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Order of State Food and Drug Administration
(No. 16)
The "Measures for the Administration of Medical Device Registration", which were examined and adopted at the working affairs meeting of State Food and Drug Administration on May 28, 2004, are hereby promulgated, and shall come into force on the date of their promulgation.
Zheng Xiaoyu, Director General
August 9, 2004
Measures for the Administration of Medical Device Registration
| | 国家食品药品监督管理局令
（第16号）
《医疗器械注册管理办法》于2004年5月28日经国家食品药品监督管理局局务会审议通过，现予公布，自公布之日起施行。
局长 郑筱萸
二00四年八月九日
医疗器械注册管理办法
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Chapter I General Provisions
| | 第一章 总则
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Article 1 These Measures are formulated in accordance with the "Regulations on the Supervision and Administration of Medical Devices" in order to regulate the administration of medical device registration, and ensure the security and utility of medical devices.
| | 第一条 为规范医疗器械的注册管理，保证医疗器械的安全、有效，根据《医疗器械监督管理条例》，制定本办法。
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Article 2 Whoever sells or uses medical devices inside the People's Republic of China shall apply for registration in accordance with these Measures, and no medical device, which is not approved to be registered, shall be sold or used.
| | 第二条 在中华人民共和国境内销售、使用的医疗器械均应当按照本办法的规定申请注册，未获准注册的医疗器械，不得销售、使用。
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Article 3 Medical device registration means the process of carrying out systematic appraisal pursuant to legal procedures on the security and utility of the medical devices planned to be sold on market and to be used, so as to decide whether to consent to the sale and use or not.
| | 第三条 医疗器械注册，是指依照法定程序，对拟上市销售、使用的医疗器械的安全性、有效性进行系统评价，以决定是否同意其销售、使用的过程。
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Article 4 The state administers medical devices by classified registration.
The medical devices of Class I inside China shall be examined by the (food) drug administration at the level of a city divided into districts, and after approval, a medical device registration certificate shall be issued to the party concerned.
The medical devices of Class II inside China shall be examined by the (food) drug administration of the province, autonomous region, or municipality directly under the Central Government, and after approval, a medical device registration certificate shall be issued to the party concerned.
The medical devices of Class III inside China shall be examined by the State Food and Drug Administration, and after approval, a medical device registration certificate shall be issued to the party concerned.
The medical devices from abroad shall be examined by the State Food and Drug Administration, and after approval, a medical device registration certificate shall be issued to the party concerned.
The registration of medical devices from the regions of Taiwan, Hong Kong and Macao shall, unless otherwise prescribed by these Measures, be handled with reference to that for medical devices from abroad.
The validity period for a medical device registration certificate shall be 4 years.
| | 第四条 国家对医疗器械实行分类注册管理。
境内第一类医疗器械由设区的市级（食品）药品监督管理机构审查，批准后发给医疗器械注册证书。
境内第二类医疗器械由省、自治区、直辖市（食品）药品监督管理部门审查，批准后发给医疗器械注册证书。
境内第三类医疗器械由国家食品药品监督管理局审查，批准后发给医疗器械注册证书。
境外医疗器械由国家食品药品监督管理局审查，批准后发给医疗器械注册证书。
台湾、香港、澳门地区医疗器械的注册，除本办法另有规定外，参照境外医疗器械办理。
医疗器械注册证书有效期4年。
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Article 5 The medical device registration certificate shall be uniformly printed and made by State Food and Drug Administration, with the corresponding contents to be filled in by the (food) drug administration responsible for examination, approval and registration.
The registration number shall be laid out as follows:
×(×) 1 (Food) Drug Administration Devices (×2) Coded ××××3 No. ×4××5××××6.
Among which,
×1 shall be the shortened form of the locality of the registration and approval organ:
For the medical devices of Class III inside China, medical devices from abroad and those from the regions of Taiwan, Hong Kong and Macao, such shortened form shall be indicated as the character of "Guo", which means national;
For the medical devices of Class II inside China, such shortened form shall be indicated as that of the province, autonomous region, or municipality directly under the Central Government where the registration and approval organ is located;
For the medical devices of Class I inside China, such shortened form shall be indicated as that of the province, autonomous region, or municipality directly under the Central Government where the registration and approval organ is located, plus that of the administrative area at the level of city divided into districts, namely, ××1 (if there is no corresponding administrative area at the level of city divided into districts, it shall only be the shortened form of the province, autonomous region, or municipality directly under the Central Government);
×2 shall be the registration form (whether approved, imported or permitted):
The form of being "Approved" shall apply to the medical devices inside China;
The form of being "Imported" shall apply to the medical devices from abroad;
The form of being "Permitted" shall apply to the medical devices from the regions of Taiwan, Hong Kong and Macao;
××××3 shall be the year in which the registration is approved;
×4 shall be the class of product administration;
××5 shall be the number of the product variety;
××××6 shall be the registration sequence number.
A medical device registration certificate shall be attached with a "Medical Device Registration Form" (see Appendix 1 of these Measures), which shall be used simultaneously with the medical device registration certificate.
| | 第五条 医疗器械注册证书由国家食品药品监督管理局统一印制，相应内容由审批注册的（食品）药品监督管理部门填写。
注册号的编排方式为：
×（×）1（食）药监械（×2）字××××3第×4××5××××6号。其中：
×1为注册审批部门所在地的简称：
境内第三类医疗器械、境外医疗器械以及台湾、香港、澳门地区的医疗器械为“国”字；
境内第二类医疗器械为注册审批部门所在的省、自治区、直辖市简称；
境内第一类医疗器械为注册审批部门所在的省、自治区、直辖市简称加所在设区的市级行政区域的简称，为××1（无相应设区的市级行政区域时，仅为省、自治区、直辖市的简称）；
×2为注册形式（准、进、许）：
“准”字适用于境内医疗器械；
“进”字适用于境外医疗器械；
“许”字适用于台湾、香港、澳门地区的医疗器械；
××××3为批准注册年份；
×4为产品管理类别；
××5为产品品种编码；
××××6为注册流水号。
医疗器械注册证书附有《医疗器械注册登记表》（见本办法附件1），与医疗器械注册证书同时使用。
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Article 6 A production enterprise may hold a medical device registration certificate after its application for medical device registration has been approved, and shall bear the corresponding legal obligations,.
A person handling an application for medical device registration shall be entrusted by the production enterprise, have the corresponding professional knowledge, and be familiar with the laws, regulations, rules and technical requirements on medical device registration and administration.
A production enterprise outside China shall, when applying for registration of medical devices from abroad, appoint an institution inside China as its agent, who shall assume legal liabilities accordingly; in addition, the production enterprise outside China shall entrust a legal person institution inside China with corresponding qualification or entrust its office in China to undertake after-sale services for the medical devices.
| | 第六条 生产企业提出医疗器械注册申请，承担相应的法律义务，并在该申请获得批准后持有医疗器械注册证书。
办理医疗器械注册申请事务的人员应当受生产企业委托，并具有相应的专业知识，熟悉医疗器械注册管理的法律、法规、规章和技术要求。
申请境外医疗器械注册的，境外生产企业应当在中国境内指定机构作为其代理人，代理人应当承担相应的法律责任；并且，境外生产企业应当委托中国境内具有相应资格的法人机构或者委托其在华机构承担医疗器械售后服务。
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Article 7 With respect to the medical devices under application for registration, there shall be applicable product standards. For this purpose, national standards or industry standards may be adopted or standards for registered products may be made, however the standards for registered products may not be lower than national standards or industry standards.
The standards for registered products shall be compiled in accordance with the requirements prescribed by State Food and Drug Administration for standard administration of medical devices.
| | 第七条 申请注册的医疗器械，应当有适用的产品标准，可以采用国家标准、行业标准或者制定注册产品标准，但是注册产品标准不得低于国家标准或者行业标准。
注册产品标准应当依据国家食品药品监督管理局规定的医疗器械标准管理要求编制。
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Article 8 A production enterprise applying for registration of medical devices of Class II or Class III shall meet the production conditions prescribed by State Food and Drug Administration or the relevant quality system requirements.
| | 第八条 申请第二类、第三类医疗器械注册，生产企业应当符合国家食品药品监督管理局规定的生产条件或者相关质量体系要求。
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Chapter II Medical Device Registration Test
| | 第二章 医疗器械注册检测
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Article 9 For the medical devices of Class II and Class III, registration test shall be carried out by a medical device testing institution accredited by State Food and Drug Administration jointly with State General Administration of Quality Supervision, Inspection and Quarantine, and only after the medical devices have been tested as meeting the applicable product standards may they be used for clinical trial or may they apply for registration.
The catalogue of the medical device testing institutions accredited by State Food and Drug Administration jointly with State General Administration of Quality Supervision, Inspection and Quarantine (hereinafter referred to as medical device testing institutions) shall be separately promulgated.
| | 第九条 第二类、第三类医疗器械由国家食品药品监督管理局会同国家质量监督检验检疫总局认可的医疗器械检测机构进行注册检测，经检测符合适用的产品标准后，方可用于临床试验或者申请注册。
经国家食品药品监督管理局会同国家质量监督检验检疫总局认可的医疗器械检测机构（以下简称医疗器械检测机构）目录另行发布。
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Article 10 A medical device testing institution shall, within the testing scope recognized by State Food and Drug Administration and State General Administration of Quality Supervision, Inspection and Quarantine, and according to the applicable product standards for production enterprises (including applicable national standards, industry standards, or standards made by the production enterprise for registered products), carry out registration test for the products under application, and issue a testing report.
The medical devices, which have not been listed into the scope of authorized test by medical device testing institutions, shall be tested by a capable testing entity appointed by the involved registration and approval organ.
The registration test of medical devices from abroad shall apply the "Provisions on Registration Test of Medical Devices from Abroad".
| | 第十条 医疗器械检测机构应当在国家食品药品监督管理局和国家质量监督检验检疫总局认可的检测范围内，依据生产企业申报适用的产品标准（包括适用的国家标准、行业标准或者生产企业制定的注册产品标准）对申报产品进行注册检测，并出具检测报告。
尚未列入各医疗器械检测机构授检范围的医疗器械，由相应的注册审批部门指定有承检能力的检测单位进行检测。
境外医疗器械的注册检测执行《境外医疗器械注册检测规定》。
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Article 11 The products tested within one registration unit shall be the typical products which can represent security and utility of other products within this registration unit.
| | 第十一条 同一注册单元内所检测的产品应当是能够代表本注册单元内其他产品安全性和有效性的典型产品。
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Article 12 With respect to the products of the same class which are produced by one production enterprise with the same raw materials, if the production process and anticipated purpose remain unchanged, no biocompatibility trial needs to be carried out during the biological evaluation of the products at the time of re-registration.
With respect to the products of the same class which are produced by one production enterprise with raw materials having passed biological evaluation, if the production process or anticipated purpose remains unchanged, or if there is no new potential biological risks, no biocompatibility trial needs to be carried out during the biological evaluation of the products at the time of application for registration.
| | 第十二条 同一生产企业使用相同原材料生产的同类产品，如果生产工艺和预期用途保持不变，重新注册时，对产品的生物学评价可以不再进行生物相容性试验。
同一生产企业使用已经通过生物学评价的原材料生产的同类产品，如果生产工艺保持不变，预期用途保持不变或者没有新增的潜在生物学风险，申请注册时，对产品的生物学评价可以不再进行生物相容性试验。
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Article 13 Whichever production enterprise applies for medical device registration under Class II or Class III may, when meeting the following conditions simultaneously, be exempted from registration test:
| | 第十三条 申请第二类、第三类医疗器械注册，同时满足以下条件的，可以免予注册检测：
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(1) The basic theory, main functions and structure, materials used, and anticipated purpose of the medical devices under application for registration and those of its medical devices approved for registration fall in the same class;
| | （一）所申请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；
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(2) It has passed the inspection on its quality management rules for production of medical devices or has obtained the quality system certification for medical devices, and is able to provide the testing report accredited by the former institution for examination of enterprise production conditions;
| | （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；
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(3) When the medical devices under application for registration are compared with its products of the same class which have been approved for registration and have passed registration test, there is no change in the security or utility, or although there is change in the security or utility, both the changed part and the part causing other relevant changes in the security or utility of the products have passed the test carried out by the medical device testing institution;
| | （三）所申请注册的医疗器械与本企业已经获准注册并且已经通过注册检测的同类产品比较，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；
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(4) No serious ill incident is found from the ill medical device incident monitoring conducted as prescribed upon its products of the same class which have been approved for registration;
| | （四）已经获准注册的本企业同类产品按照规定进行医疗器械不良事件监测，并且未发现严重不良事件；
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(5) No records of being unqualified are kept on its products of the same class which have been approved for registration within 1 year from the selective supervisory product quality inspection made by the (food) drug administration; and
| | （五）已经获准注册的本企业同类产品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；
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(6) The medical devices from abroad have been approved by the governmental medical device authority at the place of their origin to be on market.
| | （六）境外医疗器械已经通过境外政府医疗器械主管部门的上市批准。
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Article 14 Whichever production enterprise applies for re-registration of medical devices or products of Class II or Class III may, when meeting the following conditions simultaneously, be exempted from registration test:
| | 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：
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(1) The basic theory, main functions and structure, materials used, and anticipated purpose of the medical devices under application for re-registration and those of its medical devices approved for registration fall in the same class;
| | （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；
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(2) It has passed the inspection on its quality management rules for production of medical devices or has obtained the quality system certification for medical devices, and is able to provide the testing report accredited by the former institution for examination of enterprise production conditions;
| | （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；
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(3) When the medical devices under application for re-registration are compared with the former registered products which have passed registration test, there is no change in the security or utility, or although there is change in security or utility, both the changed part and the part causing other relevant changes in the security or utility of the products have passed the test carried out by the medical device testing institution
| | （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；
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(4) No serious ill incident is found from the ill medical device incident monitoring conducted within the validity period of the former medical device registration certificate as prescribed upon the medical devices under application for re-registration; and
| | （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；
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(5) No records of being unqualified are kept on its originally registered medical devices within 1 year from the selective supervisory product quality inspection made by the (food) drug administration.
| | （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。
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Article 15 With respect to large medical devices which have been approved by the governmental medical device authority of a foreign country or region to be on market, but whose installation place is under particular requirements and whose testing is difficulty, the production enterprise may apply for temporary delay of testing, and apply for supplementary testing after obtaining the medical device registration certificate.
With respect to the products whose testing is temporarily delayed according to the preceding paragraph and which are approved for registration, the production enterprise must, after the first medical device enters into China and before it is put into use, complete the registration test. Only after they have been tested as qualified may they be put into use.
| | 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。
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。 |
Chapter III Clinical Trial of Medical Devices
| | 第三章 医疗器械临床试验
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Article 16 Whichever production enterprise applies for registration of medical devices of Class II or Class III shall submit clinical trial documents.
The method of submitting clinical trial documents shall be in accordance with the "Provisions on Itemization of Clinical Trial Documents for Medical Device Registration" (see Appendix 12 of these Measures).
| | 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。
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）。
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Article 17 Whichever production enterprise carries out clinical trial of medical devices inside China shall strictly implement the "Provisions on Clinical Trial of Medical Devices".
| | 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》。
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Article 18 For the medical devices whose clinical trial is carried out inside China, the clinical trial documents shall include clinical trial contract, clinical trial program and clinical trial report.
A (food) drug administration may, when considering it necessary, require the production enterprise to submit the directions for clinical trial, the consent letter on knowing about the information, and the original clinical trial records.
| | 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。
（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。
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Chapter IV Application for, Examination and Approval of Medical Device Registration
| | 第四章 医疗器械注册申请与审批
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Article 19 When applying for medical device registration, the applicant shall, according to the classification of medical devices, file an application to the corresponding (food) drug administration as prescribed in Article 4 of these Measures, and shall fill out the application form for medical device registration, and submit the application documents pursuant to the corresponding requirements in Appendix 2, Appendix 3, Appendix 6, Appendix 8 or Appendix 9 of these Measures. The application documents shall be in Chinese. When submitting the application documents translated from a foreign language, the original text shall be provided meanwhile.
The medical device directions submitted by the applicant shall conform to the "Provisions on the Administration of Medical Device Directions, Labels and Packing Marks".
The applicant shall be responsible for the authenticity of all contents in the application documents.
| | 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。
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》。
申请人应当对其申请材料全部内容的真实性负责。
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Article 20 The (food) drug administration shall, after receipt of an application, deal with the application in light of the following circumstances:
| | 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：
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(1) If the matters in application do not fall in the scope of its powers in accordance with the law, it shall immediately make a decision on not accepting the application, and inform the applicant to apply to other relevant administrative organ;
| | （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；
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(2) If any error which may be corrected on site exists in the application documents, it shall permit the applicant to make corrections on site;
| | （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；
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(3) If the application documents are incomplete or do not meet the requirements for formal examination, it shall issue a "Notice on Supplementing Documents" to the applicant on site or within 5 working days, and inform the applicant for once of all the contents to be supplemented. If it fails to so inform the applicant within the time limit, it shall be regarded as having accepted the application as of the date when the application documents are received;
| | （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；
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(4) If the application documents are complete and meet the requirements for formal examination, or the applicant has submitted all the supplemented application documents as required, the application shall be regarded as having been accepted.
The (food) drug administration shall, whether or not accepting the application for medical device registration, issue a "Notice on Accepting the Application" or "Notice on Not Accepting the Application" which is affixed with its special stamp and indicated with the 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。
（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》。
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Article 21 A (food) drug administration shall, after accepting the application for medical device registration, make substantive examination on the application within the time limit prescribed in Article 22 of these Measures, and make a written decision on whether to approve the registration. If the application is examined as conforming to the provisions and the registration is approved, the (food) drug administration shall issue the medical device registration certificate within 10 working days as of approving the decision in writing. If the application is examined as not conforming to the provisions, the (food) drug administration shall make a written decision on not approving the registration, state the reason, and meanwhile inform the applicant of the right to lawfully apply for administrative reconsideration or to bring an administrative lawsuit.
| | 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。
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Article 22 The (food) drug administration at the level of a city divided into districts shall, within 30 working days as of accepting an application, make a decision on whether to approve the registration.
The (food) drug administration of a province, autonomous region, or municipality directly under the Central Government shall, within 60 working days as of accepting an application, make a decision on whether to approve the registration.
State Food and Drug Administration shall, within 90 working days as of accepting an application, make a decision on whether to approve the registration.
If, in the process of examination of an application for registration, it is necessary to hold a test, expert appraisal or hearing, the time needed for it shall not be calculated into the time limit prescribed in this Article. The (food) drug administration shall inform the applicant in writing of the time needed.
| | 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。
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。
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。
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。
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Article 23 With respect to the medical devices from abroad, which are not permitted to be on market, the applicant may apply for registration with reference to the requirements for technical examination for registration of products of the same class inside China (see Appendix 8 and Appendix 9 of these Measures for necessary documents to be submitted).
| | 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）。
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Article 24 A (food) drug administration shall, when making technical examination on the application documents for medical device registration, send a one-time written notice on supplementing documents, if the production enterprise needs to supplement documents,.
A production enterprise shall, within 60 working days, supplement all the documents as required by the notice for once, and the time for supplementing documents shall not be calculated into the time limit for the (food) drug administration to make substantive examination. If the production enterprise fails to supplement the documents within the prescribed time limit and has no justifiable reason, the examination shall be terminated.
| | 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。
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。
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Article 25 Where the examination of an application for registration is terminated, the applicant may not file a second application within 6 months as the termination of the examination.
| | 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。
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Article 26 Where a production enterprise has any objections to the contents in the notice on supplementing documents, it may, within the prescribed time limit, propose written opinions to the (food) drug administration, state the reasons, and provide technical support documents, so that the (food) drug administration may make a decision from examination.
| | 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。
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Article 27 The registration units of medical device products shall, in principle, be divided on the basis of technical structure, performance index and anticipated purpose.
| | 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。
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Article 28 With respect to the medical devices registered as components, the applicant shall state the recommended product to be used along with such components, as well as the name, model and specifications of such components.
For a complete machine assembled with components approved for registration, the complete machine registration procedures must be fulfilled.
With respect to the medical devices registered as a complete machine, the enterprise involved shall, when applying for registration, list the main configurations. In the event that the performance or specifications of the components of a certain main configuration are changed, the production enterprise involved shall make re-registration of the complete machine.
With respect to the medical devices registered as a complete machine, if the combined components listed in the column of "Product Performance, Structure and Composition" in the attached schedule of the medical device registration certificate are sold independently on the condition that neither the form of combination nor the anticipated purpose is changed, specific registration may be exempted.
| | 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。
由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。
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。
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。
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Article 29 A (food) drug administration shall announce the conditions, procedures and time limit for the medical device registration, a catalogue of all documents to be submitted, and a sample version of the application letter, etc. on the administrative organ's website as well as in the work place for medical device registration.
| | 第二十九条 （食品）药品监督管理部门应当在行政机关的网站和医疗器械注册办公场所公示相应的医疗器械注册所需的条件、程序、期限、需要提交的全部材料的目录和申请书示范文本等。
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Article 30 A (food) drug administration shall, when examining an application for medical device registration, announce the process of the examination and result of approval. The applicant and an interested party may submit its/his written opinions on the matters directly related to its/his major benefits, make statements and contentions.
| | 第三十条 （食品）药品监督管理部门对医疗器械注册申请进行审查时，应当公示审批过程和审批结果。申请人和利害关系人可以对直接关系其重大利益的事项提交书面意见进行陈述和申辩。
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Article 31 State Food and Drug Administration shall regularly announce on its governmental website the catalogue of the medical devices which have been approved for registration, for the public's consulting.
| | 第三十一条 国家食品药品监督管理局应当定期在其政府网站上公布已经获准注册的医疗器械目录，供公众查阅。
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Article 32 Where an application for medical device registration is directly involved with the major benefit relationship between the applicant and others, the (food) drug administration shall inform the applicant and the interested party that it/he may, in accordance with the laws, regulations, and other provisions of State Food and Drug Administration, have the right to apply for a hearing. When examining an application for medical device registration, the (food) drug administration shall announce to the public the major issues for permission which it deems to be involved with public benefits, and shall hold a hearing.
| | 第三十二条 医疗器械注册申请直接涉及申请人与他人之间重大利益关系的，（食品）药品监督管理部门应当告知申请人、利害关系人可以依照法律、法规以及国家食品药品监督管理局的其他规定享有申请听证的权利；在对医疗器械注册申请进行审查时，（食品）药品监督管理部门认为涉及公共利益的重大许可事项，应当向社会公告，并举行听证。
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Chapter V Re-registration of Medical Devices
| | 第五章 医疗器械的重新注册
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Article 33 When the validity period of a medical device registration certificate has expired, and the production enterprise needs to continue selling or using the medical devices, it shall, within 6 months prior to the expiry of the validity period of the medical device registration certificate, apply for re-registration. If it fails to do so within the time limit, registration test on the products shall be made at the time of re-registration.
| | 第三十三条 医疗器械注册证书有效期届满，需要继续销售或者使用医疗器械的，生产企业应当在医疗器械注册证书有效期届满前6个月内，申请到期重新注册。逾期办理的，重新注册时应当对产品进行注册检测。
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Article 34 In the event of any change in the following contents on a medical device registration certificate, the production enterprise shall apply for modification and re-registration within 30 days as of the change:
| | 第三十四条 医疗器械注册证书中下列内容发生变化的，生产企业应当自发生变化之日起30日内申请变更重新注册：
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(1) model, specifications;
| | （一）型号、规格；
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(2) address of production;
| | （二）生产地址；
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(3) product standards;
| | （三）产品标准；
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(4) product performance, structure and composition;
| | （四）产品性能结构及组成；
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(5) scope of products.
| | （五）产品适用范围。
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Article 35 If, within the validity period of a medical device registration certificate, the class for administration of the product is changed, the production enterprise shall, within 6 months, apply to the corresponding (food) drug administration for modification and re-registration on the basis of the modified class.
| | 第三十五条 医疗器械注册证书有效期内，产品管理类别发生改变的，生产企业应当在6个月内，按照改变后的类别到相应的（食品）药品监督管理部门申请变更重新注册。
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Article 36 Whichever production enterprise applies for re-registration of medical devices shall fill out the medical device registration application form, and shall, pursuant to the requirements in Appendix 4, Appendix 5 or Appendix 7 of these Measures, submit application documents to the (food) drug administration.
The procedures for acceptance, examination and approval of applications for re-registration shall, in case of no relevant provisions in this Chapter, be governed by the relevant provisions of Chapter IV of these Measures.
| | 第三十六条 申请医疗器械重新注册的，应当填写医疗器械注册申请表，并按照本办法附件4、附件5或者附件7的相应要求向（食品）药品监督管理部门提交申请材料。
重新注册的受理与审批程序，本章没有规定的，适用本办法第四章的相关规定。
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Article 37 Medical devices under any of the following circumstances shall not be re-registered:
| | 第三十七条 有下列情形之一的医疗器械，不予重新注册：
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(1) The requirements proposed according to the relevant provisions of State Food and Drug Administration by the (food) drug administration at the time of approval of being on market have not been fulfilled;
| | （一）未完成（食品）药品监督管理部门在批准上市时按照国家食品药品监督管理局有关规定提出的要求的；
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(2) The medical devices are re-appraised by State Food and Drug Administration to be eliminated;
| | （二）经国家食品药品监督管理局再评价属于淘汰品种的；
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(3) The medical device registration certificate has been revoked in accordance with the "Regulations on the Supervision and Administration of Medical Devices".
| | （三）按照《医疗器械监督管理条例》的规定撤销医疗器械注册证书的。 |
Chapter VI Modification and Re-issuance of Medical Device Registration Certificates
| | 第六章 医疗器械注册证书的变更与补办
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Article 38 Where the contents of a medical device registration certificate has any of the following changes, the production enterprise shall, within 30 days as of the occurrence of the change, apply for modification of the medical device registration certificate:
| | 第三十八条 医疗器械注册证书载明内容发生下列变化的，生产企业应当自发生变化之日起30日内申请医疗器械注册证书变更：
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(1) change of the name of the production enterprise, but without any change with the entity;
| | （一）生产企业实体不变，企业名称改变；
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(2) change of the registered address of the production enterprise;
| | （二）生产企业注册地址改变；
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(3) literal change of the production address;
| | （三）生产地址的文字性改变；
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(4) literal change of the product name or commodity name;
| | （四）产品名称、商品名称的文字性改变；
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(5) literal change of the model or specifications;
| | （五）型号、规格的文字性改变；
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(6) literal change of the title or code of the product standards;
| | （六）产品标准的名称或者代号的文字性改变；
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(7) change of the agent; or
| | （七）代理人改变；
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(8) change of the after-sale service office.
| | （八）售后服务机构改变。
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Article 39 Whichever production enterprise applies for modification of a medical device registration certificate shall fill out the application form for modification of the medical device registration certificate, and shall, pursuant to the requirements in Appendix 10 of these Measures, submit the relevant documents and statements to the former registration and approval organ. The former registration and approval organ shall carry out a formal examination on the application documents, inform by once either on site or within 5 working days the applicant of all the contents to be supplemented, and issue the "Notice on Accepting the Application" to the applicant who meets the requirements.
| | 第三十九条 申请医疗器械注册证书变更的，应当填写医疗器械注册证书变更申请表，并按照本办法附件10的要求向原注册审批部门提交有关材料和说明。原注册审批部门对申请材料进行形式审查，当场或者在5个工作日内一次性告知申请人需要补正的全部内容，符合要求的发给《受理通知书》。
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Article 40 The former registration and approval organ shall, within 20 working days after accepting the application for modification, make a written decision on whether to approve the modification or not. If the application is examined as qualified for modification, the former registration and approval organ shall issue a modified medical device registration certificate, and write off the former medical device registration certificate. If, however, the application is examined as unqualified, the former registration and approval organ shall make a written decision on not approving the modification, state the reasons, and meanwhile inform the applicant of the right to lawfully apply for administrative reconsideration or to bring an administrative lawsuit.
．．．．．． | | 第四十条 原注册审批部门受理变更申请后，应当在20个工作日内作出是否同意变更的书面决定。经审查符合规定予以变更的，发给变更后的医疗器械注册证书，并对原医疗器械注册证书予以注销。经审查不符合规定的，作出不予变更的书面决定，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。
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