Regulations on Good Clinical Practice  for Medical Devices  
 
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 /Human 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 ca nnot 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 E vent (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 in accordance with the following provisions:  
1. Comply with the ethical principles of the Declaration of Helsinki;   
2. Conform to scientific principles;  
3. Adhere  to principles of risk minimization to minimize harm to subjects and ensure 
that risks and benefits are balanced;  
4. Obtain approval from  the Institutional Review Board ( hereinafter “ IRB”); 
5. Obtain the consent of subjects; and    
6. Protect the autonomy and privac y of subjects.  
Article 4  The sponsor shall draft a clinical investigation plan and submit it to the IRB 
and the central competent authority for approval before conducting the clinical trial.  
The investigator and clinical trial institution shall conduct cli nical trial in accordance 
with clinical investigation plan that has been approved in the preceding paragraph.  
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 functional ity testing,  
3. Risk analysis, and  
4. Other necessary preclinical stud ies. 
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 n ame of the  clinical trial institution,  
2. The n ame of the sponsor , 
3. The n ame 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 d ate of approval,  
7. The purpose of the clinical trial,  
8. The i nclusion and exclusion criteria,  
9. The n umber of subjects,  10. The n ame of the investi gational medical device , 
11. The s tages 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 procedu re 
(SOP),  and other terms and regulations.  
Article 9  The sponsor shall be held liable for medical care, compensation for 
damages and losses, and other legal responsibilities in the event of injury, death, or 
other losses of the clinical trial subjects.  
Under any of the following circumstances , the sponsor  shall be exempted from the 
compensation liability for  damages and losses specified  in the preceding paragraph:  
1. The subject consent form has  listed the possible adverse reactions, side effects , 
or risks  in the clinical trial.  
2. The sponsor  can prove that  the due care in carrying out a medical procedure has 
been exercised.  
3. The sponsor can prove that such harm is not caused by willful act or negligence . 
If the clinical trial is initiated by the investigator , provisions of the preceding two 
paragraphs shall apply to the clinical trial institution.  
Articl e 10 Prior to  commencement of the clinical trial , the sponsor shall obtain  
written agreement  with the  clinical trial  institution s 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 all investigational medical devices and label 
them as “for clinical trial use only”.  The development and manufacture of  the devices specified  in the preceding paragraph 
shall comply with the requirements of the Regulations Governing Medical Device Quality 
Management System .  
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 institution s and investigator s 
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  institution s and investigator s 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/lo gin 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 an d 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 investigator s and investigation site team  have received the 
most up-to-date documents related to the clinical trial.  
The sponsor may assign external professionals (hereinafter “the monitor”) to perform 
monitoring activities specified in the preceding paragraph.  
Article 18  The monitor shall submit a written report containing the following 
information to the sponsor after each site visit : 
1. The d ate and  investigation  site of the monitoring,  
2. The n ame of the monitor,  
3. The n ame 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 shall  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 compl iance  with the clinical investigation 
plan, SOPs, the present Regulations, applicable regulatory requirements , and ethics.  
Article 20  Audit of a clinical trial referred to in the preceding article shall be 
conducted in accordance with the following provisions:  
1. The sponsor shall formulate an audit plan and standard operating regulations in 
accordance with the importance of the clinical trial, number of subjects, trial type, 
complexity of the trial, and degree of risk.  
2. Comply with the audit plan and standard operating regulations referred to in the 
preceding paragraph.  
3. The auditor’s observations, findings, and conclusions shall be recorde d in writing.  
Article 21  The sponsor  shall immediately suspend  or terminat e 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 freque ncy or irregular degree of severity of adverse effects ;  4. Events that may affect evaluation of the clinical trial  results ; and 
5. Specific facts exists b efore 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 document s 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 th is 
Act. Whichever date is later shall prevail.  
Article 23  If the  clinical trial uses an electronic data processing system, the 
following s 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 use rs 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 c onduct the clinical trial, the clinical trial  institution sh all 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 investi gator 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 th is Act, clinical trials 
that do not involve significant  risks may be conducted by professional medical 
personnel who hold a medi cine-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 o f 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. Possess ing necessary ability to operate the investigational medical  device an d 
related certificates;  
Individuals who have been subject to medical personnel disciplinary action , or 
whose license have been suspend ed 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 
recorde d 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 la ws 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 medica l 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 content s 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 investigat ional 
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 risk s 
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 investi gator shall not obstruct, evade, or refuse the 
aforementioned inspection or demand s. 
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 design and execution of clinical trials must co mply with the principles of risk minimization to minimize harm to subjects and ensure that risks and benefits are 
balanced.  
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 m anagement 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 
situation s: 
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 follow ing 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 risk s and 
benefit s.  
Article 4 6 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 n oncompliance 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 Subject s 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  refer s 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 t he current ly 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 potentia l 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 part icipate 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 i s 
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 provid ing 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 understand s 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 p receding 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 n ame of the sponsor and the clinical trial institution ;  
2. The n ame, title, and contact information of the investigator ; 
3. The purpose  and method of the clinical trial; 
4. The e xpected risks and side effects ; 
5. The e xpected 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 affect s 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 participat e 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 
nutrit ion-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 p ermit,  
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 c ompensation  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 ad dress of the sponsor ;  
3. The n ame of the  clinical trial  institution ; 
4. The n ame, 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 d ata-processing ; 
11. Statistical considerations ;  
12. Adverse events , adverse de vice effects , and medical device deficiencies ; 
13. Procedures for recording , reporting, and analy zing clinical investigation plan 
deviations ; and 
14. Criteria and arrangements for s uspension or termination of the clinical trial.  
Article 60  The following items shall  be specified in  the Investigator’s Broch ure: 
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 investiga tional 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 o nly be resumed after approval has been 
obtained from the IRB and the central competent authority.  
Article 66  The sponsor, clinical trial institution, or investigator shall not publish or 
promote the results of the clinical trial before the final report is approved for reference or 
before project closure.  
The restrictions on  the publishing and promoting of results specified  in the preceding 
paragraph shall not be circumvented by the  sponsor , clinical trial institution, or 
investigator through interviews or reports.  
Articl e 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 requirement s for approval from the central competent authority as 
stipulated in Articles 4 and 65 do also not apply.  
Chapter 7  Adverse Events  Handling  
Article 6 8 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 
report s. 
Article 6 9 In addition to those  provided in Article 38 of  this Act , the sponsor shall 
report to the central competent authority about device deficiencies t hat 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 trial s 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 present Regulations shall come into force as of May 1, 2021.