December

December 10, 2018

3 New Requirements for Legal Agent in China

NMPA (CFDA) published Guideline for Imported Medical Device Legal Agent (Draft) for feedback on Aug 3rd, 2018. The draft guideline lists 3 responsibilities for legal agents for the first time: […]
December 3, 2018

Era of transformation: 2018 NMPA (CFDA) Major Regulation Updates

Do you know the NEW Registration Holder System for Medical Devices in China? Do you know the NEW post-market surveillance requirements in China? Do you know the latest clinical requirements […]