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 Staff
2. Work environment and Equipment
3. Control of Documents and Records
4. Design and Development
7. Control of Quality
With 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.