An easy Journey of Medical Device Registration (including IVD) in China

National Medical Products Administration (NMPA, formerly China Food and Drug Administration, CFDA) is Chinese authority of drugs, medical devices and cosmetics.

*In-vitro Diagnostics Regulation belongs also to regim of NMPA

The way of medical device (including IVD) commercialization seems to be in-transparent at first important product registration in China. In the reality the regulation is quite similar to or rather goes behind the western regulation as 2017/745 at Medical Device Regulation (MDR) or In-vitro Diagnostics Regulation (IVDR) in EU and Federal Food, Drug, and Cosmetic Act (FD&C Act) in US.

By end of 2019, China’s medical devcie expenditure was $96 billion, approximately 14% of the size of the pharmaceuticals market, far away from the average percent in developed country. After outbreak of Cowid-19, China will reinforce the medical device market on any account.

Since 2014, the Chinese legislative is developing in rapid move. They are aligning more and more international level as state-of-the-art product-specific guidance and standards, post market surveillance (periodic risk evaluation report), verification and validation requirements (biocompatibility test, clinical evaluation and study, packaging validation, shelf life validation and sterilisation validation). In 2019 NMPA has introduced electronic regulated product submission (eRPS) to provide a smooth acceptance - and technical review and tried to abridge the review time. Since 2022 there are new quality management elements in the submission dossier.

We want to accompany your journey of exceptional business in China in this platform sharing knowledge of medical device regulation and providing premium regulatory affairs service in China.