The purpose of renewing medical device items periodically is to ensure the safety and effectiveness of products. According to the revision of the Medical Device Act, manufacturers and importers must extend the validity period to continue to manufacture and import products after the end of the specified validity period.
The Ministry of Food and Drug Safety (Medical Device Safety Evaluation Division) posted a notice to introduce the medical device item renewal system, which will begin in earnest in 2024, and to inform the operation plan and submission data.
The Ministry of Food and Drug Safety's renewal system operation plan is applied step by step for each renewal cycle as follows.
1st cycle, '25 ~ '29 : Improvement of distribution product status
2st cycle, '30 ~ '34 : Securing safety and effectiveness
Please refer to the link below for more information.
식품의약품안전처>법령/자료>홍보물자료>일반홍보물 | 식품의약품안전처
의료기기 품목갱신 운영계획 안내문 분야 #의료기기 #갱신 등록일 2023-07-07 조회수 798 의료기기 품목갱신 운영계획 안내문입니다. 첨부파일 첨부파일 전체 다운로드 --> ★ 의료기기 품목갱신 운
www.mfds.go.kr
If you have any questions about medical device certification,
Please contact us with the below.
info@jnmglobal.net
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