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;
(四)临床评价资料;4、工商行政管理部门出具的《企业名称预先核准通知书》申请人以欺骗、贿赂等不正当手段取得《医疗器械经营企业许可证》的,(食品)药品监督管理部门应当撤销其《医疗器械经营企业许可证》,给予警告,并处1万元以上2万元以下罚款。申请人在3年内不得申请《医疗器械经营企业许可证》。办理三类医疗器械经营许可证的办理流程:
1.向食品药品监督管理局提交医疗器械经营许可证申请材料;
2.食品药品监督管理局数据形式审查;
3.数据正式受理;
4.有关部门的行政审查;
14 of the Regulations on the Supervision and Administration ofMedical Devices 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) data onproduct risk analysis; (2) technical requirements of the product;(3) product inspection report; and (4) clinical evaluation data; 4.Notice of Pre-approval of Enterprise Name issued by theadministrative department for industry and commerce If theapplicant obtains the Medical Device Operating Enterprise Licenseby cheating or bribery, The (food) and drug regulatory departmentshall revoke its Medical Device Trading Enterprise License, Give awarning, And shall be fined not less than 10,000 yuan but not morethan 20,000 yuan. The applicant shall not apply for the MedicalDevice Business Enterprise License again within 3 years. Proceduresfor handling the business license of Class III medical devices: 1.Submit the application materials for the medical device businesslicense to the Food and Drug Administration; 2. Data form review ofthe Food and Drug Administration; 3. Official acceptance of data;4. Admini