The Ministry of Food and Drug Safety has established an integrated guideline for authorization, certification, and examination of wound dressing (a guide to civil petitioners).
The wound dressing material is manufactured in various forms, such as item shape, sheet shape, liquid shape, powder shape, etc., and is a medical device used to absorb exudate from wounds, bleed or lose body fluid, and prevent contamination.
Since various raw materials are used, the items and grades vary depending on the characteristics of each raw material, and the purpose of use, the principle of action, and the method of use vary.
The guidelines include the following key points.
- Classification and definition
- Procedures for approval, certification, and examination of technical documents by grade
- Example of how to create a technical document by item
- Requirements for materials required for examination
- Criteria for determining the subject of clinical data review
Please refer to the link below for detailed .
점착성투명창상피복재 허가 및 기술문서 작성을 위한 가이드라인 상세보기|공지사항 | 광
점착성투명창상피복재 허가 및 기술문서 작성을 위한 가이드라인 의료기기 제조, 수입업체가 허가 및 기술문서 신청 시 필요한 관련 절차, 작성요령 등을 안내하고자 "점착성투명창상피복재 허
mfds.go.kr
If you have any questions about medical device certification,
Please contact us with the below.
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