All medical devices are required to obtain pre-market approval from the Chinese State Food and Drug Administration (SFDA). This medical device registration provides SFDA registration consultation for class I, Ⅱ and Ⅲ medical devices. All medial devices will be certified to meet with the EU and CE safety standards.
- SFDA registration consultation for IVD.
- SFDA import registration.
- EU, CE (MDD, IVDD, PPE, AIMDD).
- US FDA (Listing, 510k, PMA).