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| Order of the State Council of the People's Republic of China | | 中華人民共和國國務院令 |
| (No. 739) | | （第739號） |
| The Regulation on the Supervision and Administration of Medical Devices, as revised and adopted at the 119th executive meeting of the State Council on February 21, 2020, is hereby issued and shall come into force on June 1, 2021. | | 《醫療器械監督管理條例》已經2020年12月21日國務院第119次常務會議修訂通過，現予公布，自2021年6月1日起施行。 |
| Premier: Li Keqiang | | 總 理 李克強 |
| February 9, 2021 | | 2021年2月9日 |
| Regulation on the Supervision and Administration of Medical Devices | | 醫療器械監督管理條例 |
| (Issued by Order No. 276 of the State Council of the People's Republic of China on January 4, 2000, revised and adopted at the 39th executive meeting of the State Council on February 12, 2014, revised in accordance with the Decision of the State Council to Amend the Regulation on the Supervision and Administration of Medical Devices on May 4, 2017, and revised and adopted at the 119th executive meeting of the State Council on December 21, 2020) | | （2000年1月4日中華人民共和國國務院令第276號公布 2014年2月12日國務院第39次常務會議修訂通過 根據2017年5月4日《國務院關于修改〈醫療器械監督管理條例〉的決定》修訂 2020年12月21日國務院第119次常務會議修訂通過） |
| Chapter I General Provisions | | 第一章 總 則 |
| Article 1 This Regulation is developed for the purposes of ensuring the safety and effectiveness of medical devices, guaranteeing human health and life safety and promoting the development of the medical device industry. | | 第一條 為了保證醫療器械的安全、有效，保障人體健康和生命安全，促進醫療器械產業發展，制定本條例。 |
| Article 2 Whoever engages in the research and development, production, distribution or use of medical devices as well as the supervision and administration thereof within the territory of the People's Republic of China shall abide by this Regulation. | | 第二條 在中華人民共和國境內從事醫療器械的研制、生產、經營、使用活動及其監督管理，適用本條例。 |
| Article 3 The medical products administration of the State Council shall be responsible for the supervision and administration of medical devices nationwide. | | 第三條 國務院藥品監督管理部門負責全國醫療器械監督管理工作。 |
| The relevant departments of the State Council shall be responsible for the supervision and administration related to medical devices within their respective functions. | | 國務院有關部門在各自的職責範圍內負責與醫療器械有關的監督管理工作。 |
| Article 4 The local people's governments at or above the county level shall strengthen the leadership over the supervision and administration of medical devices within their respective administrative regions, organize and coordinate the supervision and administration of medical devices and the emergency response work within their respective administrative regions, strengthen the building of medical device supervision and administration capabilities, and provide guarantees for the safety of medical devices. | | 第四條 縣級以上地方人民政府應當加強對本行政區域的醫療器械監督管理工作的領導，組織協調本行政區域內的醫療器械監督管理工作以及突發事件應對工作，加強醫療器械監督管理能力建設，為醫療器械安全工作提供保障。 |
| The medical products administrations of the local people's governments at or above the county level shall be responsible for the supervision and administration of medical devices within their respective administrative regions. The relevant departments of the local people's governments at or above the county level shall be responsible for the supervision and administration related to medical devices within their respective functions. | | 縣級以上地方人民政府負責藥品監督管理的部門負責本行政區域的醫療器械監督管理工作。縣級以上地方人民政府有關部門在各自的職責範圍內負責與醫療器械有關的監督管理工作。 |
| Article 5 Medical device supervision and administration shall follow the principles of risk management, management and control in the whole process, scientific regulation and co-governance by the whole society. | | 第五條 醫療器械監督管理遵循風險管理、全程管控、科學監管、社會共治的原則。 |
| Article 6 The state shall conduct the classification administration of medical devices according to their risk levels. | | 第六條 國家對醫療器械按照風險程度實行分類管理。 |
| “Medical devices of Class I” means the medical devices with low risks, whose safety and effectiveness can be ensured through routine administration. | | 第一類是風險程度低，實行常規管理可以保證其安全、有效的醫療器械。 |
| “Medical devices of Class II” means the medical devices with moderate risks, which shall be strictly controlled and administered to ensure their safety and effectiveness. | | 第二類是具有中度風險，需要嚴格控制管理以保證其安全、有效的醫療器械。 |
| “Medical devices of Class III” means the medical devices with relatively high risks, which shall be strictly controlled and administered through special measures to ensure their safety and effectiveness. | | 第三類是具有較高風險，需要采取特別措施嚴格控制管理以保證其安全、有效的醫療器械。 |
| The evaluation of the risk levels of medical devices shall take consideration of the expected objectives, structural features, use methods and other factors of medical devices. | | 評價醫療器械風險程度，應當考慮醫療器械的預期目的、結構特征、使用方法等因素。 |
| The medical products administration of the State Council shall be responsible for developing the classification rules for and the classified catalogues of medical devices, and, according to the information on the production, distribution and use of medical devices, analyzing and evaluating in a timely manner the risk changes of medical devices and adjusting the classification rules and classified catalogues; and shall develop and adjust the classification rules and classified catalogues, fully listen to the opinions of medical device registrants, recordation entities, production and distribution enterprises, use entities and industry organizations, and conduct the classified practices by reference to those for international medical devices. The classification rules for and the classified catalogues of medical devices shall be announced to the general public. | | 國務院藥品監督管理部門負責制定醫療器械的分類規則和分類目錄，並根據醫療器械生產、經營、使用情況，及時對醫療器械的風險變化進行分析、評價，對分類規則和分類目錄進行調整。制定、調整分類規則和分類目錄，應當充分聽取醫療器械注冊人、備案人、生產經營企業以及使用單位、行業組織的意見，並參考國際醫療器械分類實踐。醫療器械分類規則和分類目錄應當向社會公布。 |
| Article 7 Medical device products shall satisfy the national compulsory standards for medical devices, and, if no such standard is available, meet the compulsory industry standards for medical devices. | | 第七條 醫療器械產品應當符合醫療器械強制性國家標准；尚無強制性國家標准的，應當符合醫療器械強制性行業標准。 |
| Article 8 The state shall develop the plans and policies on the medical device industry, include medical device innovation in the scope of development priorities, give priority to the evaluation and approval of innovative medical devices, support the clinical promotion and use of innovative medical devices, and promote the high-quality development of the medical device industry. The medical products administration of the State Council shall cooperate with the relevant departments of the State Council to implement the national plans and guiding policies on the medical device industry. | | 第八條 國家制定醫療器械產業規劃和政策，將醫療器械創新納入發展重點，對創新醫療器械予以優先審評審批，支持創新醫療器械臨床推廣和使用，推動醫療器械產業高質量發展。國務院藥品監督管理部門應當配合國務院有關部門，貫徹實施國家醫療器械產業規劃和引導政策。 |
| Article 9 The state shall improve the medical device innovation system, support the basic research and application research of medical devices, promote the promotion and application of new medical device technologies, and provide support in initiation of scientific and technological projects, financing, credit, procurement through bidding, medical insurance and other aspects. Enterprises shall be supported in establishing or jointly forming research and development institutions, and be encouraged to cooperate with institutions of higher education, scientific research institutes, and medical institutions, among others, in conducting research and making innovations on medical devices, strengthen the intellectual property protection for medical devices, and improve independent innovation capabilities in terms of medical devices. | | 第九條 國家完善醫療器械創新體系，支持醫療器械的基礎研究和應用研究，促進醫療器械新技術的推廣和應用，在科技立項、融資、信貸、招標采購、醫療保險等方面予以支持。支持企業設立或者聯合組建研制機構，鼓勵企業與高等學校、科研院所、醫療機構等合作開展醫療器械的研究與創新，加強醫療器械知識產權保護，提高醫療器械自主創新能力。 |
| Article 10 The state shall strengthen the information technology construction for the supervision and administration of medical devices, enhance the level of online government services, and facilitate the handling of administrative licensing and recordation of medical devices. | | 第十條 國家加強醫療器械監督管理信息化建設，提高在線政務服務水平，為醫療器械行政許可、備案等提供便利。 |
| Article 11 Medical device industry organizations shall strengthen industry self-regulation, promote the construction of the credit system, urge and supervise enterprises' implementation of production and distribution activities according to the law, and direct enterprises to act in good faith. | | 第十一條 醫療器械行業組織應當加強行業自律，推進誠信體系建設，督促企業依法開展生產經營活動，引導企業誠實守信。 |
| Article 12 The entities and individuals that have made outstanding contributions in research and innovation of medical devices shall be commended and rewarded in accordance with the relevant provisions issued by the state. | | 第十二條 對在醫療器械的研究與創新方面做出突出貢獻的單位和個人，按照國家有關規定給予表彰獎勵。 |
| Chapter II Registration and Recordation of Medical Device Products | | 第二章 醫療器械產品注冊與備案 |
| Article 13 The medical devices of Class I shall be subject to product recordation administration, and the medical devices of Class II and Class III shall be subject to product registration administration. | | 第十三條 第一類醫療器械實行產品備案管理，第二類、第三類醫療器械實行產品注冊管理。 |
| Medical device registrants and recordation entities shall strengthen the whole life-cycle quality management of medical devices, and assume responsibilities according to the law for the safety and effectiveness of medical devices in the process of research and development, production, distribution and use thereof. | | 醫療器械注冊人、備案人應當加強醫療器械全生命周期質量管理，對研制、生產、經營、使用全過程中醫療器械的安全性、有效性依法承擔責任。 |
| Article 14 The following materials shall be submitted for the recordation of the medical device products of Class I and the application for registration of the medical device products of Class II and Class III: | | 第十四條 第一類醫療器械產品備案和申請第二類、第三類醫療器械產品注冊，應當提交下列資料： |
| (1) Product risk analysis materials. | | （一）產品風險分析資料； |
| (2) Product technical requirements. | | （二）產品技術要求； |
| (3) Product inspection reports. | | （三）產品檢驗報告； |
| (4) Clinical evaluation materials. | | （四）臨床評價資料； |
| (5) Sample manuscripts of product instructions and labels. | | （五）產品說明書以及標簽樣稿； |
| (6) Quality management system documents with respect to product research, development and production. | | （六）與產品研制、生產有關的質量管理體系文件； |
| (7) Other materials required to prove the safety and effectiveness of the products. | | （七）證明產品安全、有效所需的其他資料。 |
| Product inspection reports shall meet the requirements of the medical products administration of the State Council, which may be the self-inspection reports of medical device registration applicants and recordation entities or the inspection reports issued by the qualified medical device inspection institutions commissioned by them. | | 產品檢驗報告應當符合國務院藥品監督管理部門的要求，可以是醫療器械注冊申請人、備案人的自檢報告，也可以是委托有資質的醫療器械檢驗機構出具的檢驗報告。 |
| Those falling under the circumstances that clinical evaluation may be exempted as prescribed in Article 24 of this Regulation may be exempt from submitting clinical evaluation materials. | | 符合本條例第二十四條規定的免于進行臨床評價情形的，可以免于提交臨床評價資料。 |
| Medical device registration applicants and recordation entities shall ensure that the materials submitted are legal, authentic, accurate, complete and traceable. | | 醫療器械注冊申請人、備案人應當確保提交的資料合法、真實、准確、完整和可追溯。 |
| Article 15 For the recordation of the medical device products of Class I, recordation entities shall submit the recordation materials to the medical products administrations of the local people's government at the districted city level. | | 第十五條 第一類醫療器械產品備案，由備案人向所在地設區的市級人民政府負責藥品監督管理的部門提交備案資料。 |
| Where any overseas recordation entity exports the medical devices of Class I to the territory of China, the enterprise legal person within the territory of China designated by it shall submit to the medical products administration of the State Council the recordation materials and the documents certifying the approval of the marketing of such medical devices by the competent department in the country (region) where the recordation entity is located. For innovative medical devices that have not been marketed abroad, it is allowed not to submit the documents certifying the approval of the marketing of such medical devices by the competent department in the country (region) where the recordation entity is located. | | 向我國境內出口第一類醫療器械的境外備案人，由其指定的我國境內企業法人向國務院藥品監督管理部門提交備案資料和備案人所在國（地區）主管部門准許該醫療器械上市銷售的證明文件。未在境外上市的創新醫療器械，可以不提交備案人所在國（地區）主管部門准許該醫療器械上市銷售的證明文件。 |
| Recordation formalities are completed once a recordation entity submits the recordation materials that meet the provisions of this Regulation to the medical products administration. The medical products administration shall, within five working days from the date of receipt of the recordation materials, announce relevant recordation information to the general public through the online government service platform of the medical products administration of the State Council. | | 備案人向負責藥品監督管理的部門提交符合本條例規定的備案資料後即完成備案。負責藥品監督管理的部門應當自收到備案資料之日起5個工作日內，通過國務院藥品監督管理部門在線政務服務平台向社會公布備案有關信息。 |
| In case of any change of the matters as specified in the recordation materials, the recordation shall be modified at the original recordation department. | | 備案資料載明的事項發生變化的，應當向原備案部門變更備案。 |
| Article 16 To apply for the registration of the medical device products of Class II, registration applicants shall submit registration application materials to the medical products administrations of the people's governments of the provinces, autonomous regions or municipalities directly under the Central Government where such applicants are located. To apply for the registration of the medical device products of Class III, registration applicants shall submit the registration application materials to the medical products administration of the State Council. | | 第十六條 申請第二類醫療器械產品注冊，注冊申請人應當向所在地省、自治區、直轄市人民政府藥品監督管理部門提交注冊申請資料。申請第三類醫療器械產品注冊，注冊申請人應當向國務院藥品監督管理部門提交注冊申請資料。 |
| Where any overseas registration applicant exports the medical devices of Class II or III to the territory of China, the enterprise legal person within the territory of China designated by it shall submit to the medical products administration of the State Council the registration application materials and the documents certifying the approval of the marketing of such medical devices by the competent department in the country (region) where the registration applicant is located. For innovative medical devices that have not been marketed abroad, it is allowed not to submit the documents certifying the approval of the marketing of such medical devices by the competent department in the country (region) where the registration applicant is located. | | 向我國境內出口第二類、第三類醫療器械的境外注冊申請人，由其指定的我國境內企業法人向國務院藥品監督管理部門提交注冊申請資料和注冊申請人所在國（地區）主管部門准許該醫療器械上市銷售的證明文件。未在境外上市的創新醫療器械，可以不提交注冊申請人所在國（地區）主管部門准許該醫療器械上市銷售的證明文件。 |
| The medical products administration of the State Council shall provide for the procedures and requirements for the examination of medical device registration, and strengthen the supervision and guidance of the registration examination by the medical products administrations of the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government. | | 國務院藥品監督管理部門應當對醫療器械注冊審查程序和要求作出規定，並加強對省、自治區、直轄市人民政府藥品監督管理部門注冊審查工作的監督指導。 |
| Article 17 The medical products administrations that accept registration applications shall examine the safety and effectiveness of medical devices as well as registration applicants' capabilities of ensuring the safe and effective quality management of medical devices. | | 第十七條 受理注冊申請的藥品監督管理部門應當對醫療器械的安全性、有效性以及注冊申請人保證醫療器械安全、有效的質量管理能力等進行審查。 |
| The medical product administration that accepts a registration application shall, within three working days from the date of acceptance of the registration application, transfer the registration application materials to a technical review institution. The technical review institution shall, after completing the technical review, submit the review opinions to the medical products administration that accepts the registration application as the basis for approval. | | 受理注冊申請的藥品監督管理部門應當自受理注冊申請之日起3個工作日內將注冊申請資料轉交技術審評機構。技術審評機構應當在完成技術審評後，將審評意見提交受理注冊申請的藥品監督管理部門作為審批的依據。 |
| Where the medical products administration that accepts a registration application deems that it is necessary to verify the quality management system when organizing a technical review of any medical devices, it shall organize the verification of the quality management system. | | 受理注冊申請的藥品監督管理部門在組織對醫療器械的技術審評時認為有必要對質量管理體系進行核查的，應當組織開展質量管理體系核查。 |
| Article 18 The medical products administration that accepts a registration application shall make a decision within 20 working days from the date when the review opinions are received. The medical devices which meet the requirements shall be granted registration, and the medical device registration certificate shall be issued thereto. For those failing to meet the requirements, the registration shall be denied and the reasons therefor shall be given in writing. | | 第十八條 受理注冊申請的藥品監督管理部門應當自收到審評意見之日起20個工作日內作出決定。對符合條件的，准予注冊並發給醫療器械注冊證；對不符合條件的，不予注冊並書面說明理由。 |
| The medical products administration that accepts a registration application shall, within five working days from the date when medical devices are granted registration, release relevant registration information to the public through the online government service platform of the medical products administration of the State Council. | | 受理注冊申請的藥品監督管理部門應當自醫療器械准予注冊之日起5個工作日內，通過國務院藥品監督管理部門在線政務服務平台向社會公布注冊有關信息。 |
| Article 19 With respect to the medical devices used for treating rare diseases and serious life-threatening diseases for which there has been no effective treatment method or the medical devices urgently needed to respond to public health emergencies, the medical products administrations that accept registration applications may make conditional approval decisions, and specify relevant matters in the medical device registration certificates. | | 第十九條 對用于治療罕見疾病、嚴重危及生命且尚無有效治療手段的疾病和應對公共衛生事件等急需的醫療器械，受理注冊申請的藥品監督管理部門可以作出附條件批准決定，並在醫療器械注冊證中載明相關事項。 |
| In the case of any particularly serious public health emergency or any other emergency that poses a serious threat to public health, the health department of the State Council shall offer a proposal on the urgent use of medical devices as required for the prevention and control of the event, and medical devices may be put into urgent use within a certain scope and during specified period with the approval after discussions organized by the medical products administration of the State Council. | | 出現特別重大突發公共衛生事件或者其他嚴重威脅公眾健康的緊急事件，國務院衛生主管部門根據預防、控制事件的需要提出緊急使用醫療器械的建議，經國務院藥品監督管理部門組織論證同意後可以在一定範圍和期限內緊急使用。 |
| Article 20 Medical device registrants and recordation entities shall perform the following obligations: | | 第二十條 醫療器械注冊人、備案人應當履行下列義務： |
| (1) Establishing the quality management systems commensurate with products and maintaining the effective operation thereof. | | （一）建立與產品相適應的質量管理體系並保持有效運行； |
| (2) Developing the plans for research after the marketing of medical devices and risk management and control and ensuring the effective implementation thereof. | | （二）制定上市後研究和風險管控計劃並保證有效實施； |
| (3) Conducting adverse event monitoring and re-evaluation according to the law. | | （三）依法開展不良事件監測和再評價； |
| (4) Establishing and implementing the product traceability and recall rules. | | （四）建立並執行產品追溯和召回制度； |
| (5) Other obligations as prescribed by the medical products administration of the State Council. | | （五）國務院藥品監督管理部門規定的其他義務。 |
| The domestic enterprise legal persons designated by overseas medical device registrants and recordation entities shall support registrants and recordation entities in fulfilling the obligations as prescribed in the preceding paragraph. | | 境外醫療器械注冊人、備案人指定的我國境內企業法人應當協助注冊人、備案人履行前款規定的義務。 |
| Article 21 In case of any substantial changes of the designs, raw materials, production technologies, scopes of application or application methods, among others, of the registered medical device products of Class II or Class III, which may affect the safety and effectiveness of such medical devices, registrants shall apply to the original registration departments for undergoing the formalities for registration modification. In case of any other change thereof, recordation formalities shall be undergone or a report shall be made in accordance with the provisions issued by the medical products administration of the State Council. | | 第二十一條 已注冊的第二類、第三類醫療器械產品，其設計、原材料、生產工藝、適用範圍、使用方法等發生實質性變化，有可能影響該醫療器械安全、有效的，注冊人應當向原注冊部門申請辦理變更注冊手續；發生其他變化的，應當按照國務院藥品監督管理部門的規定備案或者報告。 |
| Article 22 A medical device registration certificate shall be valid for five years. If the registration of a medical device registration certificate needs to be renewed upon the expiration of its validity period, an application for registration renewal shall be filed with the original registration department six months before the validity period expires. | | 第二十二條 醫療器械注冊證有效期為5年。有效期屆滿需要延續注冊的，應當在有效期屆滿6個月前向原注冊部門提出延續注冊的申請。 |
| Except for the circumstances as prescribed in Paragraph 3 of this Article, the medical products administration that receives the registration renewal application shall make a decision on whether to approve the renewal thereof prior to the expiration of the medical device registration certificate. Any failure to make such a decision during a specified period shall be deemed as the approval of the renewal. | | 除有本條第三款規定情形外，接到延續注冊申請的藥品監督管理部門應當在醫療器械注冊證有效期屆滿前作出准予延續的決定。逾期未作決定的，視為准予延續。 |
| Under any of the following circumstances, registration shall not be renewed: | | 有下列情形之一的，不予延續注冊： |
| (1) The registrant fails to file a registration renewal application during a specified period. | | （一）未在規定期限內提出延續注冊申請； |
| (2) The compulsory standards for medical devices have been revised, and the medical devices subject to the application for registration renewal fail to meet the new requirements. | | （二）醫療器械強制性標准已經修訂，申請延續注冊的醫療器械不能達到新要求； |
| (3) The matters as specified in the medical device registration certificates for the medical devices subject to conditional approval fail to be completed during a specified period. | | （三）附條件批准的醫療器械，未在規定期限內完成醫療器械注冊證載明事項。 |
| Article 23 For the newly researched and developed medical devices which have not been listed in the classified categories, applicants may directly apply for product registration in accordance with the provisions of this Regulation on the registration of the medical device products of Class III, or, according to the classification rules, determine product categories, and apply for product registration or recordation in accordance with the provisions of this Regulation after applying for category confirmation to the medical products administration of the State Council. | | 第二十三條 對新研制的尚未列入分類目錄的醫療器械，申請人可以依照本條例有關第三類醫療器械產品注冊的規定直接申請產品注冊，也可以依據分類規則判斷產品類別並向國務院藥品監督管理部門申請類別確認後依照本條例的規定申請產品注冊或者進行產品備案。 |
| For any direct applications for the registration of the medical device products of Class III, the medical products administration of the State Council shall determine the categories according to risk levels, and incorporate the medical devices granted registration into the classified catalogues in a timely manner. Where any application for category confirmation is filed, the medical products administration of the State Council shall, within 20 working days from the date of acceptance of the application, determine the category of relevant medical devices and inform the applicant of the determination result. | | 直接申請第三類醫療器械產品注冊的，國務院藥品監督管理部門應當按照風險程度確定類別，對准予注冊的醫療器械及時納入分類目錄。申請類別確認的，國務院藥品監督管理部門應當自受理申請之日起20個工作日內對該醫療器械的類別進行判定並告知申請人。 |
| Article 24 Clinical evaluation is required for the registration and recordation of medical device products. However, medical devices may be exempt from clinical evaluation under any of the following circumstances: | | 第二十四條 醫療器械產品注冊、備案，應當進行臨床評價；但是符合下列情形之一，可以免于進行臨床評價： |
| (1) The same categories of the marketed medical devices with clear and definite working mechanisms, finalized designs and mature production technologies have been put into clinical application for years, with no record of any severely adverse event and with their general purposes unchanged. | | （一）工作機理明確、設計定型，生產工藝成熟，已上市的同品種醫療器械臨床應用多年且無嚴重不良事件記錄，不改變常規用途的； |
| (2) The safety and effectiveness of such medical devices can be proved through non-clinical evaluation. | | （二）其他通過非臨床評價能夠證明該醫療器械安全、有效的。 |
| The medical products administration of the State Council shall develop the guidelines for clinical evaluation of medical devices. | | 國務院藥品監督管理部門應當制定醫療器械臨床評價指南。 |
| Article 25 In the clinical evaluation of medical devices, the safety and effectiveness of medical devices may be proved by conducting clinical trials or by conducting analysis of clinical literatures and materials on different types of medical devices and clinical data based on product features, clinical risks, existing clinical data, and other information. | | 第二十五條 進行醫療器械臨床評價，可以根據產品特征、臨床風險、已有臨床數據等情形，通過開展臨床試驗，或者通過對同品種醫療器械臨床文獻資料、臨床數據進行分析評價，證明醫療器械安全、有效。 |
| In accordance with the provisions issued by the medical products administration of the State Council, if existing clinical literatures and materials or clinical data are insufficient to confirm the safety and effectiveness of medical devices during the clinical evaluation of medical devices, clinical trials shall be conducted. | | 按照國務院藥品監督管理部門的規定，進行醫療器械臨床評價時，已有臨床文獻資料、臨床數據不足以確認產品安全、有效的醫療器械，應當開展臨床試驗。 |
| Article 26 The clinical trials of medical devices shall be conducted in the clinical trial institutions that meet the corresponding conditions in accordance with the requirements of the quality management norms for the clinical trials of medical devices, and be filed with the medical products administrations of the people's governments of the provinces, autonomous regions or municipalities directly under the Central Government where sponsors of clinical trials are located. The medical products administrations that accept the clinical trial recordation shall notify the recordation information to the medical products administrations and health departments at the same level at the places where clinical trial institutions are located. | | 第二十六條 開展醫療器械臨床試驗，應當按照醫療器械臨床試驗質量管理規範的要求，在具備相應條件的臨床試驗機構進行，並向臨床試驗申辦者所在地省、自治區、直轄市人民政府藥品監督管理部門備案。接受臨床試驗備案的藥品監督管理部門應當將備案情況通報臨床試驗機構所在地同級藥品監督管理部門和衛生主管部門。 |
| Medical device clinical trial institutions shall be subject to recordation administration. The conditions that medical device clinical trial institutions shall satisfy and recordation administration measures and clinical trial quality management norms shall be developed and published by the medical products administration of the State Council in conjunction with the health department of the State Council. | | 醫療器械臨床試驗機構實行備案管理。醫療器械臨床試驗機構應當具備的條件以及備案管理辦法和臨床試驗質量管理規範，由國務院藥品監督管理部門會同國務院衛生主管部門制定並公布。 |
| The state shall support medical institutions in conducting clinical trials, include the evaluation of conditions and capacities of clinical trials in the rating of medical institutions, and encourage medical institutions to conduct clinical trials of innovative medical devices. | | 國家支持醫療機構開展臨床試驗，將臨床試驗條件和能力評價納入醫療機構等級評審，鼓勵醫療機構開展創新醫療器械臨床試驗。 |
| Article 27 The medical devices of Class III which may pose relatively high risks to human bodies shall be subject to approval by the medical products administration of the State Council. The medical products administration of the State Council shall, when approving a clinical trial, conduct a comprehensive analysis on the devices, professionals and other conditions of the institution that is to undertake the medical device clinical trial, the risk level of such medical devices, the implementation plan for the clinical trial, and the clinical benefit and risk comparison and analysis report, among others, and make a decision within 60 working days of acceptance of the application and notify the sponsor of the clinical trial. Where it fails to notify the sponsor during the specified period, it shall be deemed to have approved the clinical trial. Where any clinical trial is approved, a notification shall be given to the medical products administration and the health department of the people's government of the province, autonomous region or municipality directly under the Central Government at the place where the clinical trial institution is located. | | 第二十七條 第三類醫療器械臨床試驗對人體具有較高風險的，應當經國務院藥品監督管理部門批准。國務院藥品監督管理部門審批臨床試驗，應當對擬承擔醫療器械臨床試驗的機構的設備、專業人員等條件，該醫療器械的風險程度，臨床試驗實施方案，臨床受益與風險對比分析報告等進行綜合分析，並自受理申請之日起60個工作日內作出決定並通知臨床試驗申辦者。逾期未通知的，視為同意。准予開展臨床試驗的，應當通報臨床試驗機構所在地省、自治區、直轄市人民政府藥品監督管理部門和衛生主管部門。 |
| The catalogue of the medical devices of Class III which may pose relatively high risks to human bodies shall be developed, adjusted and published by the medical products administration of the State Council. | | 臨床試驗對人體具有較高風險的第三類醫療器械目錄由國務院藥品監督管理部門制定、調整並公布。 |
| Article 28 To conduct clinical trials of medical devices, ethical review shall be conducted as required, the subjects shall be notified of the trial purposes, uses, possible risks and other details, and their written informed consent shall be obtained. If the subject is a person without capacity for civil conduct or with limited capacity for civil conduct, the written informed consent of his or her guardian shall be obtained. | | 第二十八條 開展醫療器械臨床試驗，應當按照規定進行倫理審查，向受試者告知試驗目的、用途和可能產生的風險等詳細情況，獲得受試者的書面知情同意；受試者為無民事行為能力人或者限制民事行為能力人的，應當依法獲得其監護人的書面知情同意。 |
| When clinical trials are conducted, no fees related to clinical trials may be collected from subjects in any form. | | 開展臨床試驗，不得以任何形式向受試者收取與臨床試驗有關的費用。 |
| Article 29 The medical devices that are undergoing clinical trials and used for the treatment of serious life-threatening diseases for which there has been no effective treatment method, and may possibly benefit patients as indicated by medical observation may, upon ethical review and informed consent, be used free of charge to treat patients suffering from the same diseases in the institutions that conduct the clinical trials of medical devices, and the safety data on such medical devices may be used for medical device registration applications. | | 第二十九條 對正在開展臨床試驗的用于治療嚴重危及生命且尚無有效治療手段的疾病的醫療器械，經醫學觀察可能使患者獲益，經倫理審查、知情同意後，可以在開展醫療器械臨床試驗的機構內免費用于其他病情相同的患者，其安全性數據可以用于醫療器械注冊申請。 |
| Chapter III Production of Medical Devices | | 第三章 醫療器械生產 |
| Article 30 An enterprise engaging in the production of medical devices shall meet the following conditions: | | 第三十條 從事醫療器械生產活動，應當具備下列條件： |
| (1) Having the production site, environmental conditions, production equipment and professional technicians commensurate with the medical devices produced by it. | | （一）有與生產的醫療器械相適應的生產場地、環境條件、生產設備以及專業技術人員； |
| (2) Having the institution or full-time inspection personnel and the inspection equipment for the quality inspection of the medical devices produced by it. | | （二）有能對生產的醫療器械進行質量檢驗的機構或者專職檢驗人員以及檢驗設備； |
| (3) Having the management system able to ensure the quality of medical devices. | | （三）有保證醫療器械質量的管理制度； |
| (4) Having the after-sales service abilities commensurate with the medical devices produced by it. | | （四）有與生產的醫療器械相適應的售後服務能力； |
| (5) Meeting the requirements as prescribed in the production research and development and production process documents. | | （五）符合產品研制、生產工藝文件規定的要求。 |
| Article 31 The enterprises engaging in the production of the medical devices of Class I shall undergo the recordation formalities with the medical products administrations of the local people's governments at the districted city level, and recordation formalities are completed once the enterprises submit the relevant materials that meet the conditions as prescribed in Article 30 of this Regulation. | | 第三十一條 從事第一類醫療器械生產的，應當向所在地設區的市級人民政府負責藥品監督管理的部門備案，在提交符合本條例第三十條規定條件的有關資料後即完成備案。 |
| The medical device recordation entities which produce the medical devices of Class I by themselves may, when undergoing the product recordation formalities in accordance with the provisions of Article 15 of this Regulation, submit the relevant materials that meet the conditions specified in Article 30 of this Regulation, then that is completing the production recordation formalities. | | 醫療器械備案人自行生產第一類醫療器械的，可以在依照本條例第十五條規定進行產品備案時一並提交符合本條例第三十條規定條件的有關資料，即完成生產備案。 |
| Article 32 The enterprises engaging in the production of the medical devices of Class II and Class III shall apply for production licenses to the medical products administrations of the local people's governments of the provinces, autonomous regions or municipalities directly under the Central Government, and submit the materials certifying their compliance with the conditions as prescribed in Article 30 of this Regulation and the registration certificates of the medical devices produced by them. | | 第三十二條 從事第二類、第三類醫療器械生產的，應當向所在地省、自治區、直轄市人民政府藥品監督管理部門申請生產許可並提交其符合本條例第三十條規定條件的有關資料以及所生產醫療器械的注冊證。 |
| A medical products administration that accepts a production license application shall review the application materials, conduct verification in accordance with the requirements of the quality management norms for the production of medical devices developed by the medical products administration of the State Council, and make a decision within 20 working days from the date of acceptance of the application. Where an application meets the specified conditions, approval shall be granted and a medical device production license shall be issued thereto; otherwise, no approval shall be granted and the reasons therefor shall be given in writing. | | 受理生產許可申請的藥品監督管理部門應當對申請資料進行審核，按照國務院藥品監督管理部門制定的醫療器械生產質量管理規範的要求進行核查，並自受理申請之日起20個工作日內作出決定。對符合規定條件的，准予許可並發給醫療器械生產許可證；對不符合規定條件的，不予許可並書面說明理由。 |
| A medical device production license shall be valid for five years. If a medical device production license needs to be renewed upon the expiration of its validity period, the renewal formalities shall be handled in accordance with the relevant legal provisions on administrative licensing. | | 醫療器械生產許可證有效期為5年。有效期屆滿需要延續的，依照有關行政許可的法律規定辦理延續手續。 |
| Article 33 The quality management norms for the production of medical devices shall explicitly specify the design and development of medical devices, production equipment conditions, raw material purchase, production process control, product release, institutional setup and staffing of the enterprises and other matters which may affect the safety and effectiveness of medical devices. | | 第三十三條 醫療器械生產質量管理規範應當對醫療器械的設計開發、生產設備條件、原材料采購、生產過程控制、產品放行、企業的機構設置和人員配備等影響醫療器械安全、有效的事項作出明確規定。 |
| Article 34 Medical device registrants and recordation entities may produce medical devices by themselves, or commission the enterprises that comply with the provisions of this Regulation and meet corresponding conditions to produce medical devices. | | 第三十四條 醫療器械注冊人、備案人可以自行生產醫療器械，也可以委托符合本條例規定、具備相應條件的企業生產醫療器械。 |
| In case of commissioned production of medical devices, medical device registrants and recordation entities shall be responsible for the quality of the medical devices the production of which is commissioned, and strengthen the administration of the production by the commissioned production enterprises to ensure that they are produced according to legal requirements. Medical device registrants and recordation entities shall conclude commission agreements with the commissioned production enterprises to specify the rights, obligations and responsibilities of both parties. The commissioned production enterprises shall organize production in accordance with laws, regulations, quality management norms for the production of medical devices, compulsory national standards, technical requirements for products and commission agreements, be responsible for production, and be subject to supervision by the commissioning parties. | | 委托生產醫療器械的，醫療器械注冊人、備案人應當對所委托生產的醫療器械質量負責，並加強對受托生產企業生產行為的管理，保證其按照法定要求進行生產。醫療器械注冊人、備案人應當與受托生產企業簽訂委托協議，明確雙方權利、義務和責任。受托生產企業應當依照法律法規、醫療器械生產質量管理規範、強制性標准、產品技術要求和委托協議組織生產，對生產行為負責，並接受委托方的監督。 |
| The implantable medical devices with high risks may not be produced on a commission basis. The specific catalogues shall be developed, adjusted and published by the medical products administration of the State Council. | | 具有高風險的植入性醫療器械不得委托生產，具體目錄由國務院藥品監督管理部門制定、調整並公布。 |
| Article 35 Medical device registrants and recordation entities and commissioned production enterprises shall, in accordance with the quality management norms for the production of medical devices, establish and improve the quality management systems commensurate with the medical devices produced by them and ensure the effective operation of such medical devices; and shall organize production in strict accordance with the technical requirements for the products subject to registration or recordation to ensure the medical devices leaving factory meet the compulsory standards and the technical requirements for the products subject to registration or recordation. | | 第三十五條 醫療器械注冊人、備案人、受托生產企業應當按照醫療器械生產質量管理規範，建立健全與所生產醫療器械相適應的質量管理體系並保證其有效運行；嚴格按照經注冊或者備案的產品技術要求組織生產，保證出廠的醫療器械符合強制性標准以及經注冊或者備案的產品技術要求。 |
| Medical device registrants and recordation entities and commissioned production enterprises shall conduct self-inspection on the operation of the quality management system on a regular basis, and submit self-inspection reports according to the provisions issued by the medical products administration of the State Council. | | 醫療器械注冊人、備案人、受托生產企業應當定期對質量管理體系的運行情況進行自查，並按照國務院藥品監督管理部門的規定提交自查報告。 |
| Article 36 Where the production conditions of medical devices change and no longer meet the requirements of the medical device quality management system, medical device registrants and recordation entities and commissioned production enterprises shall immediately take rectification measures; and, if the safety and effectiveness of such medical devices may be affected, immediately stop the production thereof, and report to the original production licensing or production recordation departments. | | 第三十六條 醫療器械的生產條件發生變化，不再符合醫療器械質量管理體系要求的，醫療器械注冊人、備案人、受托生產企業應當立即采取整改措施；可能影響醫療器械安全、有效的，應當立即停止生產活動，並向原生產許可或者生產備案部門報告。 |
| Article 37 Medical devices shall have generic names. Generic names shall comply with the naming rules for medical devices developed by the medical products administration of the State Council. | | 第三十七條 醫療器械應當使用通用名稱。通用名稱應當符合國務院藥品監督管理部門制定的醫療器械命名規則。 |
| Article 38 The state shall, according to the categories of medical device products, implement the unique identification system for medical devices step by step and realize the traceability of medical devices. The specific measures shall be developed by the medical products administration of the State Council in conjunction with relevant departments of the State Council. | | 第三十八條 國家根據醫療器械產品類別，分步實施醫療器械唯一標識制度，實現醫療器械可追溯，具體辦法由國務院藥品監督管理部門會同國務院有關部門制定。 |
| Article 39 Medical devices shall be accompanied with instructions and labels. The contents of instructions and labels shall be kept consistent with the relevant contents subject to registration or recordation, and the authenticity and accuracy thereof shall be ensured. | | 第三十九條 醫療器械應當有說明書、標簽。說明書、標簽的內容應當與經注冊或者備案的相關內容一致，確保真實、准確。 |
| ．．．．．． | | 醫療器械的說明書、標簽應當標明下列事項： |
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