Foreign Medical Device Applicants are Required to Supplement the Chinese Information to CFDA

Food and Drug Administration (CFDA) issued an announcement about 'The Applicant Name, Address and Manufacturing Site for Imported Medical Device Registration and Filing Should be in Chinese' (CFDA Notice No. 131, 2017). According to the announcement, any imported medical device registration should change the company names into Chinese before Dec.31st 2018 and the initial imported medical device registration is required to submit the Chinese information from July 1st 2018.
 
Scope of Chinese Information Subject to CFDA
The registration applicants or registrant names for medical device registration in China (plan to register or already registered in CFDA).
 
General Principle on Chinese Use in CFDA Registration
  • The Chinese company names should be in simplified Chinese
  • The Chinese information should be consistent with the foreign language information
  • The Chinese name should be different from other applicants and be legal
 
The Procedure to Supplement the Chinese Information for Medical Device Registration or Filing in China
  • For the already registered or recorded imported medical device, foreign medical device manufacturers can supplement the Chinese company names through Registration Change Application Process based on CFDA regulations
  • When Chinese company names changed, applicants should apply for Registration Change from CFDA
  • The declaration of Chinese company names should be complied with the CFDA regulations and be consistent with the information filled in the application form.
 
Enforcement Timeline

Timeline Scope Act plan
From July 1st2018 Application of initial registration, registration renewal, registration change or record Fill the Chinese company name in the application forms
Before Dec 31st2018 Already recorded class I medical devices Apply for record-keeping change to supplement the Chinese company names.
From Jan 1st2019 For all imported medical devices Provide the Chinese instructions, label with Chinese company names.
 
The Cost and Duration to Chinese Information Supplement Application
For the already registered medical devices, foreign medical device manufacturers are required to apply for registration change to supplement the Chinese company names. This application is not an administrative process under CFDA regulations, so it is free of charge from CFDA. And it will take within one month (may be one or two weeks) to obtain the approval.
 
CIRS can Help Foreign Medical Device Manufactures to Comply with This New CFDA Polices:
  • Translate Chinese company names
  • Review the Chinese company names
  • Applications of registration change to supplement the Chinese information
  • Applications of China Legal Agents change from CFDA
  • Prepare the declaration of Chinese information and related Chinese documents
  • Coordinate with the China authorities to obtain the CFDA approval
  • Regulations training provided
*If you have any comments or questions, please contact us at md@cirs-group.com
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Mrs.Emily (Beijing office)
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