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

is data; (2) technical re of the product; (3) product inspection report; (4) clinical evaluation data; (5) product specification and label samples; (6) management system documents related to product development and production; (7) other data required to prove the safety and effectiveness of the product. The product inspection report shall meet the re of the drug regulatory department under The State Council, and may be the self-inspection report of the medical device registration applicant and the record holder, or the inspection report issued by a medical device inspection institution. Those who are exempted from the conduct of the clinical evaluation in accordance with the provisions of Article 24 of these Regulations may be exempted from the submission of the clinical evaluation data. The registration applicant and applicant of medical devices shall ensure that the submitted materials are legal, true, accurate, complete a