The drug administration of all provinces, autonomous regions, municipalities directly under the central government and Xinjiang production and Construction Corps and relevant units:

The unique identification system of medical devices is an important measure to implement the regulations on the supervision and administration of medical devices, effectively promote the reform of the State Council in the governance of high-value medical consumables and the deepening of the reform of the medical and health system. It is an important means to innovate the supervision mode, improve the supervision efficiency, strengthen the fine management of the whole life cycle and promote the high-quality development of the industry. Since the implementation of the first batch of unique identification of medical devices was carried out on January 1, 2021, the unique identification has been successfully demonstrated and applied in the whole chain of production, circulation and use of medical devices, which has greatly promoted the whole chain linkage of medical devices from source production to clinical use.

In order to further promote the only sign and demonstration, the State Pharmaceutical Regulatory Commission has organized the selection of the demonstration unit of the only identification model in the field of medicine, health and medical insurance. It has consistently advanced and demonstrated the characteristics of the first batch of 15 medical devices.

Each unique identification implementation demonstration unit should further expand the implementation and application of unique identification, actively connect with upstream and downstream, and strengthen the whole chain linkage of unique identification; We should further sum up experience, form a long-term mechanism, constantly improve the work level and give full play to the leading and exemplary role; A specially assigned person shall be assigned to take charge of the training, reasonably formulate the training plan according to the training needs, seriously organize the publicity and implementation training and observation and learning of the unique logo, encourage cooperation and exchange among demonstration units, further improve the effect of demonstration application, summarize the work of demonstration application every half a year and submit it to the State Food and drug administration.

All provinces (autonomous regions and municipalities) food and drug administrations should strengthen demonstration guidance, actively promote the construction of unique identification demonstration projects under their jurisdiction, formulate annual work plans, make full use of unique identification to implement demonstration units, expand areas from point to area, and solidly promote the effective implementation of the unique identification system. The demonstration and promotion work shall be submitted to the State Food and drug administration before the end of the year.

It is hereby notified.

Annex: list of the first batch of demonstration units for the implementation of unique identification of medical devices

Comprehensive Department of the State Food and Drug Administration

January 26, 2022

enclosure

List of the first batch of demonstration units for the implementation of unique identification of medical devices

一、 Unique identification implementation demonstration unit (registrant)

1. Beijing Aikang Yicheng Medical Equipment Co., Ltd

2. Shanghai minimally invasive medical devices (Group) Co., Ltd

3. Shenzhen Mairui Biomedical Electronics Co., Ltd

4. Weigao Group Co., Ltd

5. Nanwei Medical Technology Co., Ltd

6. Boke International Trading (Shanghai) Co., Ltd

7. Mike biology Co., Ltd

二、 Unique identification implementation demonstration unit (operating enterprise)

1. China Medical Devices Co., Ltd

2. China Resources Guangdong Pharmaceutical Co., Ltd

三、 Unique identification implementation demonstration unit (user)

1. Beijing Shijitan Hospital

2. The First Affiliated Hospital of Sun Yat sen University

3. Shanghai First People's Hospital

4. The Third Hospital of Peking University

5. The First Affiliated Hospital of Zhengzhou University

6. Quanzhou Zhenggu hospital

Source: State Drug Administration