【中英文对照版】医疗器械经营监督管理办法(2022).docx

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1、医疗器械经营监督管理方法（2022年3月10日国家市 场监督管理总局令第54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 器械经营监督管理，规范医 疗器械经营活动，保证医疗 器械平安、有效，根据医 疗器械监督管理条例，制 定本方法。医疗器械经营监督管理方法(2022)Measures for the Supervision and Administration of Medical Device Business (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54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

2、药材进出口Issuing Authority : State Administration for Market RegulationDocument Number : Order No. 54 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

3、Medicine MaterialsMeasures for the Supervision and Administration of Medical Device Business(Issued by Order No. 54 of the State Administration for Market Regulation on March 10, 2022 and shall come into force on May 1, 2022)Chapter I General PrinciplesArticle 1 For the purposes of strengthening the

4、 supervision and administration of medical device business, regulating business activities involving medical devices, and guaranteeing the safety and effectiveness of medical devices, these Measures are hereby developed in accordance with the Regulationapplication for renewal within 30 working days

5、to 90 当在有效期届满前 90 个工working days before the expiration of the validity period. An application for renewal shall no longer be accepted, where it is not filed within the prescribed time limit.The original permit-issuing department shall, according to the provisions of Article 13 of these Measures, exa

6、mine an application for renewal, conduct on-site inspection if necessary, and decide whether or not to renew the Business Permit for Medical Devices before it expires.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，不再受理其延续 申请。原发证部门应当按照本方法 第十三条的规定对延续申请 进行审查，必要时开展现场 核查，在医疗器械经营许可证有效期届满前作出是否准 予延续的决定。Upon examination, wh

7、ere the relevant conditions aresatisfied, renewal shall be granted, and the number of 经审查符合规定条件的，准the renewed Business Permit for Medical Devices shall stay the same. Where the relevant conditions are not satisfied, rectification within a prescribed time limit shall be ordered. Renewal shall not be

8、granted if the relevant conditions are not satisfied upon rectification, and the reasons shall be explained in writing. For failure to make a decision within the prescribed time limit, renewal shall be deemed to have been granted.If the approval time for the renewal of a permit is within the validit

9、y period of the original permit, the start date of the renewal shall be the day following the expiry date of the original permit; if the approval time is not within the validity period of the original permit, the start date of the renewal shall be the date on which the renewal of the permit is appro

10、ved.Article 17 If a business enterprise sets up warehouses across districted cities, the authority issuing the Business Permit for Medical Devices or the recordation department shall notify the medical products administrative department at the districted city level at the places where the warehouses

11、 are予延续，延续后的医疗器械 经营许可证编号不变。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。予延续，延续后的医疗器械 经营许可证编号不变。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。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。第十七条经营企业跨 设区的市设置库房的，由医 疗器械经营许可发证部门或 者备案部门通报库房所在地 设

12、区的市级负责药品监督管10located.理的部门。第十八条经营企业新 设立独立经营场所的，应当 依法单独申请医疗器械经营 许可或者进行备案。第十九条医疗器械经 营许可证遗失的，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 经营许可证，补发的医疗器 械经营许可证编号和有效期 限与原许可证一致。Article 18 Where a business enterprise sets up a new independent business premise, an application for a business permit for medical devices shall

13、 be filed separately or recordation formalities shall be undergone separately in accordance with the law.Article 19 Where a Business Permit for Medical Devices is lost, an application for reissuance shall be filed with the original permit-issuing department. The original permit-issuing department sh

14、all reissue a Business Permit for Medical Devices in a timely manner, and the number and validity period of the reissued Business Permit for Medical Devices shall be consistent with those of the original permit.第二十条有以下情形 之一的，由原发证部门依法 注销医疗器械经营许可证， 并予以公告：Article 20 Under any of the following circumsta

15、nces, the original permit-issuing department shall cancel the Business Permit for Medical Devices in accordance with the law, and issue an announcement:（一）主动申请注销的;(1) An application for cancellation is filed proactively.(2) The certificate is not renewed upon expiry.（二）有效期届满未延续 的；市场主体资格依法终is （四）医疗器械

16、经营许可证依法被撤消或者撤销的；The eligibility status as a market participant is (三) terminated in accordance with the law.止的；(3) The Business Permit for Medical Devices revoked or canceled according to the law.(4) Other circumstances under which administrative licensing shall be canceled as prescribed by the laws

17、 and regulations.Article 21 To engage in Class II medical device business, a business enterprise shall undergo the recordation formalities with the medical products administrative department at the districted city level at the place where it is located, submit the materials in compliance with the pr

18、ovisions of Article 10 of these Measures (other than item 7), upon which business recordation is completed and the serial number of business recordation may be obtained.An applicant for recordation of medical device business shall ensure that the submitted materials are legal, authentic, accurate, c

19、omplete and traceable.Article 22 If necessary, the medical products administrative department at the districted city level at the place where it is located shall, within three months from the date of completion of recordation, conduct an on-site inspection of the submitted materials and the implemen

20、tation of the quality management standards for medical device business.（五）法律、法规规定应当 注销行政许可的其他情形。第二十一条从事第二 类医疗器械经营的，经营企 业应当向所在地设区的市级 负责药品监督管理的部门备 案，并提交符合本方法第十 条规定的资料（第七项除 外），即完成经营备案，获 取经营备案编号。医疗器械经营备案人应当确 保提交的资料合法、真实、 准确、完整和可追溯。第二十二条必要时， 设区的市级负责药品监督管 理的部门在完成备案之日起 3个月内，对提交的资料以 及执行医疗器械经营质量管 理规范情况开展现场检查

21、。现场检查发现与提交的资料 不一致或者不符合医疗器械 经营质量管理规范要求的， 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。If it is found in the on-site inspection that it is inconsistent with the submitted materials or the requirements of the quality management standards for medical device business are not satisfied, it shall be ordered to take co

22、rrective action within a prescribed time limit; and if the product safety and effectiveness cannot be guaranteed, the recordation shall be canceled and an announcement shall be made to the public.12An entity that concurrently files an application for business permit for Class III medical devices and

23、 undergoes the recordation formalities for business activities involving Class II medical devices, or has obtained business permit for Class III medical devices and undergoes the recordation formalities for business activities involving Class II medical devices may be exempted from submitting corres

24、ponding materials.Article 23 A Class II medical device business enterprise that modifies its business premise, mode of operation, business scope, address of warehouses, etc., shall undergo the recordation formalities for modification in a timely manner. If necessary, the department responsible for s

25、upervision and administration of medical products at the districted city level shall conduct on-site inspections. If it is found in the on-site inspection that the requirements of the quality management standards for medical device business are not satisfied, it shall be ordered to take corrective a

26、ction within a prescribed time limit; and if the product safety and effectiveness cannot be guaranteed, the recordation shall be canceled and an announcement shall be made to the public.Article 24 For Class II medical devices whose product safety and effectiveness are not affected by the circulation

27、 process, business recordation may be exempted. The list of specific products shall be developed, adjusted and published by the NMPA.Article 25 An institution engaged in the storage,第二十三条同时申请 第三类医疗器械经营许可和 进行第二类医疗器械经营备 案的，或者已经取得第三类 医疗器械经营许可进行第二 类医疗器械备案的，可以免 予提交相应资料。第二十三条同时申请 第三类医疗器械经营许可和 进行第二类医疗器械经营备

28、 案的，或者已经取得第三类 医疗器械经营许可进行第二 类医疗器械备案的，可以免 予提交相应资料。第二十四条第二类医 疗器械经营企业的经营场 所、经营方式、经营范围、 库房地址等发生变化的，应 当及时进行备案变更。必要 时设区的市级负责药品监督 管理的部门开展现场检查。 现场检查不符合医疗器械经 营质量管理规范要求的，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。第二十五条对产品安 全性、有效性不受流通过程 影响的第二类医疗器械，可 以免予经营备案。具体产品 名录由国家药品监督管理局 制定、调整并公布。第二十六条从事非营13allocation and supply of

29、non-for-profit contraceptive medical devices shall comply with relevant regulations and is not required to apply for a Business Permit for Medical Devices or recordation.Article 26 An applicant for registration and recordation of medical devices selling medical devices for which it has undergone the

30、 formalities for registration and recordation at its domicile or production address is not required to apply for a business permit for medical devices or recordation, but shall meet the prescribed business conditions; and an applicant selling medical devices at other places shall obtain a business p

31、ermit for medical devices or undergo the recordation formalities in accordance with regulations.Article 27 No entity or individual is allowed to forge, alter, trade, lease or lend a Business Permit for Medical Devices.Chapter III Business Quality ControlArticle 29 To engage in medical device busines

32、s, an entity shall, in accordance with the laws and regulations, and the requirements of the quality management standards for medical device business, develop quality management rules and quality control measures covering the whole process of procurement, acceptance, storage, sale, transportation, a

33、nd aftersales service, and effectively make relevant records to利的避孕医疗器械贮存、调 拨和供应的机构，应当符合 有关规定，无需办理医疗器 械经营许可或者备案。第二十七条医疗器械 注册人、备案人在其住所或 者生产地址销售其注册、备 案的医疗器械，无需办理医 疗器械经营许可或者备案， 但应当符合规定的经营条 件；在其他场所贮存并销售 医疗器械的，应当按照规定 办理医疗器械经营许可或者 备案。第二十八条任何单位 和个人不得伪造、变造、买 卖、出租、出借医疗器械经 营许可证。第三章经营质量管理第二十九条从事医疗 器械经营，应当按照法律法

34、 规和医疗器械经营质量管理 规范的要求，建立覆盖采 购、验收、贮存、销售、运 输、售后服务等全过程的质 量管理制度和质量控制措14ensure that operating conditions and business activities continuously satisfy the requirements.施，并做好相关记录，保证 经营条件和经营活动持续符 合要求。Article 30 A medical device business enterprise shall establish and implement a product traceability system to

35、 ensure product traceability.第三十条医疗器械经 营企业应当建立并实施产品 追溯制度，保证产品可追 溯。A medical device business enterprise shall implement the unique identification system for medical devices in accordance with relevant rules of the state.医疗器械经营企业应当按照 国家有关规定执行医疗器械 唯一标识制度。Article 31 A medical device business enterprise

36、shall purchase medical devices from applicants for registration and recordation of medical devices and business enterprises with lawful qualifications.第三十一条医疗器械 经营企业应当从具有合法资 质的医疗器械注册人、备案 人、经营企业购进医疗器 械。Article 32 A medical device business enterprise shall establish a purchase inspection recording sys

37、tem, and when purchasing medical devices, it shall inspect the qualifications of the supplier, as well as the medical devices registration certificate and recordation information, and qualification certificate. The purchase inspection records shall be truthful, accurate, complete and traceable. The

38、purchase inspection records shall include:第三十二条医疗器械 经营企业应当建立进货查验 记录制度，购进医疗器械时 应当查验供货企业的资质， 以及医疗器械注册证和备案 信息、合格证明文件。进货 查验记录应当真实、准确、 完整和可追溯。进货查验记 录包括：(1) the name, model, specification and quantity of the (一)医疗器械的名称、型medical device;号、规格、数量；15（三）医疗器械注册人、备 案人和受托生产企业名称、 生产许可证号或者备案编 号；（五）供货者的名称、地址进货查验记录应当保

39、存至医疗器械有效期满后2年；没有有效期的，不得少于5 年。植入类医疗器械进货查 验记录应当永久保存。第三十三条医疗器械 经营企业应当采取有效措 施，确保医疗器械运输、贮 存符合医疗器械说明书或者 标签标示要求，并做好相应 记录。对温度、湿度等环境条件有 特殊要求的，应当采取相应 措施，保证医疗器械的安 全、有效。(2) the medical devices registration certificate number (二)医疗器械注册证编号or recordation number;或者备案编号；(3) the names, production license numbers or r

40、ecordation numbers of the applicant for registration and recordation of medical devices and the entrusted manufacturing enterprise;the production batch number or serial number,(四)医疗器械的生产批号 period of use or expiration date, purchase date, etc. of 或者序歹U号、 使用期限或者 the medical device; and失效日期、购货日期等；(4) t

41、he name, address and contact method of thesupplier.supplier.以及联系方式。The purchase inspection records shall be retained until two years after expiration of the validity period of a medical device. Where a medical device does not have a validity period, the records shall be retained for not less than fi

42、ve years. Purchase inspection records for implantable medical devices shall be retained indefinitely.Article 33 A medical device business enterprise shall adopt effective measures to ensure that the transportation and storage of medical device comply with the requirements for the medical devices ins

43、tructions, labels or signs, and effectively keep the relevant records.Where there are special requirements for environmental conditions such as temperature and humidity, corresponding measures shall be taken to ensure the safety and effectiveness of medical devices.16Article 34 An applicant for regi

44、stration and recordation of medical devices and a business enterprise entrusting the transportation and storage of medical devices to other entities shall evaluate the quality assurance capability of the party to which transportation and storage of medical devices are entrusted, and enter into an en

45、trustment agreement with it, specifying quality responsibility during the process of transportation and storage to ensure quality safety during the process of transportation and storage.Article 35 An entity that specifically provides transportation and storage services for an applicant for registrat

46、ion and recordation of medical devices and a business enterprise shall enter into a written agreement with the entrusting party, clarifying the rights, obligations and quality responsibilities of both parties, have the conditions for transportation and storage of the products, and the equipment and

47、facilities suitable for the scale, and have the information management platform on which real-time electronic data are exchanged with the entrusting party and the traceability of the whole process of product operation and quality management is realized, and technical means.Article 36 An applicant fo

48、r registration and recordation of medical devices entrusting sale to other parties shall entrust the sale to eligible medical device business enterprises and enter into entrustment agreements, specifying the rights and obligations of both parties.Article 37 An applicant for registration and第三十四条医疗器械 注册人、备案人和经营企业 委托其他单位运输、贮存医 疗器械的，应当对受托方运 输、贮存医疗器械的质量保 障能力进行评估，并与其签 订委托协议，明确运输、贮 存过程中的质量责任，确保 运输、贮存过程中的质量安 全。第三十四条医疗器械 注册人、备案人和经营企业 委托其他单位运输、贮存医 疗器械的，应当对受托方运 输、贮存医疗器械的质量保 障能力进行评估，并与其签 订委托协议，明确运输、贮 存过程中的质量责任，确保 运输、贮存过程中的质量安 全。第三十五条为医疗器 械注册人、备案人和经营企 业专门提供运输、贮存服务 的，应当与委托方签订书面