China will implement classified management of medical devices

Business Club September 7th The State Council Legislative Affairs Office announced on the 6th the "Regulations on Medical Device Supervision and Management (Draft for Comment)" stipulates that the state implements classified management of medical devices.

The draft of the Opinions stipulates that medical devices may be classified into three categories according to the expected purpose, structural characteristics, use patterns, and the state of use of medical devices. The risks are relatively low for Class I medical devices; The third category of medical devices, such as implanted into the human body or used to support and sustain life of medical devices, etc.; the degree of risk between the first and third types of medical devices for the second type of medical devices.

Among them, the state will implement the record management for the first type of medical equipment, and implement registration management for the second and third types of medical equipment.

The Exposure Draft stipulates that the first type of medical device should be filed and no clinical trials are required. Clinical trials are required to apply for registration of Type II and Type III medical devices. However, clinical trials may be exempted from clinical trials in any of the following circumstances: the working mechanism is clear, the design is finalized, the production process is mature, and the clinical application is not serious for many years. Records of adverse events that do not change conventional use; Non-clinical performance evaluation can prove its safety and effectiveness; Analysis and evaluation of data obtained from clinical trials or clinical use of similar products can prove its safety and effectiveness. of.

The draft of the consultation also stipulates that the import of the first type of medical device should be filed with the State Food and Drug Administration. The import of the second type and the third type of medical device should be applied to the national food and drug supervision and administration department for product registration.