海淀西苑北京医疗器械三类经营许可证可全包代办专业快捷包下证

（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；
（五）产品说明书以及标签样稿；
（六）与产品研制、生产有关的质量管理体系文件；
（七）证明产品安全、有效所需的其他资料。
产品检验报告应当符合国务院药品监督管理部门的要求，可以是医疗器械注册申请人、备案人的自检报告，也可以是委托有资质的医疗器械检验机构出具的检验报告。
符合本条例第二十四条规定的免于进行临床评价情形的，可以免于提交临床评价资料。
医疗器械注册申请人、备案人应当确保提交的资料合法、真实、准确、完整和可

s: (1) product risk analysis data; (2) technical requirements(3) product; (3) product inspection report; (4) clinical evaluationdata; (5) product instructions and label samples; (6) qualitymanagement system documents related to product development andproduction; (7) other materials required to prove the safety andeffectiveness of the product. The product inspection report shallmeet the requirements of the drug regulatory department under TheState Council, and may be the self-inspection report of the medicaldevice registration applicant or record holder, or the inspectionreport issued by a qualified medical device inspection institution.Those who are exempted from clinical evaluation in accordance withthe provisions of Article 24 of these Regulations may be exemptedfrom the submission of clinical evaluation data. The registrationapplicant and applicant of medical devices shall ensure that thesubmitted materials are legal, true, accurate, complete andacceptable