Medical network - on February 23, "" much starker choices-and graver consequences-in" national drug safety planning "has been published, offered to adhere to the most rigorous standards, strict regulation, the most severe punishment, the most serious accountability, which involves the main task of the medical equipment safety and targets include:
First, deepen the reform of the medical device review for examination and approval system.
1, encouraging innovation.
Encourage clinical institutions and physicians involved in innovative research and development of medical equipment. With product core technology invention patents, has significant clinical value of innovative medical devices, and included in the national key research and development, science and technology major projects for urgent clinical needs of medicine medical apparatus and instruments, a priority review for approval.
2, improve the review mechanism of examination and approval.
The review of the quality control system. Establish medical devices with a core of clinical drug review mechanism, perfect the indications on the assessment team, project managers, technical dispute resolution, communication, priority review, review of public information system, gradually formed with technical evaluation as the core, on-site inspection and product inspection drugs to support medical curative effect and security system.
3, we will accelerate reform of the medical device classification management.
Formation of 16 professional medical device classification, the optimization adjustment category framework and structure, release a new version of the catalog of medical device classification; According to the field to develop guidelines for 22 medical instrument named term set research, gradually implement according to the medical apparatus and instruments generic name; Set the encoding rules of medical equipment, medical equipment coding system. Establish medical device classification, naming and coding database.
Second, improve the laws and regulations standard system.
Basically complete medical equipment form a complete set of regulations and revising; To speed up the medical instrument research into international standard, the priority to improve medical instrument based general standard and high-risk products; Revision of the medical device registration technical review guidelines, such as making medical devices use and adverse event monitoring technology guide the production and business operation.
"Medical devices standards improve action plan include:
1, medical apparatus and instruments and revising standards, 500 class standard 80 items including diagnosis reagent, the active medical devices standards, passive medical equipment and other 200 standard 220;
2, medical apparatus and instruments and revising the technical review and guiding principles for clinical trials of 200 items. Development of in vitro diagnostic reagents standard 150 kinds of materials;
3, establish and improve the standardization of medical equipment management system, relying on existing resources, strengthening the construction of national medical instrument standard management center, with satisfy need standard management personnel.
Third, strengthen the supervision of the whole process.
1, the full implementation of the quality control standard for clinical trials of medical equipment, strengthen supervision and inspection of the clinical trials, to crack down on the clinical data of fraudulent;
2, the full implementation of the medical device production quality management standard, strengthen the supervision of sterile and implantable medical devices production;
3, full implementation of medical equipment management and the quality control standard, strengthen the supervision of cold-chain transport storage quality and production management enterprise procurement business people online registration and verification system;
4, strictly implement the quality supervision measures for the administration of medical devices are, strictly the purchase, acceptance, storage, maintenance, deployment and use each link quality, timely report adverse events of medical equipment. Strengthen the management of using such high-risk medical planted instruments.
Fourth, comprehensively strengthen the on-site inspection and supervision to sample.
Focus around the norms, process compliance, reliable data, etc., to check quality management all the projects, to crack down on fraud and other kinds of illegal behavior, urge the enterprise strict quality management standard. Increase register check, check and outside check flight frequency, to improve inspection ability. More to sterile, implantable medical devices and inspections of in vitro diagnostic reagents.
Strengthen medical equipment inspection plans include:
1, every year to all national third class medical device manufacturing enterprise and the second category of sterile medical device manufacturing enterprise for a whole project inspection. Since 2018, every two years for the rest of the second category of medical device manufacturing enterprise and all the first kind of medical device manufacturing enterprise for a whole project inspection.
2, every year to 30-40 overseas medical device manufacturing enterprise quality management system to carry out the inspection, during the period of "much starker choices-and graver consequences-in" realizing a complete coverage of the high-risk medical equipment products to be imported.
3, complete coverage of annual inspection have special request for storage and transportation enterprise, "much starker choices-and graver consequences-in" during implementation of sterile, implantable medical devices and in vitro diagnostic reagents enterprise full coverage checking.
4, complete coverage of annual inspection third rate of medical institutions the usage of medical equipment, during the period of "much starker choices-and graver consequences-in" realizing a complete coverage of for other use unit inspection.
Fifth, strengthen supervision to sample.
Reasonable division of proper national and local varieties and project, intensify to sample to high-risk varieties, expand the sample coverage.
Every year to 40-60 kinds of national medical devices to carry out the supervision to sample.
Sixth, the state-level review center construction.
Explore innovative drug review of medical equipment management system and corporate governance institutions. Reform business unit of choose and employ persons mechanism, establish a reasonable mechanism of incentive and constraint, and scientific research institutes, joint training of medical review of hospital personnel. Consummate the drug approval medical device review database.
Seven, the examination ability construction.
Standards for the construction of medical device testing ability depends on the construction of the food and drug verification research institute of China national medical device testing institutions, and upgrade medical equipment inspection institutions at the provincial level. Construction of a batch of medical device regulatory key laboratory.
Carry out all kinds of digital products, medical equipment, individualized diagnosis and treatment of biomedical materials quality evaluation and testing technology research and testing specification, strengthen medical apparatus and instruments commonly used fast inspection system, high-risk medical instrument testing platform. Carried out in medical device field test method, test platform and equipment research.
Eight, adverse reactions and adverse events monitoring capacity building.
Medical device adverse event monitoring and evaluation ability has reached the international advanced level.
Using the electronic data of medical institutions, the establishment of pharmaceutical medical equipment safety initiative monitoring and evaluation system. Set up the 300 adverse drug reactions in general hospital and medical device adverse event monitoring sentinel. Focus on monitoring of 100 medical equipment products. Medical device adverse events county (city, area) report more than 80%.
Nine, medical equipment safety evaluation system and research.
Strengthen the medical equipment safety evaluation technology and standard system research, system to carry out safety studies, such as high risk medical planted instruments to carry out medical robot, medical material manufacturing innovative medical devices standards system research. |
