China
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.
Overseas inspection
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.