进口美国医疗器械所需文件清单和要求(英文版).docVIP

PAGE 2 Please provide the files (hard copy) as below: And please prepare the files according to the requirements No. Name of document Remark 1 Manufacturer’s License Notarization is necessary. 2 Quality Management System (ISO 13485) Notarization is necessary. 3 EC Certificate Notarization is necessary. 5 IEC 60601-1 Test Report Notarization is necessary with the cover page signed and sealed. 6 Laboratory qualification certificate(LQC) Notarization is necessary. Please provide LQC. The a