第一类医疗器械是指，通过常规管理足以保证其安全性、有效性的医疗器械。
一类医疗许可证无需办理经营许可证。如果是生产医疗器械，则需要到相关部门备案。
二、公司增加二类医疗器械经营范围
二类医疗器械备案要求，根据《医疗器械监督管理条例》凡是从事二类医疗器械经营的单位都需要到所在地设区的市级食品药品监督管理部门备案，二类医疗器械是具有中度风险，需要控制管理以保证其安全、有效的医疗器械。如：医用缝合针、血压计、体温计、心电图机、脑电图机、显微镜、针灸针、生化分析系统、助听器、超声消毒设备、不可吸收缝合线等。
要求：
1.商用性质办公60平，仓储40平
2.2名医学专业人员为企业负责人
3.产品经营目录
ient to ensure their safety and effectiveness through routinemanagement. Class I medical license does not need for a businesslicense. If it is making medical devices, it needs to file with therelevant departments. 2. The company has increased the businessscope of class II medical devices According to the filingrequirements of Class II medical devices, according to theRegulations on the Supervision and Administration of MedicalDevices, all units engaged in the business of Class II medicaldevices need to file with the food and dr
