NMPA

The NMPA (National Medical Products Administration) is the Chinese authority for the approval of medical produacts. The approval process consists of several phases, which can generally be summarized as follows:

1. preparation phase: in this phase, the necessary documents and data for approval are compiled. This includes clinical studies, safety and efficacy data as well as information on the manufacture and quality of the product.
2. submission phase: As soon as all the necessary documents are available, the application is submitted to the NMPA. The authority then checks the completeness and accuracy of the documents submitted.
3. evaluation phase: In this phase, the NMPA reviews the submitted data and carries out a comprehensive evaluation of the product. This includes a review of the clinical data, quality assurance and manufacturing processes.
4. inspection phase: If the product passes the evaluation, an inspection of the manufacturing site may be conducted by the NMPA to ensure that manufacturing standards are met.
5. approval phase: Once all previous phases have been completed, the NMPA can grant approval if all requirements are met.

The duration of each phase may vary depending on the product and individual circumstances. However, on average, the entire approval process in China can take several years. It should also be noted that there are specific requirements and procedures that may vary depending on the type of medical device.