The liberalization of medical device registration and inspection has allowed more and more inspection institutions not affiliated to the Food and Drug Administration to have the qualification and scope of medical device inspection, so that medical device registrants have more options in medical device registration and inspection. The nature of the profit organization of the third-party medical device registration and inspection agency determines the better service and more market-oriented, but because the third-party inspection agency needs to adapt to the existing review and approval mechanism, it takes a certain amount of time to accumulate experience and experience.
What should medical device registrants pay attention to when entrusting a qualified third-party inspection agency?
The medical device registrant shall entrust a qualified medical device inspection agency to conduct the inspection, which shall comply with the relevant provisions of Article 75 of the Regulations on the Supervision and Administration of Medical Devices.
When the technical requirements of the product do not involve or partially involve national standards and industry standards, the inspection agency shall self-declare the inspection ability in the remarks of the inspection report, and the registrant shall submit the inspection report and the qualification certificate (CMA certificate) of the inspection agency.
When the technical requirements of the product fully adopt the national standards and industry standards, the inspection agency shall stamp the qualification certification mark CMA seal on the cover of the inspection report and indicate it in the remarks of the report, and the registrant shall submit the inspection report, the catalogue of the scope of inspection (the attached table of the qualification certificate of the inspection and testing institution - the scope of inspection and testing ability), and the qualification certificate of the inspection agency (CMA certificate).