第十四条 申请第二类、第三类医疗器械产品重新注册，同时满足以下条件的，可以免予注册检测：
Applying for Class II and Class III medical device re-registration will be exempted of doing registration testing if satisfy the following conditions:
（一）申请重新注册的医疗器械与本企业已经获准注册的医疗器械的基本原理，主要功能、结构，所用材料、材质，预期用途属于同一类；
Applying re-registration medical device and applied medical device is same in the basic principle, main function, structure, material and intended use.
（二）生产企业已经通过医疗器械生产质量管理规范检查或者已经获得医疗器械质量体系认证，并且生产企业能够提供经原企业生产条件审查机构认可的检测报告；
The manufacturers have passed the medical device manufacturing quality administration regulation testing or get approval of medical device quality system certification, meanwhile the manufacturers can provide the admissive testing report by inspection institution under former manufacturing condition.
（三）申请重新注册的医疗器械与已经通过注册检测的原注册产品相比较，未发生涉及安全性、有效性改变，或者虽然涉及安全性、有效性改变，但是改变部分和由其引起产品其他相关安全性、有效性变化的部分都已经通过了医疗器械检测机构检测；
Comparing with approved registration medical devices , the same kind of applying re-registration medical devices do not have changes concerning safety and effectiveness areas or despite of having changes concerning safety and effectiveness areas which have been tested by medical device testing institution.
（四）申请重新注册的医疗器械在原医疗器械注册证书有效期内按照规定进行医疗器械不良事件监测，并且未发现不良事件；
Applying for re-registration medical devices have not been found adverse events in the process of MDR within the expiration date of the former medical device certificate.
（五）原注册医疗器械1年内无（食品）药品监督管理部门产品质量监督抽查不合格记录。
The former approved registration medical devices have not been found ineligible records in the process of product quality selective examination by food drug supervision administration within one year.
第十五条 已经通过境外政府医疗器械主管部门的上市批准、对安装场地有特殊要求、检测困难的大型医疗器械，可以申请暂缓检测，于取得医疗器械注册证书后再对产品进行补充检测。
Huge medical equipments which have got pre-market notification by overseas medical device supervision department, need special requirements on spot installation and have difficulty for testing can applying for postpone testing can be done supplement testing after getting medical device certificate.
根据前款规定申请暂缓检测而获准注册的产品，生产企业必须在首台医疗器械入境后、投入使用前完成注册检测。经检测合格后方可投入使用。
For the products satisfied with above regulation that get registration approval when applying for postpone testing, the manufacture shall complete registration testing after importing the first medical device, until the testing is eligible the product can be put into use.
第三章 医疗器械临床试验
Chapter 3 Medical device clinical trial
第十六条 申请第二类、第三类医疗器械注册，应当提交临床试验资料。
When applying for Class II and Class III medical devices registration, clinical trial material should be submitted.
临床试验资料提供方式执行《医疗器械注册临床试验资料分项规定》（见本办法附件12）。
The submission methods of clinical trial material shall comply to ‘Medical Device Registration on Clinical Trial Material Itemize Regulation’.(Refer to attachment 12)
第十七条 在中国境内进行医疗器械临床试验的，应当严格执行《医疗器械临床试验规定》。
The clinical trial processed in China shall strictly comply to ‘Medical Device Clinical Trial Regulation’.
第十八条 在中国境内进行临床试验的医疗器械，其临床试验资料中应当包括临床试验合同、临床试验方案、临床试验报告。
The clinical trial material of medical devices processed in China shall include clinical trail agreement, clinical trial project and clinical trial report.
（食品）药品监督管理部门认为必要时，可以要求生产企业提交临床试验须知、知情同意书以及临床试验原始记录。
Food drug supervision administration could ask manufacture to provide clinical trial memorandum, acknowledgment letter and clinical trial original records.
第四章 医疗器械注册申请与审批
Chapter 4 Medical device registration application and inspection
第十九条 申请医疗器械注册，申请人应当根据医疗器械的分类，向本办法第四条规定的相应（食品）药品监督管理部门提出申请，并应当填写医疗器械注册申请表，按照本办法附件2、附件3、附件6、附件8或者附件9的相应要求提交申请材料。申请材料应当使用中文；根据外文资料翻译的申请材料，应当同时提供原文。
When applying for medical devices registration, applicants shall accord with the medical device classification and apply to concerning food drug supervision administration according to item 4 of this methods.
申请人提交的医疗器械说明书应当符合《医疗器械说明书、标签和包装标识管理规定》。 Medical device user manual submitted by applicants shall accord with ‘Administration Regulation of Medical Device user manual, labeling and package '.
申请人应当对其申请材料全部内容的真实性负责。
Applicants shall take the responsibility of the truth about the fully application material.
第二十条 （食品）药品监督管理部门收到申请后，应当根据下列情况分别作出处理： Food drug supervision administration shall treat respectively depending on the following conditions:
（一）申请事项依法不属于本部门职权范围的，应当即时作出不予受理的决定，并告知申请人向有关行政机关申请；
If application articles legally do not belong to authorized scope of this department, should issue a rejection notice and advance applicants to apply for concerning administration unit.
（二）申请材料存在可以当场更正的错误的，应当允许申请人当场更正；
If there is mistake in the application material that could be correct on-spot, the applicants shall be permitted to correct on spot.
（三）申请材料不齐全或者不符合形式审查要求的，应当当场或者在5个工作日内发给申请人《补正材料通知书》，一次性告知申请人需要补正的全部内容，逾期不告知的，自收到申请材料之日起即为受理；
If the application material is incomplete or not in accord with formal inspection requirement, please inform applicant on-spot or issue applicant with ‘Supplement Material Notice Letter’ within 5 workdays and inform applicant all the requested supplementary material at one time. Without informing within appointed period, the material receiving date should be regarded as the acceptance date.
（四）申请材料齐全、符合形式审查要求的，或者申请人按照要求提交全部补正申请材料的，予以受理。
It should be accepted if the application material is complete, accord with formal inspection request or applicants submit all requested supplement material according to the concerning requirements.
（食品）药品监督管理部门受理或者不予受理医疗器械注册申请，应当出具加盖本部门专用印章并注明日期的《受理通知书》或者《不予受理通知书》。
Whatever food drug supervision administration accept medical devices application or not, an acceptance notice or a rejection letter should be issued by department with special seal and date.
第二十一条 （食品）药品监督管理部门受理医疗器械注册申请后，应当在本办法第二十二条规定的期限内对申请进行实质性审查并作出是否给予注册的书面决定。经审查符合规定批准注册的，自书面批准决定作出之日起10个工作日内发给医疗器械注册证书。经审查
不符合规定的，作出不予注册的书面决定，并说明理由，同时告知申请人享有依法申请行政复议或者提起行政诉讼的权利。
Food drug supervision administration shall do substantiality inspection on application and make a paper decision on whether administer registration according to the stipulated term in item 22 of this method. On the condition that material accords with inspection regulation and administer registration, medical device registration certificates shall be issued within 10 workdays counted from date of the paper approval decision-making.
第二十二条 设区的市级（食品）药品监督管理机构应当自受理申请之日起30个工作日内，作出是否给予注册的决定。
Food Drug regulatory authority of the government of the municipalities consisting of districts shall make a division whether to administer registration within 30 workdays from the date of application.
省、自治区、直辖市（食品）药品监督管理部门应当自受理申请之日起60个工作日内，作出是否给予注册的决定。
Food Drug regulatory authorities of the provinces, autonomous regions and municipalities shall make a division whether to administer registration within 60 workdays form the date of application.
国家食品药品监督管理局应当自受理申请之日起90个工作日内，作出是否给予注册的决定。
Food Drug regulatory authority directly under State Council shall make a make a division whether to administer registration within 90 workdays form the date of application.
在对注册申请进行审查的过程中，需要检测、专家评审和听证的，所需时间不计算在本条规定的期限内。（食品）药品监督管理部门应当将所需时间书面告知申请人。
In the process of inspection, if testing, technical review by specialists and audit are needed, the requested time is besides from the regulated period of this article. Food Drug Administration shall inform applicants with paper notice about the needed time.
第二十三条 未获得境外医疗器械上市许可的境外医疗器械，申请注册时，参照境内同类产品注册的技术审查要求执行（需要提交的材料见本办法附件8、附件9）。
When apply for registration, the imported medical devices without marketing permission at overseas shall refer to registration technical inspection requirements of the domestic products in the same kind (the requested submission material shall refer to attachment 8 and attachment 9).
第二十四条 （食品）药品监督管理部门在对医疗器械注册申请材料进行技术审查时，需要生产企业补充材料的，应当一次性发出书面补充材料通知。
In the inspection process of medical devices registration application material, SFDA shall issue paper supplementary notice to manufacture at one time if supplementary material is needed.
生产企业应当在60个工作日内按照通知要求将材料一次性补齐，补充材料的时间不计算在（食品）药品监督管理部门进行实质审查的期限内。生产企业未能在规定的时限内补充
材料且没有正当理由的，终止审查。
Manufacture shall submit all the requested supplementary material at one time according to requirement within 60 workdays. The additional time can not be counted to the SFDA’s substantial inspection time. Inspection shall be discontinued that manufactures do not supplement the requested material within regulated time and have no allowable reason.
第二十五条 注册申请被终止审查的，在被终止审查后的6个月内不得再次申请。 For the discontinued inspection, re-registration should not applied within 6 months from the discontinued date.
第二十六条 生产企业对补充材料通知内容有异议的，可以在规定的时限内向（食品）药品监督管理部门提出书面意见，说明理由并提供技术支持材料，经（食品）药品监督管理部门审查后作出决定。
If manufactures have suspicion for the supplementary material notice, a paper suggestion can be advanced to SFDA at limited time, explain excuse and offer technical supporting material that shall be inspected by SFDA, finally SFDA will give a decision.
第二十七条 医疗器械产品的注册单元原则上以技术结构、性能指标和预期用途为划分依据。
Basically the classification basis of medical devices registration unit is technological structure, performance and intended use.
第二十八条 作为部件注册的医疗器械，申请人应当说明与该部件配合使用的推荐产品、部件的名称、型号、规格。
For medical devices registered as parts, applicants shall explain the recommended products, parts name, model and specifications to work with them.
已经获准注册的部件组合成的整机，必须履行整机注册手续。
A complete machine combined with all registered parts shall implement complete unit registration procedure.
以整机注册的医疗器械，申请注册时应当列出其主要配置。如果某个主要配置部件性能规格发生改变，整机应当重新注册。
When medical devices registering as a complete unit, its main deployment should be listed. A new re-registration should be requested if the main deployments change their performance and specifications.
以整机注册的医疗器械，其医疗器械注册证书附表中的“产品性能结构及组成”栏内所列出的组合部件在不改变组合形式和预期用途的情况下单独销售的，可以免予单独注册。 If the combination parts which have been registered as a complete unit listed on column ‘performance, structure and components of the product’ of the ‘Medical Device Registration Record ’would be allowed to exempt from sole registration when be sold solely without changing its combination form and intended use.