We can guide you through the complete CFDA Medical Device approval processes
Qserve can help you obtain regulatory approval for your medical device or In Vitro Diagnostics (IVD) in China. Our experts work directly with the CFDA, coordinating the submission of regulatory files and answering the CFDA feedback.
In China, medical devices are divided into 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.
"China is a challenging market, but our China team have the regulatory knowledge to help you succeed"
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.
We help foreign medical device manufacturers to find suitable local distributors in China through a practical approach. Through extensive international and local networking, we can help to pool, short-list potential distributors, and to assist you to expand or change existing distribution network.
China Regulatory Strategy
Legal agent and service agent
Determine Device Classification
CFDA Mock audit
prepare CFDA submissions