The State Food and Drug Administration has made it clear that this year will be a special, focused inspection of medical and medical enterprises and products

On April 4th, the medical network strictly controlled the strict control of medical device safety risks, implemented the company's main responsibilities in the whole life cycle of medical devices, strengthened on-site inspections, focused on sampling inspections 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 the socialist ideology of Chinese characteristics in the new era and implement the “four most stringent” guidelines to implement We will focus on advancing the six key tasks in the "Opinions on Deepening the Review, Evaluation and Approval System, and Encouraging the Innovation of Drugs and Medical Devices" (hereinafter referred to as the "Innovative Opinions").

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 guard against and eliminate hidden risks.

We continued to investigate the '1018' project against smuggling of old medical equipment. The meeting demanded that the relevant provinces intensify their efforts to complete the case as soon as possible. In 2018, the investigation of relevant cases will be supervised, continue to be included in the annual assessment 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 high 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 focus on the deployment of documents 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 condoms and decorative color plain contact lenses to rectify the market order.

The conference 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-disciplined' supervision, and implement the various reform tasks proposed by the 'Innovative Opinion'.

Implementing the main responsibility of the holders of adverse event monitoring. The “Administrative Measures on Medical Device Adverse Event Monitoring and Reevaluation” 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 inspection and inspection of adverse event reports, strengthen the 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 daily inspections, 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 were being drafted. The meeting demanded that all local supervisory departments should actively and actively report to 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 inspection 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 quality management specifications for medical devices, and fully understand the operation status of the quality management systems of different types of manufacturing enterprises in the jurisdiction.

All provinces (autonomous regions and municipalities) shall formulate supervision and inspection plans and intensify inspections. In accordance with the principle of 'double randomness and publicity', annual inspections shall be carried out on the first category and the second type of medical device manufacturing enterprises shall be no less than 50%, paying special attention to 2017. The outstanding problems discovered during the annual flight inspection. Resolutely punished according to law for violations of law and regulations, publicly inspected the results, exposed companies that violated the law and regulations, supervised enterprises to implement their main responsibilities, and ensured that the regulations were fully implemented.

For medical device operation, in 2018, the third type of medical device operating enterprise will organize the full implementation of supervision and inspection of the medical device operation quality management standard. 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 to severely investigate and punish violations of laws and regulations. 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 supervision of provincial bureaus, and continue to carry out overseas inspections. Combining inspections and product inspections at the trials, the company will increase disclosure of information and force companies to improve product quality and safety protection 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 was informed that 2018 will further improve the sampling inspection.

The first is to revise the “Regulations on the Administration of Quality Supervision, Inspection and Inspection of National Medical Devices”, and to specify that supervisory sampling should be carried out in accordance with mandatory standards and product technical requirements, and improve the work procedures of selection, sampling, and inspection of varieties.

The second is to shorten the sampling period. All provinces (autonomous regions and municipalities) must organize and carry out sampling inspections in strict accordance with the time limit.

The third is to strengthen the analysis of sampling results, and study and judge.

The fourth is to strengthen problem disposal. For non-conforming products, all localities must investigate and deal with the problem in accordance with regulations and establish a quality risk consultation and communication mechanism. Fifth, do a good job of information disclosure and reporting. Meeting requirements, provinces (autonomous regions, municipalities) in addition to completing the annual country Apart from pumping work, it is necessary to combine the actual conditions of the local area and work hard to do a good job in the 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 information construction. 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 measures will also be carried out simultaneously. It will continue to be based on the actual conditions of supervision and revise a series of rules and regulations. file.

Including the formulation of the Measures for the Supervision and Administration of Imported Medical Device Agents.drug Medical Device Overseas Inspection Management Regulations, Regulating Overseas Owners 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 corporate management representatives in quality management, supervise and promote the company's quality consciousness 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, with the implementation of enterprise license filing, product registration and registration, supervision and inspection, supervision and random inspection, adverse event monitoring and inspection and punishment information, etc. Checkable', production and operation permit electronic.

At the same time, we will build an inspector management subsystem to realize the 'one enterprise and one file', electronic inspection and inspection forms, and standardization. We will promote the construction of a network transaction monitoring platform (second phase). We will build and improve the basic information database to create a nationwide medical device regulatory system. Information data resources 'a game of chess' to build a three-dimensional control network.