National medical equipment, 9 major events to be done in the next few years!
The monitoring and evaluation ability of adverse events of medical devices has reached the international advanced level. Using the electronic data of medical institutions, an active monitoring and evaluation system for the safety of drugs and medical devices was established. 300 monitoring posts for adverse drug reactions and adverse medical device events were set up in the general hospital. Focus on monitoring 100 medical device products. The reporting rate of adverse events of medical devices in counties (cities and districts) reached more than 80%. 9、 Research on safety evaluation system of medical devices.
1、 We will deepen the reform of the medical device review and approval system.
1. Encourage R & D innovation.
Clinical institutions and doctors are encouraged to participate in the research and development of innovative medical devices. Priority will be given to the review and approval of innovative medical devices with product core technology invention patents and significant clinical value, as well as clinical urgently needed drugs and medical devices listed in national key R & D plans and major scientific and technological projects.
2. Improve the review and approval mechanism.
Improve the review quality control system. Establish a clinical centered drug and medical device review mechanism, improve the systems of indication team review, project manager, technical dispute resolution, communication and exchange, priority review, and review information disclosure, and gradually form a drug and medical device efficacy and safety assurance system with technical review as the core and on-site inspection and product inspection as the support.
3. We will accelerate the reform of classified management of medical devices.
Set up 16 medical device classification technology professional groups, optimized and adjusted the classification directory framework and structure, and issued the new version of medical device classification directory; Research and develop 22 nomenclature guidelines for medical devices according to professional fields, and gradually implement nomenclature according to common names of medical devices; Formulate medical device coding rules and build a medical device coding system. Establish a database for classification, naming and coding of medical devices.
2、 We will improve the system of regulations and standards.
Basically completed the formulation and revision of supporting regulations for medical devices; Accelerate the research and transformation of international standards for medical devices, and give priority to improving the basic general standards for medical devices and high-risk product standards; Revise the guiding principles of registration and technical review of medical devices, and formulate technical guidelines for the production, operation and use of medical devices and adverse event monitoring.
The "medical device standard improvement action plan" includes:
1. Prepare and revise 500 medical device standards, including 80 diagnostic reagent standards, 200 active medical device standards, 220 passive medical devices and other standards;
2. Prepare and revise 200 guiding principles for technical review and clinical trials of medical devices. 150 kinds of in vitro diagnostic reagents and reference materials were developed;
3. Establish and improve the standardized management system of medical devices, rely on existing resources, strengthen the construction of national medical device standard management center, and equip standard management personnel to meet the needs.
3、 Strengthen the supervision of the whole process.
1. We will fully implement the quality management standards for clinical trials of medical devices, strengthen the supervision and inspection of clinical trials, and severely crack down on the falsification of clinical data;
2. Fully implement the medical device production quality management standards, and strengthen the production supervision of sterile and implantable medical devices;
3. We will fully implement the quality management standards for the operation of medical devices, strengthen the supervision of the quality of cold chain transportation and storage, and implement the online filing and verification system for the purchase and sales personnel of production and operation enterprises;
4. Strictly implement the quality supervision and management measures for the use of medical devices, strictly control the quality of purchase, acceptance, storage, maintenance, deployment and use, and timely report the adverse events of medical devices. Strengthen the use and management of implantable and other high-risk medical devices.
4、 Comprehensively strengthen on-site inspection and supervision sampling inspection.
Focusing on the aspects of code of conduct, process compliance and data reliability, we will carry out the whole project inspection on quality management of enterprises, crack down on various illegal acts such as fraud, and urge enterprises to strictly implement relevant quality management norms. Increase the frequency of registration inspection, flight inspection and overseas inspection, and improve the inspection capacity. Strengthen the inspection of sterile and implantable medical devices and in vitro diagnostic reagents.
The plan of "strengthening medical device inspection" includes:
1. The national level shall conduct a full project inspection on all class III medical device manufacturers and class II sterile medical device manufacturers once a year. From 2018, the whole project inspection will be conducted every two years for the remaining class II medical device manufacturers and all class I medical device manufacturers.
2. The quality management system of 30-40 overseas medical device manufacturers shall be inspected every year, and the full coverage inspection of imported high-risk medical device products shall be realized during the "13th five year plan".
3. Annual full coverage inspection for operating enterprises with special requirements for storage and transportation. During the 13th Five Year Plan period, full coverage inspection for enterprises operating sterile, implantable medical devices and in vitro diagnostic reagents will be realized.
4. Every year, the use of medical devices in class III class a medical institutions will be fully covered. During the 13th Five Year Plan period, the use of medical devices in other users will be fully covered.
5、 Strengthen supervision and sampling inspection.
We will rationally divide national and local varieties and projects for random inspection, increase the intensity of random inspection of high-risk varieties, and expand the coverage of random inspection.
The national level conducts supervision and sampling inspection on 40-60 kinds of medical device products every year.
6、 Construction of national evaluation center.
Explore and innovate the institutional mechanism and corporate governance mode of drug and medical device evaluation institutions. Reform the employment mechanism of public institutions, establish a reasonable incentive and restraint mechanism, and jointly train reviewers with scientific research institutes and hospitals. We will improve the database for drug and medical device review and approval.
7、 Inspection and testing capacity building.
Prepare standards for the construction of medical device inspection and testing capacity, build national medical device inspection and testing institutions based on China Institute for food and drug control, and transform and upgrade provincial medical device inspection institutions. Build a number of key laboratories for medical device supervision.
We will carry out research on the quality evaluation, testing technology and testing standards of various digital medical equipment, personalized medical products and biomedical materials, and strengthen the research on common medical device rapid testing systems and high-risk medical device testing platforms. Carry out research on on-site inspection methods, testing platforms and equipment of medical devices in use.
8、 Adverse reactions and adverse events monitoring capacity building.
The monitoring and evaluation ability of adverse events of medical devices has reached the international advanced level.
Using the electronic data of medical institutions, an active monitoring and evaluation system for the safety of drugs and medical devices was established. 300 monitoring posts for adverse drug reactions and adverse medical device events were set up in the general hospital. Focus on monitoring 100 medical device products. The reporting rate of adverse events of medical devices in counties (cities and districts) reached more than 80%.
9、 Research on safety evaluation system of medical devices.
Strengthen the research on the safety evaluation technology and standard system of medical devices, systematically carry out the research on the safety of high-risk medical devices such as implantability, and carry out the research on the standard system of innovative medical devices such as medical robots and medical additive manufacturing.