[Asia Economy Reporter Eunmo Koo] Molecular diagnostics specialist Seegene announced on the 1st that it has obtained certification as an ‘Innovative Medical Device Company’ from the Ministry of Health and Welfare.
As Seegene has been selected as an innovative medical device company, it will receive benefits such as ▲preferential participation in research and development (R&D) projects ▲tax support (tax incentives, exemption from various burdens including preferential health insurance benefits) ▲export support (approval support, etc.) ▲preferential participation in government projects ▲special provisions related to the construction of research facilities.
Seegene will also receive additional points when participating in new product user evaluation projects in the future, and if the company’s products are designated as innovative medical devices, they will be given priority review over other medical devices or expedited review at each development stage, among other special provisions.
A Seegene official said, “With this certification as an innovative medical device company, our strength in product development using the three core technologies?DPO, TOCE, MuDT?and the AI-based development automation system SGDDS has been recognized,” adding, “We hope to firmly establish ourselves as a global leader in the molecular diagnostics field through our own technological capabilities and government support.”
The innovative medical device company certification system is a program by the Ministry of Health and Welfare that certifies medical device companies excelling in medical device R&D and supports preferential treatment in research and development projects. Innovative medical devices refer to those that contribute to improving the quality of medical services by promoting medical device technology development and revolutionary improvements in treatment methods, with significantly improved safety and efficacy compared to existing medical devices. The Ministry of Health and Welfare established the innovative medical device company certification system to foster and support the medical device industry, promote the commercialization of innovative medical device products, and strengthen the competitiveness of the medical device industry by creating a foundation for development.
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