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.
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).
For a copy of this guideline, please email info@ChinaMedDevice.com