In order to promote the high-quality development of the medical device industry, implement the Opinions of the National Standardization Management Committee of the National Drug Administration on Further Promoting the High Quality Development of Medical Device Standardization, and further improve the organizational system for medical device standardization, the National Drug Administration has decided to establish a centralized unit for standardization technology of oral digital medical devices.

It is hereby announced.

Attachment: Composition Plan of Centralized Technical Management Unit for Standardization of Oral Digital Medical Devices

State Drug Administration

March 8, 2023

Composition scheme of centralized technical management unit for standardization of oral digital medical devices

The centralized unit for standardization technology of oral digital medical devices is mainly responsible for the formulation of basic general standards, management standards, testing and evaluation method standards, product standards, standards related to reference materials, and other relevant standards in the professional field of oral digital medical devices nationwide.

Basic general standards include terms and definitions related to oral digital medical devices, and management standards mainly include risk management, quality system, research and development design, etc; The testing and evaluation method standards mainly involve the testing and evaluation method standards exclusive to oral digital medical devices and products; Product standards mainly include software, equipment, materials, etc. for the design of oral digital medical devices.

The personnel list of the first centralized technical management unit for standardization of oral digital medical devices is shown in the table below. The secretariat is undertaken by the Oral Medical Device Inspection Center of the School of Stomatology, Peking University. The Medical Device Standards Management Center of the State Drug Administration is responsible for business guidance.