B4 – An Update from the Medical Devices Branch of the TGA

Medical Devices Single Audit Program (MDSAP) Pilot Program: Update

The Medical Device Single Audit Program (MDSAP) Pilot has provided an opportunity for the Canadian Medical Device Conformity Assessment System (CMDCAS) Registrars to demonstrate their capability to undertake Quality Management System (QMS) audits on behalf of all of the participating MDSAP Regulatory Authorities (TGA- Australia, ANVISA – Brazil, MHLW/PMDA – Japan, Health Canada and the US FDA). Through their assessment experience, and from discussions with these candidate MDSAP Auditing Organisations, the participating Regulatory Authorities have been using the Pilot to refine the policies, procedures and practices that support this program of international collaboration and work sharing.

A ‘proof of concept’ analysis and report will be prepared prior to the end of the pilot, however some Regulators have already announced their commitment to an operational phase of the program and their transitional arrangements. This session will provide an update on the progress of the Pilot and explore how the results of audits will be used by the participating Regulatory Authorities in support of market authorisation within their jurisdictions.


Clinical Evidence Guidelines

The Department of Health’s Therapeutic Goods Administration (TGA) is currently developing Clinical Evidence Guidelines on Medical Devices, and earlier this year released a draft document for consultation.

The aim of developing these guidelines is to provide more clarity around the Australian regulatory decision making process and the practicalities of the clinical assessment of medical devices within the Australian regulatory framework. This is firmly based on the evaluation of the clinical evidence of safety and performance of medical devices. The intended result is to assist sponsors and manufacturers to move efficiently through the regulatory system.

The draft guidelines outline current TGA expectations for clinical evaluation reports and underlying evidence to be held by medical device manufacturers as part of their conformity assessment procedures. This may be requested by the TGA in support of applications for conformity assessment or inclusion in the Australian Register of Therapeutic Goods (ARTG), and for post-market monitoring. The draft guidelines are intended as a supplement to existing guidance documents, such as the Australian regulatory guidelines for medical devices.

This presentation will outline the draft guidelines and also the feedback received through recent consultations. The draft guidelines are available on the TGA website at https://www.tga.gov.au/consultation/consultation-draft-clinical-evidence-guidelines-medical-devices.


Chairperson: George Faithfull, Stryker