China CFDA Registration process 


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.

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.

Initiate and expand your China Sales channel

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.

Our services:

 

Regulatory Affairs

Regulations vary depending on the medical device and market you wish to enter. Our teams offer support for all regulatory compliance issues worldwide.

  

Clinical Affairs

Experience a practical approach based on your existing regulatory data. Our team supports the medical writing of clinical evaluations (MEDDEV 2.7.1.), as well as full-service CRO activities.

  

Quality Assurance

Implement and maintain a Quality Management System (QMS) to ensure your medical device meets certain specifications and requirements.

 

 

  

Auditing

Audits are executed to determine regulatory compliance and improve the effectivity of your internal processes and those of your subcontractors and suppliers



 

 

Training

In-house knowledge of regulatory and quality requirements facilitates the product-to-market process and provides insight into clinical safety and performance.



  

Global Registration

Health authorities determine market approval based on different dossier formats and requirements. With our global network, we cover a large percentage of markets around the world.




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