China NMPA Medical Device Registration

Market Access China

NMPA registration process

Qserve can help you obtain regulatory approval for your medical device or In Vitro Diagnostics (IVD) in China. Our experts work directly with the China Health Authority, coordinating the submission of regulatory files and answering the Health Authorities feedback.

Classification

In China, medical devices are divided into three categories based on their risk levels: class I, class II and class III. The classification in Europe or USA may not already reflect the correct category in China. Some innovative devices which are not included in the authority’s published category and coding system may involve further consultation with the designated authority to determine a proper one prior to submission.  Incorrect classification will lead to submission failure immediately without moving to the technical review phase.  For this reason, it is important to have confirmation of the classification before the starting the registration process.

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.

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.

Overseas inspection

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 awaring 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 management.