Notice of the National Medical Products Administration Comprehensive Department and the Office of the National Health Commission on Issuing the Pilot Program for the Medical Device Unique Identification System

National Medical Products Administration Comprehensive Department Notice of the Office of the National Health Commission on Issuing the Pilot Program for the Unique Identification System of Medical Devices

Drug Supervision Comprehensive Instrument Note 〔2019〕56No.

To all relevant units:

In order to strengthen the full life cycle management of medical devices, improve the effectiveness of medical device supervision and health management, and further ensure public safety in the use of medical devices, the National Medical Products Administration, in conjunction with the National Health Commission, is carrying out a pilot program for the unique identification system of medical devices. The "Pilot Program for the Unique Identification System of Medical Devices" is hereby issued for your earnest implementation.

National Medical Products Administration Comprehensive Department Office of the National Health Commission2019Year7Month1Day

Pilot Program for the Unique Identification System of Medical Devices

In order to implement the "Opinions on Deepening the Reform of the Review and Approval System and Encouraging Innovation in Drugs and Medical Devices" issued by the General Office of the Central Committee of the Communist Party of China and the General Office of the State Council, and the "Key Tasks for the Year" of the State Council's deepening of medical and health system reform, the National Medical Products Administration, in conjunction with the National Health Commission, is carrying out a pilot program for the unique identification system of medical devices. The following plan is hereby formulated.2019In order to implement the "Opinions on Deepening the Reform of the Review and Approval System and Encouraging Innovation in Drugs and Medical Devices" issued by the General Office of the Central Committee of the Communist Party of China and the General Office of the State Council, and the "Key Tasks for the Year" of the State Council's deepening of medical and health system reform, the National Medical Products Administration, in conjunction with the National Health Commission, is carrying out a pilot program for the unique identification system of medical devices. The following plan is hereby formulated.

I. Guiding Ideology

Deeply implement the Party Central Committee and the State Council's decisions and deployments on implementing the Healthy China Strategy and deepening the reform of the medical and health system, and implement General Secretary Xi Jinping's requirements on drug safety“Four strictest”requirements. Strengthen the supervision of the entire life cycle of medical devices, initially establish a unique identification system for medical devices, achieve the demonstration application of unique identification in production, operation, circulation, and use, explore the formation of a full-chain linkage from the source of production to the final clinical use, continuously accumulate experience, and lay the foundation for the later full implementation of the unique identification system for medical devices, improve the effectiveness of medical device supervision and health management efficiency, effectively ensure public safety in the use of medical devices, and promote the formation of a new pattern of medical device supervision and governance.

II. Basic Principles

(1) Emphasize key points and consider extensibility. Based on the current needs of medical and health reform, key high-risk medical devices that will be the first to implement unique identification are selected as pilot products. At the same time, considering future full implementation, typical products of different types are included in the pilot work to facilitate promotion and expansion.

(2) Multiple parties participate, demonstrating demonstration. Fully mobilize the enthusiasm of medical device registrants, production, operation, and distribution enterprises, and using units, encourage units with conditions to participate in the pilot work, achieve participation in various key links, and demonstrate the demonstration application of the entire medical device chain.

(3) Summarize in time and focus on effectiveness. Solidly promote the pilot work, summarize the experience of the pilot work in time, evaluate the implementation effect, and form replicable and promotable standards and specifications.

III. Work Objectives

(1) Establish a framework for the unique identification system of medical devices. Realize the creation and assignment of unique identification of medical devices, as well as the functions of data uploading, downloading, and sharing, form a unique identification database of pilot products, and establish a unique identification data platform.

(2) Carry out pilot applications of unique identification in various links such as production, operation, circulation, and use of medical devices, and form demonstration application standards and specifications.

(3) Explore the use of unique identification to implement the application of medical device adverse event reporting, product recall, and traceability.

(4) Explore the application of unique identification of medical devices in health, medical insurance, and other fields, and realize data sharing among registration and approval, clinical application, and medical insurance settlement information platforms.

IV. Pilot Scope

(1) Participating units. The National Medical Products Administration, the National Health Commission, some provincial medical products supervision departments, provincial health and health management departments, selected domestic and foreign medical device registrants, operating enterprises, distribution enterprises, using units, societies and associations, and coding agencies, etc.

(2) Pilot products. Focusing on high-risk implantable medical devices such as cardiac, craniocerebral implants, and prostheses, while covering typical products of different types.

V. Responsibilities and Tasks

(1) Medical device registrants. According to the rules and standards of the unique identification system, create and assign unique identification to their products, complete the uploading of unique identification database data, provide unique identification information to downstream enterprises or using units, explore the establishment of an application model for unique identification in product traceability, and form corresponding operating specifications.

(2) Operating and distribution enterprises. Formulate the workflow for applying unique identification in medical device operation and distribution business, verify the operability of multiple codes running in parallel, formulate the docking operation process between unique identification database data and business systems, and explore the coordination mechanism with medical device registrants, using units, and regulatory departments.

(3) Using units. Do a good job in docking unique identification with medical business systems, and explore the connection between unique identification and medical device management and clinical application systems.

(4) Coding agencies. Formulate standards and guidelines for unique identification compilation for this agency, guide medical device registrants to carry out unique identification creation and coding work, verify that the unique identification compilation standards of this agency comply with the relevant standards formulated by the National Medical Products Administration, and ensure the uniqueness of unique identification, and verify the readability of unique identification compiled according to its standards in circulation and use.

(5) Industry associations. Organize relevant enterprises to actively participate in the pilot program for the unique identification of medical devices, regularly collect and summarize the feedback from pilot enterprises, and put forward improvement suggestions.

(6) Relevant units of the National Health Commission. Organize research on the needs of the unique identification system construction in health and health management, put forward data sharing requirements, organize some using units to carry out pilot applications of unique identification, and further standardize the clinical application management of medical devices.

(7) Provincial health and health management departments. Together with provincial medical products supervision departments, organize using units within their administrative regions to participate in the unique identification pilot program, explore application models and methods of unique identification in daily health and health management, and form replicable experience.

(8) Relevant units of the National Medical Products Administration. Responsible for coordinating and promoting the pilot work, conducting pilot training, verifying the overall functions of the rules, standards, and database platform of the unique identification system for medical devices, trying to apply unique identification in adverse event reporting and product recall and other regulatory work, and promoting the application of unique identification in medicine, medical treatment, and medical insurance.

(9) Provincial medical products supervision departments. Urge pilot enterprises within their administrative regions to actively cooperate with the pilot work, and explore the application of unique identification in daily regulatory work.

VI. Pilot Progress Arrangement

(I)2019Year7Month, determine pilot varieties and participating units. Establish a pilot working group for the unique identification system, and issue a pilot work plan. Organize pilot training and launch pilot work. Pilot units develop implementation plans, refine tasks and measures, and clarify acceptance indicators.

(II)2019Year8Month-11Month, organize the verification of the creation and assignment of unique identification for medical devices.

(III)2019Year12Month-2020Year2Month, organize the verification of the upload, download and interface standards of the medical device unique identification database.

(IV)2020Year3Month-6Month, organize the verification of inter-departmental coordination and extended application of unique identification data.

(V)2020Year7Month, organize a pilot summary meeting, form a pilot report, and improve the implementation plan for the unique identification of the first batch of products.

VII. Support Measures

(I) Organizational support. The construction of the medical device unique identification system is an important systematic project with a wide range of involvement and far-reaching influence. It is an important means of innovating the medical device governance model and a key measure to promote medical and health system reform. The pilot work is of great significance. All pilot units should fully understand the significance of the pilot work, strengthen coordination, implement responsibilities, cooperate closely, and jointly promote the pilot work in accordance with the unified deployment of the pilot work. All pilot units should attach great importance to this, assign personnel in charge, and ensure the smooth progress of the pilot work.

(II) Technological support. The work of the medical device unique identification system is highly professional and technical, and requires strong technological support. All parties should make full use of the technology in relevant fields and establish a special technical advisory group if necessary to support pilot units in carrying out pilot work and provide long-term technical support for the full implementation of the unique identification system in the future.

(III) Mechanism support. The pilot work of the medical device unique identification system involves multiple parties and is a cross-departmental and cross-field project. All parties need to communicate actively, study problems in time, and formulate solutions to ensure the orderly progress of the pilot work. During the implementation process, pilot units should analyze and summarize in time, and report important issues and suggestions in time to ensure the smooth progress of the pilot work.

Relevant Links:

Explore the formation of a full-chain linkage from source production to clinical use Launch of the pilot program for the medical device unique identification system