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[KFDA]「의료기기 허가·신고·심사 등에 관한 규정」 일부개정고시
- Admin Hits:642
- 2019-07-26 13:38:00
안내드립니다.
식품의약품안전처 고시 제2019-62호
의료기기 허가·신고·심사 등에 관한 규정 일부개정고시
1. 개정이유
기존 SCI에 등재된 임상시험자료만 인정하던 것을 SCIE 등재 임상시험자료까지 확대 인정 및 판매업 신고 면제 대상 의료기기에 배란 시기 판단용 개인용체외진단검사시약을 추가하는 등 현행 제도의 일부 규제를 개선하고자 함
2. 주요내용
가. 기존 SCI 등재 임상시험자료만 인정하던 것을 SCIE까지 확대 인정(제29조제12호, 제33조제3항제2호라목)
나. 판매업 신고 면제 의료기기에 기존 ‘임신진단용’으로 한정하던 것을 ‘배란 시기 판단용’까지 확대 적용(제55조)
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