I. Definition of medical devices
According to the Supplementary Provisions of Chapter VIII of the Regulations on the Supervision and Administration of Medical Devices (the State Council Order No.650 of the People's Republic of China), the definition of medical devices refers to instruments, equipment, appliances, in-vitro diagnostic reagents and calibrations, materials and other similar or related items directly or indirectly used in the human body, including the required computer software; Its utility is mainly obtained by physical means, not by pharmacology, immunology or metabolism, or it only plays an auxiliary role although these methods are involved; Its purpose is:
(1) Diagnosis, prevention, monitoring, treatment or remission of diseases;
(2) Diagnosis, monitoring, treatment, mitigation or functional compensation of injury;
(3) Examination, substitution, adjustment or support of physiological structure or physiological process;
(4) Support or maintenance of life;
(5) Pregnancy control;
(6) To provide information for medical or diagnostic purposes by examining samples from human bodies.
Second, the classification of medical devices
The state implements classified management of medical devices according to the degree of risk.
The first category is medical devices with low risk, which can be guaranteed to be safe and effective by routine management.
The second category is medical devices with moderate risks, which need strict control and management to ensure their safety and effectiveness.
The third category is medical devices with high risks, which need to be strictly controlled and managed by special measures to ensure their safety and effectiveness.
To evaluate the risk degree of medical devices, we should consider the expected purpose, structural characteristics and use methods of medical devices.
III. Classification Catalogue of Medical Devices
The State Council Food and Drug Administration is responsible for formulating the classification rules and catalogues of medical devices, and analyzing and evaluating the risk changes of medical devices in a timely manner according to the production, operation and use of medical devices, and adjusting the catalogues. To formulate and adjust the classification catalogue, we should fully listen to the opinions of medical device production and operation enterprises, users and industry organizations, and refer to the international medical device classification practice. The classified catalogue of medical devices shall be announced to the public.
I believe everyone has a certain understanding of all the above.