New NMPA guidelines for QMS

On 17.03.2020, the NMPA (National Medical Products Administration) issued (No.19-2020) the Inspection Guide for the QMS (Quality Management System) of Medical Device Registrations.According to the Guide, the registrant of the medical device is responsible for implementing a suitable QMS for the product realization process. The Guide specifies the requirements for the QMS involved in the entire product life-cycle of the medical device including, but not limited to the following:1. Internal Staff2. Work environment and Equipment3. Control of Documents and Records4. Design and Development5. Procurement6. Production7. Control of QualityWith the implementation of the new administrative measures and the issuance of the Inspection Guide, the NMPA aims to strengthen the quality supervision system of medical devices.