State Administration of issued "Medical Device Standard Planning (2018-2020)"

Medical Network January 30 hearing

Food and Drug Administration of Xinjiang Province Production and Construction Corps, China Food and Drug Administration (Medical Device Management Center), Medical Device Standardization Technical Committee Administrative Organization:

In order to thoroughly implement the Guiding Opinions of the CPC Central Committee and the State Council on Carrying Out Quality Improvement (Zhong Fa [2017] No.24) and the Opinions of the General Office of the CPC Central Committee and the General Office of the State Council on Deepening the Innovation of Examination and Approval System for Pharmaceutical Products and Encouraging the Innovation of Medical Devices, (Office word 〔2017〕 42), improve the standard level of medical equipment, strengthen the supervision and inspection of the implementation of standards, to promote the innovation and development of medical equipment, in accordance with the "Medical Device Standard Management Measures" and "Medical Device Standard Revision Management Regulations" Requirements, Food and Drug Administration formulated the "Medical Device Standard Planning (2018-2020)." Is to be issued, please comply with the implementation.

Food and Drug Administration

January 29, 2018

The medical device standard is a uniform technical requirement followed by medical device development, production, operation, use and supervision and management and is also an important symbol of the development level of the medical device industry.In order to thoroughly implement the Guiding Opinions of the CPC Central Committee and the State Council on Carrying Out Quality Improvement and Opinions of the General Office of the CPC Central Committee and the General Office of the State Council on Deepening the Innovation of the Examination and Approval System for Drug Evaluation and Encouraging the Innovation of Medical Devices for Medical Devices to further enhance the medical service in accordance with the requirements of the Measures for the Administration of Medical Device Standards and the Management Regulations for the Revision and Standardization of Medical Devices Standardization of equipment, boosting innovation and development of medical equipment, give full play to the role of standard management of the basis of security, formulated this plan.

Implementing the requirements of deepening the reform of examination and approval system for pharmaceutical and medical devices, reforming the national standardization work, accelerating the establishment of the most stringent standards, implementing medical device standards, improving the standard of medical device management mechanisms, optimizing the standard system of medical devices, and strengthening medical devices Standard implementation and supervision, consolidate the technical basis of medical device standardization, enhance the consistency with international standards, enhance the international standard of medical device standards, give full play to the standard support and leading role, serve the scientific supervision of medical devices, serve the people's appliance safety and service Medical device industry development.

Demand guidance, co-ordination and coordination.Prioritarily carry out scientific regulation of medical devices and industrial development urgently needed standard revision and implementation, to build a reasonable structure, scale, content science standard medical devices.Complete the standard management mechanism, to strengthen standards and supervision, Scientific research, industry, the close combination of strengthening standards and laws Regulations , Coordination and cohesion of policies and measures, co-ordination and coordination of all forces, fully mobilize the enthusiasm of all parties and jointly promote the standardized development of medical devices.

Deepen reform, innovation and development.Comprehensively implement the reform of the medical device review and approval system and national standardization reform requirements, with innovation and development as the driving force to enhance the standard of medical device research capability, encourage innovation, develop their own standards, and strive to promote China's medical device features Advantages of international technology and standards process.

Focus on breakthroughs and overall improvement Identify the main direction and focus of medical device standard work, highlight the priority themes and key areas, focus on promoting the revision and revision of basic common standards, highlight the standard work in the field of innovative medical devices and promote the timely conversion of scientific and technological achievements As a standard, and comprehensively improve the systematic, coordinated, scientific and applicable standards revision, implementation and supervision.

By 2020, a standard system for medical devices that basically meets the regulatory requirements for medical devices will be established, and 300 standards for medical devices will be revised and revised so that the coverage of standards will be further enhanced, the validity and standardization of standards will be significantly enhanced, and the revision of standards for medical devices will be more timely, Standard revision and management more standardized, standard implementation and supervision to further strengthen the standardization of medical device international cooperation and exchanges more in-depth, international influence and the right to speak gradually increased.

(A) improve the system of mechanisms, improve the standard system of medical equipment

Strengthen the "Medical Device Standard Management Measures," "Medical Device Standard Revision revision of the work management practices," the publicity and training to ensure strict implementation of the standard management system to scientific supervision and industrial development as a starting point, continue to carry out mandatory standards for medical equipment consolidation and streamlining of work , Reviewing the recommended standards in a centralized way, and continuously improve the standard system of medical devices that the national standards and industry standards are interlinked with each other, the mandatory standards and the recommended standards are mutually supportive, and the standards for medical devices that do not meet the regulatory requirements and are not suitable for the development of the industry are fully Clean up and speed up the standardization of medical devices and international standards Actively explore and promote the deployment of national development strategies and regulatory urgently needed areas Construction of a new standardization of medical devices Technical Committee to build a scientific and rational to meet the regulatory needs and leading the development of innovative medical equipment industry standards system.

(B) to demand-oriented, promote key areas of medical equipment standards revision

Improve the demand-oriented standard project mechanism, strengthen the revision and revision of universal basic standards concerning human health and life safety, speed up the improvement of management standards covering quality management and clinical trial management, and strengthen risk management and process control to meet Regulatory Needs To carry out work on standardization of standards and methods for medical device products in key areas of active, passive and in vitro diagnostic reagents and to effectively improve standard coverage.

① medical device quality management standardization focus areas

Medical device quality management, medical device risk management, medical device clinical trial management.

② active medical equipment standardization focus areas

(I) Promote the transformation of international standards for general and specialized safety of medical electrical equipment, formulate common basic standards and supporting implementation plans and teaching materials.

(B) medical robots, active implants, medical software, PET-MRI and other multi-technology integration of medical devices, medical respiration and anesthesia equipment, medical equipment disinfection Sterilization field, the field of oral digital equipment, medical devices, radiotherapy and nuclear medicine equipment, medical ultrasound equipment, physical therapy, medical laboratory equipment, medical X-ray diagnostic equipment, medical laser equipment.

③ passive medical equipment standardization focus areas

(1) Promote the translation of international standards for the evaluation of medical device biology to further improve the standard system for general and specialized methods of biological evaluation.

(B) the field of new surgical instruments, new types of infusion apparatus, family planning instruments, assisted reproductive equipment, new medical joints, new sanitary materials and dressings, additive manufacturing, oral digital material quality evaluation, tissue engineering , Nano-medical devices, allogeneic materials, resorbable implants, new biomaterials and their products, contact lens care products and intraocular fillings.

④ in vitro diagnostic medical equipment standardization focus areas

Traceability and reference measurement systems, high-throughput sequencing and other new molecular diagnostic techniques, mass spectrometry in the field of clinical in vitro diagnostic applications, infectious diseases in vitro diagnostic reagents, POCT field.

(C) regulate the standard management, effectively improve the quality of medical equipment standards

In strict accordance with the "Medical Device Standard Management Measures", "Medical Device Standard Revision Management Regulations" to carry out the standard project, drafting, verification, soliciting opinions, technical review, approval of the release, implementation and evaluation, review and abolition of work to ensure standards Revision of legal compliance, scientific and reliable.Medical equipment standard management center to strengthen the organization and management of standard-setting revision of the work to promote the standardization of the whole process of refined management, in accordance with the relevant provisions of the Medical Device Standardization Technical Committee (hereinafter referred to as the Technical Committee) , Standardization Technical Committee of Medical Devices (hereinafter referred to as Technical Committee) and Standardization Technical focal point (hereinafter referred to as the technical focal point) to carry out quantitative assessment of assessment work to improve the standard of management .To further optimize the Technical Committee, Technical Committee and Technical Committee Technical focal point member of the composition, to prevent the emergence of technical monopoly and unfair competition.

(D) innovation to lead the standard upgrade, and gradually enhance the scientific and technological support capabilities of medical equipment standards

Adhere to the science and technology to lead the standard level to promote and promote the standardization of medical equipment and national science and technology innovation system, the depth of integration and promote the standardization of medical devices and technological innovation, industry closely integrated. Sustained and stable support for basic, strategic, cutting-edge key technical standards and common Standard research to adapt to the rapid development of science and technology under the situation of the new standard-setting requirements, through the standard upgrade to lead the development of high-tech products, enhance the overall competitiveness of China's medical device industry .Staffin improve the standard innovation collaborative promotion mechanism to encourage inspection and R & D institutions, research institutions , Manufacturing enterprises and other cooperation to carry out standard research, nurture China's medical equipment standard new competitive edge in international competition.

(5) Deepening International Exchanges and Cooperation and Striving to Make New Breakthroughs in the International Standardization of Medical Devices

We will continue to deepen international exchange and cooperation in medical device standards, actively introduce advanced management experience from international standards, and encourage standards to 'go global' and 'invite in.' We will continue to strengthen our participation in and promote international standards research for the International Forum of Medical Device Regulators (IMDRF) Depth cooperation with German Electrotechnical Commission, American Institute of Electrical and Electronics Engineers (IEEE) and other international standardization organizations to explore and promote the field of medical devices in our country to seize the new highlands of international standards.We improve the standardization of medical device experts in China to participate in international standards of working mechanism, recommend our medical Instrument experts joined counterparts of the International Organization for Standardization to keep abreast of changes in the international standard system. In full study of China's national conditions and industrial development, the work of promoting the translation of international standards was carried out to enhance the consistency with international standards.

(Vi) to promote the implementation of all medical equipment standards, and strengthen the standard supervision

Accelerate the standardization of medical device information management process, in principle, the standard published within 20 working days after the publication of standard texts, standards and standards involved in the adoption of standard text in compliance with international (foreign) standards under the premise of copyright policy to open. Training, and gradually establish an authoritative and efficient, structured publicity training system to promote the accurate and effective implementation of standards. Technical Committee, Technical Committee and technical focal points should be carried out in the standard after the release of the standard in the field of publicity, training, medical equipment standards Management Center to do a good job in organization and management of work and according to the situation to carry out a number of important standards of publicity, do a good job in the public generally concerned about the interpretation of the standard.CSC, Technical Committee and Technical focal points should increase the tracking of the implementation of the standard evaluation, Problems found in the implementation process should be organized to study and propose solutions and promptly submitted to the medical device standard management center medical device standard management center should organize research on the implementation of standards to coordinate the implementation of technical standards to solve problems and continuously improve the standard Scientific and applicable medical device manufacturers should ensure that the factory product Mandatory standards and co-registered or filing of technical requirements, food drug Regulators to strengthen right medical instruments enterprise Supervision and inspection of the implementation of the situation to further smooth complaints reporting channels to strengthen social supervision of standards implementation.

(A) to strengthen the organization and leadership.All medical device standardization The relevant units should fully understand the importance of the work of medical device standards, unify thinking, raise awareness, conscientiously strengthen the standard coordination of medical equipment and organization and leadership, and establish a scientific and rational standard management Working mechanism and increase support for the provision of necessary conditions and basic protection for undertaking the revision of medical device standards and international standardization and exchange and cooperation.

(B) to strengthen funding protection. Increase medical equipment standard work funding support efforts to form a sustained and stable funding guarantee mechanism, and earnestly safeguard the standard revision, tracking and evaluation work carried out to encourage qualified inspection and testing agencies, industry and commerce, Colleges and universities, research institutes, social groups and other inputs to participate in the standard revision of medical devices .Strengthen the standard work funding management, improve the efficiency of the use of funds.

(C) to strengthen the building of qualified personnel to strengthen the medical equipment standard management center and the technical committees, sub-technical committees and technical focal points of the standard management of full-time staff building, the technical committees, sub-technical committees and technical focal points should be Set up specialized offices and specialists responsible for standard work, equipped with standard equipment and medical work tasks match by 2020, the standard management center of medical equipment staff to 70 people, the technical committees, sub-technical committees and technical focal points secretarial Department assume unit standard management personnel to 200. Medical equipment standard management center, the various technical committees, technical committee and technical focal points should develop and implement standard staff training programs, focusing on training with an international perspective, comprehensive coordination and organizational ability Multidisciplinary professionals to improve the standard revision and management of medical equipment.

(D) to strengthen the standardization of medical device information construction.Speed ​​up the standardization of medical device management information service platform, according to the provisions of the standard text disclosure and free inquiry, promote the medical device industry standard system revision process of information management, information standards to achieve standards Project control, drafting, verification, solicitation of opinions, technical review, implementation and evaluation, review and abolition of the dynamic control and strengthen the technical committee, technical committee and technology focal point standard work management and guidance to improve medical device standards System revision work of scientific, normative and timeliness.