The Provisions for Clinical Trials of Medical Devices were passed by the State Food and Drug Administration at the administration affairs meeting on December 22 of 2003, are hereby promulgated and shall go into effect as of April 1,2004.

Provisions for Clinical Trials of Medical Devices

Chapter I General Provisions

The provisions are formulated to strengthen the administration of clinical trials of medical devices and to ensure the rights and benefits of testing subjects protected and assuring the truthfulness and reliability of the trials result is based on the Regulations for the Supervision and Administration of Medical Devices.

The implementation of, supervision over, and examination into clinical trials of medical devices shall be conducted in accordance with the provisions.

Clinical trial under the provisions refers to the process in which the medical institutions qualified for conducting clinical trial of medical devices (medical institutions, for short hereunder) testing and verifying the safety and effectiveness of the medical device submitted to register in normal condition.

The purpose of clinical trials of medical devices is to evaluate the intended safety and effectiveness of the testing products.

Clinical trials of medical devices should be conducted in accordance with the ethical principles contained in World Medical Association Declaration of Helsinki (see Appendix 1), respecting human dignity, striving for maximal benefit for the testing subject, and avoiding harm as best one may.

The clinical trials of medical devices are divided into clinical testing and clinical verification. Clinical testing refers to verifying if such factors as the theoretical principle, basic structure and performance of the concerned medical devices are able to guarantee their operating safety and effectiveness, by means of clinical application. Clinical verification refers to verifying the testing products and the products already in the market are virtually the same in terms of the basic structure, performance, safety and effectiveness. Scope of clinical testing: those medical devices that have not yet been available in the market, or whose safety and effectiveness are subject to verification. Scope of clinical verification: those medical devices whose identical products of similar kinds have already been launched onto the market, or whose safety and effectiveness need to be further verified.

Medical devices entering clinical trials must possess the following conditions:

1. The concerned product has measured up to the registered product standard or corresponding state or industrial standard undergoing re-examination.
2. The concerned product is accompanied by a self-examination report.
3. The concerned product possess qualified testing report from the testing center recognized by SFDA or State National Quality Standard Supervision department.
4. If the product to be tested is some medical device that is implanted into human body for the first time, it is necessary to present the animal experiment report for the product. For other products whose safety to human body in the clinical trials has to be verified by means of animal experiment, it is required to render an animal testing report, too.

Chapter II Assurance of Rights and Interests of Human Subjects

It is not allowed to levy any charges upon the testing subjects involved in the clinical trials of medical devices.

The person responsible for clinical trials of medical devices or his or her authorized proxy must explain the following to the testing subjects or their authorized legal representatives:

1. The testing subjects participating the clinical trials are voluntary and may withdraw from clinical trials at any stage.
2. The personal information and data of the testing subjects participating in the clinical trials are confidential. The Ethics committee, the department of (food and) drug administration, and the implementer may look up the personal information and data of the testing subjects, but must not disclose to the outside.
3. The Clinical trials proposal for Medical Devices, in particular the purpose, process and time duration of the clinical trials; the expected benefits and possible risks that may occur in the testing subjects.
4. During the course of clinical trials, medical institutions shall have the obligation to provide the testing subjects with information and data in relation to the clinical trials.
5. Implementer should provide appropriate compensation for the testing subject. The related content of compensation should be described in the clinical trials contract of the medical devices.

After sufficient understanding of content of clinical trials, testing subjects may receive ¡°Notice of Informed Consent¡±. The content of ¡°Notice of Informed Consent¡± shall include the related content stipulated under Article Eight.

1. Signature and date of signature of the person responsible for clinical trials of medical devices.
2. Signature and date of signature of each of the testing subjects or his or her authorized legal representatives.
3. In case of any unexpected clinical results discovered by medical institutions, ¡°Notice of Informed Consent¡± should be amended and such amendments shall sign again by the testing subjects or their authorized legal representatives.

Chapter III Clinical Trials Protocol

The clinical trials protocol is a document, which includes contents illustrating testing purpose, risks analysis, overall scheme and testing methods and steps. Prior to start of the clinical trials , it is required to formulate a test protocol. Clinical trials must be carried out in accordance with the clinical Trials protocol.

The clinical trials protocol shall stick to a primary principle of protecting the rights and interests, safety and health of the testing subjects to the maximum degree, and must be designed and formulated jointly by the medical institution liable for the clinical trials and the implementer as the stipulated format (see Appendix 2), as well as be submitted to the ethical committee for ratification. Any amendments should be approved by the ethics committee.

With regard to those class III medical devices implanted into human body, which is not available yet in the market or those medical device based on the theory of traditional Chinese medicines, the clinical trials protocol shall be filed with the technical evaluation agency of medical Devices.

If adverse event occurs from the same category of marketed medical device, or the product whose curative effects remain uncertain, State Food and Drug Administration may set a unified guideline on clinical trials protocol. To conduct the clinical trials of such medical devices, the implementer, the medical institutions and the clinical trials personnel shall follow the unified guideline.

The clinical trials protocol for medical devices shall refer to the characteristics of the concerned products to be tested, determine the number of testing case, time duration of the test and clinical evaluation standard, and to make the test results to be of statistical significance. The Clinical trials protocol shall verify the general descriptions of such factors as the theoretical principle, basic structure, performance, safety and effectiveness of the testing products. The clinical trials protocol shall verify the testing products and the products already in the market are virtually the same in terms of the basic structure, performance, safety and effectiveness.

The clinical trials protocol shall include the following content:

1. Title of the clinical trials.
2. Purpose, background and contents of the clinical trials.
3. Clinical evaluation standard.
4. Analysis of risks and benefits of clinical trials.
5. Name, title, post and the corresponding department of the clinical personnel.
6. Overall scheme, including success or failure feasibility analysis.
7. Time duration of clinical trials and reasons for it.
8. Number of testing cases of each disease category and reasons for it.
9. Scope of selecting subjects, quantity of subjects and reasons for the selection, and setup control group when necessary.
10. Specific indication or scope of application for those curative products.
11. Evaluation method of clinical performance and statistical processing method.
12. Expected adverse effects and the necessary measures to be taken.
13. Notice of Informed Consent for testing subjects
14. Descriptions of duties of the parties.

Clinical trials institution and the implementer shall sign a clinical trials protocol that both parties have agreed to, and sign the clinical trials contract.

The clinical trials of medical devices shall be conducted in two or more medical institutions.

Chapter IV Implementer of Clinical Trials

The implementer shall be responsible for initiating, implementing, organizing, sponsoring and supervising over the clinical trials. The implementer is the unit applying to register the concerned medical device product.

Duties of the implementer cover:

1. To select a medical institution according to regulations
2. To provide Medical Device Clinical Trials Notice for the medical institution.
3. To work together with the medical institution to design and formulate the clinical trials protocol and sign the clinical trials protocol and the contract which both parties have agreed to.
4. To provide the medical institution with the products to be tested for free.
5. To train the personnel for clinical trials.
6. To render a guarantee for medical institutions.
7. In case of occurrence of severe side effects, be sure to report to the department of (food and) drug administration of the concerned province or autonomous region or municipality originally handling the application of the registration and State Food and Drug Administration respectively in time and truthfully, and also notify all the other medical institutions conducting the clinical trials.
8. Before the implementer discontinues the clinical trials, it is necessary to notify the medical institution, ethic committee and the department of (food and) drug administration of the concerned province or autonomous region or municipality originally handling the application of the registration and State Food and Drug Administration respectively, and explain the reasons.
9. If the testing products have caused any damage to the testing subjects, the implementer shall compensate in accordance with the contract of clinical trials.

The ¡°Medical Device Clinical Trials Notice¡± shall cover the following contents:

1. Description of functional principal of testing product, expected indications, functionality and expected aims, description of operational requirement and description of installation requirement.
2. Technical indicators of the testing products.
3. Type testing report of testing products issued by testing institutions recognized by the regulatory department of food and drug and the department of quality and technical supervision under the State Council.
4. Risks that may arise, recommended preventive method and emergency treatment method;
5. Confidentiality issues that may be involved.

Chapter V Medical Institutions and Personnel of Clinical Trials

Medical institutions undertaking the clinical trials of medical devices refer to those institutions liable for clinical trials of drugs recognized by the regulatory department of food and drug and the administrative department of health under the State Council jointly.

The personnel of clinical trials for medical devices must have the following qualifications:

1. To have required the expertise, qualifications and capabilities for undertaking the clinical trials.
2. To be acquainted with those documents and data in relation to the clinical trials provided by the implementer.

The medical institution responsible for clinical trials of medical devices and the clinical personnel shall undertake the following duties:

1. To be acquainted with related documents rendered by the implementer, and to be familiar with application of the testing product;
2. To work with the implementer jointly to design and formulate a clinical trials protocol, sign the clinical trials protocol and contract.
3. To explain to the testing subjects the details of the products to be tested truthfully; before the clinical trials, enough time should be given to the testing subjects to consider whether or not to get involved in the clinical trials.
4. To faithfully record the side effects and adverse events of the testing products, and analyze the causes; in case of occurrence of any adverse events and severe side effects, be sure to report to the (food and) drug administration of the concerned province or autonomous region or municipality originally handling the application for registration of the medical devices and State Food and Drug Admonition respectively in time and truthfully; in case of occurrence of severe side effects, be sure to report to these authorities within the ensuing 24 hours.
5. In case of occurrence of any side effects, the clinical personnel shall make clinical judgment in time, adopt measures to protect the rights and interests of the testing subjects; when necessary, the ethic committee shall have the right to discontinue the clinical trials immediately.
6. When the clinical trials is discontinued, be sure to notify the testing subjects, the implementer, the ethic committee and the (food and) drug administration of the concerned province or autonomous region or municipality originally handling the application for registration of the medical devices and State Food and Drug Admonition respectively of such a discontinuity case, and also explain the reasons.
7. To present a clinical trials report, and be responsible for the correctness and reliability of the report.
8. To be liable for keeping the documents rendered by the implementer as confidential.

The medical institution responsible for the clinical trials of medical devices shall determine and appoint a medical person in charge of the clinical trials as the person responsible for clinical trials. Such a person responsible for clinical trials must possess a technical title at the physician-in-charge level or above.

Chapter VI Clinical Trials Report

After completion of the clinical trials, the medical institution shall present a clinical trials report in the form as specified (see Appendix 3), and pursuant to the requirements under the clinical trials protocol for medical devices. The report shall bear the signature of the testing personnel, the date, and comments made by the management department of the clinical trials institution, plus the date of issuance of such comments and the stamp of the same department.

The clinical trials report shall include the following information:

1. Categories of illnesses subject to test; total number of cases; gender, age and analysis by grouping of patients; establishment of a control group (when necessary);
2. Clinical trials method;
3. Statistical method and evaluation method in use;
4. Clinical evaluation standard;
5. Clinical trials results;
6. Clinical trials conclusion;
7. Adverse event and side effect during the clinical trials and treatment measures
8. Analysis of clinical trials effects.
9. Indications, scope of application, contraindications and precautions.
10. Existing problems and suggestions for improvement.

Clinical trials data of medical devices must be kept in good conditions and controlled properly. The medical institution shall keep clinical trials data within the ensuing five years after completion of the test. The implementer shall keep clinical trials data within the ensuing ten years after the products that are produced lastly have been put into use.

Chapter VII Supplementary Provisions

The State Food and Drug Administration is responsible for the interpretation of the provisions.

The provisions shall go into effect as of April 1, 2004.

Appendixes:

1. World Medical Association Declaration of Helsinki
2. Clinical trials Protocol for Medical Devices
3. Clinical Trials Report for Medical Devices