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.