Summary of the key points:
• The medical device manufacturing company supervision platform (MDMCSP) was put into trial operation on May 5, 2019.
• The platform will be used to integrate medical device life cycle and production company related data.
• The platform is scheduled to be officially put into use nationwide in the fourth quarter of 2019.
After a one-year preparation, the NMPA's first smart supervision platform in the field of medical device supervision business, “Medical Device Manufacturing Company Supervision Platform (MDMCSP)” was put into trial operation on May 5, 2019. Seventeen provinces will try the platform first. And fourteen provinces that already have similar systems will carry out data docking test operation. After the platform is revised and improved, it is scheduled to be officially put into use nationwide in the fourth quarter of 2019. The intention of the platform is to further improve the medical device manufacturing supervision mechanism and improve the supervision efficiency. The platform will be used to integrate medical device life cycle and production company related data.
The platform has the following main features:
• The platform has been introduced into the “National Key Regulatory Medical Device Catalogue”, “Regulations on Classification and Supervision of Medical Device Manufacturing Companies” and other regulations. It can automatically match the company and product information to form the inspection frequency requirements for related companies and medical devices, and form standard electronic processes and forms for Inspection plan development, inspection of inspectors, release of inspection tasks, etc.
• While being able to provide static information and dynamic data of manufacturing companies, products and inspectors in real time, the platform can also conduct statistical analysis according to standards such as region, product, personnel, inspection defects, and risk level.
• The platform focuses on medical device manufacturers, and comprehensively connects the medical device related information (including manufacturing license, product registration, supervision and inspection, sampling inspection, recall, etc.) of each system to achieve the goal of updating manufacturing companies’ information in real time.
China Medical Device Regulation Related Resources provided by CIRS:
• China NMPA Medical Device Filing and Registration Consulting
• Clinical Trial Consulting
• Medical Device GMP System Assessment
• China Medical Device Regulation Training
• Guideline: Medical Device Registration in China
• Annual Report: Medical Device Market in China