Medical device registration in China is a complex and lengthy process that requires a thorough understanding of the regulatory framework and compliance requirements. The process can take anywhere from several months to a few years, depending on the type of device and the complexity of the application.

Here are some of the key steps involved in the medical device registration process in China:

Determine the classification of the device: The first step in the registration process is to determine the classification of the medical device according to the Chinese classification system. There are three classes of medical devices in China: Class I, Class II, and Class III.

Compile the technical documentation: The next step is to compile the technical documentation required for registration. This includes information on the device's design, manufacturing process, safety and efficacy data, and clinical trial results.

Submit the application: Once the technical documentation is complete, the application can be submitted to the National Medical Products Administration (NMPA).

NMPA review: The NMPA will review the application to ensure that the device meets the safety and efficacy requirements for registration. The review process can take several months to a few years, depending on the complexity of the device and the quality of the application.

Clinical trials: If the device is classified as Class II or Class III, clinical trials may be required to demonstrate safety and efficacy. The clinical trial process can take several months to a few years.

Registration certificate issuance: If the application is approved, the NMPA will issue a registration certificate, which allows the device to be sold in China.

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