Laws & Regulations/
Provisions for Clinical Trials of Medical Devices

(SFDA Order No. 5)

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

January 17,2004




Chapter I  General Provisions

Article 1

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

Article 2

The implementation of, supervision over, and examination intoclinical trials of medical devices shall be conducted in accordance with theprovisions.

Article 3

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

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

Article 4

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

Article 5

The clinical trials of medical devices are divided intoclinical testing and clinical verification.

Clinical testing refers to verifying if such factors as thetheoretical principle, basic structure and performance of the concerned medicaldevices are able to guarantee their operating safety and effectiveness, bymeans of clinical application.

Clinical verification refers to verifying the testing productsand the products already in the market are virtually the same in terms of thebasic structure, performance, safety and effectiveness.

Scope of clinical testing: those medical devices that have notyet been available in the market, or whose safety and effectiveness are subjectto verification.

Scope of clinical verification: those medical devices whoseidentical products of similar kinds have already been launched onto the market,or whose safety and effectiveness need to be further verified.

Article 6

Medical devices entering clinicaltrials must possess the following conditions:
(1) The concerned product has measured up to the registered product standard orcorresponding 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 testingcenter recognized by SFDA or State National Quality Standard Supervisiondepartment.
(4) If the product to be tested is some medical device that is implanted intohuman body for the first time, it is necessary to present the animal experimentreport for the product.
For other products whose safety to human body in the clinical trials has to beverified by means of animal experiment, it is required to render an animaltesting report, too.

Chapter II Assurance of Rights and Interests of Human Subjects

Article 7

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

Article 8

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

(1) The testing subjects participating the clinical trials arevoluntary and may withdraw from clinical trials at any stage.

(2) The personal information and data of the testing subjectsparticipating in the clinical trials are confidential. The Ethics committee,the department of (food and) drug administration, and the implementer may lookup the personal information and data of the testing subjects, but must notdisclose to the outside.

(3) The Clinical trials proposal for Medical Devices, inparticular the purpose, process and time duration of the clinical trials; theexpected benefits and possible risks that may occur in the testing subjects.

(4) During the course of clinical trials, medical institutionsshall have the obligation to provide the testing subjects with information anddata in relation to the clinical trials.

(5) Implementer should provide appropriate compensation for thetesting subject. The related content of compensation should be described in theclinical trials contract of the medical devices.

Article 9

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 underArticle Eight.

(1) Signature and date of signature of the person responsible forclinical trials of medical devices.

(2) Signature and date of signature of each of the testingsubjects or his or her authorized legal representatives.

(3) In case of any unexpected clinical results discovered bymedical institutions, “Notice of Informed Consent” should be amended and suchamendments shall sign again by the testing subjects or their authorized legalrepresentatives.


Chapter III Clinical Trials Protocol

Article10

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

Article 11

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

Article 12

With regard to those class III medical devices implanted intohuman body, which is not available yet in the market or those medical devicebased on the theory of traditional Chinese medicines, the clinical trialsprotocol shall be filed with the technical evaluation agency of medicalDevices.

Article 13

If adverse event occurs from the same category of marketedmedical device, or the product whose curative effects remain uncertain, StateFood and Drug Administration may set a unified guideline on clinical trialsprotocol.

To conduct the clinical trials of such medical devices, theimplementer, the medical institutions and the clinical trials personnel shallfollow the unified guideline.

Article 14

The clinical trials protocol for medical devices shall refer tothe characteristics of the concerned products to be tested, determine thenumber of testing case, time duration of the test and clinical evaluationstandard, and to make the test results to be of statistical significance.

The Clinical trials protocol shall verify the generaldescriptions 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 productsand the products already in the market are virtually the same in terms of thebasic structure, performance, safety and effectiveness.

Article15

The clinical trials protocol shallinclude 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 clinicalpersonnel.
(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 theselection, 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 processingmethod.
(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.

Article 16

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

Article 17

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


Chapter IV Implementer of Clinical Trials

Article 18

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 deviceproduct.

Article 19

Duties of the implementer cover:
(1) To select a medical institution according to regulations
(2) To provide Medical Device Clinical Trials Notice for the medicalinstitution.
(3) To work together with the medical institution to design and formulate theclinical trials protocol and sign the clinical trials protocol and the contractwhich 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 toreport to the department of (food and) drug administration of the concernedprovince or autonomous region or municipality originally handling theapplication of the registration and State Food and Drug Administrationrespectively in time and truthfully, and also notify all the other medicalinstitutions conducting the clinical trials.

(8) Before the implementer discontinues the clinical trials, it isnecessary to notify the medical institution, ethic committee and the departmentof (food and) drug administration of the concerned province or autonomousregion or municipality originally handling the application of the registrationand State Food and Drug Administration respectively, and explain the reasons.

(9) If the testing products have caused any damage to the testingsubjects, the implementer shall compensate in accordance with the contract ofclinical trials.

Article20

The “Medical Device Clinical Trials Notice” shall cover thefollowing contents:

(1) Description of functional principal of testing product,expected indications, functionality and expected aims, description ofoperational requirement and description of installation requirement.

(2) Technical indicators of the testing products.

(3) Type testing report of testing products issued by testinginstitutions recognized by the regulatory department of food and drug and thedepartment of quality and technical supervision under the State Council.

(4) Risks that may arise, recommended preventive method andemergency treatment method;

(5) Confidentiality issues that may be involved.


Chapter V Medical Institutions and Personnel of Clinical Trials

Article 21

Medical institutions undertaking the clinical trials of medicaldevices refer to those institutions liable for clinical trials of drugsrecognized by the regulatory department of food and drug and the administrativedepartment of health under the State Council jointly.

Article 22

The personnel of clinical trials formedical devices must have the following qualifications:
(1) To have required the expertise, qualifications and capabilities forundertaking the clinical trials.
(2) To be acquainted with those documents and data in relation to the clinicaltrials provided by the implementer.

Article23

The medical institution responsible forclinical trials of medical devices and the clinical personnel shall undertakethe following duties:
(1) To be acquainted with related documents rendered by the implementer, and tobe familiar with application of the testing product;
(2) To work with the implementer jointly to design and formulate a clinicaltrials protocol, sign the clinical trials protocol and contract.
(3) To explain to the testing subjects the details of the products to be testedtruthfully; before the clinical trials, enough time should be given to thetesting subjects to consider whether or not to get involved in the clinicaltrials.
(4) To faithfully record the side effects and adverse events of the testingproducts, and analyze the causes; in case of occurrence of any adverse eventsand severe side effects, be sure to report to the (food and) drug administrationof the concerned province or autonomous region or municipality originallyhandling the application for registration of the medical devices and State Foodand Drug Admonition respectively in time and truthfully; in case of occurrenceof severe side effects, be sure to report to these authorities within theensuing 24 hours.
(5) In case of occurrence of any side effects, the clinical personnel shallmake clinical judgment in time, adopt measures to protect the rights andinterests of the testing subjects; when necessary, the ethic committee shallhave the right to discontinue the clinical trials immediately.
(6) When the clinical trials is discontinued, be sure to notify the testingsubjects, the implementer, the ethic committee and the (food and) drugadministration of the concerned province or autonomous region or municipalityoriginally handling the application for registration of the medical devices andState Food and Drug Admonition respectively of such a discontinuity case, andalso explain the reasons.
(7) To present a clinical trials report, and be responsible for the correctnessand reliability of the report.
(8) To be liable for keeping the documents rendered by the implementer asconfidential.

Article 24

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


Chapter VI Clinical Trials Report

Article 25

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

Article26

The clinical trials report shallinclude the following information:
(1) Categories of illnesses subject to test; total number of cases; gender, ageand analysis by grouping of patients; establishment of a control group (whennecessary);
(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 treatmentmeasures
(8) Analysis of clinical trials effects.
(9) Indications, scope of application, contraindications and precautions.
(10) Existing problems and suggestions for improvement.

Article27

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


Chapter VII Supplementary Provisions

Article 28

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

Article29

The provisions shall go into effect as of April1, 2004.