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2018 year-end inventory of medical device policies!

文章来源:www.grt3000.com 时间:2020-05-13 浏览:398

? On January 3, 2018, the former State Food and Drug Administration issued the "Notice of the General Office of the General Administration on Doing a Good Job in Medical Device Inspection", requiring all provincial drug regulatory bureaus to attach great importance to medical device inspection and strengthen their medical devices. Supervision and management of inspection agencies.
? On January 11, 2018, the former State Food and Drug Administration issued the "Guiding Principles for Accepting Medical Device Overseas Clinical Trial Data Technology", which clarified that when medical devices are registered in China, they will accept the use of overseas clinical trial data as clinical evaluation data and make it clear Relevant data and technical requirements of overseas clinical trial data.
? On January 29, 2018, the former State Food and Drug Administration issued the "Medical Device Standards Plan (2018-2020)", proposing to build a medical device standard system that basically meets the needs of medical device supervision in 2020, and completed the 300 standard system Revised.
? On January 30, 2018, the former State Food and Drug Administration and the Ministry of Science and Technology jointly issued the "Guiding Opinions of the Ministry of Food and Drug Administration on Strengthening and Promoting Food and Drug Science and Technology Innovation Work", which clearly promotes supply-side structural reforms and deepening In the reform, the scientific and technological work of food, drug and medical device supervision and management will be strengthened, and the level of supervision will be improved by innovation, thereby promoting the innovative development of the food, drug and medical device industry.
? On February 26, 2018, the Former State Administration of Food and Drug Administration issued the “Notice on Public Consultation on the Guidelines for the Technical Review of Registration of Customized Additive Manufacturing Medical Devices” (Draft for Comment) to support and encourage customization R & D of medical device products in the form of additive manufacturing, which indicates that the relevant policies for 3D printed medical devices are gradually being implemented.
? On February 27, 2018, the former State Food and Drug Administration issued the "Notice of the General Office of the State Administration on the Implementation of the" Administrative Measures for the Supervision and Administration of Medical Device Network Sales "", requiring all levels of drug regulatory departments to strengthen the medical device network in the administrative area. The supervision and management of the third-party platform providers of sales enterprises and medical device network transaction services, urge enterprises and third-party platform providers to effectively perform their main responsibilities.
? On March 15, 2018, the former State Food and Drug Administration issued the "Notice of the General Office of the General Administration of the People's Republic of China on Printing and Distributing the Evaluation and Evaluation Program of the Medical Device Standardization Technical Committee" to strengthen the management of the Medical Device Standardization Technical Committee and improve the standard work level.
? On April 9, 2018, the National Health and Safety Commission issued the "Large-scale Medical Equipment Configuration License Management Catalog (2018)", which officially announced the latest category A and B large-scale medical equipment management catalog (2018 version catalog). The large-scale medical equipment of Class A and Class B that are allowed to be configured shall be regulated. In the latest 2018 version of the catalog, it is defined that the price of large medical equipment has increased from 5 million to 10 million, and the price of large class A medical equipment has soared from 5 million to 30 million per unit.
? On April 24, 2018, the State Food and Drug Administration issued the "Special Remediation Work Plan for Strictly Cracking Down on the Operation and Use of Medical Devices in 2018", severely cracking down on the use of unlicensed medical devices and the operation of unauthorized (recorded) medical devices, etc. In violation of laws and regulations, promote the establishment of a long-term supervision mechanism to ensure the quality and safety of medical device operation and use. It was decided to carry out special rectification work from May 2018 to the end of November nationwide to crack down on illegal operation and use of medical devices.
? On May 15, 2018, the State Administration of Drug Administration issued the “Announcement of the State Drug Administration Office on the 2018 Medical Device Industry Standards Revision Plan Projects”, identifying 99 medical device industry standards revision plan items in 2018.
? On May 23, 2018, the State Food and Drug Administration issued the "Notice of the State Drug Administration Office on the Definition of the Classification of Strong Pulsed Light Hair Removal Products", confirming that the strong pulsed light hair removal products are managed according to the second category of medical devices, and the classification code It is 09-03-04, and from January 1, 2023, strong pulsed light hair removal products cannot be produced, imported and sold without obtaining a medical device registration certificate according to law.
? On May 28, 2018, the State Food and Drug Administration issued the "Management Regulations for the Revision of Guiding Principles for the Technical Review of Medical Device Registration", which is used to regulate the technical review of medical device registration and guide the registration application of medical device registration applicants.
? On May 29, 2018, the State Food and Drug Administration issued the "Notice of the State Drug Administration Office on Printing and Distributing the 2018 National Medical Device Sampling Product Inspection Program", requiring all levels of the Food and Drug Administration to organize relevant inspection agencies in accordance with mandatory standards and Registered or filed product technical requirements (registered product standards) to carry out inspection work.
? On June 25, 2018, the Ministry of Justice announced the "Amendments to the Regulations on the Supervision and Administration of Medical Devices (Draft for Review)" and solicited opinions from the public. The key contents of this revision include: improving the medical device marketing license holder system, reforming the clinical trial management system, optimizing the approval procedures, improving post-market regulatory requirements, and strengthening the supervision of used medical devices.
? On July 31, 2018, the State Food and Drug Administration issued the "Notice of the Office of the State Drug Administration on Strengthening Information Management of Medical Device Production and Operation License (Filing)", requiring each provincial drug regulatory bureau to do a good job in medical device operation Licensing (recording) information Regarding content adjustment work, a designated person is responsible for timely uploading of medical device production and business licensing (recording) information and making it publicly available in a timely manner.
? On August 3, 2018, the State Food and Drug Administration issued the "2018 Medical Device Industry Standards Revision Project", confirming that 99 projects should complete the standard drafting, verification, consultation, technical review and review in accordance with the relevant requirements of the standard system revision work. Apply for approval.
? On August 14, 2018, the State Food and Drug Administration issued the "Reply of the State Drug Administration on Approving the Pilot Work of the Medical Device Registrant System" and agreed to carry out the pilot of the medical device registrant system in the China (Tianjin) Free Trade Pilot Zone Ask for work.
? On August 31, 2018, the State Administration of Market Supervision and the National Health and Health Commission jointly issued the "Administrative Measures on the Monitoring and Re-evaluation of Medical Device Adverse Events", which clarified the main responsibilities of medical device marketing license holders and improved the monitoring system for adverse events. Strengthen the obligation of holders to directly report bad time and strengthen the risk control requirements.
? On October 23, 2018, the State Food and Drug Administration issued the "Notice of the Comprehensive Department of the State Food and Drug Administration on the Implementation of the" Administrative Measures for the Monitoring and Re-evaluation of Adverse Events in Medical Devices "", emphasizing that all provincial drug regulatory departments should supervise Holders of medical device marketing licenses effectively fulfill their responsibility for monitoring adverse events, and the National Bureau of Monitoring and Evaluation Agency should accelerate the improvement of the national medical device adverse event monitoring information system.
? On November 5, 2018, the State Food and Drug Administration issued the "Special Review Procedures for Innovative Medical Devices", requiring that the supply-side structural reform and the "deregulation" reform requirements continue to be deepened, and the reform of the review and approval system should be promoted to encourage innovation in medical devices. To encourage high-quality development of industrial innovation.
? On November 9, 2018, the State Food and Drug Administration issued the "Notice of the General Department of the State Food and Drug Administration on the Implementation of the State Council's" License Separation "Reform Requirements for Post-market Supervision and Approval of Medical Devices", requiring each provincial drug supervision Departments should put together management and management, simplify processes, improve the level of approval services, and reduce or integrate existing approval approvals as much as possible by increasing system innovation and government function transformation.
? On November 19, 2018, the State Food and Drug Administration issued the "Key Points and Judgment Principles of Clinical Trial Inspection of Medical Devices" to guide the regulatory authorities to carry out the supervision and inspection of medical device clinical trials.
? On December 10, 2018, the State Food and Drug Administration issued the "Announcement of the Comprehensive Department of the State Food and Drug Administration on the 2019 Medical Device Industry Standards Revision Plan Projects", identifying 94 medical device industry standards revision plan items in 2019 and giving Publicity.
Source: Precision Medical Information

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