Draft of Regulations on Good Clinical Practice for Medical Devices 
This Draft has been translated into English according to the 
original Chinese version. If there is any inconsistency or 
ambiguity between these two versions, the Chinese version shall 
prevail. 
 
Chapter 1 General Provisions 
Article 1 The Regulations are enacted pursuant to Paragraph 3, Article 37 of the 
Medical Devices Act (hereinafter “this Act”). 
Article 2 Terms used in the present regulations are defined as follows: 
1. Subject/Trial Subject: An individual who participates in a clinical trial, either as a 
recipient of the investigational medical device or as a control. 
2. Vulnerable Populations: Individuals who are unable to make decisions because of 
their age or mental or physical conditions; who are susceptible to harmful 
influences and threats because of their environment, identity, or socioeconomic 
conditions; or who cannot make decisions according to their free will. 
3. Investigator: An individual responsible for the conduct of a clinical trial at a 
clinical trial institution. 
4. Sponsor: An individual, company, institution, or organization that takes 
responsibility for the initiation and management of a clinical trial.  
5. Contract Research Organization: A person or an organization contracted by the 
sponsor to perform one or more of the sponsor’s clinical investigation-related 
duties and functions. 
6. Deviations: Instance(s) of failure to follow the requirements of the clinical 
investigation plan. 
7. Adverse Event (AE): Any untoward medical occurrence in a subject to whom an 
investigational medical device is administered and which does not necessarily 
have a causal relationship with the investigational medical device. 
8. Adverse Device Effect (ADE): Adverse event related to the use of an 
investigational medical device. 
9. Subjects may experience the following severe adverse effects: 
(1) Death. 
(2) Life-threatening condition. 
(3) Temporary or permanent disability. 
(4) Congenital anomaly of fetus or infant of the subject.  (5) Requiring hospitalization or prolonged hospitalization. 
(6) Other complications that may result in permanent injuries. 
10. Serious Adverse Device Effect (SADE): Serious adverse effect related to the use 
of an investigational medical device. 
Article 3 Clinical trials shall be conducted as follows: 
1. In accordance with the ethical principles of the Declaration of Helsinki;  
2. To improve citizens’ health, enhance their quality of life, and elevate people’s 
well-being; 
3. In accordance with scientific principles; 
4. In accordance with the principle of minimizing risks and under consideration of 
reasonable risks and interests; 
5. Upon the approval of the Institutional Review Board (hereinafter “IRB”); 
6. After obtaining consent from the subjects; and  
7. With protection of the subjects’ autonomy and privacy. 
Article 4 The sponsor shall draft a proposal for the clinical trial and submit it to the 
IRB and the central competent authority for approval before conducting the clinical 
trial. 
Chapter 2  Sponsor  
Article 5 The sponsor shall develop, implement, and manage the clinical trial(s), 
ensuring the completeness of the data and the rights, safety, and well-being of the 
subjects. 
Article 6 The sponsor shall complete the following preclinical studies for 
investigational medical device. The preclinical data and clinical evaluation results 
shall be comprehensive and adequate to justify the proposed clinical trial: 
1. Product design, 
2. Safety and functionality testing, 
3. Risk analysis, and  
4. Other necessary preclinical studies. 
Article 7 The sponsor shall register the following information of the clinical trial on 
the webpage designated by the central competent authority within 30 days of 
obtaining approval referred to Paragraph 1, Article 4: 
1. The name of the clinical trial institution, 
2. The name of the sponsor, 
3. The name of the investigator, 
4. The name of the clinical trial, 5. Serial number of the official document certifying the approval of the clinical 
trial, 
6. The date of approval, 
7. The purpose of the clinical trial, 
8. The inclusion and exclusion criteria, 
9. The number of subjects, 
10. The name of the investigational medical device, 
11. The stages of the clinical trial, and  
12. Other items required to be registered. 
The sponsor shall update registration information within 30 days of receiving 
approval for the amendments. 
During the clinical trial period, the sponsor shall regularly update the registration 
information in June and December every year. 
Article 8 The sponsor shall prepare the Investigator’s Brochure, clinical investigation 
plan, informed consent form, case report forms, relevant standard operating procedure 
(SOP), and other terms and regulations. 
Article 9 The sponsor shall be responsible for medical care, compensation and other 
applicable regulatory requirements for clinical-investigation-related injuries of 
subjects.  
For clinical trials initiated by the investigator, the clinical trial institution should be 
responsible for the aforementioned liabilities. 
Article 10 Prior to  commencement of the clinical trial, the sponsor shall obtain 
written agreement with the clinical trial institutions and the investigator regarding 
division of tasks, related expenses, and the principles by which injuries, death, or 
other losses shall be dealt with if they result from the trial.  
Article 11  The agreement between the sponsor and the contract research 
organization shall be established in written form. The ultimate responsibility for the 
quality and integrity of the clinical trial data shall reside with the sponsor. 
Article 12  When planning a multicenter clinical trial, the sponsor shall designate 
a coordinating investigator from all investigators. The sponsor shall also delegate 
tasks among the coordinating investigator and other investigators and produce a 
written record. 
Article 13  The sponsor shall prepare the investigational medical device and label 
it as “for use in clinical trials only”. The design, development and manufacture of 
investigational medical device shall comply with the Regulations for the Quality Control System for Medical Devices. 
Article 14  Before the IRB and central competent authority approve the clinical 
investigation plan in accordance with Paragraph 1, Article 4, the sponsor shall not 
supply clinical trial institutions and investigators with investigational medical devices. 
Article 15  The sponsor shall produce and maintain documents and records 
regarding the investigational medical device; the documents and records shall include 
the date of production, product batch number, and conditions of product delivery, 
reception, storage, installation, recycle, and disposal.  
Article 16  The sponsor shall notify all clinical trial institutions and investigators 
of following information and take corresponding responses:  
1. Information that affects the safety and soundness of the clinical trial and other 
critical information affecting the subjects’ rights, 
2. Device deficiencies that could have led to adverse effects, and 
3. Other key information related to the clinical trial. 
The sponsor shall amend the clinical investigation plan, the Investigator’s Brochure, 
the informed consent form, and related regulations, if required, and submit the 
amendments for IRB’s approval for any of the situations specified in the preceding 
paragraph. 
Article 17  The sponsor shall perform on-site monitoring visits to verify the 
following items:  
1. Investigation site team, laboratories, equipment and other related facilities are 
adequate, safely, and properly to conduct the clinical trial. 
2. The compliance of the clinical trial institutions and investigators with the 
approved clinical investigation plan, applicable regulatory requirements, and the 
present regulations. 
3. Subject recruitment progress and the signed and dated informed consent forms 
have been obtained from each subject. 
4. The accurate and completeness of recording of the following items on the case 
report form and other trial-related records: 
4.1 Cover page/login page, page header or footer/identification number of electronic 
case report form, items of case report form; 
4.2 Trial withdrawals, tests that are not conducted, and examinations or follow ups 
that are not performed, 
4.3 Adverse events or other special reactions and their reporting; 
5. The appropriateness of provision, usage, maintenance, delivery, reception, storage, 
and recycle of the investigational medical device; 6. The regular maintenance and calibration of equipment used in the clinical trial; 
and 
7. Confirmation that the investigators and investigation site team have received the 
most up-to-date documents related to the clinical trial. 
The sponsor may assign an external professional party to perform the aforementioned 
monitoring task. 
 
Article 18  The monitor shall submit a written report containing the following 
information to the sponsor after each site visit: 
1. The date and investigation site of the monitoring, 
2. The name of the monitor, 
3. The name of the investigator, 
4. Progress of the clinical trial, 
5. Deviations or drawbacks, 
6. Evaluation results of the monitoring, and 
7. Recommended actions to be secure compliance. 
Article 19  The sponsor may appoint institutions or staff members who are 
independent of the clinical trial team and the monitor to conduct audit. The audit shall 
verify that the clinical trial conduct and compliance with the clinical investigation 
plan, SOPs, the present regulations, applicable regulatory requirements, and ethics.  
Article 20  The audit specified in the previous article must comply with the 
following: 
1. SOPs developed by the sponsor; 
2. Be guided by the importance of the clinical trial, the number of subjects in the 
clinical trial, the type and complexity of the clinical trial, and the level of risks to 
the subjects; and  
3. The observations and findings of the auditor(s) shall be documented. 
Article 21  The sponsor shall immediately suspend or terminate the clinical trial 
under any of the following circumstances, and thereafter shall be handled in 
accordance with Article 64 of the present regulations: 
1. Changing the content of the clinical trial without obtaining approval from the IRB 
or the central competent authority, as stipulated by applicable regulations; 
2. Obvious evidence that the subjects’ rights or safety have been affected; 
3. Obvious abnormal frequency or irregular degree of severity of adverse effects;  
4. Events that may affect evaluation of the clinical trial results; and 
5. Specific facts exists before the completion of the clinical trial proving that the clinical trial has no substantial benefits, higher risks than potential benefits, or 
substantial benefits that are disadvantageous to the control group. 
Article 22  The sponsor shall maintain all relevant documents of the clinical trial, 
including all versions of the documents. The preservation period shall be either 3 
years after the completion of the clinical trial, or 3 years after the approval of the 
marketing application of the investigational medical device in accordance with the 
present regulations. Whichever date is later shall prevail. 
Article 23  If the clinical trial uses an electronic data processing system, the 
followings shall be performed: 
1. Set the requirements for the system specifications; 
2. Ensure that the system complies with the requirements specified per the previous 
subsection; 
3. Ensure the accuracy, completeness, reliability and consistency of inputted data;  
4. Ensure the correctness of the reports outputted; 
5. Ensure that all data changes are documented, the raw data and previous data 
revisions cannot be deleted, and that audit trail, data trail, and edit trail are 
maintained; 
6. Maintain the protection system to prevent unauthorized parties from accessing the 
data; 
7. Maintain a list of individuals authorized who have access to the system as well as 
records regarding their permissions and period of usage; 
8. Ensure that the case report form are signed by the investigator or authorized 
designee; 
9. Regularly backup system information; and 
10. Train system users regarding proper use of the system. 
Article 24  For clinical trials initiated by an investigator, the regulations regarding 
the sponsor should be applicable to the investigator. 
Chapter 3 Clinical Trial Institution and Investigator 
Article 25  Before conducting the clinical trial, the clinical trial institution shall 
evaluate the characteristics of the investigational medical device as well as the human 
resources, space, facilities, and equipment of the clinical trial institution for the proper 
conduct of the clinical trial and produce an evaluation report based on this 
information. 
Article 26  Prior to conduct the clinical trial, the clinical trial institution shall be 
reviewed and approved by the IRB of the clinical trial institution of interest, the IRB of another institution, or any other IRB agreed upon by all interested parties. 
Article 27  An investigator shall possess the following qualifications:  
1. Being a licensed physician with 5 or more years of experience in clinical 
treatment. However, according to Paragraph 1, Article 37 of the present 
regulations, clinical trials that do not involve significant risks may be conducted 
by professional medical personnel who hold a medicine-related professional 
certificate of the specialist category issued by the Competent Authority and have 
engaged in related practice for 5 years or more. 
2. Having received 30 hours of clinical trials related training within the past 6 years, 
including at least 9 hours of related training courses each for clinical trial of 
medical devices, and medical ethics. 
3. Possessing necessary ability to operate the investigational medical device and 
related certificates;  
Individuals who have been subject to medical personnel disciplinary action, or 
whose license have been suspended for more than 1 month or abolished due to any 
violation of laws and regulations related to clinical trials shall not serve as an 
investigator specified in the previous paragraph. 
Article 28   
The investigator shall strictly conduct the clinical trial in compliance with the clinical 
investigation plan, except in cases of emergency where necessary measures must be 
taken.  
Such proviso demands that the investigator state his or her reason within 7 days of 
completing the treatment and report the event to the IRB and the sponsor for review. 
Article 29  Clinical trial data shall be accurately, completely, and immediately 
recorded on the case report form. When revisions are made, the content of the revision 
and the name of the reviser shall be documented, and information regarding the 
original content shall be retained. The investigator shall sign the case report form and 
ensure the data correctness. 
Article 30  The clinical trial institution and the investigator shall maintain clinical 
trial related records, documents, and information for at least 3 years after the 
completion of the clinical trial. However, in cases where other laws and regulations 
stipulate a preservation period longer than 3 years, record preservation shall accord 
with the longer preservation period. 
Article 31  The clinical trial institution and investigator shall appropriately 
maintain the investigational medical device and ensure that it is only used in the 
approved clinical trial. Article 32  The investigator or his/her authorized designee shall fully inform the 
subjects of all pertinent aspects of the clinical trial, the contents of the informed 
consent form, or any known or potential adverse effects. The investigator, or his/her 
authorized designee, shall ensure the information was well understood, signed and 
dated by the subject. 
Article 33  The investigator shall record every adverse event or any investigational 
medical device deficiency. 
Article 34  The clinical trial institution and investigator shall provide adequate 
medical care to a subject during and after a subject’s participation in a clinical trial in 
the case of adverse events. 
Article 35  If the clinical trial institution or the investigator discovers that the risks 
to the subject outweighing the expected benefits, or identifies any factors that may 
affect the appropriateness of the clinical trial, they shall immediately suspend or 
terminate the clinical trial and report to the IRB and the sponsor.  
Article 36  The central competent authority may inspect the clinical trial 
institution and the investigator and demand clinical trial-related information.  
The clinical trial institution and the investigator shall not obstruct, evade, or refuse the 
aforementioned inspection or demands. 
Chapter 4  Clinical Trial Institutional Review Board 
Article 37  An IRB review of a clinical trial comprises the following items: 
1. Application, amendment, termination, or resumption after suspension of a clinical 
trial, 
2. Regular progress reports, 
3. Deviation reports, 
4. Serious adverse effect reports, 
5. Clinical investigation report, 
6. Disclosure of conflicts of interest from investigation site team, and 
7. Other key items related to the clinical trial. 
The IRB shall audit ongoing clinical trial at least once per year. 
Article 38  Attention shall be directed to the following items in the IRB’s review 
of the clinical investigation plan: 
1. The clinical trial design should comply with the principle of minimizing risks and 
considerations of reasonable risks and interests; 
2. Conduction and content of clinical trial comply with scientific principles; 
3. Inclusion and exclusion criteria and recruitment methods; 4. Medical care, damage or loss compensation, and other remedy provide to the 
subjects; 
5. Protection of the subjects’ privacy; 
6. The content of the informed consent form and the process of obtaining inform 
consent; 
7. The protection of vulnerable populations; and 
8. Necessary management measures protecting the safety of the subjects. 
 
Article 39  Following the review described in Article 37, a decision shall be made 
in a written form and shall include the following items: 
1. Name of the clinical investigation plan; 
2. Version number and development date of the clinical investigation plan, informed 
consent form, case report form, and other clinical trial-related information; 
3. The clinical trial institution, investigator, and sponsor; 
4. Review results and rationales; and  
5. The date upon which the review decision was made. 
Article 40  The IRB shall have at least five members, including law experts and 
other persons of disinterested community members; more than 2/5 shall not be 
affiliated with the clinical trial institution; and members of either gender shall not 
comprise less than 1/3 of the total number of members. 
Article 41   IRB members shall recuse himself/herself in any of the following 
situations: 
1. Being the investigator, coinvestigator, or sponsor of the clinical trial under review; 
2. Being, currently or in the past, the spouse, any relative within the fourth degree of 
relationship or relative by marriage of third degree of relationship of the 
investigator; 
3. Having an employment relationship with the sponsor; and 
4. Other situations deemed necessary by the IRB for the avoidance of conflicts of 
interest. 
Article 42  IRB members who have not participated in IRB reviews and 
discussions shall not participate in decision-making. 
Article 43  Without valid reasons, IRB members and other individuals who have 
participated in reviews shall not disclose any confidential they have obtained from 
performing their duties. 
Article 44  The list of members of IRB and the meeting minutes shall be published. 
Article 45  When conducting the review or inspection referred to in Article 37, the 
IRB may demand that the investigator or sponsor improve the clinical trial within a 
given period of time and may suspend or terminate the trial upon identification of any 
of the following situations: 
1. Changing the content of the clinical trial without obtaining approval from the IRB 
or the central competent authority, as stipulated by applicable regulations; 
2. Obvious evidence that the subjects’ rights or safety have been affected; 
3. Obvious abnormal frequency or irregular degree of severity of adverse effects;  
4. Evidence verifying that the clinical trial is no longer necessary; and  
5. The occurrence of other situations that affect evaluations of the trial’s risks and 
benefits.  
Article 46   
After completion of the clinical trial, the IRB shall conduct an investigation and notify 
to the clinical trial institution and the central competent authority upon identification 
of any of the following situations: 
1. Violations of laws or regulations or noncompliance with the clinical investigation 
plan, 
2. Severe late onset adverse events, and 
3. Severe effect on subjects’ rights. 
Article 47  The IRB shall preserve the clinical investigation plan, meeting minutes, 
inspection records, and other related documents for at least 3 years after clinical trial 
completion. 
Article 48  The IRB shall not obstruct, evade, impede, or refuse inspections 
conducted by the central competent authority. 
Chapter 5  Informed Consent Form  
Article 49  The informed consent form shall be signed and dated by the subject or 
the subject’s legal representative, assistant, or guardian as well as the investigator or 
the coinvestigator. 
A copy of the aforementioned informed consent form shall be given to the subject. 
Article 50  The subjects of clinical trial shall comprise only adults with disposing 
capacity. However, the preceding provision does not apply to clinical trial that is 
apparently beneficial to the health rights of specific populations or patients with 
special diseases.  
Where a subject described in the proviso of the preceding paragraph has been judicially declared to be of limited capacity or under assistance, consent shall be 
obtained from both the subject and his/her legal representative or assistant. Where the 
subject is a person with no disposing capacity, consent shall be obtained from his/her 
legal representative or guardian. Situations applicable to Paragraph 3, Article 12 of the 
Human Subjects Research Act can be handled as per the regulation.  
When the subject is a person with no disposing capacity as described in the previous 
paragraph, the investigator shall inform subject of clinical trial-related information 
within his/her ability to understand. 
When changes occur in a subject’s legal capacity or status of being under assistance, 
informed consent shall be reobtained. 
Article 51  Paragraph 2, Article 37 in this Act refers to emergency situations where 
all of the following situations are fulfilled, and where the clinical investigation plan 
has specified that the clinical trial may be conducted prior to obtaining informed 
consent form from the subject, or the subject’s legal representative, assistant, or 
guardian. 
1. The subject in a life-threatening emergency situation, 
2. No sufficient clinical benefits are anticipated from the currently available 
treatment, 
3. There is a fair possibility that the life-threatening risk to subject can be avoided if  
the investigational medical device is used, 
4. anticipated risks are outweighed by the potential benefits of applying the 
investigational medical device, and 
5. The subject is inability to communicate with, and their legal representative, 
assistant, or guardian cannot immediately be contacted for consent. 
For situations specified in the previous paragraph, the informed consent from the 
subject, or the subject’s legal representative, assistant, or guardian shall be obtained as 
soon as possible. The subject’s relevant information may not be used if the consent 
has not been obtained. 
Article 52  The subject, or the subject’s legal representative, assistant, or guardian, 
referred to the previous article may withdraw their consent at any time.  
The clinical trial institution shall continue to provide standard medical care to patients 
who decline to participate in the trial or who later withdraw their consent, as stated in 
the preceding paragraph. These individuals’ legitimate right to medical care shall not 
be infringed upon.  
Article 53  If the subject or the subject’s legally acceptable representative is 
unable to read the inform consent form and other written information provided to the 
subject, an independent witness shall be present throughout the entire discussion of informed consent.  
The witness shall read the previously mentioned informed consent form as well as the 
other written information and witness the investigator or the investigator’s authorized 
designee providing a comprehensive explanation to the subject or the subject’s legal 
representative, assistant, or guardian.  
The witness shall ensure that the subject, or the subject’s legal representative, assistant, 
or guardian, fully understands the clinical trial and the subject’s rights and obligations 
as well as that their decisions are made according to their free will.  
After completing the preceding three procedures, the subject; the subject’s legal 
representative, assistant, or guardian; and the witness shall personally sign and date 
the informed consent form. Except for the witness, finger print is an acceptable 
substitute for signature.  
Members of the investigation site team shall not serve as witnesses. 
Article 54  The informed consent form shall include the following information: 
1. The name of the sponsor and the clinical trial institution;  
2. The name, title, and contact information of the investigator; 
3. The purpose and method of the clinical trial; 
4. The expected risks and side effects; 
5. The expected result of the clinical trial; 
6. Other possible therapeutic methods and explanations; 
7. The subject’s right to withdraw their consent at any time; 
8. Loss compensation, damage compensation, or insurance mechanisms related to 
the trial;  
9. Prohibition against charging the subjects any fees for the clinical trial; 
10. That the subject’s information will be kept confidential, and the right of the 
sponsor, IRB, and central competent authority to examine the information at any 
time deemed necessary; 
11. The preservation and reutilization of the subject’s biological specimen, personal 
information, and the derivatives; and 
12. The domestic registration status or the license status of the investigational medical 
device. 
Article 55  If the informed consent form is amended in a manner that affects the 
rights of the subjects, signed and dated informed consent form shall be obtained from 
the subjects, or from their legal representative, assistant, or guardian before the trial is 
conducted in accordance with the amended informed consent form. 
Article 56   
The sponsor, clinical trial investigator, and other relevant personnel shall not entice subjects to participate in the clinical trial through unjustifiable means such as coercion 
or monetary incentives. 
The sponsor, clinical trial investigator, and other relevant personnel responsible for 
payments to the subjects, such as compensation for transportation and 
nutrition-related expenses, shall be specified in the inform consent form. 
Article 57  The sponsor or clinical trial institution shall not charge subjects for any 
fees related to the clinical trial. 
Chapter 6  Application, Suspension, Termination, and Close-out of the 
Clinical Trials  
Article 58  The clinical trial institution or the sponsor shall submit an application 
form and the following documents and information for applying for a clinical 
approval of medical devices: 
1. Medical device business permit, 
2. Proposal of the clinical investigation plan and its Chinese-language abstract, 
3. Informed consent form, 
4. Case report form, 
5. Qualification certificate of the investigator and the clinical trial institution, 
6. Evaluation report specified in Article 25, 
7. Information and related documents for compensation available in the event of 
injury and loss arising from participation in the clinical trial, 
8. Investigator’s Brochure, and 
9. Preclinical information and instructions of the investigational medical device. 
Clinical trial applications from clinical trial institutions need not include the document 
referred to in item 1 of preceding paragraph. 
Article 59  The following items shall be specified in the clinical investigation 
plan: 
1. The title of the clinical trial; 
2. The name and address of the sponsor;  
3. The name of the clinical trial institution; 
4. The name, title, and contact information of the investigator and the coinvestigator; 
5. The purpose of clinical trial; 
6. Clinical trial design; 
7. Basic information about the investigational medical device, 
8. Inclusion and exclusion criteria, recruitment method, and number of subjects; 
9. Description of the process for obtaining informed consent; 
10. Procedures for data-processing; 11. Statistical considerations;  
12. Adverse events, adverse device effects, and medical device deficiencies; 
13. Procedures for recording, reporting, and analyzing clinical investigation plan 
deviations; and 
14. Criteria and arrangements for suspension or termination of the clinical trial. 
Article 60  The following items shall be specified in the Investigator’s Brochure: 
1. General information of the investigational medical device, 
2. Preclinical testing data that has been performed on the investigational medical 
device, 
3. The relevant previous clinical trial data of the investigational medical device, and 
4. Risk management of the investigational medical device. 
Article 61  In the case of clinical investigation plan amendments, the sponsor shall 
submit the application form and attach the following documents and information to 
the central competent authority: 
1. Copies of previous official documents verifying approval from the central 
competent authority, 
2. Documents and information from before and after the amendment, and 
3. A list of changes in the clinical investigation plan to compare the content before 
and after the amendment. 
The amendment can only be conducted after approval has been obtained from the 
Competent Authority. 
Article 62  During the term of clinical trial conduction, the sponsor, investigator, 
and clinical trial institution shall present status reports of clinical trial to the central 
competent authority. 
Article 63  After close-out or premature termination of the clinical trial, the 
sponsor shall produce and submit a clinical investigation report to the central 
competent authority for recordation. 
Article 64  In cases where a trial is suspended or prematurely terminated in 
accordance with Articles 21, 35, or 45 of the present regulations or Article 39 of this 
Act, the sponsor shall immediately notify the clinical trial institution, the investigator, 
the IRB, and the central competent authority. 
For clinical trials initiated by the investigator, the notification shall be conducted by 
the clinical trial institution. 
Article 65  Suspended clinical trials can only be resumed after approval has been 
obtained from the IRB and the central competent authority. Article 66  During the clinical trial period, no results can be publicized, and no 
promotional campaigns can be conducted. 
Article 67  For the clinical trial that do not involve significant risks specified in 
the Paragraph 1, Article 37 of this Act, the provisions of Articles 58 and 61 –64 do 
not apply; the requirements for approval from the central competent authority as 
stipulated in Articles 4 and 65 do also not apply.  
Chapter 7  Adverse Events  Handling  
Article 68  The investigator shall immediately report to the clinical trial institution, 
sponsor, and IRB serious adverse events and event that could have led to a serious 
adverse device effect. The immediate reports shall be followed by detailed, written 
reports. 
Article 69  In addition to those provided in Article 38 of this Act, the sponsor shall 
report to the central competent authority about device deficiencies that could have led 
to a serious adverse device effects. 
The reporting referred to in the preceding paragraph shall be made within 7 days after 
becoming aware of the actual happening of the occurrence, and detailed investigation 
information shall be submitted to the central competent authority within 15 days. 
Article 70  The sponsor specified in Article 12 shall inform all investigators in 
writing of all the serious adverse events at all medical trial institutions that have been 
reported to sponsor, and ensure that they are reported to their IRBs. 
Chapter 8  Supplementary Provisions  
Article 71  For clinical trials conducted by the sponsor or the clinical trial 
institution that have been approved in accordance with other regulations governing 
medical device clinical trials prior to the implementation of the present Regulations, 
the previous regulations shall prevail. 
Article 72  The Regulations shall take effect on the day of promulgation.