1、Good Clinical Practice for Medical DeviceChapter I General ProvisionsArticle 1 In order to strengthen the management of clinical trials of medical devices, safeguard the rights and interests and safety of subjects, and ensure that the process of clinical trials of medical devices is standardized, an
2、d that the results are true, accurate, complete and traceable, the GCP is formulated in accordance with the Regulations on Supervision and Administration of Medical Devices.Article 2 Within the territory of the Peoples Republic of China, the relevant activities of clinical trials of medical devices
3、for the purpose of applying for the registration of medical devices (including in vitro diagnostic reagents, the same below) shall comply with the GCP.The GCP covers the whole process of clinical trials of medical devices, including protocol design, implementation, monitoring, audit, inspection and
4、data collection, recording, preservation, analysis, summary and report of clinical trials of medical devices.Article 3 Clinical trials of medical devices shall be carried out according to the ethical codes of the World Medical Association Declaration of Helsinki and relevant national specifications
5、for biomedical research involving human subjects. All parties participating in the medical device clinical trial should bear corresponding ethical responsibilities in accordance with their respective responsibilities in the trial.Article 4 Clinical trials of medical devices shall be earned out with
6、sufficient scientific basis and definite clinical trial objectives. At the same time, both the risks and benefits expected by subjects and society shall be weighed. Only when the expected benefits outweigh the risks can clinical trials be carried out or continued.Article 5 Clinical trials of medical
7、 devices shall be earned out in clinical trial institutions of medical devices which have corresponding conditions and are filed in accordance with relevant regulations.Article 6 Clinical trials of medical devices shall be approved by the Ethics Committee. Regarding the medical devices included in t
8、he Catalogue of Class III Medical Devices Requiring Approval for Clinical Trials, the clinical trials shall also be approved by the National Medical Products Administration and carried out in qualified grade A tertiary medical institutions.Article 7 The sponsor of a clinical trial of medical devices
9、 shall establish a quality management system covering the whole process of the clinical trial of medical devices to ensure that the clinical trial of medical devices complies with relevant laws and regulations, and protect the rights and interests and safety of the subjects.Chapter II Ethics Committ
10、eeArticle 8 The Ethics Committee is responsible for protecting the legal rights and interests and safety of the subjects and safeguarding their dignity.Article 9 The Ethics Committee shall abide by the ethical codes of the World Medical Association Declaration of Helsinki and relevant laws and regul
11、ations. The composition, operation and filing management of the Ethics Committee shall meet the requirements of the health administration department.Article 10 All members of the Ethics Committee shall participate in training related to ethical knowledge, the GCP and other relevant laws and regulati
12、ons, get familiar with the ethical codes about the clinical trials of medical devices and relevant laws and regulations, and abide by the working procedures of the Ethics Committee.Article 11 Prior to the clinical trials of medical devices, the sponsor shall ask principal investigators to submit the
13、 following documents to the Ethics Committee:(I) Clinical Trial Protocol;(II) Investigators brochure;(III) Text of Informed Consent Form (ICF) and any other written materials provided to subjects;(IV) Procedural documents for recruitment and promotion of subjects (if applicable);(V) Text of Case Rep
14、ort Form (CRF);(VI) Product test report based on product technical requirements;(VII) Data related to preclinical study;(VIII) Resume, professional expertise, ability, training and other documents that can prove their qualifications of the principal investigators;(IX) A Statement That the Investigat
15、ional Medical Devices are Developed in Accordance with Applicable Requirements Related to Quality Management System of Medical Devices;(X) Other documents related to ethical review.Article 12 The Ethics Committee shall review the ethicality and scientificity of the clinical trials of medical devices
16、, during which much attention shall be paid to the following contents:(I) Whether the principal investigator is qualified and experienced, and has sufficient time to participate in the trial;(II) Whether the staffing and equipment of the clinical trial meet the test requirements;(III) Whether the de
17、gree of risk the subjects may suffer is appropriate compared with the expected benefits of the trial;(IV) Whether the ethical principles are fully considered in the clinical trial protocol and whether it is scientific, including whether the research purpose is appropriate, whether the rights and int
18、erests and safety of the subjects are protected, and whether other personnel have been fully protected from possible risks.(V) Whether information and data provided to the subjects about the clinical trial is complete, and whether they have been clearly informed of their rights; whether the subjects
19、 have understood the contents of the ICF; whether the method of obtaining the ICF is appropriate;(VI) Whether the inclusion and exclusion of the subjects are scientific and impartial;(VII) Whether the subjects get reasonable compensation for participating in the clinical trial. In case of injury or
20、death related to clinical trial, whether the treatment and safeguard measures are adequate;(VIII) Whether the protection for special populations of subjects is sufficient, such as children, pregnant women, the elderly, people with mental retardation, patients with mental disorders, etc.Article 13 Th
21、e Ethics Committee can give the following review opinions:(I) Approval;(II) Approval after necessary modification;(III) Disapproval;(IV) Suspend or terminate the approved clinical trial.If modification is required or disapproval is given in the review opinion, the corresponding reasons shall be expl
22、ained.Article 14 The ICF shall generally include the following contents and explanations of matters:(I) Name of the principal investigator and other related information;(II) Name of the clinical trial institution of medical device;(III) Name, purpose, method and content of clinical trial;(IV) Clinic
23、al trial process and duration;(V) Sources of funds for the clinical trial and possible conflicts of interest;(VI) Anticipated possible benefits and known and foreseeable risks and possible adverse events of subjects;(VII) Information on the alternative diagnosis and treatment methods available to su
24、bjects and their potential benefits and risks;(VIII) If applicable, indicate that the subjects may be assigned to different groups of clinical trials;(IX) Subjects should participate in the clinical trial on a voluntary basis, and have the right to withdraw at any stage of the clinical trial without
25、 discrimination or retaliation, and their medical treatment and rights will not be affected;(X) Inform the subject that the personal data of the clinical trial is confidential, but the regulatory department of the clinical trial institution of medical devices, the Ethics Committee, the drug regulato
26、ry departments, the health administration department, or the monitors and auditors may have access to the personal data of participating in the clinical trial according to the prescribed procedures during their work;(XI) Free medical and treatment items and other related compensations that the subje
27、cts may receive during the clinical trial.(XII) In case of any injuries related to the clinical trial, the subjects can be treated and/or receive compensation;(XIII) During the clinical trial, the subjects can know the relevant information at any time.The ICF shall indicate the version and date of f
28、ormulation or the revised version and date. The language and words understandable for subjects shall be adopted for ICF. Any words in the ICF may in no way lead subjects to give up the legitimate rights and interests, nor exempt the medical device clinical trial institutions and its principal invest
29、igators and sponsor from taking their responsibilities.Article 15 Follow-up review of the Ethics Committee:(I) The Ethics Committee shall follow up and supervise the clinical trial of medical devices, and may request in writing to suspend or terminate the clinical trial at any time in case that the
30、rights and interests and safety of the subjects cannot be guaranteed.(II) The Ethics Committee needs to review the safety information such as serious adverse events reported by the investigator in this clinical trial institution, and review safety information such as serious adverse events reported
31、by the sponsor related to the investigational medical device. In addition to requesting modification of the clinical trial protocol, ICF and other information provided to the subjects, the Ethics Committee can also suspend or terminate the clinical trial;(III) The Ethics Committee needs to review th
32、e possible impact of the deviation of the clinical trial protocol on the rights and interests and safety of the subjects, or the possible impact on the scientificity and integrity of the clinical trial of medical devices.Article 16 During clinical trials of medical devices, the revision of the clinical trial protocol, ICF and other documents, the resuming of suspended clinical trials shall be implemented only after the written approval of the Ethics Committee is obtained again.Article 17 The Ethics Committee shall keep all the records of the ethical review, including the
