CFDA has a new requirement that foreign applicants, registrants and filers shall use Chinese languages for company name in medical device registration.
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The Chinese company name should meet the following requirement:
- Use simplified Chinese.
- CN company name should be consistent with the content in foreign language.
- The same company shall use the same CN company name.
The Chinese company name will be used in registration certificate, Chinese labels and IFU.
For more detailed information or English version of the documents, please contact us at info@ChinaMedDevice.com
About China Med Device, LLC
We provide turn-key solutions for western medical device/IVD companies to enter China with regulatory and commercialization services. Our CFDA regulatory services cover strategy, premarket submission, clinical evaluation, CRO, post market compliance as well as legal agent representation. Our management team in Boston and Beijing have processed 1,200+ certificates. Email info@ChinaMedDevice.com or visit www.ChinaMedDevice.com
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Grace Fu Palma
China Med Device, LLC
MA, U.S.
gpalma@chinameddevice.com978-390-4453
www.chinameddevice.com------------------------------