Good Clinical Practice for Medical Devices (Decree No. 25 of China Food and Drug Administration and National Health and Family Planning Commission of the People's Republic of China) (Abolished)

　　Issued on March 23, 2016

　　China Food and Drug Administration

　　National Health and Family Planning Commission of the People's Republic of China

　　No. 25

　　The Good Clinical Practice for Medical Devices, adopted at the executive meeting of China Food and Drug Administration and the minister's meeting of National Health and Family Planning Commission, is hereby promulgated and shall be effective as of June 1, 2016.

　　Minister: Bi Jingquan

　　Minister: Li Bin

　　March 1, 2016

　　Good Clinical Practice for Medical Devices

　　Chapter I General Provisions

　　Article 1 This GCP is hereby formulated in accordance with the Regulations for the Supervision and Administration of Medical Devices to strengthen the management of medical device clinical trials, protect the rights and interests of subjects in the process of medical device clinical trials, and ensure that the process of medical device clinical trials is standardized and the results are authentic, scientific, reliable and traceable.

　　Article 2 The conduct of medical device clinical trials within the territory of the People's Republic of China shall comply with this GCP.

　　This GCP covers the whole process of medical device clinical trials, including the design, implementation, monitoring, and it and inspection of clinical trial protocols, as well as data collection, recording, analysis and summarization, and reporting.

　　Article 3 The medical device clinical trials in this GCP refer to the process of confirming or verifying the safety and effectiveness of medical devices applied for registration under normal service conditions in the certified medical device clinical trial institutions.

　　Article 4 Medical device clinical trials shall follow the lawful principles, ethical principles and scientific principles.

　　Article 5 The food and drug administration departments at the provincial level or above shall be responsible for the supervision and administration of medical device clinical trials.

　　The competent health and family planning departments shall strengthen the administration of medical device clinical trials within the scope of their duties.

　　The food and drug administration departments and the competent health and family planning departments shall establish a quality management information notification mechanism for medical device clinical trials to strengthen the notification on the approval conditions of clinical trials of Class III medical devices and of medical devices that are included in the national catalogue for the allocation management of large medical equipments as well as the notification on supervision and administration data of the corresponding clinical trials.

　　Chapter II Pre-Clinical Trials Preparation

　　Article 6 Medical device clinical trials shall have sufficient scientific basis and clear trial objectives and weight the expected benefits and risks that will pose to the subjects' and public's health and the expected benefits shall exceed the possible damage.

　　Article 7 Before the clinical trial, the sponsor shall complete pre-clinical study of the investigational medical device, including product design (structure and composition, working principle and mechanism of action, intended use and scope of application as well as applicable technical requirements), quality control, animal test and risk analysis, and the results shall be able to support the clinical trial. The quality control results shall include self-inspection report and qualification report of product registration testing issued by a qualified testing institution within one year.

　　Article 8 Before the clinical trial, the sponsor shall prepare adequate investigational medical devices. The research and development of investigational medical devices shall comply with relevant requirements of applicable medical device quality management system.

　　Article 9 Medical device clinical trials shall be conducted in two or more medical device clinical trial institutions.

　　The clinical trial institution chosen shall be a qualified medical device clinical trial institution of which the facilities and conditions meet the requirement for safe and effective clinical trials. The investigator shall have the expertise, qualification and competencies and shall be trained to conduct the clinical trial.

　　The administrative measures for qualification of medical device clinical trial institutions shall be separately formulated by China Food and Drug Administration together with the National Health and Family Planning Commission.

　　Article 10 Before the clinical trial, the sponsor, clinical trial institution and investigator shall reach a written agreement on the trial design, trial quality control, division of duties in the trial, relevant clinical trial cost borne by the sponsor, and treatment principle of possible injury in the trial.

　　Article 11 Clinical trials shall be approved by the ethics committee of the medical device clinical trial institution. Clinical trials shall also be approved by China Food and Drug Administration if the corresponding investigational medical device is included in the class III medical device catalogue which requires clinical trial approval.

　　Article 12 Before the clinical trial, the sponsor shall file to report the clinical trial to the local food and drug administration department of the province, autonomous region or municipality directly under the central government.

　　The food and drug administration department that accepts filing shall inform the local food and drug administration department and the competent health and family planning department of the same level where the clinical trial institution is located.

　　Chapter III Protection of the Subjects' Rights and Interests

　　Article 13 Medical device clinical trials shall follow the ethical principles determined in the Declaration of Helsinki of the World Medical Association.

　　Article 14 Ethical review and informed consent are the main measures to protect the subjects' rights and interests.

　　Each stakeholder involved in the clinical trial shall take the corresponding ethical responsibilities according to its respective duties in the trial.

　　Article 15 The sponsor shall avoid improperly affecting or misleading the participants or related stakeholders of the clinical trial such as the subject, clinical trial institution and investigator.

　　The clinical trial institution and investigator shall avoid improperly affecting or misleading the participants or related stakeholders of the clinical trial such as the subjects and sponsor.

　　Article 16 The sponsor, clinical trial institution and investigator shall not exaggerate the compensation measures for participation in the clinical trial, which may mislead the subjects into participating in the clinical trial.

　　Article 17 Before the clinical trial, the sponsor shall submit the following materials to the ethics committee through the investigator and the medical device clinical trial management department of the clinical trial institution:

　　(1) Clinical trial protocol;

　　(2) Investigator's brochure;

　　(3) Template of the informed consent form and any other written materials provided to the subjects;

　　(4) Procedural documents for recruiting the subjects and giving publicity to them;

　　(5) Template of case report form;

　　(6) Self-inspection report and product registration testing report;

　　(7) Investigator's resume, professional expertise, competence, training experience and other documents that can demonstrate their qualifications;

　　(8) Overview that the facilities and conditions of the clinical trial institution can meet the trial;

　　(9) Statement that the research and development of investigational medical device conforms to the relevant requirements of the applicable medical device quality management system;

　　(10) Other documents relating to ethical review.

　　The ethics committee shall adhere to the principles of ethics and science to review and supervise the implementation of the clinical trial.

　　Article 18 For any of the following circumstances during the clinical trial, the investigator shall report it to the medical device clinical trial management department of the clinical trial institution, which will inform the sponsor and ethics committee of the circumstance in time:

　　(1) Serious adverse events;

　　(2) Progress report, including safety summary and deviation report;

　　(3) To revise a document that has been approved by the ethics committee, if the change has no impact on the subjects' rights and interests, safety and health, or the change is non-substantial to the purposes or endpoints of the clinical trial, reporting in advance is not required, although the changes shall be reported in writing afterwards;

　　(4) Suspension, termination or request to recover the clinical trial suspended;

　　(5) Deviation from the clinical trial protocol that has an impact on the subjects' rights and interests, safety and health or clinical trial scientificity, including the request deviation and report deviation.

　　In order to protect the subjects' rights and interests, safety and health, the deviation in emergency that cannot be reported in time shall be reported in writing in accordance with the relevant regulations as soon as possible afterwards.

　　Article 19 In the course of clinical trials, the revision of clinical trial protocol and informed consent form, deviation request, recovery of the clinical trial suspended shall be implemented only after the written approval of the ethics committee is obtained.

　　Article 20 Selection of the following persons as subjects shall be avoided whenever possible, such as minors, pregnant women, the elderly, mentally handicapped persons and patients in life-threatening state. When the selection of such persons is necessary indeed, the clinical trial shall follow relevant additional requirements made by the ethics committee and specific design in clinical trial shall be conducted according to their health condition, and it shall be beneficial to their health.

　　Article 21 Before a subject is to be involved in the clinical trial, the investigator shall adequately explain the details of the clinical trial to the subject or the guardians of the subject who is without capacity for civil conduct or with limited capacity for civil conduct, including known and foreseeable risks and possible adverse events. After a full and detailed explanation, the subject or the guardians shall sign and date the informed consent form, and the investigator shall also sign and date the informed consent form.

　　Article 22 The informed consent form shall generally include the following content and the description of the matters:

　　(1) Name and relevant information of the investigator;

　　(2) Name of the clinical trial institution;

　　(3) Name, purpose, method and content of the trial;

　　(4) Process and duration of the trial;

　　(5) Capital source and possible conflict of interest of the trail;

　　(6) Expectation of possible benefits and known, foreseeable risks and possible adverse events;

　　(7) Alternative treatment methods available to the subjects and the corresponding information on their potential benefits and risks;

　　(8) If necessary, explaining the different groups that the subjects may be assigned to in the trial;

　　(9) The subjects participating in the trial shall be voluntary and shall have the right to withdraw at any stage of the trial without being discriminated or retaliated, and their medical treatment, rights and interests shall not be affected;

　　(10) The subjects shall be informed that the personal data in the trial is confidential, but when necessary the ethics committee, competent health and family planning department, food and drug administration departments or the sponsor may view the personal data of the subjects in the trial in accordance with the prescribed procedures;

　　(11) The subjects may receive treatment and economic compensation for any trial-related injuries.

　　(12) The subjects may know relevant information of their condition anytime in the trial period;

　　(13) Free treatment items and other related compensation that the subjects may obtain during the trial.

　　The informed consent form shall use the language and words that the subjects or the guardians can understand. The informed consent form shall not contain such content that may cause the subjects to abandon the lawful rights or exempt the clinical trial institution, investigator, and sponsor or its agent from their responsibilities.

　　Article 23 To obtain the informed consent form, the following requirements shall be met:

　　(1) Where the ethics committee agrees in principle and the investigator considers that the participation of the subjects who are without capacity for civil conduct in the clinical trial meets their own interests, such subjects may participate in the clinical trials only after their guardians sign and date the informed consent form.

　　(2) Where the subjects or their guardians have no reading ability, a witness shall be present in the informed process. After the detailed explanation of the informed consent form, the witness shall confirm if the literal expression of the informed consent form is consistent with the verbally informed content. After the subjects or their guardians show verbal consent, the witness shall sign and date the informed consent form, and the signature of the witness and the signature of the investigator shall be on the same day.

　　(3) Where minors are as the subjects, the informed consent of their guardians and the signed informed consent form by their guardians shall be obtained; the consent of the minors shall be attained if they can express their willingness for whether to participate in the trial.

　　(4) Where important information of the investigational medical device is learned or clinical effect beyond expectation is found, relevant content of the informed consent form shall be modified, and the modified informed consent form shall be re-signed by the subjects or their guardians after it is being recognized by the ethics committee.

　　Article 24 The informed consent form shall state the date of formulation or the date of revision. Where the informed consent form is revised in the course of the trial, the revised informed consent form shall be approved again by the ethics committee before being implemented. Once the revised informed consent form is submitted to the clinical trial institution, all subjects who have not completed the trial process shall sign the revised informed consent form if they are affected.

　　Article 25 Any subject shall have the right to withdraw at any stage of a clinical trial and shall not assume any economic responsibility.

　　Chapter IV Clinical Trial Protocol

　　Article 26 Before conducting medical device clinical trials, the sponsor shall formulate scientific and reasonable clinical trial protocols in accordance with the type, risk and intended use of the investigational medical devices.

　　Article 27 For a new product which has not been approved for launching at home and abroad and of which safety and performance has not been confirmed on the clinical side, a small-size feasibility trial shall be conducted in the design of clinical trial protocol, and after the preliminary confirmation of safety, the sample size can be determined according to the statistical requirements to conduct subsequent clinical trials.

　　Article 28 The medical device clinical trial protocol shall include the following content:

　　(1) General information;

　　(2) Background information of the clinical trial;

　　(3) Trail objective;

　　(4) Trail design;

　　(5) Safety evaluation method;

　　(6) Effectiveness evaluation method;

　　(7) Statistical considerations;

　　(8) Provisions on revising the clinical trial protocol;

　　(9) Provisions on reporting of adverse events and device defects;

　　(10) Direct access to source data and files;

　　(11) Ethical issues relating to the clinical trial and relevant explanation as well as the text of informed consent form;

　　(12) Data processing and record keeping;

　　(13) Finance and insurance;

　　(14) Agreement on publication of trial results.

　　The above content may be partially included in other relevant documents of the protocol, such as the investigator's brochure. The specific information of clinical trial institution, agreement on publication of trial results, finance and insurance can be expressed in the trial protocol or otherwise specified in a separate agreement.

　　Article 29 Multicenter clinical trials are carried out by a number of investigators in different clinical trial institutions during the same period in accordance with the same trial protocol. The design and implementation of the trial protocol shall include at least the following content:

　　(1) The trial protocol shall be organized and developed by the sponsor and finalized through discussion among all clinical trial institutions and investigators involved, and the investigator from the clinical trial institution of the leading unit shall be the coordinating investigator;

　　(2) The coordinating investigator is responsible for the work coordination between the clinical trial institutions in the clinical trial, organization of the investigator meeting in the early, middle and late phases of the clinical trial, and implementation of the whole trial together with the sponsor;

　　(3) In principle the clinical trial institutions shall start and end the clinical trial at the same time;

　　(4) The trial sample size and distribution among clinical trial institutions, and the reasons why such arrangement meets statistical analysis requirements;

　　(5) The requirements of the sponsor and clinical trial institutions for the trial training plan and training records;

　　(6) Establish the transmission, management, verification and inquiry procedures of trial data; in particular, it shall make clear that the leading unit is responsible for managing and analyzing the trial data of the clinical trial institutions in a centralized way;

　　(7) When the multicenter clinical trial ends, the investigator of each clinical trial institution shall respectively issue the clinical trial summary, examine and verify the summary and the case reports according to relevant regulations, and submit them to the coordinating investigator and the coordinating investigator shall collect them and complete the summary report.

　　Chapter V Responsibilities of Ethics Committee

　　Article 30 The ethics committee of the medical device clinical trial institution shall consist of at least five members, including medical professionals and non-medical professionals, covering different sexes. In the non-medical professionals, at least one is a legal professional and one is independent of the clinical trial institution. The members of the ethics committee shall have the qualification or experience to assess and evaluate the scientific, medical and ethical aspects of the clinical trial. All members shall be familiar with the ethical guidelines and related regulations of medical device clinical trials and follow the articles of the ethics committee.

　　Article 31 The ethics committee shall follow the ethical principles of the Declaration of Helsinki of the World Medical Association and the regulations of the food and drug administration departments, establish appropriate working procedures and form documents, and perform the duties according to the working procedures.

　　The members of the ethics committee who are independent of the investigator and sponsor are entitled to comment and participate in the voting of relevant trials.

　　Article 32 The meeting of the ethics committee shall be notified in advance, and the number of participants in the review and voting shall be no less than five, and any decision shall be made by more than half of the members of the ethics committee.

　　The investigator may provide information about any aspect of the trial, but shall not participate in the review or voting or making comments.

　　The ethics committee may invite experts from the relevant field to participate in the review of certain special trials.

　　Article 33 The ethics committee shall strictly examine the trial protocol and the relevant documents from the point of view of guaranteeing the subjects’ rights and interests and shall focus on the following content:

　　(1) The qualification, experience of the investigator and whether he/she has sufficient time to participate in the clinical trial.

　　(2) Whether the staffing and equipment conditions of clinical trial institutions meet the trial requirements.

　　(3) Whether the potential severity of risk that the subjects may suffer is appropriate compared to the expected benefits of the trial.

　　(4) Whether the trial protocol fully considers the ethical principles and meets scientificity, including whether the purpose of the study is appropriate, whether the subjects' rights and interests are guaranteed, whether the protection of other persons who may suffer risk and the subject enrollment method are scientific.

　　(5) The subject enrollment method, whether the trial-related information that is provided to the subjects or the guardians is complete and understood by the subjects, and whether the method of obtaining the informed consent form is appropriate; if necessary, the ethics committee shall organize the representatives of the subject group to test the degree of comprehensibility of the material and assess whether the informed consent is appropriate. The assessment results shall be recorded in writing and kept for 10 years after the completion of the clinical trial.

　　(6) Whether the treatment and insurance measures to be given to the subjects who suffer from trial-related injuries and death are sufficient.

　　(7) Whether the modification opinions proposed to the trial protocol is acceptable.

　　(8) Whether it enables periodically analysis and assessment on the possible hazards to the subjects during the clinical trial.

　　(9) Whether the deviation from the trial protocol that may affect the subjects' rights and interests, safety and health, or affect the scientificity and integrity of the trial is acceptable.

　　Article 34 For the ethical review of multicenter clinical trials, the ethics committee of the leading unit shall be responsible for establishing a collaborative review procedure to ensure consistency and timeliness of the review.

　　Before the clinical trial institutions start the trial, the ethics committee of the leading unit shall be responsible for reviewing the trial protocol to ensure it is ethically rational and scientific. On the premise of accepting the review opinions of the ethics committee of the leading unit, the ethics committees of each clinical trial institutions participating in the trail can review the feasibility of the trial to be carried out in their own institution by meeting review or document review, including the qualification and experience of the investigators, equipment and conditions. Under normal circumstances, the ethics committees of clinical trial institutions shall not bring forward modification opinions to the design of the trial protocol, but shall have the right not to approve the trial in their own institution.

　　Article 35 After receiving the application for medical device clinical trial, the ethics committee shall hold a meeting to review and discuss it, issue written opinions affixed with the seal, and attach the list of attendants, specialties and their own signatures. The comments of the ethics committee may be:

　　(1) Approved;

　　(2) Approved after some necessary modifications;

　　(3) Disapproved;

　　(4) Suspend or terminate the approved trial.

　　Article 36 The ethics committee shall keep follow-up supervision of the clinical trials in their own clinical trial institution and may require suspension or termination of the clinical trial in writing at any time if they find that the subjects' rights and interests cannot be guaranteed.

　　The suspended clinical trials shall not be recovered without the approval of the ethics committee.

　　Article 37 The ethics committee shall retain all relevant records for at least 10 years after the completion of the clinical trial.

　　Chapter VI Responsibilities of Sponsor

　　Article 38 The sponsor shall be responsible for initiating, applying for, organizing and supervising the clinical trial, and shall be responsible for the authenticity and reliability of the clinical trial. The sponsor is usually a medical device manufacturer. Where the sponsor is an overseas enterprise, it shall designate an agent within the territory of China in accordance with the regulations.

　　Article 39 The sponsor is responsible for organizing the formulation and revision of the investigator's brochure, clinical trial protocol, informed consent form, case report form, relevant standard operating procedures and other relevant documents, and is responsible for organizing necessary trainings for the clinical trial.

　　Article 40 The sponsor shall, according to the characteristics of the investigational medical device, select the trial institutions and investigators among certified medical device clinical trial institutions. The sponsor shall provide the latest investigator's brochure and other relevant documents to the clinical trial institutions and investigators before signing the clinical trial protocol with the clinical trial institution, so that they can decide whether they are able to undertake the clinical trial.

　　Article 41 The investigator's brochure shall include the following main content:

　　(1) Basic information of the sponsor and investigator;

　　(2) Summary description of the investigational medical device;

　　(3) Summary and evaluation supporting the intended use of investigational medical device and the design reasons of clinical trial;

　　(4) The statement that the manufacture of investigational medical device complies with the requirements of applicable medical device quality management system.

　　Article 42 The sponsor shall not exaggerate the mechanism and effect of the investigational medical device in organizing the formulation of the clinical trial protocol.

　　Article 43 In the course of the clinical trial, the sponsor shall make timely change to the investigator's brochure and related documents when obtaining important information that affects the clinical trial and submit it to the ethics committee for review and approval through the medical device clinical trial management department of the clinical trial institution.

　　Article 44 The sponsor shall enter into a written agreement with the clinical trial institution and investigator on the following matters:

　　(1) Conduct the clinical trial in accordance with the clinical trial protocol and in conformity with relevant laws and regulations, and be subject to supervision, verification and inspection;

　　(2) Follow the data recording and reporting procedures;

　　(3) Keep the basic documents relating to the trial for no less than the duration legally prescribed until the sponsor informs the clinical trial institution and investigator that the document is no longer required;

　　(4) After the approval of the ethics committee, the sponsor shall be responsible for providing the investigational medical device to the clinical trial institutions and investigators, and confirm its transportation conditions, storage conditions and storage time and validity period;

　　(5) The investigational medical device shall be of good quality attached with easily identified, correctly coded "for trial" label and shall be properly packaged and stored in accordance with the requirements of the clinical trial protocol;

　　(6) The sponsor shall formulate standard operating procedures related to the quality control of clinical trials, such as the transportation, receiving, storage, distribution, handling and returning of investigational medical devices, for the compliance of the clinical trial institutions and investigators.

　　Article 45 The sponsor shall be responsible for the safety of investigational medical device in clinical trial. When finding it may affect the safety of the subjects or the implementation of the trial may change the approval of the ethics committee for the continuation of the trial, the sponsor shall immediately notify all clinical trial institutions and investigators and make corresponding handling.

　　Article 46 Where the sponsor decides to suspend or terminate the clinical trial, it shall notify the clinical trial management departments of all clinical trial institutions within five days and give a written explanation of the reasons. The medical device clinical trial management departments of clinical trial institutions shall promptly notify the corresponding investigators and ethics committee. The clinical trials suspended shall not be recovered without the consent of the ethics committee. After the completion of clinical trial, the sponsor shall inform in writing the local food and drug administration department of the province, autonomous region or municipality directly under the central government.

　　Article 47 The sponsor shall ensure that all the investigators involved in the clinical trial strictly follow the clinical trial protocol, and promptly indicate and rectify the clinical trial institutions' and investigators' noncompliance with the relevant laws and regulations, this GCP and the clinical trial protocol when finding any noncompliance; where the circumstance is serious or continued without rectification, the sponsor shall terminate the trial and report it to the local food and drug administration department of the province, autonomous region or municipality directly under the central government and to the China Food and Drug Administration.

　　Article 48 The sponsor shall bear the treatment costs and corresponding economic compensation for the subjects who suffer injuries or death related to the clinical trial, except for the damage caused by the fault of the medical institutions and its medical personnel in the diagnosis and treatment activities.

　　Article 49 The sponsor shall assume the responsibility for the monitoring of the clinical trial and choose qualified monitors to perform the duties of supervision.

　　The number of monitors and the supervision frequency depend on the complexity of the clinical trial and the number of clinical trial institutions involved in the trial.

　　Article 50 The monitor shall have relevant professional background of clinical medicine, pharmacy, biomedical engineering and statistics, undergo necessary training, be familiar with relevant laws and regulations and this GCP and be familiar with non-clinical information of the investigational medical device, clinical information of similar products, clinical trial protocol and related documents.

　　Article 51 The monitor shall follow the standard operating procedures for clinical trial supervision of the investigational medical device formulated by the sponsor, and urge the clinical trials to be carried out in accordance with the protocol. The specific responsibilities include:

　　(1) Before the trial, confirm that the clinical trial institution has appropriate conditions, where the staffing and training meets requirements, laboratory equipment is complete and works properly, there are sufficient subjects as expected and the investigators involved are familiar with the trial requirements.

　　(2) Verify whether the clinical trial institutions and investigators follow relevant regulations, this GCP and the clinical trial protocol before, during and after the trial.

　　(3) Ensure that each subject has signed informed consent form prior to participating in the clinical trial, and be aware of the subject enrollment situation and the progress of the trial; clearly and truly record the follow-up visit procedure, trial and examination not carried out by the investigators and whether corrections are made to the errors and omissions; if the informed consent form is revised, confirm that the subjects whose clinical trial process have not completed and have been affected re-sign the revised version.

　　(4) Ensure that all case report forms are filled in correctly and consistent with the source data; all errors or omissions have been corrected or indicated, and the case report forms are signed and dated by the investigators; the type of disease, the total number of cases, the gender, age and treatment effect of each case shall be confirmed and recorded.

　　(5) Ensure that the situation where the subjects withdraw from the clinical trial or are not in compliance with the requirements of the informed consent form has been recorded, and that the situation has been discussed with the investigators.

　　(6) Ensure that all adverse events, complications and other device defects are recorded and that serious adverse events and device defects that may lead to serious adverse events are recorded and reported within the specified time.

　　(7) Monitor the supply, use, maintenance and transportation, receiving, storage, distribution, handling and returning of the samples of investigational medical device.

　　(8) Verify the regular maintenance and calibration of relevant devices during the clinical trial.

　　(9) Ensure that all the documents related to the clinical trial received by the investigators are the latest version.

　　(10) Each supervision activity shall be reported to the sponsor in writing. The report shall include the name of supervisor, the supervision date, time, place and content, the name of investigator, the completion progress of the project, findings, conclusions and corrections to the errors and omissions.

　　Article 52 The sponsor may, in order to ensure the quality of the clinical trial, organize trained and experienced auditors independent of the clinical trial to verify the progress of the clinical trial and assess whether the clinical trial meets the requirements of the trial protocol.

　　The verification can be used as part of the routine work of the sponsor's clinical trial quality management and can also be used to assess the effectiveness of supervision activities or applied to serious or repeated deviations from the clinical trial protocol and suspected fraud.

　　Article 53 The auditors shall develop a verification plan and verification procedure according to the importance of the clinical trial, the number of subjects, the type and the complexity of clinical trial and the level of risk that the subjects may bear.

　　Article 54 The sponsor shall, within five working days after being informed, report serious adverse events and device defects that may lead to serious adverse events to the food and drug administration department where the sponsor makes the registration and the competent health and family planning department of the same level, at the same time inform other clinical trial institutions and investigators involved in the trial, and in a timely manner notify the ethics committee of the clinical trial institution through the medical device clinical trial management department.

　　Article 55 If the sponsor adopts an electronic clinical database or a remote electronic clinical data system, the sponsor shall ensure that the clinical data is under control and integrity and that a complete verification document is formed.

　　Article 56 For multicenter clinical trials, the sponsor shall ensure that documents are prepared prior to clinical trials and clearly define the division of responsibilities of the coordinating investigator and other investigators.

　　Article 57 For multicenter clinical trials, the sponsor shall organize to formulate standard operating procedures in accordance with the clinical trial protocol and organize the training about the clinical trial protocol and the use and maintenance of investigational medical device to all investigators involved, so as to ensure the consistency of the implementation of clinical trial protocol and the use of investigational medical device.

　　Article 58 In the multicenter clinical trial, the sponsor shall ensure that the case report form is well designed to enable the coordinating investigator to obtain all the data from each clinical trial institution.

　　Chapter VII Responsibilities of Clinical Trial Institution and Investigator

　　Article 59 Before accepting a clinical trial, the clinical trial institution shall assess relevant resources according to the characteristics of the investigational medical device to determine whether to accept that clinical trial.

　　Article 60 The clinical trial institutions shall properly keep the clinical trial records and basic documents as per the agreement with the sponsor.

　　Article 61 The investigator who is responsible for the clinical trial shall meet the following conditions:

　　(1) Having the professional technical titles and qualifications of deputy chief physician, associate professor and associate investigator in the clinical trial institution;

　　(2) Having the expertise and experience required by the investigational medical device, and having accepted relevant training if necessary;

　　(3) Familiar with the material and literatures related to the clinical trial required and provided by the sponsor;

　　(4) Competent to coordinate, control and make use of the personnel and equipment to carry out the trial, and to deal with adverse events and other associated events that may be incurred by in the investigational medical device;

　　(5) Familiar with relevant state laws and regulations and this GCP.

　　Article 62 Before the clinical trial, the medical device clinical trial management department of the clinical trial institution shall coordinate with the sponsor to submit the application to the ethics committee and submit relevant documents according to the regulations.

　　Article 63 The investigator shall ensure that the relevant working personnel involved in the trial are familiar with the principles, scope of application, product performance, operating methods, installation requirements and technical specifications of the investigational medical device, understand the pre-clinical study data and safety data of the investigational medical device, and master the prevention and emergency treatment methods for possible risks in the clinical trial.

　　Article 64 The investigator shall ensure that all clinical trial participants are fully aware of the clinical trial protocol, relevant provisions, characteristics of the investigational medical device and the respective responsibilities in the clinical trial, that sufficient subjects who meet the selection criteria in the clinical trial protocol are involved in the clinical trial and that the time decided in the agreement is sufficient to safely implement and complete the clinical trial in accordance with relevant regulations during the trial period.

　　Article 65 The investigator shall ensure that the investigational medical device is used only for the subjects of the clinical trial and shall not charge any fees.

　　Article 66 The investigator shall strictly follow the clinical trial protocol and shall not deviate from the protocol or make a substantive change of plan without the consent of the sponsor and the ethics committee or the approval of China Food and Drug Administration in accordance with the regulations. However, when immediate treatment is needed in the face of emergencies such as direct danger to the subjects, the written report can be provided afterwards.

　　Article 67 The investigator is responsible for recruiting subjects and talking with them or the guardians. The investigator shall explain to the subjects the details of the investigational medical device and details about the clinical trial, inform the subjects of possible benefits and known and foreseeable risks, and obtain signed and dated informed consent forms from the subjects or the guardians.

　　Article 68 The investigators or other personnel involved in the trial shall not force or induce subjects to participate in the trial by any improper means.

　　Article 69 If any unexpected adverse event incurred by the investigational medical device is found during the clinical trial, the investigator shall modify relevant content of the informed consent form with the sponsor, and the affected subjects or the guardians shall re-sign the modified informed consent form after it is reviewed and approved by the ethics committee in accordance with the relevant working procedures.

　　Article 70 The investigator is responsible for making medical decisions related to the clinical trial. When any adverse event related to the clinical trial occurs, the clinical trial institution and the investigator shall ensure that the subjects are in a timely manner provided with adequate treatment and solution. When the subjects develop complications which require treatment, the investigator shall promptly inform the subjects of the situation.

　　Article 71 If any serious adverse event in the clinical trial occurs, the investigator shall immediately give appropriate treatment measures to the subjects, at the same time report in writing to the relevant medical device clinical trial management department of the clinical trial institution, and notify the sponsor through the department by a written notice. The medical device clinical trial management department shall report in writing to the corresponding ethics committee and the local food and drug administration department and the competent health and family planning department of the province, autonomous region or municipality where the clinical trial institution is located within 24 hours. For death events, the clinical trial institution and the investigator shall provide the ethics committee and the sponsor with all the information needed.

　　Article 72 The investigator shall record all the adverse events occurred and the device defects found during the clinical trial and analyze the cause of the event together with the sponsor, form a written analysis report, give the opinion of continuing, suspending or terminating the trial, and report to the ethics committee for review through the medical device clinical trial management department of the clinical trial institution.

　　Article 73 The investigator shall ensure that the clinical trial data is accurately, completely, clearly and promptly entered in the case report form. The case report form shall be signed by the investigator; any change in the data shall be signed and dated by the investigator and meanwhile clear and identifiable original records shall be kept.

　　Article 74 The clinical trial institution and the investigator shall ensure that the data, documents and records formed in the clinical trial are authentic, accurate, clear and secure.

　　Article 75 The clinical trial institution and the investigator shall be subject to the supervision and verification of the sponsor and supervision of the ethics committee and shall provide all required records related to the trial. The clinical trial institution and the investigator shall cooperate with the inspectors during the inspections assigned by the food and drug administration department and the competent health and family planning department.

　　Article 76 Where the clinical trial institution and the investigator find that the risk exceeds the potential benefit, or the result obtained is enough to judge the safety and effectiveness of the investigational medical device and therefore the clinical trial needs to be suspended or terminated, they shall notify the subjects, ensure that the subjects are properly treated and followed up, and report and provide a detailed written explanation in accordance with the regulations. If necessary, they shall report to the local food and drug administration department of the province, autonomous region and municipality.

　　When receiving a notice from the sponsor or the ethics committee to suspend or terminate the clinical trial, the investigator shall inform the subjects promptly and ensure that the subjects are properly treated and followed up.

　　Article 77 Where the sponsor violates relevant regulations or requires the change of the trial data and conclusions, the clinical trial institution and the investigator shall report to the local food and drug administration departments of the province, autonomous region and municipality or China Food and Drug Administration.

　　Article 78 Upon the completion of the clinical trial, the investigator shall ensure that the records and reports are completed. At the same time, the investigator shall also ensure that the number of investigational medical devices received is consistent with that of the used, discarded or returned devices, and ensure that the remaining investigational medical devices are properly handled, recorded and documented.

　　Article 79 The investigator may, according to the needs of the clinical trial, authorize corresponding personnel to recruit subjects, communicate with the subjects, record the clinical data and manage the investigational medical device. The investigator shall carry out relevant training and form the corresponding document for the personnel authorized.

　　Chapter VIII Records and Reports

　　Article 80 In the clinical trial, the investigator shall ensure that any observation and finding are recorded in the correct and complete manner and that the case report form is carefully filled out. Records shall include at least:

　　(1) The information of the investigational medical device, including name, model, specification, date of receipt, lot number or serial number;

　　(2) Medical records and nursing records such as the medical history and progression of each subject;

　　(3) Using records of the investigational medical device by each subject, including the date and time of each use and the state of the investigational medical device;

　　(4) Signature and date of the recorder.

　　Article 81 The clinical trial records as source of information shall not be altered arbitrarily; if it is necessary to make a change, the reason shall be stated, and signed and dated.

　　Data that are significantly deviated from the clinical trial protocol or outside the clinically acceptable range shall be verified and investigator shall make necessary explanation.

　　Article 82 The sponsor shall accurately and completely record the information related to the clinical trial, including:

　　(1) Delivery and handling records of the investigational medical devices, including name, model, specification, lot number or serial number, recipient's name and address, date of delivery, returning and repairing dates or recovery and disposal dates of the medical device samples after the clinical trial as well as the relevant causes and handling method;

　　(2) Agreements with the clinical trial institution;

　　(3) Supervision and verification reports;

　　(4) Records and reports of serious adverse events and device defects which may cause serious adverse events.

　　Article 83 The investigator shall verify or confirm the safety and effectiveness of the investigational medical device in accordance with the design requirements of the clinical trial protocol and complete the clinical trial report. The clinical trial report of a multicenter clinical trial shall include the summaries of each clinical trial of the sub-site.

　　Article 84 For a multicenter clinical trial, the clinical trial summaries of each sub-site shall include at least a summary of the clinical trial, clinical general information, information for the investigational medical device and the compared device, safety and effectiveness data sets, incidence rate of the adverse events, description of deviation from the protocol and the case report form.

　　Article 85 The clinical trial report shall be consistent with the clinical trial protocol, including:

　　(1) General information;

　　(2) Summary;

　　(3) Introduction;

　　(4) Purpose of clinical trial;

　　(5) Methodology of clinical trial;

　　(6) Content of clinical trial;

　　(7) Clinical general information;

　　(8) The investigational medical device and the reference device or control treatment methods;

　　(9) Methods used for statistical analysis and evaluation;

　　(10) Clinical assessment criteria;

　　(11) Organizational structure of the clinical trial;

　　(12) Statement of ethical situation;

　　(13) Results of clinical trial;

　　(14) Adverse events found in the clinical trial and the handling;

　　(15) Analysis and discussion of clinical trial results, in particular, indications, scope of application, contraindications and precautions;

　　(16) Conclusions of clinical trial;

　　(17) Problems and suggestions for improvement;

　　(18) List of trial personnel;

　　(19) Other situations that need explanation.

　　Article 86 The clinical trial report shall be signed and dated by the investigator, and submitted to the sponsor after being issued with opinions, dated and affixed with the seal of the clinical trial institution by the medical device clinical trial management department of the clinical trial institution.

　　In a multicenter clinical trial, the summaries of each clinical trial of sub-site shall be signed and dated by the investigator of the corresponding center, and reviewed, dated and affixed with the seal of the clinical trial institution by the medical device clinical trial management department of the center, and then submitted to the leading unit.

　　Chapter IX Management of Investigational Medical Device

　　Article 87 The sponsor shall make proper identification and mark "for trial" on the investigational medical device by reference to the regulations about medical device specifications and labeling management of China Food and Drug Administration.

　　Article 88 The records of investigational medical device shall include the production-related records such as production date, product batch number and serial number, inspection records related to product quality and stability, records of transportation, maintenance and delivery to the clinical trial institutions, and information such as return and disposal dates after the trial.

　　Article 89 The use of investigational medical devices shall be in the charge of the clinical trial institution and the investigator. The investigator shall ensure that all investigational medical devices are used only for the subjects of the clinical trial, well stored and kept during the trial in accordance with relevant requirements, and properly handled after the clinical trial in accordance with relevant state regulations and the agreement with the sponsor. The above process shall be designated to and recorded by identified personnel. The investigator shall not hand over the investigational medical device to any non-clinical trial participants.

　　Chapter X Management of Basic Documents

　　Article 90 The clinical trial institution, the investigator and the sponsor shall establish a basic document keeping system. The basic documents of the clinical trial are divided into three parts according to the clinical trial phases: documents in the preparation phase, documents in the implementation phase and documents after the termination or completion.

　　Article 91 The clinical trial institution shall keep clinical trial documents for 10 years after the completion of the clinical trial, and the sponsor shall keep the clinical trial data until the medical device is out of use.

　　Article 92 The basic documents of clinical trial may be used to evaluate the implementation of this GCP and relevant requirements of the food and drug administration departments carried out by the sponsor, the clinical trial institution and the investigator. The food and drug administration departments can check the basic documents of clinical trial.

　　Chapter XI Supplementary Provisions

　　Article 93 Definitions of the following terms in this GCP:

　　The medical device clinical trial institution refers to the medical institution accredited to undertake the clinical trial of medical device by China Food and Drug Administration jointly with the National Health and Family Planning Commission. Unless otherwise stated, the term "clinical trial institution" refers to "medical device clinical trial institution" in this GCP.

　　The investigational medical device refers to the medical device applied for registration, of which the safety and effectiveness are to be confirmed or verified in the clinical trial.

　　The sponsor refers to the institution or organization that launches, manages and provides financial support for the clinical trial.

　　The investigator refers to the person who is responsible for implementing the clinical trial in a clinical trial institution. Where the trial is carried out by a group of personnel in a clinical trial institution, the investigator shall be the person who is in charge of the group, also known as the principal investigator.

　　The ethics committee refers to the independent institution which is set up by the clinical trial institution to examine the scientific and ethical nature of medical device clinical trial projects.

　　The medical device clinical trial management department refers to the internal division or department which is set up by the clinical trial institution to be responsible for the management and quality control of medical device clinical trial.

　　The multicenter clinical trial refers to the clinical trial which is performed in three (inclusive) or more clinical trial institutions under the same clinical trial protocol.

　　The subject refers to the individual who is recruited to receive the medical device clinical trial.

　　The informed consent refers to the process that a subject confirms to voluntarily participate in the clinical trial after being informed of all aspects of the clinical trial, and shall be certified by a signed and dated informed consent form as the proof document.

　　The informed consent form refers to the proof document that shows the willingness of a subject to participate in the clinical trial.

　　The supervision refers to the activities performed by special personnel who are selected by the sponsor of carrying out the evaluation and investigation of the clinical trial institutions and the investigators, and verifying, recording and reporting data during the clinical trial, so as to ensure that the clinical trial carried out is in conformity with the clinical trial protocol, standard operating procedures, this GCP and applicable management requirements.

　　The supervisor refers to the special person who is selected by the sponsor to supervise the medical device clinical trial project.

　　The verification refers to the systematic independent inspection of relevant clinical trial activities and documents organized by the sponsor, so as to determine whether the implementation of such activities, data recording, analysis and reporting conform to the clinical trial protocol, standard operating procedures, the GCP and applicable management requirements.

　　The auditor refers to the person who is entrusted by the sponsor to carry out the verification of the medical device clinical trial project.

　　The inspection refers to the supervision and administration activities carried out by the regulatory department for inspecting relevant clinical trial documents, facilities, records and other aspects.

　　The inspector refers to the person who is selected by the regulatory department to inspect the medical device clinical trial project.

　　The deviation refers to the situation where subjective or non-subjective failure to follow the requirements of the clinical trial protocol occurs.

　　The case report form refers to the document designed in accordance with the clinical trial protocol, which is used to record all the information and data of every subject during the trial.

　　The endpoint refers to an indicator used to assess the clinical trial hypothesis.

　　The source data refers to the original records of clinical findings, observations and other activities in the clinical trial and all information of approved copies, which can be used for clinical trial reconstruction and evaluation.

　　The source file refers to the printed, visualized or electronic file containing source data.

　　The adverse event refers to an adverse medical event that occurs during the clinical trial, no matter whether it is related to the investigational medical devices.

　　The serious adverse event refers to event of death or serious deterioration of physical health during the clinical trial, including deadly illnesses or injuries, permanent defect in body structure or body function, and event where hospitalization or prolonged hospitalization, medical or surgical intervention is needed to avoid permanent defect to body structure or body function; and events that causes fetal distress, fetal death, or congenital anomalies or defects.

　　The device defect refers to the unreasonable risk that may endanger the human health and life safety in the normal use of medical device during the clinical trial, such as label errors, quality problems and breakdowns.

　　The standard operating procedure refers to the standard and detailed written procedure which is formulated for the effective implementation and completion of each work in the clinical trial.

　　The clinical data refers to the safety and performance information which is obtained from relevant literature or in the clinical use of medical device.

　　Article 94 The template of the application form for the ethical review of the medical device clinical trial shall be separately formulated by CFDA.

　　Article 95 This GCP does not apply to in-vitro diagnostic reagents which are regulated as medical devices.

　　Article 96 This GCP shall be effective as of June 1, 2016. The Regulations on Medical Device Clinical Trial promulgated on January 17, 2004 (Decree No. 5 of State Food and Drug Administration) shall be annulled simultaneously.

　　Note: In case of any difference in interpretation between the English version and the Chinese version, the Chinese version shall prevail.