Editor's Note From January 21 to 22, the National Medical Device Supervision and Management Work Conference was held in Beijing. The meeting deployed the key work of medical device supervision and management in 2019, aiming at protecting and promoting the safety of public equipment, comprehensively deepening the reform of the examination and approval system, focusing on strengthening the whole life cycle management, and promoting the development of regulatory science. Grasp the hand, adhere to risk management, strengthen the implementation of responsibility, promote smart supervision, further improve the scientific, legal, international and modern level of medical device supervision, and earnestly safeguard the safety of public equipment. In this issue, we will sort out the medical equipment registration and post-marketing supervision work in 2019, so stay tuned.
Prepare a medical device quality and safety situation analysis report to provide guidance for medical device supervision. Strengthen the risk analysis and judgment of innovative products, and organize the flight inspection of innovative products in a timely manner.
In accordance with the requirements of the National Drug Safety Planning Work of the 13th Five-Year Plan, we will continue to organize and organize key monitoring of 100 medical device varieties.
Continue to revise the 40 technical review guidelines for medical device registration. Completion of the task of accumulating 200 technical review guidelines during the 13th Five-Year Plan period.
The organization released four guidelines for the naming terminology of medical device naming guidelines and medical imaging, and continued to promote the development of 11 named terminology guidelines for passive surgical instruments and passive implanted devices.
Focus 1 Deepen the reform of the examination and approval system
Continuously optimize the review and approval process, study and adjust the first-line registration review and approval procedures for domestically produced third-class medical devices and imported second- and third-class medical devices, and gradually assume the responsibility for medical device review and approval by the Medical Device Technical Evaluation Center. Implement the project manager system. Continuously improve the quality management system for review, further promote the establishment of a national quality management system for medical device evaluation, and gradually realize the unification of the second class of medical device evaluation standards and norms. Continue to encourage medical device research and development and innovation, in accordance with the "Innovative Medical Device Special Review Procedures", continue to do a good job in innovative medical device application review and priority review. Improve the review and approval system for special medical devices that are urgently needed for clinical treatment. Continue to strengthen clinical trial management, revise the "Guidelines for Clinical Evaluation of Clinical Devices", improve the clinical trial approval procedures for high-risk medical devices, strengthen the supervision and spot check of clinical trials, and explore the establishment of a GCP inspector team for medical devices.
Focus 2 Strengthening the construction of the registration management system
The "Amendment of the Medical Device Supervision and Administration Regulations (Draft for Review)" was publicly solicited on the website of the Ministry of Justice in June 2018, and is expected to be officially released this year. It is necessary to promptly revise the supporting regulations and normative documents such as the Measures for the Administration of Registration of Medical Devices and the Measures for the Registration of In Vitro Diagnostic Reagents. Implement the medical device registrant system. On the basis of summarizing the pilot work experience of the medical device registrant system in Shanghai, Guangdong and Tianjin, the pilot scope of the registrant system will be gradually expanded. Improve the technical review guidelines. Conducted training on the registration of laws and regulations.
Focus 3 Build a registration management foundation
Enhance medical device standards, strengthen medical device standard system research, continue to implement medical device standard improvement plan, carry out 100 or so medical device standard revision and revision, expand international standard cooperation and exchange, and deeply participate in international medical device regulatory body forum (IMDRF) international standard Research work related to the working group. Improve the scientific level of classification management, continue to promote the implementation of the new classification catalogue, and research and release the "Working Procedures for Dynamic Adjustment of Medical Device Classification Catalogue". Organize research and develop guidelines for the implementation of the naming terminology guide, and gradually standardize the generic names of medical device products in various fields. To study and formulate the implementation policy for the unique identification of medical devices, and initially establish a unique database of medical devices to lay the foundation for the construction of a unique identification system for medical devices.
Focus 4 Implementation of the Scientific Plan of Action for Supervision
Strengthen the construction of the regulatory science system, organize relevant units to carry out research on a number of regulatory science projects such as drug and drug combination, artificial intelligence, and real-world data applications. Strengthen cooperation with institutions such as associations and associations, continue to pay attention to and in-depth study of new products, new technologies and new developments at home and abroad such as artificial intelligence precision medical treatment. Establish an effective working mechanism, early intervention, professional guidance, and full-service, and provide strong technical support for innovation in the field of innovation. Continue to promote the research on the two new work items of "Medical Device Clinical Evaluation" and "Update IMDRF Members Approved International Standard List" proposed by China. Strengthen China's right to speak in the Asian Medical Device Regulatory Coordination Organization (AHWP), strengthen bilateral multilateral exchanges between China, the United States, China and Europe, and enhance China's international influence in the field of medical devices.
Focus 5 Promote smart supervision
Complete the electronic submission and review and approval of the unified online declaration platform construction, carry out the pilot work of electronic registration of medical device registration, and firstly issue the electronic registration certificate in the "two products and one weapon". Further improve the quality of medical device registration data, and continue to track the situation of the province's second-class medical device registration data and the first-class medical device registration data reported by the provinces (autonomous regions, municipalities), and organize the first class of medical device record clearing and special action . Promote the construction of medical device variety files, comprehensively link the data of the national bureau and the provincial (district, city) bureau, so that big data can better serve the whole process of medical device registration management and optimize public services.
Focus 6 Strengthen the construction of the review and approval team
All provinces (autonomous regions and municipalities) must strengthen the construction of medical device registration management teams and improve the professional level of medical device review and approval personnel through multi-level, multi-form and multi-path training. All directly affiliated units should increase the construction of professional talents and provide technical support for medical device registration management.
Post-marketing supervision Ten key tasks
Focus 1 Continuously improve the supervision and management laws and regulations
Cooperate with the revision of the Regulations on the Supervision and Administration of Medical Devices, and timely adjust the measures for the supervision, management and management of the production, operation and use of medical devices, and focus on the revision of the provisions on the implementation of the main responsibility of enterprises, and implement the responsibility and law of the quality and safety of enterprises. responsibility. The "Measures for the Supervision and Administration of Importers of Medical Devices" was issued to strengthen the supervision of the entire life cycle of imported medical devices. To study and adjust the relevant provisions in the regulations governing the classification and classification of medical device production and management enterprises. Study and formulate the list of responsibilities of operating enterprises and users, and the main points of the annual self-examination report, and compact the main responsibilities of enterprises. Continuously deepen the reform of "distribution service".
Focus 2 Practically strengthen risk management
Conduct safety situation analysis, organize multi-sectoral participation in medical device risk assessment meetings, and analyze multi-dimensional data such as daily inspection, flight inspection, supervision and sampling, case investigation, adverse event monitoring, product recall, public opinion monitoring, complaint reporting, etc. To clarify the key objectives, key links, key varieties and key areas of medical device supervision, and continuously improve the risk information analysis and evaluation, precision judgment, coordination and scientific decision-making level. Strengthen the management of recall work and implement the responsibility of quality and safety of enterprises.
Focus 3 Strengthen production supervision and inspection
All provinces (autonomous regions and municipalities) shall formulate an annual inspection plan and organize implementation, urge production enterprises to implement the main responsibility of the product life cycle, conduct regular self-inspection of the quality management system and submit self-inspection reports in accordance with regulations. The listing permit holders will establish a monitoring and re-evaluation system for adverse events, equip institutions and personnel, and carry out monitoring and evaluation work as one of the key points of supervision and inspection. Focus on high-risk medical devices. Conduct flight inspections and supervise provincial (district, municipal) bureaus to implement daily regulatory duties. Continue to carry out overseas inspections, further expand the scale of production inspections of overseas enterprises, gradually expand the coverage of varieties, and strengthen the supervision and management of imported products. Organize special inspections for special inspections of sterile and implantable medical devices and label identification instructions. Strengthen the risk investigation and control of key regions, key enterprises and key products. Increase the investigation and handling of production links.
Focus 4 Strengthening the use of business supervision
All provinces (autonomous regions and municipalities) shall guide and supervise the municipal and county market supervision departments to formulate and implement the annual inspection plan for medical device operation and use units, and supervise the operating and use units to strictly implement the rules and regulations for the quality supervision and management of medical devices, and the quality management regulations. Self-examination and reporting of implementation. Strengthen the supervision of online transactions and organize the development of medical equipment to clear the network. Strengthen the responsibility for monitoring and disposing of medical device networks, and further implement the main responsibility of the third-party platform of the network and the responsibility for territorial supervision. Strengthen the business guidance for the investigation and handling of business use cases, and severely punish illegal and illegal use of medical devices.
Focus 5 Strengthening adverse event monitoring
Formulate supporting guidelines for the introduction of monitoring guides for adverse events, and guide the supervisory departments, holders, and operating units at all levels to carry out relevant work as required. Improve the monitoring information network and database construction. Supervise the holder to register as a monitoring information system user, proactively maintain their user and product information, report medical device adverse events, and continuously track and process monitoring information. Do a good job in monitoring risk assessment and disposal, study the establishment of procedures for monitoring the exchange of adverse event information, enrich the means of risk communication, and urge all provinces (autonomous regions, municipalities) to take timely risk control measures for adverse events.
Focus 6 Do a good job of supervision and sampling
Continue to strengthen the organization and leadership of the sampling inspection work, and organize the revision of the "Regulations on the Management of Medical Device Quality Supervision, Inspection and Inspection." Organize the 2019 medical device supervision and sampling work. All provinces (autonomous regions and municipalities) should deepen the analysis of the sampling data, combine the daily supervision situation, summarize and summarize the quality risk points discovered through sampling inspection, and timely grasp the product quality and safety trends, and carry out targeted follow-up supervision in a targeted manner. jobs. A column for the provincial sampling results, non-conforming product recall information, and subsequent disposal status will be publicized to the public and submitted to the national medical device sampling system in time.
Focus 7 Improve the regulatory work mechanism
Establish a regulatory risk negotiation mechanism, conduct risk consultations on a regular basis, and enhance the integrity and synergy of supervision. Rationalize the supervision and inspection and the investigation and handling mechanism, further optimize and improve the judgment principle of the flight inspection and inspection results of production enterprises and the methods and methods of information release, implement the main responsibility of product quality and safety, and consolidate the supervision responsibility of the provincial (district, municipal) bureaus. In the operation and use links, establish the working mechanism of the guidance of the national bureau, the supervision of the provincial (district, municipal) bureaus, and the supervision and inspection of the municipal and county market supervision departments. Do a good job of connecting the sentence. Focus on the investigation, control and disposal of illegal products. Establish cross-sectoral and inter-disciplinary coordination mechanisms to form a regulatory force.
Focus 8 Strengthening regulatory capacity building
Continue to promote the construction of a national medical device inspector team and guide the local government to establish a team of full-time inspectors. Innovate training methods to strengthen the training of supervisors of provincial (district, municipal) bureaus and municipal and county regulatory authorities. Strengthen supervision and information construction, promote the construction of medical device production supervision platform, and build a medical device big data supervision platform. Promote the construction of the network transaction monitoring platform (Phase III) and improve the level of network monitoring. Further improve the medical device production and operation license filing system, promote the integration of medical device supervision platform, and gradually realize smart supervision.
Focus 9 Deeply promote social co-governance
Further deepen cooperation with industry associations, societies, universities, etc., and study and establish a cooperation mechanism that leads and standardizes industry associations and implements corporate responsibility. Encourage industry associations to carry out pilot demonstrations of production and operation enterprises. Through the association, the training of administrative counterparts such as production and operation enterprises and users will be strengthened to enhance the self-discipline awareness of the industry. Give full play to the role of think tanks in higher education institutions and research institutions. Organize research and traceability systems and other regulatory science topics to enhance the level of supervision. Increase the propaganda of science popularization and promote social co-governance.
Focus 10 Strengthen international exchanges and cooperation
Continue to strengthen international exchanges and cooperation, learn from international advanced management concepts, and improve the level of internationalization of supervision. Implement the results of IMDRF work, strengthen research on international regulations, absorb the experience of international experience, and transform and apply it in light of China's actual conditions. Promote the improvement of the information exchange mechanism for medical device adverse event monitoring and promote the international exchange of risk warning information. Increase the participation of AHWP work and play a role in the field of Asian regulatory coordination.