.

This consultation seeks views on where appropriate alignment should occur with the conformity assessment procedures of the European Regulation 2017/745 on medical devices (MDR) and the European Regulation 2017/746 for in vitro diagnostic medical devices (IVDR), collectively referred to as the European Regulations. We have reviewed the current Australian conformity assessment procedures against the European Regulations (see Appendix 1 for details of the comparison) and we propose to align with the European Regulations, where practicable.

This consultation also seeks feedback on proposed stronger alignment with the guidance published by the International Medical Device Regulators Forum (IMDRF) and the regulatory approach of countries that are members of the MDSAP. In addition to the TGA, the MDSAP members include the medical device regulators from Brazil, Canada, Japan and the United States of America (US), as well as an increasing number of observer and affiliate regulatory authority members from other countries. As a member of the MDSAP, alignment with the other participating regulatory authorities, where possible, will ensure Australia realises the full benefits of this rapidly growing program. 

Conformity Assessment

The aim of the conformity assessment procedures is to provide objective evidence about the safety, performance, benefits and risks of a medical device. More formally, conformity assessment is the systematic and ongoing examination of evidence and procedures to ensure that a medical device complies with regulatory requirements. For medical devices, these are the Australian safety and performance requirements known as the Essential Principles.

Conformity assessment is primarily the responsibility of the medical device manufacturer. The TGA uses conformity assessment evidence to confirm that medical devices are safe and effective and that any quality, safety or performance problems are quickly identified and resolved.

Conformity Assessment Procedures

The conformity assessment procedures are regulatory requirements described in the Therapeutic Goods Act 1989 (the Act), and detailed in Schedule 3 of the Therapeutic Goods (Medical Devices) Regulations 2002 (the Australian Regulations).

The Australian Regulations currently describe eight parts of the conformity assessment procedures (see Appendix 1 for a summary). Depending on the types of medical devices being manufactured at a location, more than one of these conformity assessment procedure parts may apply, with the regulatory oversight of the manufacturer increasing as the risk of safety of the medical device increases. The different conformity assessment procedure parts require different kinds of evidence to demonstrate that the necessary oversight was applied.

Generally, a person or company (known as the sponsor) must apply to the TGA to have a medical device included in the Australian Register of Therapeutic Goods (ARTG) to then import, export or supply within Australia. The sponsor provides information on the manufacturer’s conformity assessment with their application. The TGA considers the conformity assessment evidence to make regulatory decisions on the inclusion of the device in the ARTG.

A sponsor may provide conformity assessment documents or certificates that have been issued by the TGA, an Australian conformity assessment body (note there are not yet any Australian conformity assessment bodies), or specified comparable overseas regulators as evidence of the manufacturer’s compliance with the conformity assessment requirements. Proposals 1-5 of this consultation focus mainly on the conformity assessment procedures relied upon for TGA conformity assessment certification, or certification by any future Australian conformity assessment body. Proposals 6, 7 and 8 also apply to medical devices certified by comparable overseas regulators.

None of the proposals in this consultation would change the way we recognise comparable overseas regulator approvals and assessments.

Benefits of the proposals 

The proposals aim to harmonise requirements internationally, strengthen the design and performance documentation, as well as the monitoring and follow-up of devices in use. Recent incidents involving medical devices, such as transvaginal mesh and breast implants, have highlighted the need for manufacturers to have stringent post-market monitoring processes, to require or access more complete clinical performance and adverse event data, as well as rapidly share information on emerging safety issues. There is a strong focus in these proposals to more promptly identify and address threats to patient safety and to take quicker action.

We expect these proposals will:

• provide clarity and consistency for manufacturers by simplifying the requirements
• decrease regulatory compliance costs by aligning more closely with the European Regulations, the MDSAP and IMDRF guidance
• reduce the time for the benefits of new technologies to become available to Australians
• ensure manufacturers implement robust quality management systems with improved control over the design and construction and ongoing monitoring of medical devices, including medical device software, artificial intelligence, and other advanced manufacturing technologies, resulting in enhanced quality and safety of medical devices throughout their lifecycle
• minimise public health and safety risks
• increase consumer and healthcare professional confidence in the regulation of medical devices.

Proposals

Your views are sought on the following proposals.

• Proposal 1 – Repeal unnecessary procedures
• Proposal 2 – Require control of design and development
• Proposal 3 – Design examination of medium risk devices
• Proposal 4 – Reduce barriers for innovation
• Proposal 5 – Include the MDSAP in the procedures
• Proposal 6 – Reusable surgical instruments
• Proposal 7 – Clinical and post-market planning and reporting
• Proposal 8 – General alignment and transition arrangements