Medical Device 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

Medical
Devices
Approval Testing Clinical
Trial
Authorities Deadline
Class I Record
Self-
 testing
N/A CFDA Pre-market
Class II
Initial
 Registration
Required Required CFDA Pre-market
Updates TBA TBA CFDA Within 1months after being updated
Renewal TBA N/A CFDA 6 months before the date of  certificate expired
Class III
Initial
 Registration
Required Required CFDA Pre-market
Updates TBA TBA CFDA Within 1months after being updated
Renewal TBA N/A CFDA 6 months before the date of  certificate  expired
 
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
How to Get the Free Registration Proposal
You will get the free registration proposal upon your requests via email, application form or fill out the form online. If you have any questions, please feel free to contact us.

Email
Please send your request for free proposal @
Mr. Edwin Wen | Edwin.wen@cirs-group.com , or
Mr. Michael Petersen| Michael@cirs-group.com
 
Application Form
Please download this Application Form, complete it and send it to Mr. Edwin Wen via email or fax.
Email: Edwin.wen@cirs-group.com
Fax: (0086) 571-87206533
 




 
Contact Us
CIRS China

Ms. Elaine (Head office)
Tel: +86-571 87206559 | Fax: +86-571 87206533
Email: md@cirs-group.com
Mrs.Emily (Beijing office)
Tel: +86-10 63984062 | Fax: +86-10 63984032
Email: md@cirs-group.com

CIRS Europe

Ms. Louise Halpin
Tel: +353 41 9806 916 | Fax: +353 41 9806 999
Email: md@cirs-group.com