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The statement itself is wrong, medical devices simply do not have GMP certification that, GMP is the drug industry certification, medical devices is called production quality management standard, generally referred to as GMP. national bureau also does not recognize the device GMP this call. In fact, it is the so-called medical device system assessment, in accordance with this specification after acceptance Approach System assessment notification, covering your application for the system assessment through the product. If there is no new product first registration or re-registration of the old product, in a not a new start-up enterprise can not apply for this assessment.