Regulatory Strategy for Medical Devices in China

China's medical device market is about $7.5 billion. To be successful in this market, medical device companies need an excellent regulatory strategy.

China Medical Device Regulations

The first step to developing your medical device regulatory strategy is to classify your products. Sometimes, your medical product may be classified one way in the U.S. or the EU but differently according to China medical device regulations. If your product classification is not clear, you can summarize your rationale and the SFDA will send the information to hundreds of doctors throughout China for clarification.

If your company does not sell any medical device products in China, and then enters the market with a Class 3 medical device, clinical trials in China will often be required to support the product registration.

According to SFDA regulations, product registration in China not only involves submitting a dossier, but also type testing. Companies develop a Product Standard detailing the specification of their product and how to test for those specifications. A Testing House in China will then conduct the tests on samples based on that Product Standard. Make sure to pick the right Testing House who is experienced in your kind of medical device.

Bundling medical devices' product registration may be possible in certain situations. Another thing to keep in mind is to register as many models and iterations of your product as possible. Adding new models to an existing product registration can sometimes mean a whole new registration.

For more information issues regarding medical device regulations in China, please see the following PBM publications and/or contact us to discuss your specific needs.

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