审批三类医疗器械许可的条件：
1、经营场所使用面积应当不小于40平方米，法人单位分支机构的经营场所使用面积应当不小于25平方米(跨设区市设置的除外);经营助听器的，经营场所使用面积应当不小于25平方米;经营隐形眼镜及护理用液的，经营场所使用面积应当不小于10平方米。
2、仓库使用面积应当不小于30平方米;经营一次性使用无菌医疗器械的，仓库应当在同一建筑物内，使用面积应当不小于200平方米。
3、质量管理人、质量机构负责人应当具有国家认可的、与经营产品相关专业，大专以上学历或相关专业中级以上技术职称。经营一次性使用无菌医疗器械的,还应当有一名以上持有医疗器械质量管理体系内审员证书的内审员等其他相关申请条件。
Where there are errors in the applicationmaterials that can be corrected on the spot, The applicant shall beallowed to make corrections on the spot; if the applicationmaterials are incomplete or do not conform to the statutory form,Should inform the applicant on the spot or within five days of allthe contents to be corrected, Failure to inform you after the timelimit, It shall be accepted from the date of receipt of theapplication materials; The matters to apply for fall within thescope of the functions and powers of the administrative organ, Theapplication materials are complete and in line with the legal form,Or where the applicant submits all the supplementary and correctedapplication materials as required by the respective administrativeorgan, The application for administrative license shall beaccepted.
