Current location - Health Road Network - Medical equipment - For design and construction, medical device workshop GMP requirements are not to follow the 2010 version of the GMP, there are other normative requirements?

For design and construction, medical device workshop GMP requirements are not to follow the 2010 version of the GMP, there are other normative requirements?

There is no official GMP for medical devices in SFDA,

So we should refer to the requirements of pharmaceutical production to build the corresponding plant.

The FDA has requirements for medical devices that are in direct contact with the human body,

Basic requirements are the same as those for pharmaceuticals

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