办理医疗器械经营企业备案程序和材料要求 (适用于经营第一类医疗器械 )经营第一类医疗器械的企业 ,必须办理备案盖章手续。备案程序和申报材料 :一、经营 (包括兼营 )企业提出申请 ,填写《医疗器械经营企业备案表》一式 3份 (复印件无效 ) ,由法人代表签字和企业盖公章 ;二、 Procedures and material requirements for filing procedures and materials for medical device operators (applicable to the operation of the first type of medical device) Enterprises that operate the first type of medical device must go through the formalities of filing and stamping. Filing procedures and application materials: 1. The enterprise that manages (including concurrently run) an application shall fill in 3 copies of the “Record Form for Medical Device Distribution Enterprises” (with invalid photocopies), and shall be signed and sealed by the legal representative;