一、什么是医疗器械?
医疗器械:是指单独或者组合使用于人体的仪器、设备、器具、材料或者其他物品,包括所需要的软件;其用于人体体表及体内的作用不是用药理学、免疫学或者代谢的手段获得,可能有这些手段参与并起一定的辅助作用。
二、医疗器械分几类?
一共三类:
经营第一类医疗器械不需许可和备案,执照上面加上销售医疗器械一类就可以正常销售;
经营第二类医疗器械需要办理备案;
经营第三类医疗器械需要办理经营许可证。
三、办公室和库房需要多大面积?
根据Zui新法规要求:
6840体外诊断试剂含冷链:办公室30平,库房40平,冷链20立方米
剩下所有产品都是:办公室30平,库房40平
四、办理医疗器械三类,交件需要哪些材料?
1. 营业执照副本原件,公章
2. 法人、企业负责人、质量管理人身份证跟毕业证原件及复印件、职称证明
3. 办公室房产证、租赁合同复印件;
4. 库房房产证、租赁合同复印件;(委托三方储存的,需要三方物流资质复印件、库房的产权证明和租赁合同复印件、物流服务协议和质量保证协议复印件;)
五、验收之前需要注意的事项:
房子:
1.面积达到要求。
2. 办公室设备设施齐全(办公桌椅、文件柜、电脑、打印机、固定网络等办公设备)
3.门牌号、门牌logo
4.现场与平面图一致;
5.不能有家居用品;
6.库房要是空置状态
7.摆放地拍或者货架,温湿度计,粘鼠板,灭火器,空调等
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. What is a medical device? Medical devices: refers toinstruments, equipment, appliances, materials or other articlesused individually or in combination, including required software;their use in the body is not obtained by pharmacological,immunology or metabolic means, but may participate and play acertain auxiliary role. 2. How many categories are medical devicesdivided into? There are three categories: The operation of thefirst type of medical devices does not need permission and record,the license plus sales of medical devices can be sold normally; Theoperation of type II medical devices needs to be put on record; Theoperation of the third type of medical equipment requires theoperation license. How much area does the office and the warehouseneed? According to the latest regulatory requirements: 6840 Invitro diagnostic reagent includes cold chain: 30 square meters inoffice, 40 square meters in warehouse, 20 cubic meters in coldchain. All products remain: 30 square meters in office, 40 squaremeters in warehouse For the three types of medical devices, whatmaterials do you need to