The manufacturer shall present a statement of compliance with the concerning National standard or industrial standard, a statement that taking the quality responsibilities of entering into market, and a classification illustration of concerning product models, specifications.
这里的“签章”是指：企业盖章，或者其法定代表人、负责人签名加企业盖章（以下涉及境内医疗器械的，含义相同）；
Sign/Chop refer to: enterprise chop, or signed by the legal responsible personnel/principal and chop together.(same meaning for followings domestic medical devices)
（四）产品全性能检测报告； Testing report for total performance
（五）企业生产产品的现有资源条件及质量管理能力（含检测手段）的说明；
The illustration for the manufacturing resources and quality management abilities(testing resources are included.)
（六）医疗器械说明书； Medical device user manual
（七）所提交材料真实性的自我保证声明：
Self-guarantee letter for the authenticity of providing documents.
应当包括所提交材料的清单、生产企业承担法律责任的承诺。
It shall include the list of providing documents, the statement of taking the legal responsibilities by manufacturer.
附件3： Annex 3:
境内第二类、第三类医疗器械注册申请材料要求
Registration applicant material requirement of domestic Class II, III medical device
（一）境内医疗器械注册申请表；
Domestic Medical Device Registration Applying Form
（二）医疗器械生产企业资格证明： Qualification of Medical Device Manufacturer
包括生产企业许可证、营业执照副本，并且所申请产品应当在生产企业许可证核定的生产范围之内；
Include manufacturing license, Counterpart of Business License, and the applying products falls into the approved manufacturing scope of manufacturing license;
（三）产品技术报告：
Product technical report
至少应当包括技术指标或者主要性能要求的确定依据等内容；
At least shall include technical specifications or foundation of main performance specifications;
（四）安全风险分析报告： Safety risk analysis report
按照YY0316《医疗器械风险分析》标准的要求编制。应当有能量危害、生物学危害、环境危害、有关使用的危害和由功能失效、维护不周及老化引起的危害等五个方面的分析以及相应的防范措施；
It shall be scheduled according to the requirement of YY0316
（五）适用的产品标准及说明： Applied product standard and illustration
采用国家标准、行业标准作为产品的适用标准的，应当提交所采纳的国家标准、行业标准的文本；注册产品标准应当由生产企业签章。
If manufacturer take National standard or industrial standard as the applied product standard, the manufacturer shall provide concerning copy of National standard or industrial standard; Registration product standard shall be signed/chopped by manufacturer.
生产企业应当提供所申请产品符合国家标准、行业标准的声明，生产企业承担产品上市后的质量责任的声明以及有关产品型号、规格划分的说明；
The manufacturer shall present a statement of compliance with the concerning National standard or industrial standard, a statement that taking the quality responsibilities of entering into market, and a classification illustration of concerning product models, specifications.
（六）产品性能自测报告： Self testing report on performance
产品性能自测项目为注册产品标准中规定的出厂检测项目，应当有主检人或者主检负责人、审核人签字。执行国家标准、行业标准的，生产企业应当补充自定的出厂检测项目； The tested item shall be compliance with delivery testing item in the registration standard, the report shall be signed by main testing personnel or main testing responsible personnel, and auditor.
（七）医疗器械检测机构出具的产品注册检测报告： Registration testing report issued by medical device testing facility
需要进行临床试验的医疗器械，应当提交临床试验开始前半年内由医疗器械检测机构出具的
检测报告。不需要进行临床试验的医疗器械，应当提交注册受理前1年内由医疗器械检测机构出具的检测报告。
The medical device that needs clinical trial, the provided testing report can be issued within half a year before clinical trail. The medical device that needs no clinical trial, the provided testing report shall be issued within one year.
执行本办法第十一条、第十二条、第十三条、第十四条的规定的，应当提供相应的说明文件；
A illustration documents shall be provide if Clause 11, Clause 12, Clause 13, and Clause 14 applied.
（八）医疗器械临床试验资料（具体提交方式见本办法附件12）；
Medical Device Clinical trial material (For detailed providing method, please refer to annex 12)
（九）医疗器械说明书； Medical device user manual
（十）产品生产质量体系考核（认证）的有效证明文件——根据对不同产品的要求，提供相应的质量体系考核报告：
Valid certificate of manufacturing quality system audit---providing corresponding quality system audit report for different product requirement.
1、省、自治区、直辖市（食品）药品监督管理部门签章的、在有效期之内的体系考核报告；
Quality system audit report within valid period signed or chopped by drug regulatory authorities of provinces, autonomous regions and municipalities directly under the central government.
2、医疗器械生产质量管理规范检查报告或者医疗器械质量体系认证证书；
Medical device manufacturing management criterion testing report or medical device quality system certificate.
3、国家已经实施生产实施细则的，提交实施细则检查验收报告；
Provide implementary testing report for the details rules if nation having implemented manufacturing details rules.
（十一）所提交材料真实性的自我保证声明：
Self-guarantee letter for the authenticity of providing documents.
应当包括所提交材料的清单、生产企业承担法律责任的承诺。
It shall include the list of providing documents, the statement of taking the legal responsibilities by manufacturer.
附件4： Annex 4:
境内第一类医疗器械重新注册申请材料要求
Re-registration applicant material requirement of domestic Class I medical device
（一）境内医疗器械注册申请表；
Domestic Medical Device Registration Applying Form
（二）医疗器械生产企业资格证明： Qualification of Medical Device Manufacturer
营业执照副本； Counterpart of Business License
（三）原医疗器械注册证书：
Original medical device registration certificate
属于本办法第五章第三十三条情形的，提交原医疗器械注册证书复印件。属于本办法第五章第三十四条、第三十五条情形的，应当提交原医疗器械注册证书原件；
If falling into this method Clause 33, please submit original medical device registration copy certificate. If falling into this method Clause 34 and Clause 35, please submit the original medical device registration certificate.
（四）适用的产品标准及说明： Applied product standard and illustration
采用国家标准、行业标准作为产品的适用标准的，应当提交所采纳的国家标准、行业标准的文本；注册产品标准应当由生产企业签章。
If manufacturer take National standard or industrial standard as the applied product standard, the manufacturer shall provide concerning copy of National standard or industrial standard; Registration product standard shall be signed/chopped by manufacturer.
生产企业应当提供所申请产品符合国家标准、行业标准的声明，生产企业承担产品上市后的质量责任的声明以及有关产品型号、规格划分的说明；
The manufacturer shall present a statement of compliance with the concerning National standard or industrial standard, a statement that taking the quality responsibilities of entering into market, and a classification illustration of concerning product models, specifications.
（五）产品质量跟踪报告； Product quality tracking report
（六）医疗器械说明书； Medical device user manual
（七）属于本办法第五章第三十四条情形的，应当提交相应的情况说明和证明性文件；
Please provide corresponding situation illustration and probative files if the situation falls into Article 5, clause 34 of this method.
（八）所提交材料真实性的自我保证声明：
Self-guarantee letter for the authenticity of providing documents.
应当包括所提交材料的清单、生产企业承担法律责任的承诺。
It shall include the list of providing documents, the statement of taking the legal responsibilities by manufacturer. 附件5： Annex 5:
境内第二类、第三类医疗器械重新注册申请材料要求
Re-registration applicant material requirement for domestic Class II, Class III medical device
（一）境内医疗器械注册申请表；
Domestic Medical Device Registration Applying Form
（二）医疗器械生产企业资格证明： Qualification of Medical Device Manufacturer
包括生产企业许可证、营业执照副本，并且所申请产品应当在生产企业许可证核定的生产范围之内；
Include manufacturing license, Counterpart of Business License, and the applying products falls into the approved manufacturing scope of manufacturing license;
（三）原医疗器械注册证书：
Original medical device registration certificate
属于本办法第五章第三十三条情形的，提交原医疗器械注册证书复印件。属于本办法第五章第三十四条、第三十五条情形的，应当提交原医疗器械注册证书原件；
If falling into this method Clause 33, please submit original medical device registration copy certificate. If falling into this method Clause 34 and Clause 35, please submit the original medical device registration certificate.
（四）医疗器械检测机构出具的产品注册检测报告： Registration testing report issued by medical device testing facility
需要进行临床试验的医疗器械，应当提交临床试验开始前半年内由医疗器械检测机构出具的检测报告。不需进行临床试验的医疗器械，应当提交注册受理前1年内由医疗器械检测机构出具的检测报告。
The medical device that needs clinical trial, the provided testing report can be issued within half a year before clinical trail. The medical device that needs no clinical trial, the provided testing