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9 major events to be done in the next few years!

9 major events to be done in the next few years!

  • Categories:Industry News
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  • Time of issue:2017-10-30 13:37
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(Summary description)1、 We will deepen the reform of the examination and approval system for medical devices. 1. Encourage R & D innovation. Encourage clinical institutions and doctors to participate in the research and development of innovative medical devices. Priority shall be given to the examination and approval of innovative medical devices with product core technology invention patents and significant clinical value, as well as medical devices that are urgently needed in clinical practice and listed in the national key R & D plan and major scientific and technological projects. 2. The review and approval mechanism was improved. Improve the quality control system of evaluation. Establish a drug and medical device evaluation mechanism with clinical as the core, improve the system of indication team review, project manager, technical dispute resolution, communication and exchange, priority review, review information disclosure, etc., and gradually form a drug and medical device efficacy and safety guarantee system with technical review as the core, on-site inspection and product inspection as the support. 3. We will accelerate the reform of classified management of medical devices. Set up 16 professional groups of medical device classification technology, optimize and adjust the framework and structure of classification catalog, and issue the new version of medical device classification catalogue; research and develop 22 medical device nomenclature guidelines according to professional field setting, and gradually implement naming according to the common name of medical device; formulate coding rules of medical device and construct coding system of medical device. The database of medical device classification, naming and coding was established. 2、 We will improve the system of regulations and standards. We have basically completed the formulation and revision of supporting regulations for medical devices, accelerated the research and transformation of international standards for medical devices, given priority to improving the basic general standards and high-risk product standards for medical devices, revised the guiding principles for technical review of medical device registration, and formulated technical guidelines for the production, operation, use and adverse event monitoring of medical devices. "Medical device standard improvement action plan" includes: 1. 500 medical device standards were formulated and revised, including 80 diagnostic reagent standards, 200 active medical device standards, 220 passive medical device standards and other standards; 2. 200 guiding principles for technical review and clinical trials of medical devices were formulated and revised. 150 kinds of reference materials for in vitro diagnostic reagents were developed; 3. To establish and improve the standardized management system of medical devices, relying on the existing resources, strengthen the construction of the national medical device standard management center, and provide standard management personnel to meet the needs. 3、 Strengthen the whole process supervision. 1. We should fully implement the quality management standards for clinical trials of medical devices, strengthen the supervision and inspection of clinical trials, and crack down on the falsification of clinical data; 2. We should fully implement the quality management standard of medical device production, and strengthen the production supervision of sterile and implantable medical devices; 3. We should fully implement the quality management standards for medical devices, strengthen the quality supervision of cold chain transportation and storage, and implement the online filing and verification system for purchasing and selling business 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 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, data reliability, etc., we will carry out the whole project inspection of quality management for enterprises, severely crack down on various illegal behaviors such as fraud, and urge enterprises to strictly implement relevant quality management standards. Increase the frequency of registration inspection, flight inspection and overseas inspection, and improve the inspection ability. Strengthen the inspection of sterile and implantable medical devices and in vitro diagnostic reagents. The "enhanced medical device inspection" program includes: 1. The national level carries out a full project inspection for all the third class medical device manufacturers and the second class sterile medical device manufactu

9 major events to be done in the next few years!

(Summary description)1、 We will deepen the reform of the examination and approval system for medical devices.
1. Encourage R & D innovation.
Encourage clinical institutions and doctors to participate in the research and development of innovative medical devices. Priority shall be given to the examination and approval of innovative medical devices with product core technology invention patents and significant clinical value, as well as medical devices that are urgently needed in clinical practice and listed in the national key R & D plan and major scientific and technological projects.
2. The review and approval mechanism was improved.
Improve the quality control system of evaluation. Establish a drug and medical device evaluation mechanism with clinical as the core, improve the system of indication team review, project manager, technical dispute resolution, communication and exchange, priority review, review information disclosure, etc., and gradually form a drug and medical device efficacy and safety guarantee system with technical review as the core, on-site inspection and product inspection as the support.
3. We will accelerate the reform of classified management of medical devices.
Set up 16 professional groups of medical device classification technology, optimize and adjust the framework and structure of classification catalog, and issue the new version of medical device classification catalogue; research and develop 22 medical device nomenclature guidelines according to professional field setting, and gradually implement naming according to the common name of medical device; formulate coding rules of medical device and construct coding system of medical device. The database of medical device classification, naming and coding was established.
2、 We will improve the system of regulations and standards.
We have basically completed the formulation and revision of supporting regulations for medical devices, accelerated the research and transformation of international standards for medical devices, given priority to improving the basic general standards and high-risk product standards for medical devices, revised the guiding principles for technical review of medical device registration, and formulated technical guidelines for the production, operation, use and adverse event monitoring of medical devices.
"Medical device standard improvement action plan" includes:
1. 500 medical device standards were formulated and revised, including 80 diagnostic reagent standards, 200 active medical device standards, 220 passive medical device standards and other standards;
2. 200 guiding principles for technical review and clinical trials of medical devices were formulated and revised. 150 kinds of reference materials for in vitro diagnostic reagents were developed;
3. To establish and improve the standardized management system of medical devices, relying on the existing resources, strengthen the construction of the national medical device standard management center, and provide standard management personnel to meet the needs.
3、 Strengthen the whole process supervision.
1. We should fully implement the quality management standards for clinical trials of medical devices, strengthen the supervision and inspection of clinical trials, and crack down on the falsification of clinical data;
2. We should fully implement the quality management standard of medical device production, and strengthen the production supervision of sterile and implantable medical devices;
3. We should fully implement the quality management standards for medical devices, strengthen the quality supervision of cold chain transportation and storage, and implement the online filing and verification system for purchasing and selling business 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 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, data reliability, etc., we will carry out the whole project inspection of quality management for enterprises, severely crack down on various illegal behaviors such as fraud, and urge enterprises to strictly implement relevant quality management standards. Increase the frequency of registration inspection, flight inspection and overseas inspection, and improve the inspection ability. Strengthen the inspection of sterile and implantable medical devices and in vitro diagnostic reagents.
The "enhanced medical device inspection" program includes:
1. The national level carries out a full project inspection for all the third class medical device manufacturers and the second class sterile medical device manufactu

  • Categories:Industry News
  • Author:
  • Origin:
  • Time of issue:2017-10-30 13:37
  • Views:
Information
1、 We will deepen the reform of the examination and approval system for medical devices.
1. Encourage R & D innovation.
Encourage clinical institutions and doctors to participate in the research and development of innovative medical devices. Priority shall be given to the examination and approval of innovative medical devices with product core technology invention patents and significant clinical value, as well as medical devices that are urgently needed in clinical practice and listed in the national key R & D plan and major scientific and technological projects.
2. The review and approval mechanism was improved.
Improve the quality control system of evaluation. Establish a drug and medical device evaluation mechanism with clinical as the core, improve the system of indication team review, project manager, technical dispute resolution, communication and exchange, priority review, review information disclosure, etc., and gradually form a drug and medical device efficacy and safety guarantee system with technical review as the core, on-site inspection and product inspection as the support.
3. We will accelerate the reform of classified management of medical devices.
Set up 16 professional groups of medical device classification technology, optimize and adjust the framework and structure of classification catalog, and issue the new version of medical device classification catalogue; research and develop 22 medical device nomenclature guidelines according to professional field setting, and gradually implement naming according to the common name of medical device; formulate coding rules of medical device and construct coding system of medical device. The database of medical device classification, naming and coding was established.
2、 We will improve the system of regulations and standards.
We have basically completed the formulation and revision of supporting regulations for medical devices, accelerated the research and transformation of international standards for medical devices, given priority to improving the basic general standards and high-risk product standards for medical devices, revised the guiding principles for technical review of medical device registration, and formulated technical guidelines for the production, operation, use and adverse event monitoring of medical devices.
"Medical device standard improvement action plan" includes:
1. 500 medical device standards were formulated and revised, including 80 diagnostic reagent standards, 200 active medical device standards, 220 passive medical device standards and other standards;
2. 200 guiding principles for technical review and clinical trials of medical devices were formulated and revised. 150 kinds of reference materials for in vitro diagnostic reagents were developed;
3. To establish and improve the standardized management system of medical devices, relying on the existing resources, strengthen the construction of the national medical device standard management center, and provide standard management personnel to meet the needs.
3、 Strengthen the whole process supervision.
1. We should fully implement the quality management standards for clinical trials of medical devices, strengthen the supervision and inspection of clinical trials, and crack down on the falsification of clinical data;
2. We should fully implement the quality management standard of medical device production, and strengthen the production supervision of sterile and implantable medical devices;
3. We should fully implement the quality management standards for medical devices, strengthen the quality supervision of cold chain transportation and storage, and implement the online filing and verification system for purchasing and selling business 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 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, data reliability, etc., we will carry out the whole project inspection of quality management for enterprises, severely crack down on various illegal behaviors such as fraud, and urge enterprises to strictly implement relevant quality management standards. Increase the frequency of registration inspection, flight inspection and overseas inspection, and improve the inspection ability. Strengthen the inspection of sterile and implantable medical devices and in vitro diagnostic reagents.
The "enhanced medical device inspection" program includes:
1. The national level carries out a full project inspection for all the third class medical device manufacturers and the second class sterile medical device manufacturers every year. From 2018, a full project inspection will be conducted for the remaining class II medical device manufacturers and all class I medical device manufacturers every two years.
2. The quality management system of 30-40 overseas medical device manufacturers is inspected every year. During the 13th Five Year Plan period, full coverage inspection of imported high-risk medical device products will be realized.
3. Annual full coverage inspection for enterprises with special requirements for storage and transportation, during the "13th five year plan" period, full coverage inspection will be carried out for enterprises operating aseptic and implantable medical devices and in vitro diagnostic reagents.
4. During the period of the "13th five year plan", the use of medical devices in other institutions will be covered every year.
5、 Strengthen supervision and sampling inspection.
Reasonably divide the national and local sampling inspection varieties and projects, increase the sampling inspection of high-risk varieties, and expand the coverage of sampling inspection.
The national level carries out supervision and sampling inspection on 40-60 kinds of medical device products every year.
6、 Construction of national evaluation center.
To explore and innovate the institutional mechanism and corporate governance mode of drug and medical device evaluation institutions. We should 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 of drug and medical device review and approval.
7、 Inspection and detection capacity building.
To establish the standards for the construction of medical device inspection and testing capacity, relying on the China Academy of food and drug control, to build a national medical device inspection and testing institution, and to transform and upgrade the provincial medical device inspection institution. We will build a number of key laboratories for medical device supervision.
We will carry out research on quality evaluation, testing technology and testing standards of various types of digital diagnosis and treatment equipment, personalized diagnosis and treatment products and biomedical materials, and strengthen the common medical devices

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