1、三类医疗器械经营许可证办理方式如下:
(1)申请人提交申请资料到相关部门;
(2)相关部门受理申请人的申请;
(3)到实际场地进行勘察以及对产品进行审核;
(4)准予颁发三类医疗器械许可证。
2、法律依据:《医疗器械监督管理条例》第十四条
第一类医疗器械产品备案和申请第二类、第三类医疗器械产品注册,应当提交下列资料:
(一)产品风险分析资料;
(二)产品技术要求;
(三)产品检验报告;办理三类医疗器械经营许可证的办理流程:
5、三类医疗器械经营许可证,需要直接去市级人民政府食品药品监督管理部门办理,在接受资料后的30天内进行审核,如果符合相关规定,就可以颁发三类医疗器械经营许可证。
医疗企业经营许可证一共有三类,其中办理一类医疗器械许可证可以直接办理,经营二类产品是需要办理二类医疗器械经营备案凭证,经营三类产品则需要办理三类医疗器械经营许可证。
首先,经营企业必须明确申请三类医疗器械经营许可证的条件并满足相关要求。
(一)具有与经营规模和经营范围相适应的质量管理机构或者质量管理人员两个。质量管理人员应当具有国家认可的相
the Class III medical device license.2. Legal basis: Article 14of the Regulations on the Supervision and Administration of MedicalDevices for the filing of Class I medical devices and theapplication for the registration of Class II and Class III medicaldevices, the following materials shall be submitted: (1) riskanalysis data of products; (2) technical re for theproduct; (3) Product inspection report; handling process for thebusiness license of Class III medical devices: 5. The businesslicense of Class III medical devices is required directly to thefood and drug regulatory department of the municipal people'sgovernment, and reviewed within 30 days after receiving thematerials, if meeting relevant regulations, issue the businesslicense of Class III medical devices. There are three types ofmedical enterprise business licenses, among which the first classmedical device license can be directly handled, the operation ofsecond class products needs to apply for the record certificate ofsecond class medical devices, and the operation of third classproducts needs to apply for the business license of third classmedical devices. First of all, the operating enterprise mustclarify the conditions for applying for the third type of medicaldevice business license and meet the relevant re. (1) Itshall have two control agencies or man