医疗器械注册管理办法(中英文)-2004-两种翻译对照

-窗体顶端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 郑筱萸二四年八月九日医疗器械注册管理办法Medical Devices Registration Administration Method 总则Chapter 1 General Provisions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。 Article 1 To regulate medical device registration management and ensure their safety and effectiveness of medical device, we set down the management measure according to Regulations for the Supervision and Administration of Medical Device. These Measures have been formulated in accordance with the Regulations on the Supervision and Administration of Medical Devices to standardize the administration on the medical device registration and ensure the safety and efficiency of medical devices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。 Article 2 All the medical device which would like to sell and use within the territory of the Peoples Republic of China shall apply for registration complying with this measure. These medical devices which not get China registration approval should be prohibited to sell and use. The medical devices sold and used in the territory of the Peoples Republic of China must be registered according to the provisions of these Measures; no medical appliance without registration will be allowed to sell and use.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。Article 3 Medical device registration is the process of doing systemic evaluation of plan-market medical device on their safety and effectiveness, then decide if medical device can be allowed to sell and use. The medical device registration is a process in which the systematic evaluation on the safety and efficacy of the medical device to be sold on market and used shall be conducted according to the legal procedures so as to determine whether the medical device is allowed to sell and use第四条国家对医疗器械实行分类注册管理。 Article 4 The state shall classify medical devices and administer them based on this classification. The state will implement classified registration management on medical devices.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。Domestic Class I medical devices shall be inspected, approved and granted with a registration certificate by the food drug regulatory authority of the government of the municipalities consisting of districts. The registration of the domestic Class I medical devices should be examined and approved by the municipality (with district)-level (Food and) Drug Administrative Agency and the Medical Devices Registration Certificate will be issued after approved.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。Domestic Class II medical devices shall be inspected, approved and granted with a registration certificate by the food drug regulatory authorities of provinces, autonomous regions and municipalities directly under the central government. The registration of the domestic Class II medical devices should be examined and approved by the (Food and) Drug Administrative Agency at the level of province, autonomous region or municipality directly under the central government and the Medical Devices Registration Certificate will be issued after approved.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。Domestic Class III medical device shall be inspected, approved and granted with registration certificate by State Food Drug Administration.The registration of the domestic Class III medical devices should be examined and approved by the State Food and Drug Administration and the Medical Devices Registration Certificate will be issued after approved.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。Imported medical devices shall be inspected, approved and granted with registration certificate by State Food Drug Administration. The registration of the overseas medical devices should be examined and approved by the State Food and Drug Administration and the Medical Devices Registration Certificate will be issued after approved.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。Taiwan, Hongkong and Macaos medical device registration shall refer to the regulation of imported medical device.Unless otherwise specified in these Measures, the registration of the medical devices in Taiwan, Hong Kong and Macao will be handled by consulting the registration of overseas medical devices.医疗器械注册证书有效期4年。Medical devices certificate is valid for 4 years. The valid period of the Medical Devices Registration Certificate will be four (4) years.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。Article 5 Medical devices registration certificate shall be pressed by State Food Drug Administration and the content shall be filled in by inspection department of food drug administration.The Medical Devices Registration Certificate should be uniformly printed and manufactured by the State Food and Drug Administration and appropriate contents should be completed by the (Food and) Drug Administrative Agency for the registration examination and approval.注册号的编排方式为： Registration is arranged as the following:The registration number is arranged as:（）1(食)药监械（2）字3第456号。其中： X (X) 1 SFDA (X2) 字3第456号1 为注册审批部门所在地的简称：X 1 : Shortened form of registration inspection department s locus () 1 SFDA (2) Letter 3 No. 456; in which,“1” refers to the location of the registration examination and approval department in short; Domestic Class III medical devices, overseas medical devices, and the medical devices in Taiwan, Hong Kong and Macao will be identified with the letter “State (S)”;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；“国” is for domestic Class III medical devices, imported medical devices and medical devices of Taiwan, Hongkong and Macao. Domestic Class III medical devices, overseas medical devices, and the medical devices in Taiwan, Hong Kong and Macao will be identified with the letter “State (S)”;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。Medical device registration certificate is attached with medical device registration record, and shall be used along with medical device registration certificate.Domestic Class II medical devices will be identified with the short name of the province, autonomous region and municipality directly under the central government where the registration examination and approval department is located at;Domestic Class I medical devices will be identified with the short name of the province, autonomous region or municipality directly under the central government plus the municipal administrative division with district where the registration examination and approval department is located at; in case of 1 (i.e., the municipality administrative division without appropriate district, it will be identified with the short name of the province, autonomous region or the municipality directly under the central government) ;“2” refers to the registration type (Approval, Import, and Permit): “Approval” is applicable to the domestic medical devices;“Import” is applicable to overseas medical devices;“Permit” is applicable to the medical devices in Taiwan, Hong Kong and Macao.“3” refers to the year when the registration is approved;“4” refers to the product management category;“5” refers to the code number of product variety;“6” refers to the registration journal number. The Medical Devices Registration Certificate is attached with the Medical Devices Registration Form (see the Appendix 1 of these Measures), which will be used together with the Medical Devices Registration Certificate.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。Manufacturers put forward medical device registration application, take relevant regal responsibility and keep medical device registration certificate after getting application approval. The manufacturing enterprises applying for the medical device registration should bear appropriate legal obligations and will hold the Medical Devices Registration Certificate after the registration application is approved.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。Individuals who do medical device registration application should be authorized by manufacturer, possess professional knowledge, are familiar with medical device registration administration law, regulation, rules and technical requirement. The personnel handling the medical device registration should be authorized by manufacturing enterprise, be provided with appropriate expertise, and familiar with the laws, rules and regulations, and technical requirements related to the management on the medical device registration.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。When doing imported medical devices registration, the overseas manufactures shall authorize an unit to be their agent in Chinese territory and the agent should take relevant legal responsibilities. Meanwhile overseas manufactures shall authorize qualified body corporate or theirs own organ located in China to do after sales service. For the registration of overseas medical devices, the overseas manufacturing enterprise should appoint its agent within the territory of the Peoples Republic of China, who will bear appropriate legal responsibilities; the overseas manufacturing enterprise should appoint a corporate body with appropriate qualification within the territory of the Peoples Republic of China or its representative office in China to undertake the after-sales service for the 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。Article 7 Medical devices which applying for registration shall have suitable product standard that can adopt state standard, industry standard or edit registration standard, but registration standard should not inferior to state standard or industry standard. The medical devices applying for registration should have applicable product standard and may adopt the national standards and industrial standards or work out the standard for the registered product; however, the standard for the registered product should in no way be lower than the national standards or industrial standards.The standard for registered product should be drawn up according to the requirements as specified in the Management on Medical Devices Standards by the State Food and Drug Administration.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。Registration standard shall be edited according to medical device standard administration regulation stipulated by state food drug supervision administration. The standard for registered product should be drawn up according to the requirements as specified in the Management on Medical Devices Standards by the State Food and Drug Administration.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。Article 8 Applying for Class II and Class III medical device registration, manufacture shall comply with relevant manufacturing condition or quality system requirement stipulated by state food drug supervision administration. For applying for the registration of Class II and Class III medical devices, the manufacturing enterprise should meet the requirements on the manufacturing conditions or the related quality systems as specified by the State Food and Drug Administration.第二章 医疗器械注册检测Chapter 2 Medical devices registration testing Chapter 2 Registration Test on Medical Devices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。Article 9 Class II and Class III medical devices shall be tested by medical device testing organization approbated by State Food Drug Supervision Administration and State Quality Supervision Inspection and Quarantine, then can be used in clinical trial or apply for registration. The registration test on Class II and Class III medical devices should be conducted by the State Food and Drug Administ ration jointly with the medical device test agency authorized by the State Administration of Quality Supervision, Inspection, and Quarantine; those medical devices should not be used for clinical test or registered until being tested as conforming to applicable product standard. 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。The list of medical device testing organization approbated by State Food Drug Supervision Administration and State Quality Supervision Inspection and Quarantine (medical device testing organization for short in the following) shall be issued at another time. The catalogue of the medical device test agencies (hereinafter referred to as medical device test agency) approved by the State Food and Drug Administration jointly with the State Administration of Quality Supervision, Inspection, and Quarantine will be published separately.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。Article 10 Medical device testing organization should do registration testing on applicant products according to available product standard including state standard, industry standard or registration product standards edited by manufacture within the specific testing range approbated by State Food Drug Supervision Administration and State Quality Supervision Inspection and Quarantine. Medical device test agency should conduct registration test on the product applying for registration and issue registration test report according to the product standard applicable to the manufacturing enterprise (including applicable national standards, industrial standards or the product standard drawn up by the manufacturing enterprise) within the range of the test approved by the State Food and Drug Administration and the State Administration of Quality Supervision, Inspection, and Quarantine.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。For the medical device that have not been listed in testing range of all medical device testing organization should be tested by qualified testing united approbated by registration inspection department. For the medical devices that have not been listed in the range of the test conducted by the medical device test agencies, the test on those medical devices should be carried out by the test agencies with appropriate competence designated by appropriate registration examination and approval departments.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。Imported medical device registration shall perform “Imported Medical Device Registration Testing Regulation”.The registration test on overseas medical devices should follow the Regulations on the Registration Test of Overseas Medical Devices.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。Among one testing unit the tested product should be the typical product that can representing the safety and effectiveness of other products. The product tested within the same registration unit should be the typical product capable of representing the safety and efficacy of other products in the same registration unit.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。For re-registration the same kind products which made of same material and manufactured by one manufacturer would not be tested for biological compatibility item during biological evaluation if manufacturing technics and intended use do not change.For the similar products manufactured by the same manufacturing enterprise with the same raw materials, if the production process and the intended usage remain unchanged, the biocompatibility test may be exempted in the biological evaluation on the product when re-registration. 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。When register the products which manufactured by one manufacturer, made of same material that have done biological evaluation and do not change their manufacturing technics, intended use and have no new potential biological risk would not be tested for biological compatibility during biological evaluation. For the similar products manufactured by the same manufacturing enterprise with the raw materials that have passed the biological evaluation, if the production process and the anticipating usage remain unchanged or no new potential biological risk is added, the biocompatibility test may be exempted in the biological evaluation on the product when applying for registration.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：Applying for Class II and Class III medical device registration will be exempted of doing registration testing if satisfy the following conditions:The registration test may be exempted for the registration of Class II and Class III medical devices meeting the following conditions concurrently:（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；Applying medical device and applied medical device is same in the basic principle, main function, structure, material and intended use.(I) The medical device applying for registration falls into the same category as the medical device already obtained the registration by the enterprise in basic principle, main functions, structure, materials used, quality of materials, and intended usage;（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 manu