EMERGO SUMMARY OF KEY POINTS:

• Chinese medical device regulators want to require foreign registrants’ company names and addresses to be provided in Chinese.
• New Chinese market applicant would be impacted by this requirement starting in January 2018.
• Existing CFDA registrants would have to comply by the end of 2018.

The China Food and Drug Administration (CFDA) has proposed requiring foreign medical device manufacturers to provide their company information in Chinese as part of their registration submissions; currently, the regulator accepts this information in English as well.

According to the CFDA’s draft regulation (link in Chinese), foreign registration applicants would have to translate their company names and addresses into simplified Chinese; applicants may translate this information on their own as long as their translations are “consistent” with their English names. However, for applicants with representative offices in China, these firms’ Chinese names should be the same as the names of their Chinese representative offices.

How existing CFDA registrants will be affected

According to Emergo consultants in Hong Kong, foreign medical device companies already registered with the CFDA will have to take the following steps depending on their device classifications:

• Class I: Registrants will have to submit change notifications that add company name and address information in Chinese no later than December 31, 2018. For devices manufactured after January 1, 2019, Indications for Use (IFU) and labels should include manufacturer information translated into Chinese.
• Class II and III: Registrants should submit administrative modifications for at least one of their device registrations by December 31, 2018 that include Chinese translations of their company names and addresses. Firms’ other registrations may undergo updates when they apply for modifications or extensions for these products. Again, for Class II and III devices manufactured after January 1, 2019, IFU and labels must include manufacturer information in Chinese.

The CFDA will accept public and industry comment on the draft regulation through September 9, 2017. Once finalized and adopted, the regulation will take effect starting January 1, 2018 for foreign market applicants.

Additional Chinese medical device regulatory information:

• CFDA registration and approval support for medical device companies
• Agent Representation in-country representation in China
• Video overview: Chinese medical device registration