Last week, the Australian Therapeutic Goods Administration (TGA) published the final guidelines on Clinical Evidence for devices. The guidelines reiterate key elements of clinical evaluation that are often missing from Clinical Evidence Reports. The guidelines also provide specific requirements for certain high risk devices.
TGA will replace the cumbersome and ineffective Low Value Turn Over (LVT) scheme with a new set of Fee exemptions for products without commercial sales
All new entries on the ARTG are automatically qualified for ACE exemption subject to a sponsor declaration made at the end of the first year confirming if there were in fact no sales. TGA also signalled introducing fee waivers for devices which do not achieve commercial viability but which for public health reasons needs to remain on the register.
“Brandwood Biomedical, through their extensive depth of experience in working with the TGA in Australia, were able to successfully gain approval for our Variant Application. We appreciated Brandwood’s timely and thorough communications with us as they led us through the process. Their expertise helped the application proceed smoothly allowing us to avoid any potential pitfalls along the way.”
US Headquartered Device Manufacturer
“We have been using Brandwood Biomedical for scientific and regulatory guidance on Biocompatibility and Clinical Evidence on our range of surgical products. We are impressed with their in-depth knowledge in Biological Risk Assessment and Clinical Evaluation, as well as the clarity and utility of their expert reports.”
International manufacturer of surgical products
“Our Chinese application for a Class III medical device had been stalled and was in danger of rejection by CFDA. Brandwood Biomedical were able to resolve the impasse and to take us forward to approval. We were delighted with their ability to understand our product, communicate effectively with CFDA at the right level and achieve a positive and timely outcome.”
European manufacturer of advanced wound care products
“I very much enjoyed the round table discussions, with Arthur’s great depth and breadth in medical device regulatory matters, across the types of devices and different regions and countries. I continued to be amazed by Arthur’s ability to have very interesting and insightful comments on almost every subjects brought out by different people around the table, especially the last remark on reversed engineering challenges in China…”
Seminar participant – Singapore