As per the regulations Regulations for the Supervision and Administration of Medical Devices, Administrative Measures for Medical Device Registration, Administrative Measures for IVD Registration and Regulations on Manuals and Labeling of Medical Devices and so on, Chinese should be used for the name of the registrant or file submitter for the imported medical devices marketed or to be marketed in China.
For further implementation of the relevant requirements, meeting public needs and accepting social supervision better, the following announcement is developed on related issues about using Chinese for the name of the registrant or file submitter for the imported medical devices.（Registrant or file submitter for the imported medical devices will be called “company” below:
1. Principles for using Chinese information
1) Chinese should be translated by the company itself as per translation principle. Simplified Chinese should be used as Chinese name of the company, and also should comply with general language specification of China.
2) The Chinese name should be corresponding to the foreign name, addition or deletion is not allowed. One company should have only one Chinese name.
3) Related contents which are detrimental to China or public interest, or causing deceit or misunderstanding to the public, or prohibited by other law, regulation, norms are not allowed to be included in the Chinese name.
Principlely, Chinese company name is not allowed to be changed if the foreign company name keeps same. If the Chinese name is to be changed as per regulation, registration licensing matters or filing changing should be carried out.
2. Requirements on procedure and submission documents
Registrant or file submitter of the imported medical devices whose CFDA certificates have been issued, the Chinese name can be added by registration licensing matters or filing changing.
Statement on Chinese name of the company should be submitted, and also the information about the company name complying with the announcement, as well as the information about related responsibility of the company should be included in the statement, in which the Chinese name should be consistent with that in the application form. In addition, signature/seal of the statement should be consistent with that in other submission documents.
One original statement on the Chinese name is enough for the company who has more than one product, for which the Chinese name is same. Photocopy of the statement for other products with only seal of the China agent (without signature/seal of the company) for such change can be accepted if source of the original can be marked and consistency of the original and photocopy is promised by the China agent.
3. Requirements on time
1) From the date the announcement is issued, Registrant or file submitter of the imported medical devices whose CFDA certificate have been issued could add the information of Chinese company name through licensing matters changing or filing changing
2) From July 1st, 2018, when applying for initial registration, renewal, licensing matters changing and filing, Chinese company name should be filled in the application form.
3) For imported class I medical devices whose CFDA certifiacate was issued, but without showing the Chinese company name, the Chinese name should be added before Dec. 31th, 2018.
From January 1st, 2019, all imported class I medical devices manufactured after January 1st, 2019, Chinese company name should be included in the Chinese IFU and Label, and should be consistent with informaiton for filing, and should be consistent with that for filing or filing changing.
4) For the imported class II, III medical devices whose CFDA certificates have been issued, if with same company name, the company should apply for at least one changing certificate to add the Chinese company name before December 31th, 2018; CFDA registration certificates of other medical device don’t have to be changed independently but can apply for changing together with renewal or changing other items. Chinese IFU and labels can be printed as per the Chinese company name included in the CFDA certificate of the product whose Chinese name has been approved.
From January 1st, 2019, all imported class II and III products manufactured after January 1st, 2019, Chinese company name should be included in the Chinese IFU and Label, and should be consistent with that in the CFDA certificate of the product (or other products with same company name).
4. Other items.
Should any disputes occur due to the Chinese company name, it should be solved as per related law and regulations.
Hereby notified the above.
China Food and Drag Administration
Oct. 31th, 2017
