Medical Device CFDA Registration & Approval

For all medical devices and in vitro diagnostic reagents(IVD), companies who plan to place medical products on Chinese market must apply for and acquire Medical Device Registration Certificate (Chinese:医疗器械注册证) from the China Food and Drug Administration (CFDA, former SFDA). Foreign firms should designate local legal agent and service agent to deal with registration and after-sales service if there is not subsidiary or representation office in China. 

Registration Scope

Any healthcare product meets the definition of medical device or IVD under CFDA regulations and is being to enter the Chinese market. The more information on how to determine the product regulatory obligation in China can be found here  

Types of Registration for imported Medical device

 
Flow Chart of Medical Device Registration Process
 

Procedure of Registration Management

Data Requirements for Medical Device Registration

1. Application form

2. Documents for evidence

3. The document to prove the safety and effectiveness of medical device

4. Summary related to the registered product

5. Study report (product designed, developed and verified report)

6. Manufacturing process explanation

7. Clinical evaluation documents

8. Product risk assessment report

9. Document of product technical requirements (former product standard)

10. Product test report for registration

11. Draft instructions and labels

12. Self assurance statement