Innovative Medical Devices Group Classification

The Innovative Medical Devices Group Classification is designated after deliberation by the committee in consideration of promoting medical device research and development, improving treatment methods, and treating rare and intractable diseases in accordance with Article 20 of the Medical Devices Industry Act. Medical devices designated as innovative medical devices are valid for three years from the date of designation and can be extended through re-evaluation. The designation process will be announced by the Ministry of Health and Welfare after deliberation by the Medical Device Industry Promotion and Support Committee, and the applied innovative medical devices will be designated by the Minister of Food and Drug Safety in consultation with the Minister of Health and Welfare.

혁신 의료기기·군 분류체계(Innovative Medical Devices Group Classification)는 의료기기산업법 제20조에 따라 의료기기 연구개발 촉진, 치료법 개선, 희귀난치성 질환 치료 등을 고려해 위원회 심의를 거쳐 지정됩니다. 혁신의료기기군으로 지정된 의료기기는 지정일로부터 3년간 유효하며, 재평가를 통해 지정 연장이 가능합니다. 지정 절차는 의료기기산업육성·지원위원회 심의를 거쳐 보건복지부 고시로 이루어지며, 신청된 혁신의료기기는 식약처장이 복지부 장관과 협의하여 지정됩니다.