Decree 131 Announcement On Using Chinese Name For Registrant Or File Submitter Of Imported Medical Devices

CFDA Announcement on Using Chinese Name for Registrant or
File Submitter of Imported Medical Devices（No. 131, 2017）
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:
I. 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 alsoshould
comply with general language specification of China. 2) The Chinese name should be corresponding to the foreign name, addition or deletionis
not allowed. One company should have only one Chinese name. 3) Related contents which are detrimental to China or public interest, or causing deceitor
misunderstanding to the public, or prohibited by other law, regulation, norms are not
allowed to be included in the Chinese name. 4) Principally, Chinese company name is not allowed to be changed if the foreigncompany
name keeps same. If the Chinese name is to be changed as per regulation, registration
licensing matters or filing changing should be carried out.
II. 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.
III. Requirements on time
1) From the date the announcement is issued, Registrant or file submitter of theimported
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, licensingmatters
changing and filing, Chinese company name should be filled in the applicationform. 3) For imported class I medical devices whose CFDA certifiacate was issued, butwithout
showing the Chinese company name, the Chinese name should be added before Dec. 31th, 2018. 4) 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