In 2011, BBS (IMDRF), the international medical device regulatory forum, raised the guiding final document of medical device UDI system, promoting the unique device label as the basic means of global medical device traceability. As a member of IMDRF, China has been committed to promoting the coding of medical devices
In February 2017, the notice of ‘The state council on the issuance of the 13th five-year national food safety plan and the 13th five-year national drug safety plan’ proposed to formulate coding rules for medical devices and build a coding system for medical devices.
On July 1, 2019, the comprehensive bureau of state food and drug administration, the national health committee general office jointly issued ‘The unique identification of medical equipment system pilot scheme’, the pilot scheme has been clear about the guiding ideology, basic principles, work objectives, the scope of the pilot, responsibilities, schedules, and safeguard measures, marks a unique identification system of medical equipment in China . The first batch of key experimental varieties are heart, brain implants, prostheses and other high-risk implant medical devices.
The unique mark of medical devices (UDI) is the id card of medical devices, which is the "international language" of medical devices. As an international practice, European and American countries and regions are actively promoting UDI system. In China, the industry has called to establish a UDI system for a long time, medical devices for each given id, which can realize every link of production, management, use of transparent, visualization, and improve the traceability of the product, to purify the market, optimize the business environment, improving the quality of medical services, power transformation and upgrading, and play a positive role in the healthy development of medical equipment industry.
According to the plan, the pilot will selected high-risk medical apparatus and instruments as a pilot varieties, fully mobilize the registrant of medical equipment, manufacturers, distributors and units used enthusiasm, encourage conditional units to participate in, to establish a unique identification of medical equipment system framework, to develop a unique identifier in medical equipment production, management and use of each link such as pilot application. To explore using a unique identifier for the medical device adverse event reports, product recall and implement applications such as tracking back, Moreover, the unique mark of medical devices can be connected and applied in medical treatment, medical insurance and other fields, and sharing data in registration and approval, clinical application, medical insurance settlement and other information platforms.
The pilot program clarifies the scope of the pilot: selected medical device registrants, manufacturers, distributors, users, etc. The pilot varieties are mainly medical devices with high-risk implantation such as heart, brain implants and prostheses, and cover different types of typical products.
The pilot program also defines the responsibilities and tasks of medical device registrants, manufacturers, distributors, users, code issuing institutions, trade associations, drug regulatory and health departments.
The pilot program will be launched in July 2019 and will be divided into five stages.
- The first stage is to determine the pilot variety and the participating units.
- the second stage is to organize and verify the creation and entrustment of unique marks for medical devices.
- The third stage is to organize and verify the functions of the unique identification database of medical devices and the standards of data upload, download and interface.
- In the fourth stage, the organization verifies the interdepartmental convergence and extension application of unique identification data.
- The fifth stage is to organize and hold the pilot summary meeting, form the pilot report, and improve the implementation plan of the first batch of products with unique labeling.
For the detailed pilot plan, you could find the source on NMPA official website: http://www.nmpa.gov.cn/WS04/CL2197/338683.html