Work specifications for medical devices inspection

On September 6, the National Medical Products Administration issued the work specifications of medical device inspection to improve the inspection ability and management level of medical device inspection institutions, and to improve the quality and efficiency of medical device inspection. Those specifications are applicable to the inspection institutions that conform to the Regulations on the Supervision and Administration of Medical Devices, Measures for the Administration of Qualification Recognition of Inspection and Testing Institutions, and Conditions for Qualification Recognition of Medical Device Inspection Institutions. Specifications first make detailed requirements for institutions and personnel, sample management, inspection, reporting and recording, ethics andRead More →

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