Month August 2021

TGA publishes business plan 2021-2021

TGA Australia has published its 2021-2022 business plan. The 19 page document is packed with a wide range of priorities and they include the following: Priority 1- Product regulation and safety Digital transformation The four-year digital transformation will deliver simpler,…

CMDh updates August 2021

CMDh Minutes for the meeting on 22-23 June 2021 The minutes for the above meeting are now available here (24 page document) and the following items are included: 1. Brexit (pg 7) The CMDh discussed a topic included under 8.3…

MDCG updates August 2021

The Medical Device Coordination Group (MDCG) has published the following updates: MDCG number Notes MDCG 2021- 23 Guidance for notified bodies, distributors and importers on certification activities in accordance with Article 16(4) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746…