To access the Chinese market with a medical device, you must acquire the Medical Device Registration Certificate from the National Medical Product Administration (NMPA). In case you do not have a subsidiary in China, you have to appoint a local legal agent to deal with registration and after-sales service.
We help foreign medical device manufacturers in our role as China agent with our practical approach.
Clinical Situation China
For the registration file in China, one of the required documents is Clinical Evaluations. Although you should have this document for your EU and US registrations, the requirements in China are slightly different. China positions the clinical safety in between the requirements of the EU (Notified Bodies) and the US (FDA). The new acceptance criteria on clinical data are published since early 2018, while the new clinical requirements have been updated in 2021.
Submission technical file
The contents of preparing Submission Technical File are rapidly changing over the years accompanied by the updated China governance MD supervision regulations and registration administration measures.
China is currently following the IMDRF working document to review the Table of Contents as its TF checklist, and IMDRF clinical guidance documents to require the clinical evaluation files. A good starting point is to get familiar with these international documents and perform internal gap assessment. Another new requirement for foreign manufactures is part of their oversea quality system files are requested to be included in the submission package.
China regulations have been dynamically changed. One of the impacts is that the China Health Authority has increased the overseas manufacturing site inspection. These are audits comparable to MDSAP, Notified Bodies and US FDA. It is a potential risk to the foreign manufacturers if they are not aware of the gaps between China requirements and their own countries. Major non-conformity notice may lead to certificate suspension/cancellation. Mock-audits and trainings to get prepared for the China Health Authority inspection teams are important factors to consider for internal QMS manageme