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의료기기 허가 준비서류

빠르고 확실한 허가등록을 해드립니다!

의료기 허가 신청 준비 서류

Item Document Requirement
1 Certificate of Manufacturer Copy, then notarized
2 Free sales of certificate Original with the signature, then notarized
3 KFDA approval certificate Copy, then notarized
4  List of basic requirements for safety and
effectiveness of medical device
Copy, then notarized
5 Summary Original with the signature, then notarized
6 Research Information Original with the signature, then notarized
7 Manufacturing Information Original with the signature, then notarized
8 Clinical evaluation material Original with the signature, then notarized
9 Risk analysis material of products Original with the signature, then notarized
10 Instruction for use of the product, designed package and
label samples of minimum sales unit
Original with the signature, then notarized
11 Conformity statement Original with the signature, then notarized
12 Agent  Authorization  Letter Original with the signature, then notarized.