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

August 8^th 2017, China Food and Drug Administration (CFDA) issued a solicitation letter about “The Applicant Name, Address and Manufacturing Site for Imported Medical Device Registration and Filing Should be in Chinese” (CFDA Notice No. 43 2017). According to the solicitation letter, any imported medical device registration should change the company names, address and manufacturing sites into Chinese before Dec.31^st 2018 and the initial imported medical device registration is required to submit the Chinese information from Jan. 1^st 2018.

Scope of Chinese Information Subject to CFDA
The registration applicants or registrant names, applicants’ address and manufacturing sites 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, address and manufacturing sites should be in simplified Chinese
The Chinese information should be consistent with the foreign language information
One applicants should be use only Chinese name and it should be consistent with the Chinese name of China branch office.
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, address and manufacturing sites through Registration Change Application Process based on CFDA regulations
When Chinese company names, address and manufacturing sites changed, applicants should apply for Registration Change from CFDA
The declaration of Chinese company names, address and manufacturing sites 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 Aug. 8^th 2017	Already registered or recorded imported medical devices	Apply for Registration change to supplement the Chinese company names, address and manufacturing sites
From Jan. 1^st 2018	Application of initial registration, registration renewal, registration change or record	Fill the Chinese company name, address and manufacturing sites in the application forms
Before Dec. 31^st 2018	Already recorded class I medical devices	Apply for record-keeping change to supplement the Chinese company names, address and manufacturing sites
From Jan. 1^st 2019	For all imported medical devices	Provide the Chinese instructions, label with Chinese company names, address and manufacturing sites

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, address and manufacturing sites. 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, address and manufacturing sites
Review the Chinese company names, address and manufacturing sites
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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