Dear collegues,
I'd like to know your experience with medical device registration process in China. In particular I'm looking for share experience in the registration of combination product (Medical Device + IVD). The company I work for manufactures products that combine medical device class IIa (93/42/EEC) and a general IVD (98/79/EEC). In Europe we market the product as a Medical Device class IIa. We are registering the product in China and SFDA considers the product as two separate product so they apply different requirement for the medical device and IVD. Do you think there's a way to explain to SFDA the product must be registered as a unique product as the single components alone cannot reach the product intended use?
Thanks for your help
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Alberto Poli
Regulatory Affairs Manager
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