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On March 19, the government announced the "Innovative Regulation of Medical Device Regulation and Industrial Growth Plan for the Expansion of Innovative Growth" jointly with the relevant departments.
According to the government announcement, the government decided to expand the scale of investment in R & D and shorten the regulatory period to foster innovation and the advanced medical device industry as the new industry of the 4th industrial revolution.
However, there has been an indication that the technology industry can not keep pace with rapid technological change.
In particular, the medical device industry is subject to government health and safety regulations and has undergone various regulatory processes (up to 520 days) since the development of medical devices up to date. at market entry
19659002] In the future, the government announced that it planned to radically innovate medical technology (medical device) with fewer concerns about of security, according to the "entry-to-evaluation" method (global negative regulation).
In particular, the badessment of new medical technologies in the field of in vitro diagnostic tests goes from pre-evaluation to post-evaluation, and the period necessary for entry into the market for DIVs are reduced from "390 days" to "80 days".
Future promising innovations using artificial intelligence (AI), 3D printing, robots, and so on. If the minimum security of advanced medical technology is ensured, it will be allowed to enter the market first and then used for 3 to 5 years in the clinical field.
We will rebadess our patients based on their abundant clinical evidence.
In addition to regulatory innovation, we will promote measures to promote the medical device industry.
First, it is planned to create a "cooperation group on mountain disease" in a research center hospital and establish a basis for the hospital to become a research and commercialization center for innovative medical technologies.
In addition, based on the patient experience, we are actively pushing policies that lead the medical industry, such as the development of innovative medical devices, improving the performance of domestic medical devices , the promulgation of the law on the education of the medical industry.
The detailed project of this measure is as follows:
The gray area (unpredictability) of the regulatory process is resolved. In order to resolve the restriction of the participation of the regulatory process in the provision of individual information of the regulatory bodies of medical devices (Ministry of Health, Welfare and Family Affairs, HIRA), strengthen the function " Medical Device Industry Support Center, "Performing Periodic Integrated Counseling
In particular, it plans to build an" integrated information portal system "connected to the home page of each regulatory body in order to Increase access to regulatory information
Plan to increase the transparency of the regulatory process by actively disclosing regulatory progress (regulatory standards, results of proceedings, etc.) to applicants and by strengthening the participation guarantee
Recruitment of additional experts in innovation and hau technology to the evaluation committee on the recommendation of the relevant badociations, etc., and appointment of these experts as members of the evaluation committee
In particular, the Ministry of Health and Welfare be informed the Ministry of Health of the examination procedure of the new evaluation of medical technology, the examination standard and the result of the evaluation (such as the result of the deliberation) .
A substantial one-stop system for the licensing process will be established. In order to shorten the regulatory period, plans will be developed to streamline the process of evaluating new medical technology and to simultaneously review rebadurance and the new evaluation of medical technology, such as insurance.
↑ Comparison before and after the improvement of the system
The integrated examination (certification of the medical device – new evaluation of medical technology) constitutes the 'examination team' integrated 'As the main agent of responsibility (pharmacy), to eliminate confusion in duplicate data requests and to share data with the integrated system of examination of operations
L & 39 Innovation and advanced medical technology are being supported to enter the early market.
A preliminary licensing system and compensation system for the value of innovation will be put in place to enable the rapid entry of innovative and advanced medical technologies that were lacking in the new medical technology badessment.
The KFDA establishes a "rapid clearance guideline" that allows rapid and high-speed access to innovative and advanced medical devices at the licensing stage of medical devices
L & # 39; HIRA agreement will enter the market by the issuance of a preliminary clbadification code or certificate of the HIRA (new procedure for evaluation of medical technology omitted)
Ministry of Health and Welfare runs a distinct evaluation pathway that allows entry to the market, given the potential value of innovation and advanced medical technology, even though the literary base is somewhat lacking
In addition, the HIRA will set up an appropriate compensation system by improving the system of evaluation of technological innovation and improved therapeutic materials.
"Complete negative regulation" of safe medical devices will be introduced. In the case of medical devices where human security is of little concern, the policy will be to innovate the regulatory system by adopting a "first in post-badessment" approach (negative overall regulation).
By shifting the badessment of new medical technologies from the field of in vitro diagnostic tests from pre-badessment to post-badessment, in vitro diagnostic devices will significantly shorten entry into the market in 80 days, more than 390 days after development.
In the case of an in vitro diagnostic device compared to an existing device, minor modifications (eg intended use), but minor modifications, are exempted from the permit to change delivery location ( 60 days).
The research and industrialization capabilities of medical and medical equipment of doctors and hospitals will be strengthened.
The government promotes ecosystem innovation to foster the medical device industry by building the capacity of hospitals and research physicians, who are the focus of R & D and of innovative marketing of medical devices.
Hospitals plan to participate actively in research and development of medical devices in order to put their achievements into practice.
First, institutional barriers to the research and practical use of innovative medical technologies focused on research-based hospitals are resolved.
Establish a system of self-organization that will be devoted to the commercialization of medical technology patents and start-up support for hospitals such as mountaineering cooperatives
establish a plan to convert the designation system into a certification system and develop, step by step, hospitals with research capacity as research center hospitals.
In addition, a consortium between hospitals of research centers and local hospitals will be created to support the research of local hospitals and to encourage local hospitals as hubs for regional innovation growth. It will support joint research such as companies, universities and exhibitions since 1919.
Based on the experience in patient care, we intend to strengthen the training system of doctors of research as a leader in the development of innovative medical devices.
First, we plan to establish a training course for clinical research physicians at the Resident Training Center for New and Middle Doctors, with a focus on hospitals with research capacity.
The Ministry of Health and Welfare plans to shorten the hours of medical examination to guarantee research time and help doctors become independent researchers by receiving research funds, equipment and medical examinations. Hospital and Government Research Funds
To support collaborative research between clinical physicians and basic research scientists within the university, 30 leading research centers (MRCs), which support universities with colleges of higher sciences,%
to participate.
Government to Have Support System to Improve Competitiveness of National Medical Device Technology Development and Improve Competitiveness at Global Enterprise Level by Improving Performance
Ministry of Health and Welfare Plans significantly expand the hospital bed support project to improve the performance of national medical devices and conduct comparative tests (demonstration of performance equivalence) with foreign products.
Companies that participated in test bed support activities began providing medical products to hospitals in Korea and increased sales by up to 49%.
The Ministry of Health, the Ministry of Information and Communication and the Ministry of Industry plan to grant an evaluation point when hospitals with a high rate use of national medical devices participate in national research and development projects
The relevant ministries (well-being, period, industry, food) will cooperate to integrate research and development activities of medical equipment in offices
The integrated business plan provides for the creation and operation of a single corporation and the provision of a one-stop shop for consumers by participating in licensing agencies. license and health insurance
The infrastructure to promote the medical device industry will be expanded. It plans to promulgate the "Medical Device Industry Education Law" and the "in vitro diagnostic device technique", which are longstanding requirements of the medical device industry , and strengthen the legal system of education.
The Ministry of Health and Welfare is cooperating with the National Assembly to develop the law on the promotion of the medical device industry in order to harmonize regulations on medical devices and industrial promotion policies
Designation and support of the company "Innovative Medical Device" and support for R & D related companies plan to create an industrial ecosystem capable of developing innovative medical devices such as artificial intelligence and 3D printing
In particular, in the case of innovative medical devices, it will promote rapid market production and penetration by providing for such provisions as rapid authorization, in addition to content related to the support and education.
KFDA plans to adopt the "In Vitro Diagnostic Medical Device Technique" in order to establish a legal system that corresponds to the technical characteristics of in vitro diagnostic medical devices
The Ministry of Health Health and Welfare plans to operate the "Fund for the early establishment of technology in the health industry (total of more than 30 billion KRW by public and private institutions) to from August this year. "
Provides personalized training (education, counseling, IR, etc.) according to the result of the diagnosis of an investment company and investing in early medical equipment companies
By moreover, thanks to the "Business Support Center of the Health Industry", which has been running since last February, we have found promising ideas (technologies) through technology facilitators, mentors and investor relations . Support the growth of appliance companies.
In addition to the regulatory amendments to the licensing and licensing of medical devices, the government plans to revitalize the use of medical data, an important resource for R & D and commercialization in the medical field, and to badist the public to use medical data.
The Minister of Health and Welfare, Park Yong-sung, said: "I think this measure will serve as a bridgehead for the development of the national medical device and penetration industry. national enterprises in the world market. "
In addition, the establishment of research co-operation hospitals in research centers' hospitals makes it possible to recruit stable researchers and create good jobs, as well as joint research with local hospitals, Research hospitals, businesses, innovation will grow as well as the local economy.
Finally, Minister Park said, "However, since the field of medical devices is directly related to people's lives, we will continue to innovate regulation while considering personal safety as a top priority." [19659002]
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