After the festival came the good news: The customer of SUNGO providing technical services nanchang Hye Health Material Co., LTD successfully obtained the MDR certification of sterilizing mask issued by BSI. Our services for this client include CE MDR certification counseling provided by SUNGO China and EU authorized representative services provided by SUNGO Netherlands.
As a "visa" for products to enter the European market, MDR certification is a mandatory requirement for product access in the EU market. As a new regulation for the market access of medical devices in the EU, more stringent requirements are put forward for medical device manufacturers in terms of pre-market review, application scope, market regulation and traceability. The first MDR announcement institution certificate was issued, which opened the prelude of SUNGO's MDR consulting project, and played an important demonstration role in the subsequent certification work. It is a solid step on the road of SUNGO to serve global customers with high-quality compliance products.
SUNGO has long attached importance to the requirements of laws and regulations in various regions of the world, and at the same time, combined with a large amount of research and development investment, to quickly respond to the regulatory requirements of medical devices in the overseas market. The technical services provided to epidemic prevention material manufacturers this time include:
· CE registration of non-sterile materials (MDD and MDR)
· CE certification consultation for sterilized materials (MDD and MDR)
· PE directive announcement agency CE certification consultation
· FDA enterprise registration and device listing
· FDA 510K declaration service
· FDA EUA approval Service
· Canadian MDEL Registration
· Australian TGA registration
· NMPA product filing and production filing guidance
· MPA product registration and production licensing guidance