Medical devices are subject to classified management, specifically divided into the following three categories:
The first category refers to medical devices whose safety and effectiveness can be guaranteed through routine management.
The second category refers to medical devices whose safety and effectiveness should be controlled.
The third category refers to medical devices that are implanted in the human body; are used to support and maintain life; are potentially dangerous to the human body and whose safety and effectiveness must be strictly controlled.
Class I products are registered by the municipal and prefecture-level drug regulatory authorities.
Class II products are registered by the provincial drug regulatory authorities.
Class III products are registered by the national drug regulatory department.
Legal basis:
Regulations on the Supervision and Administration of Medical Devices
Article 1 In order to ensure the safety and effectiveness of medical devices and protect human health and life safety, Establish these regulations.
Article 2 Those engaged in the development, production, operation, use and supervision of medical devices within the territory of the People’s Republic of China must comply with these Regulations.
Article 3 The Food and Drug Administration Department of the State Council is responsible for the supervision and administration of medical devices nationwide. The relevant departments of the State Council are responsible for the supervision and management of medical devices within the scope of their respective responsibilities.
The food and drug regulatory departments of local people’s governments at or above the county level are responsible for the supervision and management of medical devices in their respective administrative regions. Relevant departments of local people's governments at or above the county level are responsible for the supervision and management of medical devices within the scope of their respective responsibilities.