| Announcement of the National Medical Products Administration and the National Health Commission on Issuing the Provisions on the Administration of Extended Clinical Trials of Medical Devices (for Trial Implementation) | | 国家药监局、国家卫生健康委关于发布医疗器械拓展性临床试验管理规定（试行）的公告 |
| (Announcement No. 41 [2020] of the National Medical Products Administration and the National Health Commission) | | （国家药品监督管理局、中华人民共和国国家卫生健康委员会公告2020年第41号） |
| For the purposes of implementing the Opinions of the General Office of the CPC Central Committee and the General Office of the State Council on Deepening the Reform of the Evaluation and Approval System and Encouraging Innovations on Drugs and Medical Devices and supporting extended clinical trials of medical devices, the National Medical Products Administration has, in conjunction with the National Health Commission, developed the Provisions on the Administration of Extended Clinical Trials of Medical Devices (for Trial Implementation), which are hereby issued. | | 为贯彻落实中共中央办公厅、国务院办公厅《关于深化审评审批制度改革鼓励药品医疗器械创新的意见》，支持医疗器械拓展性临床试验工作，国家药品监督管理局会同国家卫生健康委员会制定了《医疗器械拓展性临床试验管理规定（试行）》，现予发布。 |
| Annex: Provisions on the Administration of Extended Clinical Trials of Medical Devices (for Trial Implementation) | | 附件：医疗器械拓展性临床试验管理规定（试行） |
| National Medical Products Administration | | 国家药监局 |
| National Health Commission | | 国家卫生健康委 |
| March 14, 2020 | | 2020年3月14日 |
| Annex | | 附件 |
| Provisions on the Administration of Extended Clinical Trials of Medical Devices (for Trial Implementation) | | 医疗器械拓展性临床试验管理规定（试行） |
| Chapter I General Provisions | | 第一章 总 则 |
| Article 1 These Provisions are developed in accordance with the Opinions of the General Office of the CPC Central Committee and the General Office of the State Council on Deepening the Reform of the Evaluation and Approval System and Encouraging Innovations on Drugs and Medical Devices for the purposes of meeting the clinical needs of the public, enabling the patients who are in urgent need of clinical treatment to obtain medical devices for trial use as soon as possible, regulating the implementation of extended clinical trials of medical devices and the collection of safety data, and protecting the rights and interests of subjects. | | 第一条 为满足公众临床需要，使临床急需治疗的患者能够尽快获得试验用医疗器械，规范医疗器械拓展性临床试验的开展和安全性数据的收集，维护受试者权益，根据中共中央办公厅、国务院办公厅《关于深化审评审批制度改革鼓励药品医疗器械创新的意见》，制定本规定。 |
| Article 2 Whoever conducts extended clinical trials of medical devices within the territory of the People's Republic of China shall comply with these Provisions. | | 第二条 在中华人民共和国境内开展医疗器械拓展性临床试验，应当遵守本规定。 |
| Article 3 For the purposes of these Provisions, “extended clinical trials of medical devices” means the activities and process in which patients with life-threatening diseases for which there has been no effective treatment method may use the medical devices that have not yet been approved for marketing in the institutions conducting clinical trials. | | 第三条 本规定所称医疗器械拓展性临床试验，是指患有危及生命且尚无有效治疗手段的疾病的患者，可在开展临床试验的机构内使用尚未批准上市的医疗器械的活动和过程。 |
| Medical devices for extended clinical trial use may not be used unless it is found through preliminary observations that existing clinical trials may benefit the patients and the patients cannot obtain the rights to use such medical devices through the participation in the clinical trials that have been conducted because the clinical trial institutions have completed the selection of disease cases based on clinical trial protocols. | | 拓展性临床试验医疗器械的使用需基于已有临床试验初步观察可能使患者获益，且患者由于临床试验机构已按临床试验方案完成病例的入选，不能通过参加已开展的临床试验获得该医疗器械的使用。 |
| Article 4 Extended clinical trials of medical devices shall meet the relevant provisions on the quality management of clinical trials of medical devices. | | 第四条 医疗器械拓展性临床试验应当符合医疗器械临床试验质量管理的相关规定。 |
| Chapter II Rights and Interests and Responsibilities | | 第二章 权益和责任 |
| Article 5 Extended clinical trials of medical devices shall follow the code of ethics determined in the World Medical Association Declaration of Helsinki to protect the rights and interests of subjects. | | 第五条 医疗器械拓展性临床试验应当遵循《世界医学大会赫尔辛基宣言》确定的伦理准则，保障受试者权益。 |
| Before a subject participates in an extended clinical trial, the subject and the investigator shall sign an informed consent in accordance with the requirements of the Quality Management Norms for the Clinical Trials of Medical Devices. The informed consent shall ensure that the subject knows that he or she will receive treatment with the medical devices for trial use, and clearly inform the subject that the medical devices for extended clinical trial use have not yet obtained the domestic marketing license, and the risks that may exist in medical devices for trial use in terms of safety and effectiveness. The subject shall participate in the extended clinical trial of medical devices on a voluntary basis, and have the right to withdraw from clinical trial at any time during the trial. | | 在受试者参加拓展性临床试验前，受试者、研究者应当按照《医疗器械临床试验质量管理规范》的要求签署知情同意书。知情同意应当确保受试者了解其将接受试验用医疗器械的治疗，明确告知受试者拓展性临床试验所用医疗器械尚未获得境内上市许可，以及试验用医疗器械在安全性和有效性方面可能存在的风险。受试者参加医疗器械拓展性临床试验应当是自愿的，在试验过程中，受试者有权随时退出试验。 |
| At the time of an ethical review, the rights and interests of the subject shall be fully protected, and whether the benefits for the subject outweigh the risks shall be confirmed based on the potential risks of the extended use of medical devices and in consideration of the course of the disease. | | 伦理审查时应当充分保障受试者权益，基于医疗器械拓展性使用的潜在风险，考虑疾病的病程，确认受试者受益大于风险。 |
| Article 6 Subjects, investigators, sponsors and clinical trial institutions for extended clinical trials of medical devices conducted shall sign agreements to clarify the rights, obligations and responsibilities of all parties. Sponsors, investigators, clinical trial institutions and ethics committees shall assume their respective responsibilities according to the requirements of the Quality Management Norms for the Clinical Trials of Medical Devices. | | 第六条 开展医疗器械拓展性临床试验的受试者、研究者、申办者和临床试验机构应当签订协议，明确各方权利、义务和责任。申办者、研究者、临床试验机构和伦理委员会应当参照《医疗器械临床试验质量管理规范》的要求承担各自的责任。 |
When establishing a quality management system for the clinical trials of medical devices, a medical device clinical trial institution shall, for the purpose of effectively controlling the quality and risks of extended clinical trials of medical devices, add corresponding management system and standard operating specifications according to the characteristics of extended clinical trials, and submit the corresponding self-examination report when undergoing the recordation formalities for the medical device clinical trial institution, establish the publication system for extended clinical trials of medical devices, and be subject to social supervision. The content of publication shall include at least opinions of ethics committees, the necessity of extended clinical trials, and summaries of extended clinical trials.
．．．．．． | | 医疗器械临床试验机构在建立医疗器械临床试验质量管理体系时，为有效控制医疗器械拓展性临床试验质量和风险，应当针对拓展性临床试验的特点增加相应管理制度和标准操作规范，在进行医疗器械临床试验机构备案时应当提交相应的自查报告，同时建立医疗器械拓展性临床试验公示制度，接受社会监督。公示至少包括如下内容：伦理委员会意见、拓展性临床试验开展的必要性、拓展性临床试验方案摘要。
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