Author: Heyam Kalla, Associate Director, Team Lead Medical Devices / IVD, PharmaLex Australia
The Therapeutic Goods Administration (TGA) has announced an important extension for medical device products, bringing further relief for the industry. The announcement comes after much uncertainty as to how the TGA would respond to the European Union’s extended transition period for its Medical Device Regulation (EU MDR).
In May 2023, the TGA offered manufacturers and sponsors some reprieve with the announcement that they would accommodate the EU’s agreed changes within their own transitional arrangements. However, the question remained as to how these changes would accommodate the medical device reclassification reforms, which include the following types of devices:
- Active medical devices for therapy with diagnostic function (including any related software)
- Spinal implantable medical devices (motion preserving)
- Devices used in direct contact with the heart, central circulatory system, or central nervous system (including any related software)
- Devices that administer medicines or biologicals by inhalation (including any related software)
- Devices that are substances introduced into the body via orifice or applied to the skin (including any related software)
- Patient-matched medical devices
Previously in alignment with the MDR, the TGA’s transition period had been for sponsors of existing ARTG entries who notified the TGA before 25 May 2022 to meet the new requirements by 1 November 2024.
In its latest announcement, the TGA has said that the government has agreed to extend these transition arrangements to 1 July 2029 for submission of an ARTG application. The regulatory amendments are to be drafted and are expected to be in place before December 2023.
The extension should provide additional relief for the sponsors and manufacturers who should now have sufficient time to obtain MDR (or other) certification before the new deadline.
In addition, for existing patient-matched devices, the government has also agreed to extend the notification period for sponsors from 25 August 2022 to 1 November 2024. This would also allow the continuation of supply until 1 July 2029.
Note, the transition does not apply for new device applications, which must be submitted according to their new classification. The reforms on software also remain unchanged. The transition period for these devices will end on 1 November 2024.
