[Asia Economy Reporter Cho Hyun-ui] The government is supporting the medical device industry by designating COVID-19 diagnostic kits and others as innovative medical devices and conducting expedited reviews.
On the 26th, the Ministry of Health and Welfare held the 1st Medical Device Industry Promotion and Support Committee meeting to discuss the introduction of an innovative medical device company certification system. The Medical Device Industry Promotion and Innovative Medical Device Support Act, which came into effect this month, was enacted to systematically foster the medical device industry and provide new treatment opportunities in a timely manner.
Based on this law, the Medical Device Industry Promotion and Support Committee was established, chaired by the Minister of Health and Welfare, and consists of a total of 15 members including 4 government members and 10 private members. The committee deliberates and resolves key matters related to the promotion and support of the medical device industry.
At this first meeting held after the law’s enforcement, the committee reported on plans for the innovative medical device company certification and reviewed matters related to the designation of innovative medical device groups.
The innovative medical device company certification system certifies medical device companies with excellent research and development as innovative medical device companies and supports preferential treatment in R&D projects and other benefits.
Considering the medical device industry structure with many small and medium-sized enterprises, the system is divided into innovation-leading and innovation-leap types, and the certification process will proceed through an application announcement early next month.
Companies certified as innovative medical device companies will receive benefits such as preferential participation in national R&D projects and additional points when participating in new product user evaluation projects.
The innovative medical device groups define support areas aimed at promoting medical device technology development, revolutionary improvements in treatment methods, and enhancing the quality of medical services through treatment of rare and intractable diseases.
The committee classified innovative medical device groups into four categories: ▲Advanced Technology Group ▲Medical Innovation Group ▲Technology Innovation Group ▲Public Interest Medical Group, and deliberated and resolved the specific designation scope for each category.
Innovative medical devices are designated by the Ministry of Food and Drug Safety as medical devices that belong to the innovative medical device groups and have significantly improved safety and efficacy compared to existing medical devices.
Once designated as an innovative medical device, special measures such as prioritized review compared to other medical devices or expedited review divided by development stages are provided.
At the first meeting, Park Neung-hoo, Minister of Health and Welfare, said, "During the COVID-19 pandemic, global interest in Korean medical devices as quarantine and diagnostic tools has increased," and added, "We will further expand related policies so that domestically produced medical devices can be increasingly used in actual medical settings after development."
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