Registration process in China

In China medical devices are divided in 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 the confirmation of the classification before starting the registration process. Also the Clinical performance of your devices become more and more important. It is therefore important to realize upfront what your clinical position is with your devices in the Chinese market.

To access the Chinese market with a medical device, you must acquire the Medical Device Registration Certificate from the China Food and Drug Administration (CFDA). In case you do not have a subsidiary in China, you have to appoint a local legal agent and service agent to deal with registration and after-sales service.

 

China is not an easy country to enter. You need patience and a local contact person who understands the culture and is able to constantly keep updated with the regulations that are changing constantly. Depending on your product, this registration process might take 1 to 3 years. But do not worry, we set up a strategy together with you and take care of the communication with the Chinese authorities.

What can we do for you?

Market Research based on your medical device

Clinical Evaluation and Clinical Strategy

Building a Regulatory Strategy Plan

CFDA Registration

 

China Representative / Agent service

Chinese Clinical Studies

 

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