Recent Medical Device Regulation Changes

The Therapeutic Goods Administration (TGA) recently announced changes to medical device regulation.

Information about the changes can be found on the TGA website.

USANZ Member, Dr Ailsa Wilson Edwards, is the RACS-nominated representative to the TGA Womens Health Products Working Group. Ailsa prepared the following commentary about how these changes may impact USANZ Members.
 

Changes to the regulation of medical devices containing microbial, recombinant or animal substances

Changes regarding medical devices containing animal, microbial or recombinant substances have been made to the TGA (Medical Devices) Regulations, part 5.5. The TGA held consultation on this in 2023. 

The concern was certain low risk animal/microbial products were classified as Class III (high risk). Classification as Class III carries a significant regulatory burden not necessary for low risk products.

• Examples which other stakeholders are calling to be downclassified include medical grade honey and lanolin for wound healing, and other common products from microbial/recombinant origin like lactic acid, citric acid, fish oil
• Biologic grafts for reconstructive surgery are considered high risk and will remain Class III.
• Ialuril (chondroitin and hyaluronic acid) is also Class III 
• Other products may be of interest to USANZ members 
• Sponsors of affected products have until July 2026 to apply for reclassification. 

Changes have also been made to Conformity assessment evidence requirements for animal/microbial products. The TGA will now accept evidence from a broader range of comparable overseas regulators (EU, Japan, USA, Canada, Singapore) for these products. This is positive and expedites access for use in Australia.

 

Software based medical devices

The TGA regulates software that is part of a medical device if it involves management of disease, from smartphone apps to urodynamic machines. Manufacturers must provide evidence supporting the safety and performance of their software, which is proportionate to the risk and classification (Class I to Class III same as devices).

Some are transitioning to a higher classification and sponsors must apply for conformity assessment or ARTG inclusion by November 2024.

 

Medical device application audit requirements

The TGA reserves the right to audit any manufacturer supplying medical devices to Australia, to ensure they comply with medical device regulatory requirements.

The Medical Device Single Audit Program (MDSAP) is an international program which allows recognised Auditing Organizations to audit medical device manufacturers in a single program for participating regulatory authorities (including the TGA). Within this a new pathway has been established for Class III devices. Again this streamlines processes and improves access for Australians.