Regulations on self-inspection of medical device

On October 22, the National Medical product Administration issued the regulations on the self inspection management of medical device registration (including in vitro diagnostic reagents) and standardize the self inspection of registration applicants, which shall come into force as of the date of promulgation. The regulations on the supervision and administration of medical devices () clearly states that the product inspection report submitted during the registration of medical devices can be the self inspection report of the medical device registration applicant / registrant or recorder, or the inspection report issued by a qualified medical device inspection institution entrusted. The regulationsRead More →

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