Measures for the Supervision and Administration of Medical Devices | | 医疗器械经营监督管理办法 |
| (Promulgated by the Order No. 8 of the China Food and Drug Administration on July 30, 2014; and amended in accordance with the Decision to Amend Certain Rules on November 7, 2017) | | （2014年7月30日国家食品药品监督管理总局令第8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 Principles | | 第一章 总 则 |
| Article 1 For purposes of strengthening the supervision and administration of medical devices, regulating business activities involving medical devices, and guaranteeing the safety and effectiveness of medical devices, these Measures are hereby developed in accordance with the Regulation on the Supervision and Administration of Medical Devices. | | 第一条 为加强医疗器械经营监督管理，规范医疗器械经营行为，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 business activities involving medical devices or supervision and administration thereof within the territory of the People's Republic of China shall comply with these Measures. | | 第二条 在中华人民共和国境内从事医疗器械经营活动及其监督管理，应当遵守本办法。 |
| Article 3 The CFDA shall be responsible for the supervision and administration of business activities involving medical devices nationwide. A food and drug administration at or above the county level shall be responsible for the supervision and administration of business activities involving medical devices in 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经营监督管理工作。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经营监督管理工作。 |
| The food and drug administration at a higher level shall guide and supervise the food and drug administration at a lower level in supervising and administering business activities involving medical devices. | | 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经营监督管理工作。 |
| Article 4 Business activities involving medical devices shall be subject to classified administration in accordance with the medical devices' degree of risks. | | 第四条 按照医疗器械风险程度，医疗器械经营实施分类管理。 |
| Licensing or recordation is not required for business activities involving Class I medical devices. Recordation administration shall apply to business activities involving Class II medical devices. Licensing administration shall apply to business activities involving Class III medical devices. | | 经营第一类医疗器械不需许可和备案，经营第二类医疗器械实行备案管理，经营第三类医疗器械实行许可管理。 |
| Article 5 The CFDA shall prepare the rules for quality control in business activities involving medical devices and supervise the implementation thereof. | | 第五条 国家食品药品监督管理总局制定医疗器械经营质量管理规范并监督实施。 |
| Article 6 A food and drug administration shall publish the information on licensing and recordation of business activities involving medical devices in a timely manner in accordance with law. The applicant may consult the progress and outcome of examination and approval. The public may consult the outcome of examination and approval. | | 第六条 食品药品监督管理部门依法及时公布医疗器械经营许可和备案信息。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。 |
| Chapter II Business Licensing and Recordation Administration | | 第二章 经营许可与备案管理 |
| Article 7 To engage in business activities involving medical devices, the following conditions shall be met: | | 第七条 从事医疗器械经营，应当具备以下条件： |
| (1) There is a quality control institution or a quality control team compatible with the scope and scale of business, and members of the quality control team have relevant professional degrees or titles acknowledged by the state. | | （一）具有与经营范围和经营规模相适应的质量管理机构或者质量管理人员，质量管理人员应当具有国家认可的相关专业学历或者职称； |
| (2) There are business and storage facilities compatible with the scope and scale of business. | | （二）具有与经营范围和经营规模相适应的经营、贮存场所； |
| (3) There are storage conditions compatible with the scope and scale of business, but no warehouses are required if the enterprise entrusts another medical device business enterprise with storage of all its products. | | （三）具有与经营范围和经营规模相适应的贮存条件，全部委托其他医疗器械经营企业贮存的可以不设立库房； |
| (4) There is a quality control system compatible with the medical devices involved in business activities. | | （四）具有与经营的医疗器械相适应的质量管理制度； |
| (5) The enterprise has professional guidance, technical training, and after-sales service capacities compatible with the medical devices involved in its business activities, or agrees that a relevant institution shall provide technical support. | | （五）具备与经营的医疗器械相适应的专业指导、技术培训和售后服务的能力，或者约定由相关机构提供技术支持。 |
| An enterprise engaging in business activities involving Class III medical devices shall also have a computer information management system which complies with the requirements for quality control in business activities involving medical devices to ensure that the products involved in its business activities are traceable. An enterprise engaging in business activities involving Class I or Class II medical devices shall be encouraged to establish a computer information management system which complies with the requirements for quality control in business activities involving medical devices. | | 从事第三类医疗器械经营的企业还应当具有符合医疗器械经营质量管理要求的计算机信息管理系统，保证经营的产品可追溯。鼓励从事第一类、第二类医疗器械经营的企业建立符合医疗器械经营质量管理要求的计算机信息管理系统。 |
| Article 8 To engage in business activities involving Class III medical devices, a business enterprise shall file an application with the food and drug administration at the level of the districted city at the place where it is located, and submit the following materials: | | 第八条 从事第三类医疗器械经营的，经营企业应当向所在地设区的市级食品药品监督管理部门提出申请，并提交以下资料： |
| (1) A photocopy of the business license; | | （一）营业执照复印件； |
| (2) Copies of the proof of identity and the degree or professional title certificate of the legal representative, the person in charge of the enterprise, or the person in charge of quality; | | （二）法定代表人、企业负责人、质量负责人的身份证明、学历或者职称证明复印件； |
| (3) Description of the organizational structure and the departmental setup; | | （三）组织机构与部门设置说明； |
| (4) Description of its scope of business and mode of operation; | | （四）经营范围、经营方式说明； |
| (5) Copies of the location map, floor plan, and title certificate or lease agreement (with the title certificate attached) for its business facility and warehouses; | | （五）经营场所、库房地址的地理位置图、平面图、房屋产权证明文件或者租赁协议（附房屋产权证明文件）复印件； |
| (6) Catalogue of its business facility and equipment; | | （六）经营设施、设备目录； |
| (7) Catalogue of its business quality control system, work procedures, and other documents; | | （七）经营质量管理制度、工作程序等文件目录； |
| (8) Basic information on the computer information management system and description of its functions; | | （八）计算机信息管理系统基本情况介绍和功能说明； |
| (9) Authorization certificate of the handling person; and | | （九）经办人授权证明； |
| (10) Other certification materials. | | （十）其他证明材料。 |
| Article 9 Where an applicant files an application for licensing of business activities involving Class III Medical Devices, the food and drug administration at the level of the districted city shall handle the application in accordance with the following circumstances respectively: | | 第九条 对于申请人提出的第三类医疗器械经营许可申请，设区的市级食品药品监督管理部门应当根据下列情况分别作出处理： |
| (1) If the subject matter of the application falls within its scope of authority, and the application materials are complete and conform to the statutory form, the application shall be accepted. | | （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 fail to conform to the statutory form, the applicant shall be notified, on the spot or within five working days, of all the necessary supplements and corrections at one time. If no notification is made within the prescribed time limit, the application shall be deemed to have been 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) If the application materials contain errors that may be corrected on the spot, the applicant shall be allowed to make corrections 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) If the subject matter of the application does not fall within the scope of its authority, a decision on not accepting the application shall be immediately issued, and the applicant shall be notified of the relevant administrative authority that the application shall be filed with. | | （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。 |
| For acceptance or non-acceptance of an application for licensing of business activities involving medical devices, the food and drug administration at the level of the districted city shall issue a written notice on acceptance or non-acceptance. | | 设区的市级食品药品监督管理部门受理或者不予受理医疗器械经营许可申请的，应当出具受理或者不予受理的通知书。 |
| Article 10 The food and drug administration at the level of the districted city shall review the application materials within 30 working days after the date of acceptance, and conduct on-site inspections in accordance with the requirements of the rules for quality control in business activities involving medical devices. Where rectification is required, the time used for rectification shall not be included in the review period. | | 第十条 设区的市级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，并按照医疗器械经营质量管理规范的要求开展现场核查。需要整改的，整改时间不计入审核时限。 |
| If the relevant conditions are satisfied, a written decision on granting the permit shall be made in accordance with law, and a Business Permit for Medical Devices shall be issued within 10 working days. If the relevant conditions are not satisfied, a written decision on not granting the permit shall be made, and the reasons shall be explained. | | 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《医疗器械经营许可证》；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 Where an application for licensing of business activities involving medical devices directly relates to a major interest relationship between the applicant and another party, the food and drug administration shall notify the applicant and the interested party that they have the right to apply for a hearing in accordance with laws, regulations and relevant provisions of the CFDA. When reviewing licensing of business activities involving medical devices, for what is found to be a major matter subject to licensing which relates to public interests, a food and drug administration shall make an announcement to the public and hold a hearing. | | 第十一条 医疗器械经营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；在对医疗器械经营许可进行审查时，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 12 To engage in business activities involving Class II medical devices, a business enterprise shall file for recordation with the food and drug administration at the level of the districted city at the place where it is located, complete a recordation form for business activities involving medical devices, and submit the materials set out in Article 8 of these Measures (except item 8). | | 第十二条 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食品药品监督管理部门备案，填写第二类医疗器械经营备案表，并提交本办法第八条规定的资料（第八项除外）。 |
| Article 13 A food and drug administration shall verify whether the materials submitted by the enterprise are complete on the spot. If the relevant conditions are satisfied, recordation shall be granted, and a recordation certificate for business activities involving Class II medical devices shall be issued. | | 第十三条 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，符合规定的予以备案，发给第二类医疗器械经营备案凭证。 |
| Article 14 Within three months after the date of recordation of the medical device business enterprise, the food and drug administration at the level of the districted city shall conduct on-site inspections of the business enterprise of Class II medical devices in accordance with the requirements of the rules for quality control in business activities involving medical devices. | | 第十四条 设区的市级食品药品监督管理部门应当在医疗器械经营企业备案之日起3个月内，按照医疗器械经营质量管理规范的要求对第二类医疗器械经营企业开展现场核查。 |
| Article 15 A Business Permit for Medical Devices shall be valid for five years, and indicate the permit number, enterprise name, legal representative, person in charge of the enterprise, domicile, business facility, mode of operation, scope of business, address of warehouses, permit-issuing authority, date of issuance, validity period and other matters. | | 第十五条 《医疗器械经营许可证》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、经营场所、经营方式、经营范围、库房地址、发证部门、发证日期和有效期限等事项。 |
| A recordation certificate for business activities involving medical devices shall indicate the number, enterprise name, legal representative, person in charge of the enterprise, domicile, business facility, mode of operation, scope of business, address of warehouses, recordation authority, date of recordation and other matters. | | 医疗器械经营备案凭证应当载明编号、企业名称、法定代表人、企业负责人、住所、经营场所、经营方式、经营范围、库房地址、备案部门、备案日期等事项。 |
| Article 16 Modification of a matter in the Business Permit for Medical Devices shall include modification of a matter subject to licensing and modification of a matter subject to registration. | | 第十六条 《医疗器械经营许可证》事项的变更分为许可事项变更和登记事项变更。 |
| Modification of a matter subject to licensing shall include modification of the business facility, mode of operation, scope of business or address of warehouses. | | 许可事项变更包括经营场所、经营方式、经营范围、库房地址的变更。 |
| Modification of a matter subject to registration shall include modification of any matter except the ones mentioned above. | | 登记事项变更是指上述事项以外其他事项的变更。 |
| Article 17 For modification of a matter subject to licensing, an application for modification of the Business Permit for Medical Devices shall be filed with the original permit-issuing authority, and the relevant materials on contents of modification set out in Article 8 of these Measures shall be submitted. | | 第十七条 许可事项变更的，应当向原发证部门提出《医疗器械经营许可证》变更申请，并提交本办法第八条规定中涉及变更内容的有关资料。 |
| For establishment of warehouses in another administrative region, the enterprise shall file for recordation with the food and drug administration at the level of the districted city at the place where the warehouses are located. | | 跨行政区域设置库房的，应当向库房所在地设区的市级食品药品监督管理部门办理备案。 |
| The original permit-issuing authority shall, within 15 working days upon receipt of the application for modification, review the application, and issue a decision to grant modification or not to grant modification. Where it is necessary to conduct on-site inspections in accordance with the requirements of the rules for quality control in business activities involving medical devices, a decision to grant modification or not to grant modification shall be issued within 30 working days upon receipt of the application for modification. Where modification is not granted, reasons shall be explained in writing, and the applicant shall be notified. The number and validity period of the modified Business Permit for Medical Devices shall stay the same. | | 原发证部门应当自收到变更申请之日起15个工作日内进行审核，并作出准予变更或者不予变更的决定；需要按照医疗器械经营质量管理规范的要求开展现场核查的，自收到变更申请之日起30个工作日内作出准予变更或者不予变更的决定。不予变更的，应当书面说明理由并告知申请人。变更后的《医疗器械经营许可证》编号和有效期限不变。 |
| Article 18 Where a new independent business facility is established, an application for licensing or recordation of business activities involving medical devices shall be filed separately. | | 第十八条 新设立独立经营场所的，应当单独申请医疗器械经营许可或者备案。 |
| Article 19 Where any matter subject to registration is modified, the medical device business enterprise shall undergo modification formalities at the food and drug administration at the level of the districted city in a timely manner. | | 第十九条 登记事项变更的，医疗器械经营企业应当及时向设区的市级食品药品监督管理部门办理变更手续。 |
| Article 20 An ongoing medical device business enterprise after a division or merger shall file an application for licensing modification in accordance with the provisions of these Measures. For dissolution resulting from a division or merger of enterprises, an application for cancelation of the Business Permit for Medical Devices shall be filed. For formation of new business resulting from a division or merger of enterprises, an application for a Business Permit for Medical Devices shall be filed. | | 第二十条 因分立、合并而存续的医疗器械经营企业，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，应当申请注销《医疗器械经营许可证》；因企业分立、合并而新设立的，应当申请办理《医疗器械经营许可证》。 |
| Article 21 No business licensing or recordation is required when the registrant or party undergoing recordation of medical devices, or the manufacturer sells medical devices at the place where it is domiciled or where medical devices are manufactured. Where medical devices are stored and spot sales of them are conducted at any other location, business licensing or recordation shall be handled in accordance with the relevant provisions. | | 第二十一条 医疗器械注册人、备案人或者生产企业在其住所或者生产地址销售医疗器械，不需办理经营许可或者备案；在其他场所贮存并现货销售医疗器械的，应当按照规定办理经营许可或者备案。 |
| Article 22 Where it is necessary to renew a Business Permit for Medical Devices upon its expiration, the medical device business enterprise shall file an application for renewal of the Business Permit for Medical Devices with the original permit-issuing authority six months before it expires. | | 第二十二条 《医疗器械经营许可证》有效期届满需要延续的，医疗器械经营企业应当在有效期届满6个月前，向原发证部门提出《医疗器械经营许可证》延续申请。 |
| The original permit-issuing authority shall review the application for renewal in accordance with the provisions of Article 10 of these Measures, conduct on-site inspections if necessary, and make a decision as to whether to renew the Business Permit for Medical Devices before it expires. Where the relevant conditions are satisfied, renewal shall be granted, and the number of 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 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. | | 原发证部门应当按照本办法第十条的规定对延续申请进行审核，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。符合规定条件的，准予延续，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。 |
| Article 23 Where the enterprise name, legal representative, person in charge of the enterprise, domicile, business facility, mode of operation, scope of business, address of warehouses or any other matter subject to recordation in the recordation certificate for business activities involving medical devices is changed, recordation shall be modified in a timely manner. | | 第二十三条 医疗器械经营备案凭证中企业名称、法定代表人、企业负责人、住所、经营场所、经营方式、经营范围、库房地址等备案事项发生变化的，应当及时变更备案。 |
Article 24 Where a Business Permit for Medical Devices is lost, the medical device business enterprise shall immediately make a statement on the loss in the media designated by the original permit-issuing authority. The enterprise shall apply to the original permit-issuing authority for re-issuance of the permit at least one month after the statement on loss is made. The original permit-issuing authority shall re-issue the Business Permit for Medical Devices in a timely manner.
．．．．．． | | 第二十四条 《医疗器械经营许可证》遗失的，医疗器械经营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《医疗器械经营许可证》。
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