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.
In China, medical devices are divided into three risk level categories: class I, class II and class III. For the higher risk classifications, there is again a division in requirements. For this reason, it is important to have confirmation of the classification before starting the registration process.
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China Compliance check
China regulations changed rapidly in the last 3 years and the impacts are now to be seen. The impact on the inspection regulation has resulted in last year that China Health Authority has performed X overseas inspections. These are audits comparable to MDSAP or Notified Bodies. It is an additional burden for the manufacturer with potentially high risks if you are stopped selling to China. Preparations for these audits are becoming increasingly important. Mock-audits to prepare the organization for the China Health Authority inspection teams are a successful tool.
To access the Chinese market with a medical device, you must acquire the Medical Device Registration Certificate from the China Food and Drug Administration (CFDA). In case you do not have a subsidiary in China, you have to appoint a local legal agent and service agent to deal with registration and after-sales service.
We help foreign medical device manufacturers to find suitable local distributors in China through a practical approach. Through extensive international and local networking, we can help to pool, short-list potential distributors, and to assist you to expand or change the existing distribution network.
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 requirement on clinical evaluation is to be released in 2019.