From January 1st, 2019, China requires foreign company names to be provided in Chinese. The Chinese company name must meet following requirements:
ChinaMed Device, LLC can produce the label that meets the new NMPA (CFDA) requirement. Also, we can give you the file format which you can print locally, or we can print for you in China. info@ChinaMedDevice.com.
For all imported class II and III products manufactured after January 1st, 2019, Chinese company name must be included in the Chinese IFU and Label and must be kept the same name as in the approved NMPA certificate.
NMPA (CFDA) imposes severe penalties if IFU and labels are not in line with this regulation. Penalties include stopping production, suspension of importation and fines.
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.
ChinaMed Device, LLC (www.ChinaMedDevice.com), a Boston headquartered company, provides regulatory and commercialization turnkey solutions for western medical device, IVD, CDx and combination products to enter China. Our NMPA (CFDA) regulatory services include: RA, regulatory strategy, regulatory submissions, clinical evaluation reports (CER), clinical trials, QA, GMP and post-market compliance. Our commercialization services include: market assessment research, reimbursement, partnership strategies, and distribution qualification. We are a NMPA (CFDA) certified legal agent with offices in Boston and Beijing enabling us to service our clients 24/7.