Strictly prevent and strictly control the safety risks of medical devices, implement the main responsibilities of enterprises in the whole life cycle of medical devices, strengthen on-site inspections, do a good job of random inspections and problem handling, strengthen the construction of laws and regulations, and promote smart supervision-the 2018 nationwide held in Shanghai recently The medical device supervision and management work conference clarified that in 2018, the post-marketing supervision of medical devices will deeply study Xi Jinping’s new era of socialism with Chinese characteristics, and implement the spirit of the "four strictest" instructions to implement the "Regarding Deepening the Review and Approval System The Opinions on Reforming and Encouraging the Innovation of Drugs and Medical Devices (hereinafter referred to as the “Innovation Opinions”) will focus on promoting six key tasks.
1 Make efforts to prevent and control risks in the same direction
The reporter was informed that in 2018, the post-market supervision of medical devices will start with case investigation, special rectification as the driving force, and special inspection as the starting point. We will continue to prevent and eliminate hidden risks in the same direction.
Continue to investigate and handle the "1018" project to combat the smuggling of old medical equipment. The meeting requested that the relevant provinces step up their efforts and handle the case as soon as possible. In 2018, the investigation and handling of relevant cases will be supervised and will continue to be included in the annual assessment key items, and the progress of the investigation and handling of the cases will be notified in a timely manner.
Organize a special rectification action against unlicensed operation of medical devices and operation of unlicensed medical devices. In 2018, the “offline” remediation and the “online” remediation work were simultaneously promoted, strictly inspected for medical device operation and online sales activities without permission or filing, and strictly inspected for operation (import), online sales and use without obtaining a registration certificate or The medical devices with the record vouchers are strictly investigated for illegally operating products such as sodium hyaluronate for injection and contact lenses that are used by the masses and are of high concern.
Deploy a one-time infusion device to add a special inspection of fluorescent whitening substances. In the near future, relevant working documents will be issued for the special inspection of the addition of fluorescent whitening substances to disposable infusion devices, and special inspections will be deployed from the aspects of standard publicity and implementation, enterprise self-inspection, supervision and inspection, supervision and random inspection, severe punishment and establishment of mechanisms.
In addition, this year will also issue documents for strengthening the supervision of sterile and implantable medical devices to clarify the focus of work; coordinate the remediation of condoms and decorative color flat contact lenses, and vigorously regulate the market order.
2 Promote the implementation of the "Innovation Opinions" task
The meeting emphasized that we must pay close attention to the implementation of the main responsibility of enterprises in the whole life cycle of medical devices, change the concept of supervision, change from "nanny" supervision to "self-discipline" supervision, and implement various reform tasks proposed in the "Innovation Opinions".
Implement the main responsibility of the holder's adverse event monitoring. The "Administrative Measures for the Monitoring and Re-evaluation of Adverse Events of Medical Devices" shall be issued as soon as possible to implement the main and legal responsibilities for the monitoring and re-evaluation of adverse events of enterprises. In addition, it has carried out a series of supporting work in areas such as carrying out laws and regulations publicity and implementation training, monitoring the construction of information networks and databases, paying close attention to the supervision and inspection of adverse event reports, strengthening the risk evaluation of adverse event reports, and continuing to carry out key monitoring work.
Improve the holder re-evaluation system. According to the "Innovation Opinions", in 2018, we will further promote the re-evaluation of medical devices after they are on the market, and carry out the risk assessment of powdered medical gloves. The meeting requested that all provinces (autonomous regions and municipalities) should urge medical device marketing license holders to implement the main responsibility for re-evaluation during daily inspections, continue to carry out post-market research on listed products, and actively carry out re-evaluation based on the results of adverse event evaluations .
Consolidate the construction of professional inspectors. The reporter was informed that the relevant opinions on strengthening the construction of professional inspectors are in the process of drafting. The meeting requested that local regulatory agencies actively and actively report to local party committees and governments, and strive for policy, funding, and establishment support. If the establishment cannot be resolved, the government will purchase services and contract inspectors to make up for the gap. At the same time, strengthen the selection and training of part-time inspectors. This year, we will continue to hold national inspector training courses and plan to train 80 inspectors.
3 Strengthen on-site inspection and punishment
Supervision and inspection is an important means of preventing and controlling risks. The reporter was informed that in 2018, the regulatory authorities will strengthen on-site inspections of medical devices and increase penalties to effectively perform product quality and safety supervision responsibilities.
In response to the medical device production process and meeting requirements, all localities should pay attention to the implementation of medical device production quality management regulations, and have a comprehensive understanding of the operation status of the quality management system of different types of production enterprises within their jurisdiction. All provinces (autonomous regions and municipalities) shall formulate supervision and inspection plans and increase inspection efforts. According to the principle of "double randomness and one openness", no less than 50% of the first and second types of medical device manufacturers shall be randomly inspected each year, with special attention to 2017 Outstanding problems found in annual aerial inspections. Resolutely punish violations of laws and regulations in accordance with the law, disclose the results of inspections, expose enterprises that violate laws and regulations, and urge enterprises to implement their main responsibilities to ensure the full implementation of regulations.
Aiming at the medical device business link, in 2018, it will organize and carry out the third-class medical device business enterprises to fully implement the supervision and inspection of medical device business quality management standards. The meeting required that all provinces (autonomous regions and municipalities) should have a comprehensive understanding of the operation status of the quality management system of local third-class equipment product operators, and ensure that the implementation of the regulations is implemented through unannounced inspections and cross-checks.
Regarding the use of medical devices, in 2018, we will organize special rectification of the use of unregistered medical devices by equipment users, and strictly investigate and deal with violations of laws and regulations. Organize and carry out self-inspections of machinery users, and strengthen supervision and inspection. The meeting requested that all localities should fully cover from hospitals to clinics, and urge users with problems to rectify in place and conduct risk analysis; and further publicize and implement the "Medical Device Use Quality Supervision and Management Measures", strengthen training for users, and ensure that relatives know Law and abiding by the law.
The meeting also made it clear that in 2018, unannounced medical device inspections will continue to increase, especially for products that are unqualified in random inspections, complaints and reports, and targeted inspections will be carried out; and some of the first and second types of equipment and customized products will be randomly inspected. The implementation of the norms of the denture manufacturing enterprises, the supervision of the implementation of the enterprises is in place, and the supervision of the provincial bureaus are in place; will continue to carry out overseas inspections, combined with the inspections due to causes and inspections of products under review, increase information disclosure, and force enterprises to improve their product quality and safety assurance capabilities To ensure the quality of imported products.
4 Do a good job of random inspection and problem handling
Sampling inspections and problem resolution work are one of the important means of implementing post-marketing supervision of medical devices, and they play an important role in risk management and control.
The reporter was informed that in 2018, there will be further improvements in sampling inspections. The first is to revise the "National Medical Device Quality Supervision and Sampling Inspection Management Regulations", clarify that the supervision and sampling inspections should be carried out in accordance with mandatory standards and product technical requirements at the same time, and improve the working procedures of variety selection, sampling, inspection and other links. The second is to shorten the sampling period. All provinces (autonomous regions and municipalities) must organize and carry out random inspections strictly within the time limit. The third is to strengthen the analysis and judgment of random inspection results. The fourth is to strengthen problem handling. For substandard products, all localities must investigate and deal with them in accordance with laws and regulations, and establish a quality risk consultation and communication mechanism. Fifth, do a good job in information disclosure and reporting. The meeting requested that in addition to completing the annual national sampling work, all provinces (autonomous regions and municipalities) should also work hard to do a good job in the provincial sampling in light of local conditions.
Regarding recall management, in 2018, it will formulate a recall plan, recall effect evaluation guidelines and recall report information release procedures, improve recall report receiving methods, and carry out recall information construction work. The meeting requested that all localities resolutely implement the requirements of the recall management measures, strengthen the evaluation of corporate recall plans, and release recall information in a timely manner.
5Strengthen the construction of regulatory laws and regulations
In 2018, in addition to continuing to do a good job in the revision of the Regulations on the Supervision and Administration of Medical Devices, the revision of the supervision and management measures for the production, operation, and use of medical devices will also be carried out simultaneously, and will continue to be based on the actual supervision, formulating and revising a series of regulations and norms document. Including the formulation of the "Measures for the Supervision and Administration of Imported Medical Device Agents" and the "Regulations on the Administration of Overseas Inspections of Pharmaceuticals and Medical Devices" to regulate the agency behavior of overseas holders and overseas inspections; the formulation of the "Regulations for Unannounced Medical Device Inspections" to standardize process control , Strengthen the handling of results, and further supervise the implementation of territorial supervision responsibilities; formulate the "Management Guidelines for Manager Representatives of Medical Device Manufacturers", implement the quality management responsibilities of corporate managers, supervise and urge the improvement of corporate quality awareness and quality level; formulate "Medical Device Use Quality Site "Inspection Guidelines" to guide local areas to carry out inspections of users; promote the formulation of the "Regulations for the Supervision and Administration of Non-profit Contraceptive Medical Devices", and strengthen the supervision of non-profit contraceptive devices.
6 Build a complete data monitoring platform
In terms of smart supervision methods after the listing of medical devices, in 2018, the construction of the medical device production supervision platform will be further strengthened, and information such as enterprise license filing, product registration filing, supervision and inspection, supervision and random inspection, adverse event monitoring, and inspection penalties will be realized. Can be checked", the production and operation license is electronic. At the same time, the inspector management subsystem is built to realize "one company, one file", and the inspection process and inspection forms are electronic and standardized. Promote the construction of the online transaction monitoring platform (Phase II). Build and improve the basic information database, create a national “game of chess” for medical device supervision information data resources, and build a three-dimensional prevention and control network.