Defining six key points after the listing of medical devices in 2018

Medical Network March 27th, Yanxi strictly controlled the strict control of medical device security risks, implemented the company's main responsibility for the entire lifecycle of medical devices, strengthened on-site inspections, focused on sampling inspection and problem disposal, strengthened regulations, and promoted smart supervision. The 2018 National Conference on Medical Device Supervision and Management held in Shanghai made it clear that the supervision of post-marketing medical devices in 2018 will further study Xi Jinping’s socialist ideology with Chinese characteristics in the new era and implement the “four most strict” guidelines to implement The “Opinions on Deepening the Review, Approval, and System Reform to Encourage the Innovation of Drugs and Medical Devices” (hereinafter referred to as the “Innovative Opinions”) focuses on the six key tasks.

The reporter was informed that in 2018, after the listing of medical devices, the supervisory work will be preceded by case investigation, special rectification will be the promoter, special inspection will be the starting point, and the same force will be used to continue to prevent and eliminate hidden risks.

We continued to investigate and deal with the '1018' project against smuggling of old medical equipment. The meeting requested that relevant provinces intensify their efforts and conclude the case as soon as possible. In 2018, the investigation of the relevant cases will be supervised and will continue to be included in the annual evaluation key projects, and timely notification of case investigation progress will be made. Happening.

Organized a special campaign to crack down on unlicensed medical device management and the use of unlicensed medical devices. In 2018, we promoted 'offline' remediation and 'on-line' rectification work, and conducted strict investigations without authorization or filing for medical device operations and online sales. Activities, strict inspections of operations (imports), network sales and the use of medical devices that have not obtained a registration certificate or record vouchers, strict investigation of illegal operations such as sodium hyaluronate for injections, contact lenses, etc., are used by a large number of people with a high degree of concern.

Deploying a one-time infusion device to add fluorescent whitening substances for special inspections. The relevant work documents for the special inspection of fluorescent whitening substances added to disposable infusion devices will be introduced in the near future. The standard will be publicized, the company will conduct self-inspection, supervision and inspection, and supervise random inspections. Deploy special inspections in terms of penalties and construction mechanisms.

In addition, this year will also deploy documents issued to strengthen the supervision and administration of aseptic and implantable medical devices, and clarify the focus of the work. We will make overall arrangements for the improvement of condoms, decorative colored plain contact lenses, and vigorously regulate the market order.

The meeting emphasized that we must pay close attention to implementing the main responsibility of the company in the whole life cycle of medical devices, change the concept of supervision, shift from 'nanny-style' supervision to 'self-discipline' supervision, and implement various reform tasks proposed by the 'innovative opinions'.

Implementing the main responsibility of the holders of adverse event monitoring. The “Measurement of adverse events monitoring and re-evaluation of medical devices” shall be issued as soon as possible to implement the main responsibility and legal responsibility for monitoring and re-evaluation of adverse events of enterprises. Network and database construction, pay close attention to the inspection and inspection of adverse event reports, strengthen risk assessment of adverse event reports, continue to carry out key monitoring work and other aspects to carry out a series of supporting work.

Improve the holder's re-evaluation system. In accordance with the "Innovative Opinions", 2018 will further promote the listing of medical devices after the evaluation of related work, and carry out risk assessment of powdered medical gloves. Meeting requirements, provinces (autonomous regions, municipalities) in the daily inspection, etc. In the work, it is necessary to urge holders of medical device marketing licenses to implement the responsibility of re-evaluation of the main body, conduct post-marketing research on the listed products, and actively conduct re-evaluations based on the evaluation results of adverse events.

Strengthen the construction of a team of professional inspectors. The reporter was informed that relevant opinions to strengthen the construction of professional inspectors are being drafted. The meeting requested that all local supervisory departments should actively and actively report to the local party committees and governments, and strive for policies, funds, preparation, etc. Support. Compiling can not be resolved through the government to purchase services, contract inspection inspectors to make up for the gap. At the same time, strengthen the selection and training of part-time inspectors. This year will continue to organize national inspector training courses, plans to train 80 inspectors.

Supervision and inspection are important means for preventing and controlling risks. The reporter was informed that in 2018, the supervision department will strengthen the on-site examination of medical devices and increase penalties to effectively fulfill the responsibility for product quality and safety supervision.

For the production of medical devices, the meeting requested that all localities should pay attention to the implementation of the medical device manufacturing quality management standards and fully understand the operation status of different types of production enterprises in the jurisdiction. The provinces (autonomous regions and municipalities) must formulate supervision and inspection plans. In accordance with the principle of 'double randomness and publicity', the inspection has conducted a random inspection of the first category and the second category of medical device manufacturing enterprises by no less than 50% every year. Special attention should be paid to the outstanding problems found in the 2017 flight inspection. Reliance on violations of laws and regulations Punishment in accordance with the law, open inspection results, expose companies that violate the law and regulations, supervise enterprises to implement their main responsibilities, and ensure that the regulations are fully implemented.

For medical device operation, in 2018, the third type of medical device operators will be organized to fully implement the supervision and inspection of medical device operation quality management standards. The meeting requires that all provinces (autonomous regions and municipalities) must fully understand the operation of local third-type device products. The operation status of the company's quality management system, through flight inspections and cross-checks, ensures that the implementation of the standards is implemented.

For the use of medical devices, in 2018, special rectifications will be organized for the use of unregistered medical devices by mechanical units, and violations of laws and regulations will be severely investigated and dealt with. Organizations will carry out self-inspection by the armed units and intensify supervision and inspection. To From hospital Full coverage of the clinic, supervising the use of corrective units in place and risk analysis; and further publicizing the "Medicine equipment use quality supervision and management measures" to strengthen the use of training units to ensure that the relatives know the law, law-abiding.

The meeting also made it clear that the 2018 medical equipment flight inspection efforts will continue to increase, especially for unsatisfactory sampling inspections, complaints and reports of products, will carry out targeted inspections; and will sample part of the first category, the second category of equipment and customization The production enterprises of standard dentures implement standardized conditions, supervise enterprises to implement them in place, supervise the inspection of provincial bureaus, and continue to carry out overseas inspections. In combination with inspections and product inspections at the trials, efforts are made to increase publicity of information and force companies to improve product quality and safety assurance capabilities. , Guarantee the quality of imported products.

Sampling and problem-solving work is one of the important measures for the implementation of post-market surveillance of medical devices, and plays an important role in risk management and control.

The reporter learned that 2018 will further improve sampling inspections. The first is to revise the "Regulations on the Administration of Quality Supervision, Inspection and Inspection of National Medical Devices." It is clear that supervision and sampling shall be carried out in accordance with mandatory standards and product technical requirements, and improve selection, sampling and inspection of varieties. The second is to shorten the sampling cycle. The provinces (autonomous regions, municipalities) must strictly follow the time limit to organize sampling inspections. The third is to strengthen the sampling analysis and analysis. Fourth is to strengthen the disposal of problems. For unqualified products, all localities must Investigate and handle in accordance with regulations, and establish a quality risk consultation and communication mechanism. Fifth, do a good job of information disclosure and reporting. The meeting requires that all provinces (regions, cities), in addition to completing the annual national pumping work, must combine local realities and make efforts to do a good job. Provincial sampling inspection.

With regard to recall management, in 2018, the recall plan and recall effect evaluation guidelines and recall report information release procedures will be developed to improve the way in which recall reports are received and to carry out recall informationization. The meeting requires that all localities resolutely implement the requirements of recall management measures and strengthen the Enterprise recall plan and other assessment work, timely release of recall information.

In 2018, in addition to continuing to do a good job in the revision of the “Regulations on the Supervision and Management of Medical Devices”, the revision of medical device production, management, and use of quality supervision and management methods will also be carried out simultaneously. It will continue to be based on regulatory practices and revise a series of rules and regulations. Document. Including the formulation of the "Measures for the Administration of Imported Medical Device Agents""drug Medical Device Overseas Inspection Management Regulations, regulating overseas holders proxy Human agency behavior and overseas inspection work;medical instruments “Flight Inspection Work Regulations”, standardize process control, strengthen results disposal, and further supervise the implementation of territorial supervision responsibilities; formulate “Medical Device Production” enterprise “Management Representation Management Guide” to implement the responsibility of quality management of corporate management representatives, supervise and promote the company's quality awareness and quality level; formulate “Guidelines for on-site inspection of medical device use quality” to guide the use of unit inspection work in various places; promote the formulation of “non-profit contraception” Measures for the Supervision and Management of Medical Devices" to strengthen the supervision of non-profit contraceptive devices.

With regard to smart supervision methods after the medical device is listed, in 2018, the construction of medical device production supervision platform will be further strengthened, and the implementation of enterprise license registration, product registration and registration, supervision and inspection, supervision and random inspection, adverse event monitoring and inspection and penalties, etc. “Can check electronic production and operation permit. At the same time, build inspector management subsystem, realize 'one enterprise and one file', inspection process and inspection form electronic, standardization. Promote network transaction monitoring platform (two) construction. Improve the basic information database, build the national medical device supervision information data resources 'play chess', build a three-dimensional control network.