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:
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 English version of Using Chinese Name for Imported Medical Devices, and Regulation on Instructions for Use and Labels of Medical Devices, please email info@ChinaMedDevice.com.
About China Med Device, LLC
China Med Device, LLC (www.ChinaMedDevice.com), a Boston headquartered company, provides regulatory and commercialization turnkey solutions for western medical device, IVD and combination-product companies to enter China. Our NMPA (CFDA) regulatory services include: regulatory strategy, RA, clinical evaluation, clinical trial, QA, GMP and post-market compliance. Our commercialization services include: market assessment research, reimbursement, partnership, distribution qualification and management. We are a NMPA (CFDA) certified legal agent. With offices in Boston and Beijing, we can service our clients 24/7.