CFDA: Be Prepared to Have Company Name in Chinese on Your Device Label

Monthly CFDA News Roundup (January 2018)
February 8, 2018
New CFDA Technical Review Guideline for CT
February 13, 2018

CFDA: Be Prepared to Have Company Name in Chinese on Your Device Label

CFDA has a new requirement that foreign applicants, registrants and filers shall use Chinese languages for company name in medical device registration. The Chinese company name should meet the following requirements:

1. Use simplified Chinese.

2. Chinese company name should be consistent with the content in foreign language.

3. The same company shall use the same Chinese company name.

The Chinese company name will be used in registration certificate, Chinese labels and IFU.