1 Draft for Medical Devices Act  
 
Chapter I  General Provisions  
 
Article 1  This Act is established to manage the safety,  effectiveness , and quality of 
medical devices and to ensure the health of citizens.  
 
Article 2  For purposes of this Act, the term "competent authority" shall  mean the 
Ministry of Health and Welfare at the central government  level, the municipal 
governments at the municipal level, and the  county/city governm ents at the 
county/city level.  
 
Article 3  The term "medical devices", as used in this Act, shall refer to any 
instrument , machine , apparatus, material , software, reagent  for in vitro use, and 
other similar or related article , which is used in diagnosing, treating, alleviating, or 
directly preventing human diseases,  regulating fertility , or which may affect the 
body structure or functions of human beings, and do es not achieve its primary 
intended functions by pharmacological, chemical reaction, immunological, or 
metabolic means in or on the human body.  
Regulations governing the categories, classification, items, and other matters  
to be  complie d with  for medical devices in the preceding paragraph shall be 
established by the central competent authority . 
 
Article 4  The term " investigational medical devices ", as used in this Act, shall refer 
to medical devices that are used in clinical trials and whose therapeutic effect  and 
safety have not yet been verified.  
 
Article 5 The term "medical device clinical trials ", as used in this Act, shall refer to 
the systematic studies on the safety or effectiveness  of medical devices carried out 
in human subjects  by medical institutions or the non -medical institutions 
announced by the central competent authority (here inafter referred to in short as 
"clinical trial institutions "). 
 
Article 6  The term " medical device  advertisement s", as used in this Act, shall refer 
to the act of advertising the therapeutic effect  and product performance of 
medical devices by means of communications for the purpose of soliciting and 
promoting the sale thereof.  
Interviews, news reports, or propaganda containing information that implies 2 or suggests therapeutic effect of medical devices for the purpose of soliciting and 
promoting the sale thereof shall be regarded as medical device advertisements.  
 
Article 7  The term "label s", as used in this Act, shall refer to the words, graphics, 
or symbols directly displayed on a medical device or the packaging thereof.  
The term "instruction s", as used in this Act, shall refer to the information of 
product related  description  on the safety,  effectiveness , and use of medical 
devices.  
 
Article 8  The term "defective medical devices", as used in this Act, shall refer to 
any medical device which falls within  any of the following circumstances after 
inspection or testing:  
1. Which misleads diagnosis or contains toxic or hazardous substances and  
consequently is detrimental to the health of human  body ; 
2. Which, when used, is liable to cause danger or harm to the health of human  
body ; 
3. Which has expired its duration of validity or storage life;  
4. Whose  performance or specification is inconsistent with that approved in 
registration, listing, or the announcement set forth in Paragraph 2 of Article 30;  
5. Which is not preserved under the storage conditions as approved in 
registration;  
6. Which has mixed or packed with foreign object that affect s the quality.  
 
Article 9  The term " medical device firms ", as used in this Act, shall refer to 
medical device manufacturers or dealers . 
 
Article 10   The term " medical device manufacturers ", as used in this Act, shall refer 
to businesses that fall into the following two types:  
1. Engaging in manufacturing, packaging, label ing, sterilization, or final inspection 
and release regarding medical devices;  
2. Designing medical  devices and marketing the devices under their  name.  
 
Article 11  The term " medical device dealers ", as used in this Act, shall refer to 
businesses which engage in the wholesale, retail, import, export, rental, or repair 
of medical devices.  
 
Article 12  The term "medical institution s", as used in this Act, shall refer to 
institution s that have  obtained approval for business commencement as applied 3 for by the medica l personnel defined in Paragraph 1 of Article 10 of the Medical 
Care Act in accordance with the provisions of the respective specialty medical 
profession laws and regulations.  
 
Chapter II  Management of Manufacturing and Sale  
 
Article 13  Those other than medical device firms  shall not engage in the business 
activities specified in all of the subparagraphs of Article 10 and Article 11.  
Any person with the intent to be a medical device firm shall file an application 
with the municipal or county/city health a uthority for approval and registration, 
and shall start the operation only after having obtained the business  permit . In 
case of any change  in the particulars registered, an application for such change 
registration shall be completed.  
For setting up a manufacturing site or a business office, a medical device firm 
shall file a separate application for medical device firm registration in accordance 
with the provisions of the preceding paragraph, and shall manufacture, sell, or 
supply medical devices at the registered place. However, those announced by the 
central competent authority shall not be required to apply separately for a medical 
device dealer permit  at the business office  or sell or supply medical devices at the 
registered place.  
 
Article 14  Those applying for being registered as a medical device manufacturer  
may also engage in such business  as wholesale, export, retail, rental, or repair of 
self-manufactured medical devices that have been listed or approved , or import of 
raw material s for their own use without applying for a medical device dealer 
permit . 
Pharmacies may concurrently engage in the retail of medical devices of the 
classes announced by the central competent authority. Except for the exemption 
from applying for a medical device dealer permit, provisions governing the medical 
device dealers  set forth in this Act  shall apply.  
 
Article 15  Medical device manufacturers and dealers engaging in the import or 
repair of medical devices shall employ qualified technicians accordin g to the 
categories of medical devices.  
The categories of medical devices, qualifications for a technician, and 
regulations governing other relevant matters  set forth in the preceding paragraph  
shall be established by the central competent authority.  
 4 Article 16  To apply for suspension of business, medical device firms  shall hand in 
the medical device business permit and their medical device license  to the 
munic ipal or county (city) competent authority, which are to be noted  clearly the 
reason and term of suspension on the business permit and  returned after 
resumption of business is approved. Each period of suspension shall not exceed 
one year. In the case that the municipal or county (city) competent authority has 
not approved the continuation of suspension when the period of suspension 
expire s, the said firm shall apply for resumption of business within 30 days before 
the period of suspension expires.  
To apply for termination of business, medical device firms  shall hand in for 
cancellation both the medical device business permit  and me dical device license  
obtained . Those which have  failed to be hand ed in for cancellation  shall be 
cancelled  by the original issuing competent authority . 
In the case that the medical device firm does not apply for suspension, 
termination, or resumption of business within the given period, the original issuing 
competent authority shall cancel related permits and licenses after the municipal 
or county (city) competent authority verifies that no business is in operation  at the 
original address.  
The permits and licenses of those violating the provisions of this Act and 
subject to suspension of business imposed by the competent authori ty, shall be 
handed in, noted, and returned in accordance with the provisions of the first 
paragraph.  
 
Article 17  Medical device firms  shall not purchase  or rent medical devices from 
unknown sources or supplied by those other than medical device firms . 
 
Article 18  The central competent authority may announce specific categories and 
items of medical devices with  restriction on their sale or suppl y type  according to 
the risk of using such medi cal devices.  
 
Article 19  Medical device firms  shall establish  and maintain  data on direct supply 
sources and flow of products. However,  this shall  not apply to the data on flow of 
products that are directly sold to consumers.  
Regulations governing t he scope , methods for establishment and 
maintenance  of data set forth in the preceding paragraph, as well as  other  matters 
to be complied with shall be established by the central competent authority.  
 
Article 20  The manufacture of medical devices shall be done by medical device 5 manufacturers . The facilities, equipment, and sanitary conditions of medical 
device manufacturers shall  be established pursuant  to the Establishment 
Standards for Medical Device Manufacturers , except for  medical device 
manufacturers set forth in Subparagraph 2  of Paragraph 1  of Article 10.  
The Establishment Standards for Medical Device Manufacturers  in the 
preceding paragraph  shall be jointly prescribed  by the central competent authority 
and central industr y authority.  
 
Article 21  Medical device m anufacturers in Paragraph  1 of Article 10 shall carry out  
factory registration pursuant to  the Factory Management Act, except when 
exemption from factory registration is allowed pursuant to the Factory 
Management Act, or if such manufacture , as approved by the central competent 
authority, is for research and development purposes.  
 
Article 22  Medical device  manufacturers shall establish a medical device  quality 
management system  govern ing the on-site facilities, equipment, organization and 
personnel, production, quality control, storage, logistics, customer compla ints, and 
other matters.  Its regulations for quality management system  shall be prescribed  
by the central competent authority.  
Medical device  manufacturers shall comply with the provisions  of the 
Regulations for Medical Device  Quality Management System  set forth  in the 
preceding paragraph, and the manufacture may only begin after receiving a  
compliance  inspection by the central competent authority and obtain ing a medical 
device  manufactur ing license . However, this shall not apply to items that, per 
public announcement by the central competent authority, do not need to  obtain 
manufactur ing license . 
The provisions of the preceding two paragraphs shall apply mutatis mutandis 
to overseas  manufacturers importing medical devices , and the  central competent 
authority shall  send personnel to locations of such overseas manufacturers for 
inspection on a periodic  basis or as necessary.  
Regulations governing the contents and methods of inspection  set forth in 
Paragraph 2, the requirements, procedures, review, issuance, validity period, 
revocation  or cancellation of approval , and other matters to be complied with shall 
be established by the central competent authority.  
 
Article 23  Medical device m anufacturers shall not commission other manufacturers 
to manufacture or accept the commissioning from other manufacturers to 
manufacture medical devices, unless otherwise approved by the central 6 competent authority.  
Medical device d ealers shall not manufacture medical devices. However, this 
shall not apply to those approved by the central competent authority to 
commission other medical device manufacturers to manufacture medical devices.  
The operational regulations  governing the application  documents , product 
liability, contractual  provisions , label ing, packaging, and other matters to be 
complied with in regard to the commissioning of manufacture set forth in the 
preceding two paragraphs shall be established by the central competent authority.  
 
Article 24  Medical device d ealers , per public announcement by the central 
competent authority, shall establish a good distribution practice system  governing 
the product storage, distribution, services, personnel deployment, and other 
relevant  operational matters . Its regulations  for g ood distribution practice shall be 
prescribed by the central competent authority.  
Medical device d ealers shall comply with the provisions of the Regulations for 
Medical Device Good Distribution Practice set forth in the preceding paragraph, 
and the wholesale, import, or export may only begin after receiving a compliance 
inspection by the central competent authority and obtaining a medical device  
distribution li cense . 
Regulations governing  the contents and methods of inspection  set forth in 
the preceding paragraph, the requirements, procedures, review, issuance, validity 
period, revocation or cancellation of approval , and other matters to be complied 
with shall be established by the central competent authority.  
 
Chapter III  Listing , Registration and Market Approval of Medical Devices  
 
Article 25  For the manufactur e and import  of medical devices, an application shall 
be filed with the central competent authority for registration and market approval. 
No manufactur e or import shall be allowed until approval is granted and a medical 
device license  is issued.  
The manufactur e or import for medical device items announced by the 
central competent autho rity shall be done by means of listing  application, and is 
exempt from the provisions of the preceding paragraph.  
The registration and m arket approval of medical devices, as required in 
Paragraph 1, shal l not be done by means of listing , as set forth in the preceding 
paragraph.  
The import of medical devices shall be done by license  holders, tho se who 
have completed the listing , or t heir authorized persons.  7 If the medical device that shall be listed in ac cord ance  with the provisions of 
Paragraph 2 has obtained medical device license approval before this Act becomes 
effective, the central competent authority shall complete the listing directly, cancel 
the original  license , and notify the license holder.  
 
Article 26  Alteration may only be made to any of the particulars of registrati on and 
market approval or listing  pertaining to any medical device designated by the 
central competent authority after approval of the central competent authority is 
obtained.  
 
Article 27  A medical device manufactur e or import license  is valid for five years. 
Where it is necessary to continue the manufactur e or import  upon expiration, a 
prior application shall be submitted to the central competent authority for 
approval of license extension. However, the period of ea ch extension shall be no 
more than five years. If upon expiration , no application for extension is submitted 
or the application for extension is not approved , the original license  shall expire 
and be cancelled by the central competent authority . 
In case that the license  set forth in the preceding paragraph can no longer be 
used due to stain  or damage, an application shall be submitted along with the 
original license  to the central competent authority for replacement. In case of loss, 
an application for re -issuance shall be filed.  
 
Article 28  Medical device firms  that have completed t he listing  of medical devices 
shall file an annual declaration with the central competent authority each year. In 
case of failure to file a declaration within the g iven period, the original listing  shall  
become invalid. This shall  also appl y to the medical devices subject to direct listing  
as stipulated in the provisions of Paragraph 5 of Article 25.  
 
Article 29  Regulations governing the following matters and other matters to be 
complied with shall be established by the central compe tent authority:  
1. Requirements, procedures, and review guidelines  in regard to the application 
for registration and market approval of medical devices and issuance of licenses  
or listing  in accordance with the provisions of Article 25;  
2. Requirements and procedures in regard to the application for alteration of the 
particulars of registration and market approval or listing  in accordance with the 
provisions of Article 26;  
3. Procedures in regard to the application for extension, replacement, and 
re-issuance of licenses  in accordance with the provisions of Article 27;  8 4. Procedures in regard to the annual declaration  in accordance with the 
provisions of Article 28.  
 
Article 30  Medical device items designated by the central competent authority 
shall comply with  specific specifications and performance.  
The items, specifications, and performance of the medical devices set forth in 
the preceding paragraph shall be announced by the central competent authority.  
 
Article 31  The central competent authority may publicize the specifications, 
instructions, and other relevant data kept and held in applications that are 
submitted by medical device firms  for the manufactur e or import  of medical 
devices . The extent and method of publication shall be stipulated in the 
Enforcement Rules of this Act.  
Any trade secret  in the contents provided by medical device firms  for 
registration and market approval or listing  shall be kept confidential.  
 
Article 32   Medical device firms  that manufactur e or import medical devices  shall 
attach labels in Chinese to the smallest packaging unit for sale and provide Chinese  
instructions before engaging in the sale, wholesale, and retail. However,  this shall 
not apply to those announced or approved by the central competent authority 
due to the difficulty in compliance.  
 
Article 33  Medical device firms  shall indicate the following particulars on the labels, 
instructions, or packaging of medical devices, as approved, registered and 
approved, or listed in accordance with Articles 13 and 25. However, this shall not 
apply to those exempt fr om such indication, as announced by the central 
competent authority:  
1. Product name;  
2. License  number or listing  number;  
3. Effectiveness , intended use , or indications;  
4. Date of manufacture and period of validity or shelf -life; 
5. Model number, specifications, or major components;  
6. Warnings, cautions, use limitations  or expected and foreseeable side effects;  
7. Name and address of the license  holder or the person who completed the 
listing ; 
8. Name and address of the man ufacturer;  
9. Lot number or serial number;  9 10. Other particulars that shall be indicated, as announced by the central 
competent authority.  
The instructions set forth in the preceding paragraph may be replaced by 
electronic instructions as announced by t he central competent authority.  
 
Article 34  Manufacturers exporting domestically manufactured medical devices to 
foreign countries may apply to the central competent authority for certificates 
required by the countries where such medical devices are to be exported.  
Medical devices referred to in the preceding paragraph  may be restrict ed for 
export  when t he central competent authority deems that there is a concern of 
insufficiency to meet domestic demand . 
Medical devices that are approved to be manufactured for export only shall 
not be sold domestically. However, this shall not apply whe n the central 
competent authority deems that there is a concern  over domestic demand . 
 
Article 35  The central competent authority may grant  special approval for 
manufactur e or import  of specific medical devices without the limitations set forth 
in Paragraphs 1 and 2 of Article 25 if any of the following circumstances applies:  
1. For the purpose of preventing, diagnosing, or treating life -threatening diseases 
or diseases causing severe disability, with no appropriate alternative treatmen t 
available yet  domestically ; 
2. The necessity of responding to public health emergencies;  
3. Investigational medical devices ; 
4. For exclusive use as samples or gifts ; 
5. Where the import thereof is for the exclusive purpose of repair, and not for 
circulat ion or sale domestically after the repair is completed.  
Regulations governing the application requirements, review procedures, 
approval criteria, restrictions on supply and sale, return, and other matters to be 
complied with in regard to the special approval set forth in the preceding 
paragraph shall be established by the central competent authority.  
 
Article 36  If any of the following circumstances applies to the medical devices for 
which special a pproval for manufactur e or import has been obtained as set forth 
in the preceding paragraph, the central competent authority may cancel the 
aforesaid approval and order the applicant  to deal with the said medical devices 
within a given period, a nd may issue recall announcements:  
1. An appropriate alternative treatment becomes available;  
2. The public health emergency situation is over;  10 3. There is concern  about the safety or therapeutic effect as evaluated and 
confirmed by the central competent authority.  
 
Article 37  The central competent authority and central industr y authority may 
provide incentives for research and development of innovative medical device 
technologies.  
Regulations governing the eligibility criter ia and review procedures of  the 
incentives set forth in the preceding paragraph, as well as  other matters to be 
complied with may be jointly established by the central competent authority and 
central industr y authority.  
 
Chapter IV  Management of Medical Device Clinical Trials  
 
Article 38  Clinical trial institutions shall submit an application to the central 
competent authority and obtain its approval before implementing any clinical trial, 
with the exception of implementing clinical trials that do not involve significant 
risks as announced by the central competent authority.  
Regulations governing the scope of management, operational  practices , 
application  procedures , review  guid elines , avoidance of conflicts of interest, 
information disclosure, supervision and administration,  inspection , and other 
matters to be complied with pertaining to clinical trials shall be established by the 
central competent authority.  
 
Articl e 39 Clinical trial institutions  shall report to the central competent authority 
when the human subject  of a medical device clinical trial experience s any of the 
following occurrences during implementation of the clinical trial : 
1. Death;  
2. Life -threatening situation ; 
3. Permanent physical or mental disability;  
4. Congenital anomaly of fetus or infant  of the human subject ; 
5. Requiring  hospitalization or prolonged hospitalization;  
6. Other complications that may result in permanent damage.  
Clinical trial institutions  shall report to the central competent authority when 
the human  subject experience s any of the occurrences in the preceding paragraph 
after termination  of the clinical trial  and when the occurrence  is related to the 
clinical trial . 
The reporting referred to in the preceding two paragraphs shall be made 
within seven days after becoming aware of the actual happening of the occurrence , 11 and detailed investigation information shall be submitted to the central competent 
authority within fifteen days for recordation.  
 
Article 40  In the event that the central competent authority deems there is a safety 
concern  of clinical trial , it may order institution s implementing the trial to sus pend 
or terminate the trial or to adopt other necessary measures.  
 
Chapter V  Management of Medical Device Advertisements  
 
Article 41  Businesses other than medical device firms  are not allowed to engage in 
advertising of medical devices.  
 
Article 42  In the event that a medical device firm wishes to publish or broadcast a 
medical device advertisement, the license holder or the person who has 
completed the listing shall, before publishing or broadcasting, submit all texts, 
pictures, or speeches c onstituting the advertisement to the municipal competent 
authority if it is located in a municipality, or to the central competent authority if it 
is located in a county (city), for approval.  The medical device firm  that has 
obtained approval shall forwar d the approval documents to mass media 
enterprises for verification before publishing or broadcasting.  
No modifications or alterations of the approved contents of a medical device 
advertisement are allowed during the period when publishing or broadcasting is 
permitted.  
If the original approving authority finds  that the content s of an approved 
medical device advertisement or the way it is published or broadcast violates the 
provisions of the preceding paragraph or possibly endangers public health, it shall 
order the medical device firm  to immediately stop publishing or broadcasting the 
advertisement and to make correction within a given period. Failure to make 
correction within the given period shall lead to cancellation of the approval.  
The authority imposing the disciplinary action set forth in the preceding 
paragraph shall also notify the mass media enterprises publishing or broadcasting 
the advertisement of the action.  
 
Article 43  No mass media enterprise shall publish or broadcast any medical device 
advertisement which has not been approved by the central or municipal 
competent authority, whose contents are different from the approved contents, 
which has been  cancelled , or for which an o rder has been issued to immediately 
stop publishing or broadcasting and to make correction within a given period but 12 no correction has been  made . 
A mass media enterprise that is commissioned to publish or broadcast a n 
advertisement shall preserve the name, number of the identification document or 
business registration certificate , domicile, firm, or business office, and telephone 
number of the principal and other relevant information, for six months following 
the last date of advertisement, and shall not evade, impede, or refuse any request 
by the competent authority for such information.  
 
Article 44  The period of validity for a medical device advertisement approval 
document shall be one year. Where i t is necessary to continue advertising upon 
expiration, an application shall be submitted one month before expiration to the 
original approving authority for extension. Each period of extension shall not 
exceed one year.  
 
Article 45  In the event that medic al devices shall be used by medical personnel as 
stated in the instructions or designated by the central competent authority by 
means of a public notice, the advertisements thereof shall be published only in the 
medical publications, on the mass media, and  during relevant medical academic 
activities that are for medical personnel exclusively.  
 
Article 46  Medical device  advertisement s shall not be made  in the following  
manners : 
1. To be publicize d in the name of others;  
2. To warrant the effectiveness or performance by making use of books  and 
periodicals , documents , or data ; 
3. To be publicize d by means of interviews or news reports;  
4. To be publicize d by any other improper means.  
 
Article 47  Unless otherwise provided in other laws, label ing or promotion of 
therapeutic effect  for non-medical devices shall not be allowed.  
 
Chapter VI  Monitoring and Prevention  
 
Article 48  The central competent authority may designate items and a specific 
period of time , and order medical device firms  to monitor the safety of medical 
devices that have been approved for manufactur e or import , or have been  listed, 
according to the contents of the safety monitoring plan announced or approved. 
Medical institutions shall provide medical device firms  with relevant safety 13 monitoring data.  
Medical device firms  shall prepare and submit safety monitoring reports to 
the central competent authority periodically . If there is any safety concern about 
the products or non-complian ce of the safety monitoring plan with  the approved 
one, as deemed by the central competent authority, a correction  to be made  
within a given period may be ordered  or the monitoring period  may be extended . 
When necessary, an order may be issued to suspend the ir manufactur e, import, or 
sale. If the situation is severe, the ir licenses  or listings  may be directly  cancelled . 
This shall also appl y to those failing to submit safety monitoring reports 
periodically . 
The central competent authority shall establish regulations governing the 
methods of submission, time  period , contents, formats, restriction  and 
maintenance of the collect ed data, monitoring  period , evaluation , and other 
matters to be complied with in regard to the safety monitoring data and reports 
set forth in the preceding two paragraphs.  
 
Article 49  Medical device firms  or medical institutions shall report any serious 
adverse reaction  caused by medical devices to the central competent authority.  
Regulations governing the conditions , reporting methods  and contents, as 
well as other matters to be complied with in regard to the serious adverse reaction 
set forth in the preceding paragraph shall be established by the central competent 
authority.  
 
Article 50  Upon the finding  that a medical device is likely to endanger the safety of 
human body, medical device firms  shall immediately and proactively repor t to the 
central competent authority and undertake corrective and preventive measures.  
The corrective and preventive measures set forth in the preceding paragraph 
include prepar ation  of advisory contents , replacement of parts and accessories, 
product testing, suspension of use, product recall , or other necessary measures , 
and shall be disclosed in a reasonable manner for user  aware ness . 
 
Article 51  If there is concern about the safety or therapeutic effect of a medical 
device that has been approved for manufactur e or import , or has been listed, as 
re-evaluated and confirmed by the central competent authority  during the period 
of validity of its manufactur e or import license  or listing , the medical device firm  
may be ordered to make correction within a given period. When necessary, an 
order may be issued to withdraw, recall, or suspend the manufactur e, import, or 
sale of the said medical device. If there is a serious safety concern, its license  or 14 listing  may be cancelled . 
 
Chapter VII  Investigation and Interdiction  
 
Article 52  The competent authority may send officials to inspect the facilities and 
relevant business operations of medical device firms  or medical institutions, and 
may randomly test their medical devices . Those being inspected shall not evade, 
impede, or refuse . The quantity of samples to be taken shall be limited to the 
extent sufficien t for use in testing , and receipts shall be given to business 
operators.  
 
Article 53  Medical device items designated by the central competent authority may 
only be imported after passing required random inspections or tests at the time of 
import.  
Regulations governing the imported medical device items set forth in the 
preceding paragraph, the items, manners, methods, scope, and fees in regard to 
the random inspections and tests, and other matters to be complied with shall be 
establishe d by the central competent authority.  
 
Article 54  The municipal or county (city) competent authority shall conduct a 
census of medical device firms  at least every two years , to which the m edical 
device firms  shall not evade, impede, or refuse . 
 
Article 55  If the central competent authority finds that a medical device may cause 
serious harm  to the health of human body, it shall immediately prohibit its 
manufactur e or import, and shall cancel  its medical device license  or listing . As for 
such medical device that has been manufactured or imported, the export, sale, 
supply, transport, storage, brokerage, transfer, or display thereof with the intent to 
sell shall be prohibited within a given period. Such medical dev ice may be 
confiscated and destroyed if necessary.  
 
Article 56  The municipal or county (city) competent authority shall take samples of 
medical devices suspected to have not been registered and approved or listed or 
to be defective, and may place the sa id medical devices in confinement at the site 
if necessary. As for those which have caused serious  harm , the municipal or county 
(city) competent authority shall report to the central competent authority and 
obtain its approval before conf iscating and destroying them.  
The quantity of the samples set forth in the preceding paragraph shall be 15 limited to the extent sufficient for use in inspection or testing , and receipts shall 
be given to business operators.  
The competent authority m ay order withdrawal of the medical devices set 
forth in Paragraph 1 or suspend the manufactur e, import, or sale thereof.  
 
Article 57  In case of any defective medical device  or medical device  that has not 
been registered and approved or listed, the following measures shall be 
undertaken according to the circumstances in addition to the actions to be taken 
under applicable provisions of this Act:  
1. For those that manufacture or import medical devices that have not been 
registered and approved or  listed or that use the licenses  of others, the original 
approving authority may cancel  all or part of the medical device licenses  or 
listing s, medical device business  permits, medical device manufacturing  
license s, or registered particulars regarding the company, business, or factory.  
2. For those that sell or display with the intent to sell medical devices that have 
not been registered and approved or  listed, a sales ban shall be imposed. In 
case of repeated violations, their business operations may be suspended.  
3. For those that manufacture, import, sell, or display with the intent to sell 
defective medical devices, in case of a serious violation or repeated violation , 
the original approving authority may cancel  all of their medical device licenses  
or listing s and medical device manufacturing  licenses , or may suspend their 
business operations . 
The competent authority may announce the name, address, and responsible 
person of the firm or business subject to the disciplinary actions set forth in the 
preceding paragraph, the name of the medical devices involved, and the details of 
violation.  
 
Article 58  In case that the defective medic al devices seized are domestically 
manufactured and may, after inspection or testing , still be usable through 
modification, the municipal or county (city) competent authority shall assign 
officials to supervise the original manufacturer in c arrying out the modification 
within a given period. Those that cannot be modified or are not modified within 
the given period shall be confiscated and destroyed. Imported defective medical 
devices shall be immediately placed in confinement, and the municip al or county 
(city) competent authority shall order the original importer to return and export 
such devices within a given period. Those which are not returned within the given 
period shall be confiscated and destroyed.  
In case that any defective medical d evice set forth in Subparagraph 6 of 16 Article 8 is seized, the municipal or county (city) competent authority shall order 
the medical device firm  that manufactures or imports the device to correct  its 
quality management system within a given period according to the severity of its 
situation.  
The provisions of Paragraph 1 shall apply to medical devices that have been 
determined in accordance with the law to be manufactured or imported without 
approval or listing . 
 
Article  59 If any of the following circumstances is found to apply to any medical 
device, the medical device manufacturing or importing  firm shall immediately 
notify medical institutions, pharmacies, and other medica l device firms , and shall 
recall device s in question on the market within the given period and handle 
device s in stock  together in accordance with the applicable provisions of this Act:  
1. Where a license  has been obtained or listing  has been completed for the 
medical device, but its manufactur e or import is prohibited by means of a 
public notice;  
2. Where the medical device is defective or has not been registered and approved 
or listed; 
3. Where the medical device is found to potentially  harm the life, body, or health 
of users after inspection , test ing, or other risk assessment ; 
4. Where the medical device manufacturing license  has been cancelled  by the 
central competent authority, or the medical device is manufactured or 
imported during the period when the medical device manufacturing license  is 
not valid;  
5. Where the manufactur e or import of medical devices violates the provisions of 
Article 26, 32, or 33;  
6. Other situations in which a necessary recall is announced by the central 
competent authority.  
Medical institutions, pharmacies, and medical device firms  shall cooperate 
with medical device manufacturing or importing firms  in recalling the medical 
devices set forth in all of the subparagraphs of the preceding paragraph.  
Regulations governing the classification, method s of handling, ways to 
implement recall  operation , and other matters to be complied with in regard to 
medical devices required to be recalled under the provisions of Paragraph 1, shall 
be established by the central competent authority.  
 
Article 60  The competent authority shall not only strictly keep  confidential the 
identity information of those reporting defective medical devices that have been 17 seized or medical devices that have not been registered and approved or listed, 
but also provide them incentives  at its discretion . 
 
Chapter VIII  Penal Provisions  
 
Article 61  Any person who manufactures or imports the defective medical devices 
set forth in Subparagraph 1 of Article 8 hereof shall be subject to imprisonment for 
not more than five years, detention, or in addition thereto  a fine of not more than 
NT$50,000,000.  
Any person who commits the aforementioned offence by negligence shall be 
subject to imprisonment for not more than three years, detention, or in addition 
thereto  a fine of not more than NT$10,000,000.  
Any person who knowingly sells, supplies, transports, stores, engages in 
brokerage of, transfers, or displays with the intent to sell the defective medical 
devices set forth in Paragraph 1 shall be subject to imprisonment  for not more 
than three years, detention, or in addition thereto  a fine of not more than 
NT$10,000,000.  
Any person who commits the aforementioned offence by negligence shall be 
subject to detention or a fine of not more than NT$1,000,000.  
 
Article 62 Any person who uses, without authorization or as an infringement, the 
name, instructions, or labels of other medical devices shall be subject to 
imprisonment for not more than five years, detention, or in addition thereto  a fine 
of not more than NT$20,000,000.  
Any person who knowingly imports, sells, supplies, transports, stores, 
engages in brokerage of, transfers, or displays with the intent to sell the medical 
devices set forth in the preceding paragraph shall be subject  to imprisonment for 
not more than two years, detention, or in addition thereto  a fine of not more than 
NT$10,000,000.  
 
Article 63  Any person who violates Paragraph 1 of Article 25 and manufactures or 
imports medical devices without approval or who violates Paragraph 3 of Article 
25 and applies for listing  instead of the required registration and market approval 
shall be subject to imprisonment for not more than three years, detention, or in 
addition thereto  a fine of not more than NT$10,000,0 00. 
This shall also apply to any person who knowingly sells, supplies, transports, 
stores, engages in brokerage of, transfers, or displays with the intent to sell the 
medical devices set forth in the preceding paragraph.  18 Any person who commit s the offences set forth in the preceding two 
paragraphs by negligence shall be subject to imprisonment for not more than six 
months, detention , or a fine of not more than NT$5,000,000.  
 
Article 64  In the event that the representative of a legal entity , or an agent, 
employee, or any other personnel of a legal entity or a natural person commits any 
of the offences set forth in Article 61 through the preceding article while 
performing his/her duty, the offender shall be punished in accordance with the 
provisions of all of the articles. Moreover, the said legal entity or natural person 
shall also be subject to up to ten times of the fine as set forth in all of the articles.  
 
Article 65  Any person who manufactures or imports the defective medical devices 
set forth in Subparagraphs 2 through 5 of Article 8 shall be subject to a fine of not 
less than NT$60,000 but not more than NT$50,000,000.  
Any person who sells, supplies, transports, stores, engages in brokerage of, 
transfers, or displays with the intent to sell the defective medical devices set forth 
in the preceding paragraph shall be subject to a fine of not less than NT$30,000 
but not more than NT$20,000,000.  
When a medical device firm  commits any of the offenses set forth in the 
preceding two p aragraphs, the administrative personnel and supervisors of its 
medical devices shall also be subject to the fines set forth in all of the paragraphs.  
 
Article 66  Any person violating the provisions of Article 47 and labeling  or 
promot ing non-medical devices as having therapeutic effect s shall be subject to a 
fine of not less than NT$600,000 but not more than NT$25,000,000.  
A fine of not less than NT$200,000 but not more than NT$5,000,000  shall be 
imposed when any of the following circumstances occurs:  
1. Violating the provisions of Article 41 and engaging in advertising of medical 
devices without being a medical device firm ; 
2. Violating the provisions of Paragraph 1 of Article 42 and fai ling to apply for 
approval or forward approval documents to mass media enterprises for 
verification before publishing or broadcasting a medical device advertisement;  
3. Violating the provisions of Paragraph 2 of Article 42 and modifying or altering 
the originally approved contents of a medical device advertisement without 
approval;  
4. Violating the restrictions on the extent of publishing or broadcasting medical 
device advertisements as set forth in Article 45;  19 5. Where medical devices are advertised in any  of the ways set forth in all of the 
subparagraphs of Article 46;  
6. Where a medical device firm  fails to give a notice or recall medical devices 
within the given period under any of the circumstances set forth in 
Subparagraphs 1 through 3 of Paragraph 1 o f Article 59.  
 
Article 67  Any mass media enterprise which violates the provisions of Paragraph 1 
of Article 43 governing the publishing or broadcasting of advertisements shall be 
subject to a fine of not less than NT$200,000 but not more than NT$5,000,000,  
and shall be ordered to stop publishing or broadcasting the advertisements. A 
consecutive sentence shall be imposed on the mass media enterprise that fails to 
publish or broadcast the said advertisements for each violation until the said 
advertisements ar e no longer published or broadcast.  
Any mass media enterprise which violates the provisions of Paragraph 2 of 
Article 43 and fails to preserve the materials for publishing or broadcasting , or 
evades, impedes, or refuses any request by the competent authori ty for such 
materials  shall be subject to a fine of not less than NT$60,000 but not more than 
NT$300,000. A consecutive sentence shall be imposed for each violation.  
When imposing the disciplinary actions set forth in Paragraph 1, the 
municipal  or county (city) competent authority shall notify the local competent 
authority or the authority in charge of mass media enterprises for handling in 
accordance with applicable regulations.  
 
Article 68  In case of violation of the provisions of Chapter V of  this Act, 
punishments shall be imposed in accordance with the provisions of this chapter, 
and the name of the offender, the name of the medical device, and details of the 
violation committed may be announced. In addition, the following disciplinary 
action s shall be imposed according to the severity of the violation:  
1. Canceling the medical device license  or listing , and forbidding applications to 
use the original product name for a period of two years;  
2. Ordering the offender to publish or broadcast corrected advertisements or 
commercials containing an apology and excluding wrong messages in the same 
size and time slots in the original publications or on the original channels for a 
certain number of tim es within 30 days upon receipt of the notification of 
punishment. Any business that fails to publish or broadcast corrected 
advertisements or commercials shall be subject to a fine of not less than 
NT$120,000 but not more than NT$600,000. Moreover, the app roval that the 
business has obtained for all of the medical device advertisements shall be 20 cancel led, and no advertisement applications shall be accepted within two 
years.  
In case of repeated violations after a punishments is imposed i n accordance 
with the preceding paragraph, an order may be issued to terminate the business of 
the offender and cancel its company, business, or factory registration or part of the 
registered particulars.  
 
Article 69  A fine of not less than NT$60,000 but not more than NT$2,000,000 shall 
be imposed when any of the following circumstances occurs:  
1. Violating the provisions of Article 17 and purchasing or renting medical devices 
from unknown sources or supplied by those other than medica l device firms ; 
2. Violating the provisions of Paragraph 1 of Article 20 and failing to meet the 
Establishment Standards for Medical Device Manufacturers ; 
3. Where domestic manufacturers of medical devices manufacture medical 
devices in violation of the provisions of Paragraph 2 of Article 22;  
4. Where medical device dealers importing medical devices manufacture medical 
devices in violation of the provisions of Paragraph 3 of Article 22, and the 
provisions of Paragra ph 2 apply on a mutatis mutandis basis;  
5. Violating the provisions of Paragraph 1 or 2 of Article 25 and failing to complete 
registration and market approval or listing  when manufacturing or importing 
medical devices;  
6. Violating the provisions of Paragraph 3 of Article 34 and selling domestically the 
medical devices that are for export only . 
When the circumstances set forth in Subparagraph 3 or 4 of the preceding 
paragraph occur, punishments shall be imposed in accordance with the preceding 
paragraph. In addition, the central competent authority may publicize the names 
of the medical device firms  and order them to make correction within a given 
period, during which their manufactur e, import , and business operations may be 
suspended in part or in whole. If no correction is made within the given period, no 
approval shall be granted for extension of the medical device license in accordance 
with Article 27 or annual declaration in accordance with Article 28, and any new 
applications for registration and market approval or listing  of other medical 
devices of the manufacturers shall not be accepted. In the case of serious 
violation s, the central competent authority may also cancel all or part of the 
medical device manufacturing licenses and licenses or listing s. 
 
Article 70  In case that a medical device firm  uses false documents or information to 
file applications in accordance with the provisions of this Act, a fine of not less 21 than NT$60,000 but not more than NT$2,000,000 shall be imposed. In the case of 
serious violations, no application shall be allowed within two years. The license s or 
approval s that have been obtained shall be  cancelled . 
 
Article 71  A fine of not less than NT$30,000 but not more than NT$1,000,000 shall 
be imposed when any of the following circumstances occurs:  
1. Violating the provisions of Paragraph 1 or 2 of Article 13 and engaging in the 
business activities of medical device firms  without being a medical device firm  
or failing to complete change registration for any change  in the partic ulars 
registered;  
2. Violating the provisions of Paragraph 3 of Article 13 and failing to complete 
medical device firm  registration or failing to manufacture, sell, or supply 
medical devices at the registered place;  
3. Violating the limitations announced i n accordance with Article 18;  
4. Violating the provisions of Paragraph 1 or 2 of Article 23 and commissioning 
others to manufacture or accepting the commissioning from others to 
manufacture medical devices without approval;  
5. Violating the provisions of P aragraph 1 or 2 of Article 24 and engaging in the 
wholesale, import, or export of medical devices without complying with the 
Regulations for Medical Device G ood Distribution Practice or without obtaining 
a distribution  license ; 
6. Violating the provisions of Article 26 and altering any of the original particulars 
of registration and market approval or listing  without approval;  
7. Violating the provisions of Article 32 or 33 in regard to the packaging, labels, 
and instructions of medical devices or the particulars indicated;  
8. Violating the provisions of Paragraph 1 of Article 38 and implementing a clinical 
trial without approval;  
9. Violating the provisions of Paragraph 1 of Article 49 and failing to report to the 
central competent authority;  
10. Violating the provisions of Article 52 and evading, impeding, or refusing the 
inspections or random tests.  
When the circumstances set forth in Subparagraph 5 of the preceding 
paragraph occur, punishments shall be  imposed in accordance with the preceding 
paragraph. In addition, the central competent authority may publicize the names 
of the medical device firms  and order them to make correction within a given 
period, during which their wholesale, re tail, import, and export business may be 
suspended in part or in whole. If no correction is made within the given period, 
consecutive sentences may be imposed until correction is made . 22  
Article 72  In case of violation of the regulations set forth in Paragraph 2 of Article 
35 in regard to the provisions of the restrictions on the supply and sale or return, a 
fine of not less than NT$30,000 but not more than NT$1,000,000 shall be 
imposed.  
In case of violation of the regulations set forth in Paragraph 2 of Article 35 in 
regard to return, punishments shall be imposed in accordance with the preceding 
paragraph, and no application of special approval for importing medical devices 
shall be allowed within a year.  
 
Article 73  A fine of not less than NT$20,000 but not more than NT$500,000 shall be 
imposed if any of the following acts is committed:  
1. Where a medical device firm  manufactures or imports the defective medical 
devices set forth in Subparagraph 6 of Article 8 and commits a serious violation 
or fails to make correction  after the competent authority orders it to make 
correction  within a given period;  
2. Violating the provisions of Paragraph 1 of Article 15 and failing to employ 
qualified technicians;  
3. Violating the provisions of Paragraph 1 of Article 19 or the regulations 
established in accordance with Paragraph 2 in regard to the scope of relevant 
data and the methods for the establishment or main tenance thereof;  
4. Where a medical device firm  violates the provisions governing avoidance of 
conflicts of interest, information disclosure, supervision and administration, or  
inspection , as set forth in Paragraph 2 of Article 38, or fails to make correction  
after the competent authority orders it to make correction  within a given 
period;  
5. Violating the provisions of Article 39 and failing to report or report for 
recordation, or failing to report or report for recordation within a given period;  
6. Violating the provisions of Article 50 and failing to conduct reporting or 
undertake corrective and preventive measures, or failing to undertake 
corrective and preventive measures in accordance with the provisions;  
7. Violating the provisions of Article 54 and evading, impeding, or refusing the 
census;  
8. Violating the provisions of Paragraph 3 of Article 56 and failing to withdraw 
medical devices or suspend the manufactur e, import, or sale thereof;  
9. Failing to  give recall notices or recall medical devices in question within a given 
period when any of the circumstances set forth in Subparagraphs 4 through 6 of 
Paragraph 1 of Article 59 occurs;  23 10. Violating the provisions of Paragraph 2 of Article 59 and  failing  to cooperate in 
recalling medical devices;  
11. Violating the provisions of the regulations established in accordance with 
Paragraph 3 of Article 59 in regard to the ways to implement recall  operation 
of medical devices.  
 
Article 74  In case that a person  fined under this Act disagrees with the imposition 
of such fine, he/she may, within fifteen days upon the receipt of the punishment 
notice, file a written objection requesting a review. However, no more than one 
objection shall be filed.  
The authorit y imposing the fine shall, within fifteen days upon receipt of the 
written objection set forth in the preceding paragraph, review the case, and shall 
alter or cancel the original punishment if it deems the objection justifiable.  
If the person fined di sagrees with the result of the review set forth in the 
preceding paragraph, he/she may file an administrative appeal and initiate an 
administrative proceeding in accordance with applicable laws.  
 
Article 75  In case that approval is not given to the application for medical device 
registration and market approval or change or extension of a license submitted in 
accordance with this Act, the disagreeing applicant may, within four months upon 
receipt of the notice of disciplinary action, clearly stat e the reasons and apply for 
re-examination. However, only one application for re -examination is allowed.  
The central competent authority shall alter or cancel the original disciplinary 
action if it deems that the application for re -examination set forth in the preceding 
paragraph is justifiable.  
If the person applying for re -examination does not agree with the decision 
made regarding the re -examination, he/she may file an administrative appeal and 
initiate an administrative proceeding in accordance with applicable laws.  
 
Article 76  Unless otherwise provided, the punishments prescribed in this Act shall 
be imposed by the municipal or county (city) competent authority, or may be 
imposed by the central competent authority if necessary. Howeve r, upon 
confirmation of the order of business termination by the municipal or county (city) 
competent authority, the cancellation of the company registration, business 
registration, factory registration, or part of the registered particulars sha ll be done 
by the industr y or business authorit y or the authority in charge of the enterprise 
instead.  
 24 Chapter IX  Supplementary Provisions  
 
Article 77  The enforcing authority may collect the necessary fees incurred by 
confiscation and destruction under this Act from offenders.  
 
Article 78  Fees shall be paid when a person applies for or declares permits, licenses, 
or other matters in accordance with this Act or formally inquir ies about the 
relevant regulations governing product registrat ion and market approval, listing , 
and annual declaration of medical devices.  
Standards for the type and amount of the fees required in the preceding 
paragraph shall be determined by the central competent authority.  
 
Article 79  When neces sary, the competent authority at any level may designate a 
subordinate agency or commission a relevant agency (or institution), legal entity, 
organization, or private institution to conduct all or part of the inspections and 
tests of medical devices. The r egulations governing such designation, 
commissioning, and related matters shall be established by the central competent 
authority.  
 
Article 80  The central competent authority may carry out accreditation of the 
relevant agency (or institution), legal entity , organization, or private institution 
commissioned to conduct inspections, as set forth in the preceding article. The 
regulations governing their accreditation and management shall be established by 
the central competent authority.  
The central competent a uthority may designate a subordinate agency or 
commission another agency (or institution), legal entity, organization, or private 
institution to carry out the accreditation work as set forth in the preceding 
paragraph. The regulations governing such design ation, commissioning, and 
related matters shall be established by the central competent authority.  
 
Article 81  The competent authority may designate a subordinate agency (or 
institution) or commission another agency (or institution) or an accredited legal 
entity or organization to conduct affairs relat ed to the review  of registration and 
market approval , change , and extension  of medical devices,  issuance of 
certification documents , clinical trial  inspection , advertisement  review , medical 
device safety monitor ing or inspect ion, serious adverse reaction  reporting , and 
medical device firm inspection  or census . The regulations governing such 
commissioning, accreditation, and related matters shall be established by the 25 central competent authority.  
The central competent authority may designate a subordinate agency (or 
institution) or commission another agency (or  institution) to carry out the 
accreditation work as set forth in the preceding paragraph. The regulations 
governing such designation, commissioning, and related matters shall be 
established by the central competent authority.  
 
Article 82  Starting from the  effective date of this Act, the provisions of this Act shall 
apply to the management of medical devices, and the provisions of the 
Pharmaceutical Affairs Act governing medical devices shall no longer be 
applicable.  
 
Article 83  The Enforcement Rules of thi s Act shall be established by the central 
competent authority.  
 
Article 84  The date for enforcing this Act shall be determined by the Executive Yuan. 
However, the Executive Yuan may set dates for enforcing this Act in full or in part 
under different  circumstances .