Whether imports of equipment based medical device classification categories?

I now want to apply for the import agent chemiluminescence apparatus medical equipment production license, does this instrument imported and domestic division of whether the instrument, are based on "Medical Device Category " and classify Ⅰ, Ⅱ, Ⅲ Class, thank you! Please help!

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Not the same


Classification is yes, but all imported equipment of the registration certificate (not a production license) by the State Food and Drug Administration review process.

Does the product is produced in the country for it?
If it is in domestic production, foreign manufacturers of brand affixed in accordance with domestic regulatory instruments, the need for manufacturers license, product registration card in the declaration, in accordance with the domestic medical equipment category classification.
If the imported products, but also need to follow the requirements of the directory category by product category, the State Food and Drug Administration to declare up.
Problems in the production license only for the domestic production of equipment are required.


"Imports of medical equipment production license", without this thing. State Food and Drug Administration issued the import certificate of registration of medical devices, according to the audit made ​​three types of standards. chemiluminescence instruments are two types of medical devices in China. ISO13485 approved more To the more difficult