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
About China Med Device, LLC
China Med Device, LLC provides turn-key solutions for western medical device/IVD companies to enter China with regulation and commercialization services. Our CFDA regulatory services cover strategy, premarket submission, clinical evaluation, CRO, post market compliance as well as legal agent representation. Our commercial services cover market assessment research, reimbursement, partnership, distribution qualification and management. We have an office in Beijing, Suzhou and Boston. Our management team have 100+ years of combined experience in medical device and IVD and had been involved with 1,000+ CFDA certificates, 200+ western companies’ entry.