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Measures for the Supervision and Administration of Medical Device Production (2017 Amendment) [Effective]
医疗器械生产监督管理办法(2017修正) [现行有效]
【法宝引证码】

Measures for the Supervision and Administration of Medical Device Production

 

医疗器械生产监督管理办法

(Promulgated by the Order No. 7 of the China Food and Drug Administration on July 30, 2014; and amended in accordance with the Decision to Amend Certain Rules adopted at the executive meeting of the China Food and Drug Administration on November 7, 2017) (2014年7月30日国家食品药品监督管理总局令第7号公布 根据2017年11月7日国家食品药品监督管理总局局务会议《关于修改部分规章的决定》修正)

Chapter I General Provisions 

第一章 总 则

 
Article 1 To strengthen the supervision and administration of medical device production, regulate the production of medical devices, and guarantee the safety and utility of medical devices, these Measures are developed in accordance with the Regulation on the Supervision and Administration of Medical Devices.   第一条 为加强医疗器械生产监督管理,规范医疗器械生产行为,保证医疗器械安全、有效,根据《医疗器械监督管理条例》,制定本办法。
Article 2 Whoever engages in the production of medical devices within the territory of the People's Republic of China and the supervision and administration thereof shall abide by these Measures.   第二条 在中华人民共和国境内从事医疗器械生产活动及其监督管理,应当遵守本办法。
Article 3 The CFDA shall be responsible for supervising and administering medical device production nationwide. The food and drug administration at or above the county level shall be responsible for supervising and administering medical device production within its administrative region.   第三条 国家食品药品监督管理总局负责全国医疗器械生产监督管理工作。县级以上食品药品监督管理部门负责本行政区域的医疗器械生产监督管理工作。
The food and drug administration at a higher level shall be responsible for directing and overseeing the supervision and administration of medical device production conducted by food and drug administrations at lower levels. 上级食品药品监督管理部门负责指导和监督下级食品药品监督管理部门开展医疗器械生产监督管理工作。
Article 4 The CFDA shall prepare quality management rules for medical device production and supervise the implementation thereof.   第四条 国家食品药品监督管理总局制定医疗器械生产质量管理规范并监督实施。
Article 5 Food and drug administrations shall, in a lawful and timely manner, issue the information on the licensing and recordation of medical device production. The applicants may inquire about the approval process and results; and the public may consult approval results.   第五条 食品药品监督管理部门依法及时公布医疗器械生产许可和备案相关信息。申请人可以查询审批进度和审批结果;公众可以查阅审批结果。
Article 6 Medical device production enterprises shall be responsible for the quality of produced medical devices. In the case of the entrusted production of medical devices, the entrusting party shall be responsible for the quality of medical devices to be produced upon entrustment.   第六条 医疗器械生产企业应当对生产的医疗器械质量负责。委托生产的,委托方对所委托生产的医疗器械质量负责。
Chapter II Production Licensing and Recordation Administration 

第二章 生产许可与备案管理

 
Article 7 To engage in medical device production, the applicant shall meet the following conditions:   第七条 从事医疗器械生产,应当具备以下条件:
(1) It has the production premise, environmental conditions, production equipment and professional technicians commensurate with the medical devices produced by it. (一)有与生产的医疗器械相适应的生产场地、环境条件、生产设备以及专业技术人员;
(2) It has the institution or full-time inspectors and the inspection equipment for the quality inspection of medical devices produced by it. (二)有对生产的医疗器械进行质量检验的机构或者专职检验人员以及检验设备;
(3) It has management rules guaranteeing the quality of medical devices. (三)有保证医疗器械质量的管理制度;
(4) It has the after-sales service capability commensurate with the medical devices produced by it. (四)有与生产的医疗器械相适应的售后服务能力;
(5) It satisfies the requirements as prescribed in production research and development and production technique documents. (五)符合产品研制、生产工艺文件规定的要求。
Article 8 To establish an enterprise engaging in the production of Class II or Class III medical devices, the applicant shall file an application for production licensing with the local food and drug administration of the province, autonomous region, or municipality directly under the Central Government, and submit the following materials:   第八条 开办第二类、第三类医疗器械生产企业的,应当向所在地省、自治区、直辖市食品药品监督管理部门申请生产许可,并提交以下资料:
(1) A photocopy of the business license. (一)营业执照复印件;
(2) Photocopies of the registration certificate of and product technical requirements for the produced medical devices held by the applicant. (二)申请企业持有的所生产医疗器械的注册证及产品技术要求复印件;
(3) Photocopies of the identity certificates of the legal representative and the person in charge of the enterprise. (三)法定代表人、企业负责人身份证明复印件;
(4) Photocopies of the identity, educational background and professional title certificates of the persons in charge of production, quality and technology. (四)生产、质量和技术负责人的身份、学历、职称证明复印件;
(5) List of the educational background and professional titles of employees on production management and quality inspection posts. (五)生产管理、质量检验岗位从业人员学历、职称一览表;
(6) Certification documents on the production premise, and the photocopies of certification documents on facilities and environment if there are special requirements for the production environment. (六)生产场地的证明文件,有特殊生产环境要求的还应当提交设施、环境的证明文件复印件;
(7) List of major production equipment and inspection equipment. (七)主要生产设备和检验设备目录;
(8) Quality manual and procedure documents. (八)质量手册和程序文件;
(9) Process flow diagram. (九)工艺流程图;
(10) Authorization certificate for the handling person. (十)经办人授权证明;
(11) Other certification materials. (十一)其他证明资料。
Article 9 The food and drug administration of a province, autonomous region or municipality directly under the Central Government shall, after receiving an application, handle the application in light of the following circumstances respectively:   第九条 省、自治区、直辖市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:
(1) The administration shall accept the application, if the subject matter of application falls under its scope of functions, and the application materials are complete and conform to the statutory form. (一)申请事项属于其职权范围,申请资料齐全、符合法定形式的,应当受理申请;
(2) If the application materials are incomplete or do not conform to the statutory form, the administration shall notify the applicant, on the spot or within five working days as of receipt of the application materials, of all the necessary supplements and corrections at one time; and if the administration fails to do so within the prescribed time limit, the application shall be deemed accepted on the date of receipt of the application materials. (二)申请资料不齐全或者不符合法定形式的,应当当场或者在5个工作日内一次告知申请人需要补正的全部内容,逾期不告知的,自收到申请资料之日起即为受理;
(3) The administration shall allow the applicant to correct on the spot any error in the application materials that can be corrected on the spot. (三)申请资料存在可以当场更正的错误的,应当允许申请人当场更正;
(4) The administration shall immediately make a non-acceptance decision, and notify the applicant that it should file an application with the relevant administrative department, if the subject matter of application does not fall under its scope of functions. (四)申请事项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部门申请。
Where the food and drug administration of a province, autonomous region or municipality directly under the Central Government makes a decision to accept or not to accept an application for a medical device production license, it shall issue an acceptance or non-acceptance notice. 省、自治区、直辖市食品药品监督管理部门受理或者不予受理医疗器械生产许可申请的,应当出具受理或者不予受理的通知书。
Article 10 The food and drug administration of a province, autonomous region or municipality directly under the Central Government shall examine the application materials within 30 working days after the date of acceptance, and conduct on-site verification according to the requirements of quality management rules for medical device production. On-site verification shall be conducted according to the actual circumstances, and repeated verification shall be avoided. If rectification is required, the time needed for rectification shall not be included in the time for examination.   第十条 省、自治区、直辖市食品药品监督管理部门应当自受理之日起30个工作日内对申请资料进行审核,并按照医疗器械生产质量管理规范的要求开展现场核查。现场核查应当根据情况,避免重复核查。需要整改的,整改时间不计入审核时限。
If the prescribed conditions are met, the food and drug administration shall make a written decision to approve licensing in accordance with law, and issue the Medical Device Production License within ten working days; and if the prescribed conditions are not met, shall make a written disapproval decision, and give an explanation on reasons. 符合规定条件的,依法作出准予许可的书面决定,并于10个工作日内发给《医疗器械生产许可证》;不符合规定条件的,作出不予许可的书面决定,并说明理由。
Article 11 To establish an enterprise producing Class I medical devices, the applicant shall undergo the formalities for the recordation of Class I medical devices at the local food and drug administration at the level of a districted city, and submit the photocopy of the recordation certificate for the produced medical devices held by the enterprise undergoing recordation and the materials as set forth in Article 8 of these Measures (excluding item (2)).   第十一条 开办第一类医疗器械生产企业的,应当向所在地设区的市级食品药品监督管理部门办理第一类医疗器械生产备案,提交备案企业持有的所生产医疗器械的备案凭证复印件和本办法第八条规定的资料(第二项除外)。
The food and drug administration shall verify the integrity of the materials submitted by the enterprise on the spot, grant recordation if the prescribed conditions are met, and issue the recordation certificate for the production of Class I medical devices to the enterprise. 食品药品监督管理部门应当当场对企业提交资料的完整性进行核对,符合规定条件的予以备案,发给第一类医疗器械生产备案凭证。
Article 12 Where an application for the production licensing of medical devices directly involves the vital interest relationship between the applicant and any other party, the food and drug administration shall inform the applicant and the interested party of the right to apply for a hearing in accordance with laws, regulations and the relevant provisions of the CFDA. Where the food and drug administration deems that any major licensing matter involves public interest when examining an application for the production licensing of medical devices, it shall make an announcement to the public and hold a hearing.   第十二条 医疗器械生产许可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、利害关系人依照法律、法规以及国家食品药品监督管理总局的有关规定享有申请听证的权利;在对医疗器械生产许可进行审查时,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。
Article 13 A Medical Device Production License shall be valid for five years, indicating the license number, enterprise name, legal representative, the person in charge of the enterprise, domicile, production address, production scope, license-issuing authority, date of issuance, validity term, and other matters.   第十三条 《医疗器械生产许可证》有效期为5年,载明许可证编号、企业名称、法定代表人、企业负责人、住所、生产地址、生产范围、发证部门、发证日期和有效期限等事项。
The Medical Device Production License shall include the registration form of produced medical devices, indicating the name, registration number and other information of the produced medical devices. 《医疗器械生产许可证》附医疗器械生产产品登记表,载明生产产品名称、注册号等信息。
Article 14 To increase new products, the medical device production enterprise shall submit the relevant materials involving modified contents as set forth in Article 8 of these Measures to the original license-issuing authority.   第十四条 增加生产产品的,医疗器械生产企业应当向原发证部门提交本办法第八条规定中涉及变更内容的有关资料。
Where the products to be increased upon application do not fall under the original scope of production, the original licensing-issuing authority shall conduct examination and on-site verification in accordance with Article 10 of these Measures, and if the prescribed conditions are met, modify the scope of production indicated in the Medical Device Production License, and indicate the product information in the registration form of produced medical devices. 申请增加生产的产品不属于原生产范围的,原发证部门应当依照本办法第十条的规定进行审核并开展现场核查,符合规定条件的,变更《医疗器械生产许可证》载明的生产范围,并在医疗器械生产产品登记表中登载产品信息。
Where the products to be increased upon application fall under the original scope of production and have similar production technique, production conditions and other requirements with the produced medical devices based on the original license, the original license-issuing authority shall examine the submitted materials, and if the prescribed conditions are met, indicate the product information in the registration form of produced medical devices. If the requirements for the production techniques and production conditions of the said products have material difference with those for the medical devices produced based on the original license, the original license-issuing authority shall conduct examination and on-site verification in accordance with Article 10 of these Measures, and if the prescribed conditions are met, indicate product information in the registration form of produced medical devices. 申请增加生产的产品属于原生产范围,并且与原许可生产产品的生产工艺和生产条件等要求相似的,原发证部门应当对申报资料进行审核,符合规定条件的,在医疗器械生产产品登记表中登载产品信息;与原许可生产产品的生产工艺和生产条件要求有实质性不同的,应当依照本办法第十条的规定进行审核并开展现场核查,符合规定条件的,在医疗器械生产产品登记表中登载产品信息。
Article 15 In the case of the non-literal modification of the production address, the applicant shall file an application with the original license-issuing authority for the modification of the medical device production license, and submit the relevant materials involving the modified contents as set forth in Article 8 of these Measures. The original license-issuing authority shall conduct examination and on-site verification in accordance with Article 10 of these Measures, and make a modification approval or disapproval decision within 30 working days. If a medical device production enterprise establishes production premises across different provinces, autonomous regions or municipalities directly under the Central Government, it shall file a separate application for the medical device production license.   第十五条 生产地址非文字性变更的,应当向原发证部门申请医疗器械生产许可变更,并提交本办法第八条规定中涉及变更内容的有关资料。原发证部门应当依照本办法第十条的规定审核并开展现场核查,于30个工作日内作出准予变更或者不予变更的决定。医疗器械生产企业跨省、自治区、直辖市设立生产场地的,应当单独申请医疗器械生产许可。
Article 16 In the case of the modification of the enterprise name, legal representative, person in charge of the enterprise, or the domicile, or the literal modification of the production address, the medical device production enterprise shall, within 30 working days as of the modification, undergo modification registration formalities for the Medical Device Production License at the original license-issuing authority, and submit certification materials of the relevant departments. The original license-issuing authority shall undergo modification formalities in a timely manner. If the modification materials are incomplete or do not conform to the provisions on formal examination, the enterprise shall be notified of all the necessary supplements and corrections at one time.   第十六条 企业名称、法定代表人、企业负责人、住所变更或者生产地址文字性变更的,医疗器械生产企业应当在变更后30个工作日内,向原发证部门办理《医疗器械生产许可证》变更登记,并提交相关部门的证明资料。原发证部门应当及时办理变更。对变更资料不齐全或者不符合形式审查规定的,应当一次告知需要补正的全部内容。
Article 17 To renew the validity term of the Medical Device Production License upon its expiry, the medical device production enterprise shall file an application for renewing the validity term of the Medical Device Production License with the original license-issuing authority at least six months before the validity term of the license expires.   第十七条 《医疗器械生产许可证》有效期届满延续的,医疗器械生产企业应当自有效期届满6个月前,向原发证部门提出《医疗器械生产许可证》延续申请。
The original license-issuing authority shall examine the extension application in accordance with Article 10 of these Measures, conduct on-site verification when necessary, and make a decision to approve or disapprove the extension before the validity term of the Medical Device Production License expires. It shall approve the extension if the prescribed conditions are met. It shall order rectification within a prescribed time limit if the prescribed conditions are not met; and if the required conditions are still not met after rectification, it shall disapprove the extension and give a written explanation on reasons. It shall be deemed approving the extension if it fails to make a decision within the time limit. 原发证部门应当依照本办法第十条的规定对延续申请进行审查,必要时开展现场核查,在《医疗器械生产许可证》有效期届满前作出是否准予延续的决定。符合规定条件的,准予延续。不符合规定条件的,责令限期整改;整改后仍不符合规定条件的,不予延续,并书面说明理由。逾期未作出决定的,视为准予延续。
Article 18 A medical device production enterprise surviving due to split or merger shall apply for modification licensing in accordance with these Measures; a medical device production enterprise dissolved due to enterprise split or merger shall apply for deregistering the Medical Device Production License; and a medical device production enterprise newly established due to enterprise merger or split shall apply for the Medical Device Production License.   第十八条 因分立、合并而存续的医疗器械生产企业,应当依照本办法规定申请变更许可;因企业分立、合并而解散的医疗器械生产企业,应当申请注销《医疗器械生产许可证》;因企业分立、合并而新设立的医疗器械生产企业应当申请办理《医疗器械生产许可证》。
Article 19 Where a Medical Device Production License is lost, the medical device production enterprise shall immediately publish a statement on the loss on the media designated by the original license-issuing authority. It shall, after one month as of the date when the enterprise publishes the statement on the loss, apply to the original license-issuing authority for the re-issuance of the license. The original license-issuing authority shall reissue the Medical Device Production License in a timely manner.   第十九条 《医疗器械生产许可证》遗失的,医疗器械生产企业应当立即在原发证部门指定的媒体上登载遗失声明。自登载遗失声明之日起满1个月后,向原发证部门申请补发。原发证部门及时补发《医疗器械生产许可证》。
Article 20 The number and validity term of the modified or reissued Medical Device Production License shall remain unchanged. The number of the renewed Medical Device Production License shall remain unchanged.   第二十条 变更、补发的《医疗器械生产许可证》编号和有效期限不变。延续的《医疗器械生产许可证》编号不变。
Article 21 In the case of any modification of the recordation certificate for the production of Class I medical devices, modification recordation shall be conducted.   第二十一条 第一类医疗器械生产备案凭证内容发生变化的,应当变更备案。
If the recordation certificate is lost, the medical device production enterprise shall undergo reissue formalities at the original recordation department in a timely manner. 备案凭证遗失的,医疗器械生产企业应当及时向原备案部门办理补发手续。
Article 22 Where a case has been docketed for investigation by the food and drug administration due to a medical device production enterprise's production in violation of any law but the case has not been concluded, or the medical device production enterprise has received any administrative penalty decision but has not implemented the decision, the food and drug administration shall suspend the licensing, until the handling of the case is concluded.   第二十二条 医疗器械生产企业因违法生产被食品药品监督管理部门立案调查但尚未结案的,或者收到行政处罚决定但尚未履行的,食品药品监督管理部门应当中止许可,直至案件处理完毕。
Article 23 Where a medical device production enterprise falls under any circumstance under which deregistration of its Medical Device Production License is required by any law or regulation, or the validity term does not expire but the enterprise voluntarily requests its deregistration, the food and drug administration of the province, autonomous region or municipality directly under the Central Government shall deregister its Medical Device Production License in accordance with law, and publish it on the website.   第二十三条 医疗器械生产企业有法律、法规规定应当注销的情形,或者有效期未满但企业主动提出注销的,省、自治区、直辖市食品药品监督管理部门应当依法注销其《医疗器械生产许可证》,并在网站上予以公布。
Article 24 The food and drug administration of a province, autonomous region or municipality directly under the Central Government shall establish licensing archives on the issuance, renewal, modification, reissue, revocation and deregistration of the Medical Device Production License.   第二十四条 省、自治区、直辖市食品药品监督管理部门应当建立《医疗器械生产许可证》核发、延续、变更、补发、撤销和注销等许可档案。
The food and drug administration at the level of a districted city shall establish archives on the recordation information on the production of Class I medical devices. 设区的市级食品药品监督管理部门应当建立第一类医疗器械生产备案信息档案。
Article 25 No entity or individual shall forge, alter, buy or sell, lease, or lend the Medical Device Production License and the recordation certificate for medical device production.   第二十五条 任何单位或者个人不得伪造、变造、买卖、出租、出借《医疗器械生产许可证》和医疗器械生产备案凭证。
Chapter III Administration of Entrusted Production 

第三章 委托生产管理

 
Article 26 The party entrusting the production of medical devices shall be the domestic registrant or the party undergoing recordation for the medical devices produced upon entrustment. To entrust the production of domestic medical devices that are not subject to approval under the special approval procedures for innovative medical devices, the entrusting party shall obtain the production license for the entrusted production of medical devices or undergo recordation formalities for the production of Class I medical devices.   第二十六条 医疗器械委托生产的委托方应当是委托生产医疗器械的境内注册人或者备案人。其中,委托生产不属于按照创新医疗器械特别审批程序审批的境内医疗器械的,委托方应当取得委托生产医疗器械的生产许可或者办理第一类医疗器械生产备案。
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