According to Article 103 of the Regulations on the Supervision and Administration of Medical Devices (State Council Order No. 739) implemented on June 1, 2021, medical devices refer to instruments, equipment, appliances, in vitro diagnostic reagents and calibrators, materials and other similar or related items, including required computer software, that are used directly or indirectly on the human body; their effectiveness is mainly obtained through physical means, not through pharmacological, epidemiological or metabolic means, or although these means are involved, they only play an auxiliary role; their purposes are:
(i) diagnosis, prevention, monitoring, treatment or relief of diseases;
(ii) diagnosis, monitoring, treatment, relief or functional compensation of injuries;
(iii) inspection, replacement, regulation or support of physiological structures or physiological processes;
(iv) support or maintenance of life;
(v) control of pregnancy;
(vi) providing information for medical or diagnostic purposes by examining samples from the human body.
Classification and management of medical devices
The state implements classification 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 through routine management (such as scalpels, surgical caps and surgical gowns, etc.).
The second category is medical devices with moderate risk, which require strict control and management to ensure their safety and effectiveness (such as thermometers, sphygmomanometers, etc.)
The third category is medical devices with high risk, which require special measures to strictly control and manage to ensure their safety and effectiveness (such as vascular stents, etc.).
The current “Medical Device Classification Catalog” was issued by the former State Food and Drug Administration in 2017 Announcement No. 104, and was adjusted and updated by the State Drug Administration in 2020 Announcement No. 147. In accordance with the relevant requirements of the “Medical Device Supervision and Administration Regulations” and the “Working Procedures for Dynamic Adjustment of the Medical Device Classification Catalog”, the State Drug Administration will adjust some contents of the “Medical Device Classification Catalog”.
According to the “Medical Device Supervision and Administration Regulations”, Class I medical devices are subject to product filing management, and Class II and Class III medical devices are subject to product registration management.
For the registration of Class I medical devices, the registrant shall submit the registration materials to the drug supervision and management department of the municipal people’s government where the registrant is located. For the registration of Class II medical devices, the registrant shall submit the registration application materials to the drug supervision and management department of the provincial, autonomous region or municipal people’s government where the registrant is located. For the registration of Class III medical devices, the registrant shall submit the registration application materials to the drug supervision and management department of the State Council.
The medical device registration certificate is valid for 5 years.