【中英文对照版】医疗器械生产监督管理办法(2022).docx

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1、医疗器械生产监督管理方法（2022年3月10日国家市 场监督管理总局令第53号 公布自2022年5月1日 起施行）第一章总那么第一条为了加强医疗 器械生产监督管理，规范医 疗器械生产活动，保证医疗 器械平安、有效，根据医 疗器械监督管理条例，制医疗器械生产监督管理方法(2022)Measures for the Supervision and Administration of Medical Device Production (2022) 【中英文对照版】发布部门：国家市场监督管理总局发文字号：国家市场监督管理总局令第53号发布日期：实施日期：效力级别：部门规章法规类别：医疗器械药品药材进

2、出口Issuing Authority : State Administration for Market RegulationDocument Number : Order No. 53 of the State Administration for Market RegulationDate Issued ： 03-10-2022Effective Date : 05-01-2022Level of Authority : Departmental RulesArea of Law : Import and Export of Medical Devices, Drugs, and Med

3、icine MaterialsMeasures for the Supervision and Administration of Medical Device Production(Issued by Order No. 53 of the State Administration for Market Regulation on March 10, 2022, and coming into force on May 1, 2022)Chapter I General ProvisionsArticle 1 These Measures are developed in accordanc

4、e with the Regulation on the Supervision and Administration of Medical Devices for the purposes of strengthening the supervision and administration of medical device production, regulating the production of medical devices, and guaranteeing the safety andaddress or expansion of its production scope,

5、 an enterprise shall apply to the original permit-issuing authority for the modification of the medical device production permit and submit the materials involving the modification as set forth in Article 10 of these Measures. The original permit-issuing authority shall examine the application mater

6、ials and conduct on-site inspection in accordance with Article 13 of these Measures.Where the transformation of a workshop or production line leads to the change of production conditions, which may affect the safety and utility of medical devices, the enterprise shall report the change to the origin

7、al permit-issuing authority. In the case of any change of licensing matters, the relevant licensing modification formalities shall be completed as required.Article 16 In the case of the modification of the enterprise name, legal representative (person in charge of the enterprise), or the domicile, t

8、he literal modification of the production address, or the reduction of production scope, the enterprise shall, within 30 working days after the modification, apply to the original permit-issuing authority for the modification of registration items and submit the relevant materials. The original perm

9、it-issuing authority shall complete the modification of registration items within five working days.Article 17 To renew the validity term of a medical device production permit upon its expiry, an enterprise shall file a renewal application within 90 to 30 working days prior to the expiry date. If th

10、e enterprise does not file a renewal application within the prescribed time limit, its renewal application will no longer be accepted.更或者生产范围增加的，应 当向原发证部门申请医疗器 械生产许可变更，并提交本 方法第十条规定中涉及变更 内容的有关材料，原发证部 门应当依照本方法第十三条 的规定进行审核并开展现场 核查。车间或者生产线进行改造， 导致生产条件发生变化，可 能影响医疗器械平安、有效 的，应当向原发证部门报 告。属于许可事项变化的， 应当按照规定办理

11、相关许可 变更手续。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，以及生产范 围核减的，应当在变更后 30个工作日内，向原发证 部门申请登记事项变更，并 提交相关材料。原发证部门 应当在5个工作日内完成登 记事项变更。第十七条医疗器械生 产许可证有效期届满延续 的，应当在有效期届满前 90个工作日至30个工作日 期间提出延续申请。逾期未 提出延续申请的，不再受理10其延续申请。The original permit-issuing authority shall, in light of 原发证部门应当结合企业遵the enterprises complia

12、nce with laws and regulations on medical device administration, GMP for medical devices, and the operation of the enterprises quality management system, conduct on-site inspection where necessary and make a decision to approve or disapprove the extension prior to the expiry of the validity period of

13、 the medical device production permit.If the prescribed conditions are met upon examination, the renewal shall be approved, and the serial number of the renewed medical device production permit shall remain unchanged. If the prescribed conditions are not met, the enterprise shall be ordered to take

14、corrective action within a prescribed time limit; and if the prescribed conditions are still not met after rectification, the renewal application shall be disapproved with a written explanation on reasons.If the approval date of renewal is within the validity period of the original permit, the start

15、ing date of renewal shall be the day following the expiry date of the original permit; or if the approval date is not within the validity period of the original permit, the starting date of renewal shall be the date of approval of renewal.守医疗器械管理法律法规、 医疗器械生产质量管理规范 情况和企业质量管理体系运 行情况进行审查，必要时开 展现场核查，在医疗

16、器械生 产许可证有效期届满前作出 是否准予延续的决定。经审查符合规定条件的，准 予延续，延续的医疗器械生 产许可证编号不变。不符合 规定条件的，责令限期改 正；整改后仍不符合规定条 件的，不予延续，并书面说 明理由。延续许可的批准时间在原许 可证有效期内的，延续起始 日为原许可证到期日的次 日；批准时间不在原许可证 有效期内的，延续起始日为 批准延续许可的日期。第十八条医疗器械生 产企业跨省、自治区、直辖 市设立生产场地的，应当向 新设生产场地所在地省、自 治区、直辖市药品监督管理 部门申请医疗器械生产许 可。Article 18 Where a medical device manufact

17、urer sets up a production site across provinces, autonomous regions, or municipalities directly under the Central Government, it shall apply to the medical products administration of the province, autonomous region, or municipality directly under the Central Government where its newly established pr

18、oduction site is located for the medical device production permit.Article 19 Where a medical device production permit is lost, an enterprise shall apply to the original permitissuing authority for re-issuance. The original permitissuing authority shall re-issue a medical device production permit in

19、a timely manner. The serial number and validity period of the re-issued medical device production permit shall remain the same as those of the original permit.第十九条医疗器械生 产许可证遗失的，应当向原 发证部门申请补发。原发证 部门应当及时补发医疗器械 生产许可证，补发的医疗器 械生产许可证编号和有效期 限与原许可证一致。Article 20 Where there is any modification of the origina

20、l and duplicate of a medical device production permit, the permit-issuing authority shall re-issue the original and duplicate of the modified medical device production permit and take back the original and duplicate before modification; if only the duplicate is modified, the permit-issuing authority

21、 shall re-issue the duplicate of the medical device production permit after modification and take back the duplicate before modification. The number and validity term of the modified medical device production permit shall remain unchanged.第二十条医疗器械生 产许可证正本、副本变更 的，发证部门应当重新核发 变更后的医疗器械生产许可 证正本、副本，收回原许可

22、证正本、副本；仅副本变更 的，发证部门应当重新核发 变更后的医疗器械生产许可 证副本，收回原许可证副 本。变更后的医疗器械生产 许可证编号和有效期限不 变。Article 21 Under any of the following circumstances, the original permit-issuing department shall deregister the medical device production permit in accordance with the law and make an announcement thereon:第二十一条有以下情 形之一的，由

23、原发证部门依 法注销医疗器械生产许可 证，并予以公告：(1) The enterprise voluntarily applies deregistration.for（一）主动申请注销的;(2) The validity period expires but is not renewed.（二）有效期届满未延续 的；（三）市场主体资格依法终(3) The market entity qualification terminates in12止的;accordance with the law.（四）医疗器械生产许可证 依法被撤消或者撤销的；(4) The medical device pro

24、duction permit is revoked or canceled in accordance with the law.（五）法律、法规规定应当 注销行政许可的其他情形。(5) Any other circumstance under which administrative licensing shall be canceled as prescribed by laws and regulations.第二十二条从事第一 类医疗器械生产的，应当向 所在地设区的市级负责药品 监督管理的部门备案，在提 交本方法第十条规定的相关 材料后，即完成生产备案， 获取备案编号。医疗器械备 案人

25、自行生产第一类医疗器 械的，可以在办理产品备案 时一并办理生产备案。Article 22 Whoever plans to engage in the production of Class I medical devices shall undergo recordation at the medical products administration at the level of a districted city where it is located, and complete the recordation of production and obtain a recordatio

26、n serial number after submitting the relevant materials prescribed in Article 10 of these Measures. If the party responsible for the recordation of medical devices produces Class I medical devices by itself, it may undergo production recordation when undergoing the recordation of the product.药品监督管理部

27、门应当在生 产备案之日起3个月内，对 提交的资料以及执行医疗器 械生产质量管理规范情况开 展现场检查。对不符合医疗 器械生产质量管理规范要求 的，依法处理并责令限期改 正；不能保证产品平安、有 效的，取消备案并向社会公 告。The medical products administration shall, within three months as of the date of recordation of production, conduct an on-site inspection of the materials submitted and the implementation

28、of the GMP for medical devices. The enterprise that fails to satisfy the requirements of the GMP for medical devices shall be punished in accordance with the law and ordered to take corrective action within a prescribed time limit; and if it fails to ensure product safety and utility, the recordatio

29、n shall be canceled and announced to the public.第二十三条第一类医 疗器械生产备案内容发生变 化的，应当在10个工作日Article 23 Where there is any change in the content of the production of Class-I medical devices granted recordation, the manufacturer shall submit the materials relating to such change, as set forth in13Article 10 of

30、 these Measures,to the original内向原备案部门提交本方法第十条规定的与变化有关的 材料，药品监督管理部门必 要时可以依照本方法第二十 二条的规定开展现场核查。第十条规定的与变化有关的 材料，药品监督管理部门必 要时可以依照本方法第二十 二条的规定开展现场核查。recordation authority within ten working days, and the medical products administration may, if necessary, conduct an on-site inspection in accordance with

31、the provisions of Article 22 of these Measures.第二十四条任何单位 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。Article 24 No entity or individual may forge, alter, trade, lease, or lend the medical device production permit.第三章生产质量管理第二十五条医疗器械 注册人、备案人、受托生产Chapter III Production Quality AdministrationThe party responsible f

32、or the registration or recordation of and entrusted manufacturer of medical企业应当按照医疗器械生产 质量管理规范的要求，建立 健全与所生产医疗器械相适 应的质量管理体系并保持其 有效运行，并严格按照经注 册或者备案的产品技术要求 组织生产，保证出厂的医疗 器械符合强制性标准以及经 注册或者备案的产品技术要 求。devices shall, as required in the GMP for medical devices, establish and improve the quality management sy

33、stem commensurate with the medical devices produced by them and maintain the systems effective operation, and organize production in strict accordance with the technical requirements for the products that have been registered or granted recordation, so as to ensure that the medical devices leaving f

34、actory satisfy the compulsory standards and the technical requirements for the products that have been registered or granted recordation.第二十六条医疗器械 注册人、备案人的法定代表 人、主要负责人对其生产的 医疗器械质量平安全面负Article 25 The legal representative and principal person in charge of the party responsible for the registration or

35、recordation of medical devices shall be fully responsible for the quality and safety of the medical devices produced by the party.14Article 27 The party responsible for the registration or recordation of and entrusted manufacturer of medical devices shall have management representatives. The managem

36、ent representative shall be appointed by the legal representative or principal person in charge to perform such responsibilities as establishing, implementing, and maintaining the effective operation of the quality management system.第二十七条医疗器械 注册人、备案人、受托生产 企业应当配备管理者代表。 管理者代表受法定代表人或 者主要负责人委派，履行建 立、实施并

37、保持质量管理体 系有效运行等责任。Article 28 The party responsible for the registration or recordation of and entrusted manufacturer of medical devices shall provide training in respect of laws, regulations, rules, standards, and quality management of medical devices, establish a training system, make training plans

38、, strengthen assessment, and properly keep training records.第二十八条医疗器械 注册人、备案人、受托生产 企业应当开展医疗器械法 律、法规、规章、标准以及 质量管理等方面的培训，建 立培训制度，制定培训计 划，加强考核并做好培训记 录。Article 29 The party responsible for the registration or recordation of and entrusted manufacturer of medical devices shall, according to the characteri

39、stics, process flow, and production environment of the manufactured第二十九条医疗器械 注册人、备案人、受托生产 企业应当按照所生产产品的 特性、工艺流程以及生产环products, reasonably set up and use the facilities and equipment, strengthen the management of facilities and equipment, and maintain their effective operation.境要求合理配备、使用设施 设备，加强对设施设备的管

40、 理，并保持其有效运行。Article 3() The party responsible for the registration or recordation of medical devices shall carry out the transition from design and development to production第三十条医疗器械注 册人、备案人应当开展设计 开发到生产的转换活动，并15进行充分验证和确认，确保 设计开发输出适用于生产。and conduct sufficient verification and confirmation to ensure th

41、at the design and development output is suitable for production.第三十一条医疗器械 注册人、备案人、受托生产 企业应当加强采购管理，建 立供应商审核制度，对供应 商进行评价，确保采购产品 和服务符合相关规定要求。Article 31 The party responsible for the registration or recordation of and entrusted manufacturer of medical devices shall strengthen procurement management, est

42、ablish the supplier examination system and evaluate suppliers to ensure that the purchased products and services comply with the relevant provisions and requirements.医疗器械注册人、备案人、 受托生产企业应当建立原材 料采购验收记录制度，确保 相关记录真实、准确、完整 和可追溯。The party responsible for the registration or recordation of and entrusted ma

43、nufacturer of medical devices shall establish the rules for raw material procurement acceptance inspection records to ensure that relevant records are true, accurate, complete, and traceable.第三十二条医疗器械 注册人、备案人委托生产 的，应当对受托方的质量保 证能力和风险管理能力进行 评估，按照国家药品监督管 理局制定的委托生产质量协 议指南要求，与其签订质量 协议以及委托协议，监督受 托方履行有关协议约

44、定的义 务。Article 32 The party responsible for the registration or recordation of medical devices that entrusts production shall assess the quality assurance capabilities and risk management capabilities of the entrusted party, enter into a quality agreement as well as an entrustment agreement with it a

45、ccording to the requirements of the guidelines for the quality agreement on entrusted production developed by the NMPA and supervise the entrusted party in fulfilling its obligations as agreed in the relevant agreements.受托生产企业应当按照法 律、法规、规章、医疗器械 生产质量管理规范、强制性 标准、产品技术要求、委托 生产质量协议等要求组织生 产，对生产行为负责，并接The

46、entrusted manufacturer shall organize production in accordance with laws, regulations, rules, GMP for medical devices, compulsory standards, technical requirements for products, quality agreement on entrusted production, and other requirements, be responsible for production acts, and accept supervis

47、ion by the party responsible for the registration or16recordation of medical devices.受医疗器械注册人、备案人 的监督。Article 33 The party responsible for the registration or recordation of and entrusted manufacturer of medical第三十三条医疗器械 注册人、备案人、受托生产devices shall establish record management rules to ensure that reco

48、rds are true, accurate, complete, and traceable.企业应当建立记录管理制 度，确保记录真实、准确、 完整和可追溯。The party responsible for the registration or recordation of and entrusted manufacturer of medical devices are encouraged to adopt advanced technical means to establish an information management system and strengthen the management of the production process.鼓励医疗器械注册人、备案 人、受托生产企业采用先进 技术手段，建立信息化管理 系统，加强对生产过程的管 理。Article 34 The party responsible for the registration or recordation of medical devices shall be responsible for the release of products on the market, e