Following the webinar held in October 2022 on the topic “Made in China in Healthcare industries: Regulatory Framework and what it means for foreign companies”, the FHA Medical Devices work group has summarised the key points on this important topic that we are happy to share here.
It gives an up to date overview of the following:
- MD classification and NMPA filing and registration processes for class 1, 2 and 3 devices
- Importation vs domestic assembly / manufacturing regulations
- Evolution of the legal framework of the “made in China for China” policies
- Volume Based Procurement 9VBP) and the new reality of the market
If you are a company looking into entering the Chines market now, or a company eager to get a full update on these important issues, feel free to download it by clicking here.
We would like to thank the contributors / co-writers of this document: Philippe Barroux, General Manager Stago China; Benoit Derinck, General Manager Thuasne China & FHA Medical Devices Working Group Lead; Yannick Ravier, General Manager Asia Cartolux-Top Clean Packaging Group; Irénée Robin, Managing Partner VVR Medical.