Medical Product Registration in China

Registration of Medical Devices in China
Registration of Pharmaceuticals/Drugs in China

Although China's medical regulatory bodies are becoming more harmonized with international standards, the Chinese registration process can still pose significant difficulties for Western medical device and pharmaceutical firms. All imported products must be registered, and Chinese regulators are short-handed. Most medical products require local testing (also called type testing), while others also require local clinical studies. Therefore, proper knowledge and experience of the Chinese regulatory system is essential to get a product approved.

The regulator of medical devices and pharmaceuticals in China is the State Food and Drug Administration (SFDA), which handles medical device and pharmaceutical registration as well as many other regulatory issues. All imported medical devices and pharmaceuticals in China (including Class I medical devices) must be approved directly by the SFDA before they can be marketed. Certain medical devices must also receive China Compulsory Certification (CCC) from the General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ).

PBM's expertise will help you navigate the Chinese regulatory system, achieve medical product registration, and access the huge Chinese medical markets. PBM will help you register your medical product in a cost-effective and timely way.

For more information on medical product registration in China, please see the following PBM publications and/or contact us to discuss your specific needs.

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