2020/3/23 Medical Devices Act - Article Content - Laws & Regulations Database of The Republic of China
https://law .moj.gov .tw/ENG/LawClass/LawAll.aspx?media=print&pcode=L0030106 1/26
Article 1
Article 2
Article 3
Article 4Article Content
Title： Medical Devices Act  CH
Announced Date ： 2020-01-15
Category ： Ministry of Health and Welfare （衛生福利部）
Chapter I General Provisions
This Act is established to ensure the safety, effectiveness, and
quality of medical devices to be used by citizens, to promote
the health of citizens, and to improve management of medical
devices.
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 governments at the county/city level.
The term "medical devices", as used in this Act, shall refer to
instruments, machines, apparatus, materials, software, reagents
for in vitro use, and related articles thereof, whose design and
use achieve one of the following primary intended actions in or
on the human body by other than pharmacological, immunological,
metabolic, or chemical means:
1. Diagnosis, treatment, alleviation, or direct prevention of
human diseases.
2. Modification or improvement of the structure and function of
human body.
3. Control of conception.
Regulations governing the categories, risk classification,
items, determination principles, and other related shall be
established by the central competent authority.
Assistive devices covered by Subparagraph 2 of Paragraph 1 that
are non-invasive, not expected to cause harm to the health of
human body, and used without the assistance of medical personnel
may be notified to the central competent authority for approval
and exempt from being listed as medical devices of the preceding
paragraph.
Assistive devices set forth in the preceding paragraph refer to
appliances, equipment, instruments, and software that assist
physically or mentally disabled persons to improve or maintain
physical function and structure, to facilitate activity and
participation, or to provide convenience to the attendance of
their caregivers.Print Time： 2020/03/23 16:022020/3/23 Medical Devices Act - Article Content - Laws & Regulations Database of The Republic of China
https://law .moj.gov .tw/ENG/LawClass/LawAll.aspx?media=print&pcode=L0030106 2/26Article 5
Article 6
Article 7
Article 8
Article 9
Article 10The term "investigational medical devices", as used in this Act, shall refer to
medical devices that are used solely in clinical trials and whose therapeutic
effect and safety have not been verified.
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 care institutions or institutions announced by the
central competent authority (hereinafter referred to as
"clinical trial institutions").
The term "medical device advertisements", as used in this Act,
shall refer to the act of publicizing the therapeutic effect 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 or suggests therapeutic effect of medical devices
for the purpose of soliciting and promoting the sale thereof
shall be regarded as medical device advertisements.
The term "labels", as used in this Act, shall refer to the
words, graphics, or symbols displayed on a medical device or the
packaging thereof.
The term "instructions", as used in this Act, shall refer to the
related materials that describe information on product safety,
effectiveness, and use of medical devices.
The term "defective medical devices", as used in this Act, shall
refer to medical devices which fall within any of the following
circumstances after inspection or testing:
1. The occurrence of misdiagnosis is prompted or toxic or
hazardous substances are contained, resulting in harm to the
health of human body.
2. The normal and reasonable use in accordance with directions
indicated on the labels or instructions is liable to cause
danger or harm to the health of human body.
3. The duration of validity or storage life has expired.
4. The performance or specification is inconsistent with the
content that has been approved in registration, listed, or
announced as set forth in Paragraph 2 of Article 30.
5. The preservation is not in accordance with the storage
conditions approved in registration.
6. Foreign objects that affect product quality are mixed or
packed.
7. Other defects announced by the central competent authority.
The term "medical device firms", as used in this Act, shall
refer to medical device manufacturers or dealers.2020/3/23 Medical Devices Act - Article Content - Laws & Regulations Database of The Republic of China
https://law .moj.gov .tw/ENG/LawClass/LawAll.aspx?media=print&pcode=L0030106 3/26Article 11
Article 12
Article 13
Article 14The term "medical device manufacturers", as used in this Act, shall refer to
businesses that fall into the following two types:
1. Engaging in the manufacturing, packaging, labeling, sterilization, or final
inspection and release of medical devices.
2. Engaging in the design of medical devices and marketing the devices under
their name.
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.
The term "medical institutions", as used in this Act, shall
refer to institutions applied for operation by medical personnel
specified in Paragraph 1 of Article 10 of the Medical Care Act
in accordance with the relevant regulations of professions and
occupation laws and have been approved for practice.
Chapter II Management of Manufacturing and Sale
Unless otherwise specified, those other than medical device
firms shall not engage in the business activities specified in
Article 10 and Article 11.
Any business with the intent to become a medical device firm
shall file an application with the municipal or county/city
competent authority for approval and registration, and shall
start the operation only after having obtained the business
permit. In case there are any changes made in the particulars
registered, the firm shall apply for change of registration.
Medical device firms shall manufacture, sell, or supply medical
devices at the registered place. Those who set up a separate
manufacturing facility or business establishment shall file a
separate application for medical device firm registration in
accordance with the provisions of the preceding paragraph;
however, those announced by the central competent authority
shall not be required to apply separately for a medical device
dealer permit at the business establishment or for selling or
supplying medical devices at the registered place.
If the medical device firms set forth in the second paragraph do
not have any company registration or business registration, they
need to submit a consent letter from the competent authority of
the target business.
Medical device firms set forth in the second paragraph shall
join the trade association in accordance with the Industrial
Group Act or Commercial Group Act.
Those applying for being registered as a medical device
manufacturer may also engage in such business as wholesale,
retail, export, rental, or repair of its self-manufactured
medical devices that have been listed or approved, or import of
raw materials for their own use, without applying for a medical2020/3/23 Medical Devices Act - Article Content - Laws & Regulations Database of The Republic of China
https://law .moj.gov .tw/ENG/LawClass/LawAll.aspx?media=print&pcode=L0030106 4/26Article 15
Article 16device dealer permit.
Pharmacies may concurrently engage in the retail business of
medical devices of the classes announced by the central
competent authority. Those who concurrently engage in the retail
business of medical devices are applicable to the provisions
governing the medical device dealers set forth in this Act, but
may be exempted from applying for a medical device dealer
permit.
Medical institutions for the necessity of conducting business
may supply medical devices related to the business and may be
exempted from applying for a medical device dealer permit.
However, those who supply medical devices for patient use not as
conducting business but for the sale or retail thereof shall
nevertheless file an application for medical device firm
registration in accordance with the provisions of Paragraph 2 of
Article 13.
Medical device manufacturers and dealers engaging in the import
or repair shall employ qualified technicians according to the
categories of medical devices.
Regulations governing the categories of medical devices,
qualifications and proportions of technicians, the number of
hours in education and training courses referred to in the
preceding paragraph, and other related matters shall be
established by the central competent authority.
If qualified technicians employed by medical device
manufacturers and dealers engaging in the import or repair as
specified in the first paragraph cannot perform their tasks due
to dismissal, resignation, or other reasons and replacements are
not employed separately, the competent authority shall order the
medical device manufacturers and dealers to make corrections
within a time period. Those who fail to make corrections within
the time period shall immediately cease the manufacture, import,
or repair of medical devices.
To apply for suspension of business, medical device firms shall
hand in medical device business permits and medical device
licenses to the municipal or county (city) competent authority,
who is to note clearly on business permit the reason and term of
suspension and to return them once the resumption of business is
approved. Each period of suspension shall not exceed one year.
Medical device firms shall apply for resumption, continued
suspension, or termination of business before the period of
suspension expires. For those who fail to apply upon the
expiration period and after being verified by the municipal or
county (city) competent authority that no business is actually
in operation at the original address, the original issuing
competent authority shall cancel their related permits and
licenses.2020/3/23 Medical Devices Act - Article Content - Laws & Regulations Database of The Republic of China
https://law .moj.gov .tw/ENG/LawClass/LawAll.aspx?media=print&pcode=L0030106 5/26Article 17
Article 18
Article 19
Article 20
Article 21
Article 22When medical device firms apply for termination of business,
medical device business permits and medical device licenses they
have obtained shall be handed in at the same for cancellation.
Those which are not handed in for cancellation shall be
cancelled by the original issuing competent authority.
For those who violate the provisions of this Act and are subject
to suspension of business imposed by the competent authority,
their permits and licenses shall be handed in, noted clearly,
and returned in accordance with the provisions of the first
paragraph.
Medical device firms shall not purchase or rent medical devices
that have not been registered and approved or listed or are
supplied by non-medical device firms.
The central competent authority may announce categories and
items of specific medical devices with restriction on their sale
or supply type according to the risk of using such medical
devices.
For medical devices with certain risk class as announced by the
central competent authority, medical device firms and medical
institutions shall establish and maintain data on direct supply
sources and flow of products.
For product items announced by the central competent authority,
data established and maintained according to the preceding
paragraph shall be reported to the central competent authority.
Regulations governing the scope, methods for establishment and
maintenance of data, retention period, report contents and
methods referred to in the preceding two paragraphs, and other
matters to be complied with shall be established by the central
competent authority.
The facilities, equipment, and sanitary conditions of medical
device manufacturers shall comply with the Establishment
Standards for Medical Device Manufacturers.
The Establishment Standards for Medical Device Manufacturers set
forth in the preceding paragraph shall be jointly prescribed by
the central competent authority and central industry competent
authority.
Medical device manufacturers in Subparagraph 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.
Medical device manufacturers shall establish a medical device
quality management system governing the on-site facilities,2020/3/23 Medical Devices Act - Article Content - Laws & Regulations Database of The Republic of China
https://law .moj.gov .tw/ENG/LawClass/LawAll.aspx?media=print&pcode=L0030106 6/26Article 23
Article 24equipment, organization and personnel, production, quality
control, storage, logistics, customer complaints, and other
matters and shall comply with the quality management system
regulations.
Medical device manufacturers shall establish a medical device
quality management system in accordance with the provisions of
the regulations set forth in the preceding paragraph, and the
manufacture may only begin after receiving a compliance
inspection by the central competent authority and obtaining a
manufacturing license. However, product items announced by the
central competent authority shall not be required to obtain a
manufacturing 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 the premises of such overseas manufacturers for
inspection on a periodic basis or as necessary.
The quality management system regulations set forth in Paragraph
1 and regulations governing the content and methods of
inspection, the requirements, procedures, review, issuance,
validity period, change, revocation, or cancellation of approval
referred to in Paragraph 2, and other matters to be complied
with shall be established by the central competent authority.
Medical device manufacturers shall not commission other
manufacturers to manufacture or accept the commissioning to
manufacture medical devices, unless otherwise approved by the
central competent authority.
Medical device dealers shall not manufacture medical devices.
However, this shall not apply to those approved by the central
competent authority to commission other medical device
manufacturers for the manufacture.
Regulations governing the application documents, product
liability, contractual provisions, labeling, packaging for the
commissioning of manufacture referred to in the preceding two
paragraphs, and other operation related matters to be complied
with shall be established by the central competent authority.
For medical devices announced by the central competent authority
and their dealers, a medical device good distribution system
shall be established to govern the product storage,
distribution, services, personnel deployment, and other related
operational matters, and shall comply with the regulations for
good distribution practice of medical devices.
Medical device dealers shall set up a good distribution system
of medical devices in accordance with the regulations 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 distribution2020/3/23 Medical Devices Act - Article Content - Laws & Regulations Database of The Republic of China
https://law .moj.gov .tw/ENG/LawClass/LawAll.aspx?media=print&pcode=L0030106 7/26Article 25
Article 26
Article 27license.
Regulations for the good distribution practice set forth in
Paragraph 1, and regulations governing the content and methods
of inspection, the requirements, procedures, review, issuance,
validity period, revocation, or cancellation of approval
referred to in the preceding paragraph, and other matters to be
complied with shall be established by the central competent
authority.
Chapter III Listing and Registration and Market Approval of Medical Devices
For the manufacture and import of medical devices, an
application shall be filed with the central competent authority
for registration and market approval. No manufacture or import
shall be allowed until such approval is granted and a medical
device license is issued. However, the manufacture and import of
product items announced by the central competent authority shall
be done by means of listing.
Medical devices that shall apply for registration and market
approval in accordance with the preceding paragraph shall not do
so by means of listing.
The import of medical devices shall be done by license holders,
those who have completed the listing, or their authorized
persons.
If the medical device that shall be listed in accordance with
the exception of Paragraph 1 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 original license holder.
Alteration may only be made to any of the particulars of
registration 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.
A medical device manufacture or import license is valid for a
period no longer than five years starting from the date of
issue. Where it is necessary to continue the manufacture or
import upon expiration, a prior application shall be filed with
the central competent authority for approval of license
extension. Each extension shall not exceed five years.
For those who fail to file an application upon the expiration
period or if the extension is disapproved, the original license
shall become invalid and be cancelled by the central competent
authority.
In case 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.2020/3/23 Medical Devices Act - Article Content - Laws & Regulations Database of The Republic of China
https://law .moj.gov .tw/ENG/LawClass/LawAll.aspx?media=print&pcode=L0030106 8/26Article 28
Article 29
Article 30
Article 31
Article 32Medical device firms that have completed the listing of medical
devices shall file an annual declaration with the central
competent authority each year. For those who fail to file a
declaration within the time period, the original listing shall
become invalid. This shall also apply to the medical devices
subject to direct listing as stipulated in the provisions of
Paragraph 4 of Article 25.
Regulations governing the following related matters shall be
established by the central competent authority:
1. Requirements, procedures, and review guidelines in regard to
the application for registration and market approval and
issuance of license or listing of medical devices 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.
4. Procedures in regard to the annual declaration in accordance
with the provisions of the preceding article.
Medical device product items designated by the central competent
authority shall comply with specific specifications and
performance.
The product items, specifications, test methods, and performance
of medical devices referred to in the preceding paragraph shall
be announced by the central competent authority. If a test
method has not been established, an internationally recognized
method may be adopted; if there is no internationally recognized
test method, the suitability thereof shall be demonstrated.
The central competent authority, with regard to data submitted
by medical device firms for registration and market approval or
listing that are information related to trade secret or business
operation, shall restrict them from being made available to the
public or provision. However, this shall not apply to
information that is necessary for the public benefit or
protection of the health of human body.
Medical device firms that manufacture 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.2020/3/23 Medical Devices Act - Article Content - Laws & Regulations Database of The Republic of China
https://law .moj.gov .tw/ENG/LawClass/LawAll.aspx?media=print&pcode=L0030106 9/26Article 33
Article 34Medical 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
Paragraph 2 of Article 13 and Paragraph 1 of Article 25.
However, this shall not apply to those exempt from 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 manufacturer.
9. Lot number or serial number.
10. Other particulars that shall be indicated as announced by
the central competent authority.
For specific medical devices announced by the central competent
authority, the instructions set forth in the preceding paragraph
may be replaced by electronic instructions.
In addition to the indication specified in the first paragraph,
medical devices that are necessary to provide braille characters
or other sufficient information for ease of reading as a
supplementary measure shall be announced by the central
competent authority.
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 set forth in the preceding paragraph may be
restricted for export when the 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 when the central competent authority deems that there is a
concern over domestic demand.
Medical device firms holding licenses of necessary medical
devices announced by the central competent authority shall, in
the case of incapable to continue to manufacture, import, or the
likelihood of insufficient supply of said medical devices,
report to the central competent authority at least six months in
advance; and shall, if unable to report within the
aforementioned period due to natural disaster or other incidents
not attributable to the medical device firms, report to the
central competent authority within 30 days after occurrence of2020/3/23 Medical Devices Act - Article Content - Laws & Regulations Database of The Republic of China
https://law .moj.gov .tw/ENG/LawClass/LawAll.aspx?media=print&pcode=L0030106 10/26Article 35
Article 36
Article 37such incidents.
The central competent authority may, upon receiving the report
set forth in the preceding paragraph or becoming aware of the
likelihood of insufficient supply of necessary medical devices,
register it on a public website.
The central competent authority may grant special approval for
manufacture or import of specific medical devices without the
limitations set forth in Paragraph 1 of Article 25 if any of the
following circumstances applies:
1. For the purpose of preventing, diagnosing, or treating life-
threatening or severe disability diseases, with appropriate
alternative treatment not yet available domestically.
2. The necessity of responding to emergency public health
circumstances.
3. Investigational medical devices.
4. For the exclusive use as samples or gifts, or for personal
use.
5. Where the import thereof is for the exclusive purpose of
repair, and not for circulation or sale domestically after the
repair is completed.
6. Where circumstances exist for incapable to continue with the
manufacture, import, or for insufficient supply of licensed
products that have been announced as necessary medical devices
in accordance with Paragraph 4 of the preceding paragraph.
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 referred to in the preceding paragraph shall be
established by the central competent authority.
If any of the following circumstances applies to the medical
devices for which special approval for manufacture or import has
been obtained as set forth in the preceding article, the central
competent authority may cancel their approval and order the
applicant to take action on or recall the said medical devices
within a time period:
1. An appropriate alternative treatment becomes available.
2. The public health emergency situation is over.
3. There is concern about the safety or therapeutic effect as
evaluated and confirmed by the central competent authority.
Chapter IV Management of Medical Device Clinical Trials
Clinical trial institutions or trial sponsors shall file an
application with the central competent authority and obtain its
approval before initiating any clinical trial. However, this
shall not apply to those that do not involve significant risks
as announced by the central competent authority.
Clinical trial institutions implementing clinical trials of the2020/3/23 Medical Devices Act - Article Content - Laws & Regulations Database of The Republic of China
https://law .moj.gov .tw/ENG/LawClass/LawAll.aspx?media=print&pcode=L0030106 11/26Article 38
Article 39
Article 40
Article 41preceding paragraph shall exercise the necessary duty of medical
care, and shall obtain consent from human subjects except in the
case of emergencies.
Regulations governing the scope of management, operational
practices, application procedures, review guidelines, avoidance
of conflicts of interest, information disclosure, supervision
and administration, inspection, particulars of the content of
informed consent referred to in the preceding two paragraphs,
and other matters to be complied with in regard to medical
device clinical trials shall be established by the central
competent authority.
Clinical trial institutions and trial sponsors shall report to
the central competent authority when the human subject of a
medical device clinical trial experiences any of the following
occurrences during implementation of the clinical trial:
1. Death.
2. Life-threatening condition.
3. Temporary or permanent 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 injuries.
Clinical trial institutions shall report to the central
competent authority when the human subject experiences 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 set forth in the preceding two paragraphs shall be
made within seven days after becoming aware of the actual
happening of the occurrence, and detailed investigation
information shall be submitted to the central competent
authority within fifteen days for recordation.
In the event that the central competent authority deems there is
concern that a medical device clinical trial may cause harm to
the health of human body, it may order trial institutions to
suspend or terminate the trial or to adopt other necessary
measures.
Chapter V Management of Medical Device Advertisements
Businesses other than medical device firms are not allowed to
engage in advertising of medical devices.
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 constituting the advertisement to the municipal
competent authority if the medical device firm is located in a2020/3/23 Medical Devices Act - Article Content - Laws & Regulations Database of The Republic of China
https://law .moj.gov .tw/ENG/LawClass/LawAll.aspx?media=print&pcode=L0030106 12/26Article 42
Article 43
Article 44
Article 45municipality, or to the central competent authority if it is
located in a county (city), for approval.
During the approved period of publishing or broadcasting, no
modification or alteration of the approved content of a medical
device advertisement shall be allowed.
If the original approving authority finds that the content of an
approved medical device advertisement or the way it is published
or broadcast violates the provisions of the preceding paragraph
or may cause harm to the health of human body, it shall order
the medical device firm to immediately stop publishing or
broadcasting the said advertisement or to make corrections
within a time period. For those who fail to make corrections
within the time period, their approval shall be cancelled.
The authority imposing the disciplinary action set forth in the
preceding paragraph shall notify with a copy to the mass media
enterprises publishing or broadcasting the advertisement of the
action.
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 content is different
from the approved content, which has been cancelled, or for
which an order has been issued to immediately stop publishing or
broadcasting or to make corrections within a time period but no
corrections have been made.
A mass media enterprise that is commissioned to publish or
broadcast an advertisement shall preserve the name, number of
the identification document or business registration
certificate, domicile, firm, or business office, telephone
number, 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.
The validity period for a medical device advertisement approval
document shall be three years, starting from the date of issue.
Where it is necessary to continue advertising upon expiration,
an application for extension shall be filed with the original
approving authority six months before the date of expiration.
Each period of extension shall not exceed three years.
In the event that the medical devices shall be used by medical
personnel as stated in the instructions or announced by the
central competent authority, the advertisements of such medical
devices shall be published only in the medical publications,
mass media, or related medical academic activities that are for
the exclusive participation of medical personnel.
Medical device advertisements shall not be made in the following
manners:2020/3/23 Medical Devices Act - Article Content - Laws & Regulations Database of The Republic of China
https://law .moj.gov .tw/ENG/LawClass/LawAll.aspx?media=print&pcode=L0030106 13/26Article 46
Article 47
Article 48
Article 491. To be publicized 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 publicized by means of interviews or news reports.
4. To be publicized by any other improper means.
Labeling or promotion of therapeutic effect for non-medical
devices shall not be allowed. However, this shall not apply if
it is otherwise provided in other laws.
Chapter VI Supervision and Prevention
The central competent authority may designate product items and
specific time periods for medical devices that have been
approved for manufacture or import or have completed the
listing, and order medical device firms to monitor their safety
according to the announced or approved safety monitoring plan.
Medical institutions shall provide medical device firms with
relevant safety monitoring data.
Medical device firms set forth in the preceding paragraph shall
prepare and submit safety monitoring reports to the central
competent authority periodically. For those who fail to submit
safety monitoring reports periodically or whose products have
safety concern as deemed by the central competent authority, or
if the methods and content for implementation of the safety
monitoring plan do not comply with the original announcement or
approval, they may be ordered to make corrections within a time
period or extend the monitoring period. When necessary, they may
be ordered to suspend the manufacture, import, or sale. If the
circumstances are severe, their licenses or listings may be
directly cancelled.
Regulations governing the methods of submission, time period,
contents, formats, restriction and maintenance of the collected
data, monitoring period, evaluation referred to in the preceding
two paragraphs, and other related matters in regard to the
safety monitoring data and reports shall be established by the
central competent authority.
Medical device firms or medical institutions shall report any
serious adverse events caused by medical devices to the central
competent authority.
Regulations governing the conditions, reporting methods, time
period, contents, and other matters to be complied with in
regard to the serious adverse events referred to in the
preceding paragraph shall be established by the central
competent authority.
Upon the finding that a medical device is likely to cause harm
to the health of human body, the holders of the medical device
license or those who have completed the listing shall2020/3/23 Medical Devices Act - Article Content - Laws & Regulations Database of The Republic of China
https://law .moj.gov .tw/ENG/LawClass/LawAll.aspx?media=print&pcode=L0030106 14/26Article 50
Article 51
Article 52
Article 53
Article 54immediately and proactively report to the central competent
authority and undertake corrective and preventive measures.
The corrective and preventive measures set forth in the
preceding paragraph include preparation 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 awareness of
medical institutions, medical device firms, and users.
If there is concern about the safety or therapeutic effect of
medical devices that have been approved for manufacture or
import or have completed the listing, as re-evaluated and
confirmed by the central competent authority during the period
of validity of their manufacture or import license or listing,
medical device firms may be ordered to make corrections within a
time period. When necessary, they may be ordered to withdraw,
recall, or suspend the manufacture, import, or sale. For those
who fail to make corrections within the time period or if there
is a serious safety concern, their licenses or listings may be
cancelled.
Chapter VII Investigation and Interdiction
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 test samples to be taken shall be
limited to the extent sufficient for use in testing, and
receipts shall be given to business operators.
Medical device product items designated by the central competent
authority shall only be released after passing random
inspections or tests at the time of import.
Regulations governing the product items and the items, modes,
methods, scope, fees for random inspection and testing of
medical devices referred to in the preceding paragraph, and
other related matters shall be established by the central
competent authority.
The municipal or county (city) competent authority shall conduct
a census of medical device firms at least every two years, to
which the medical device firms shall not evade, impede, or
refuse.
If the central competent authority finds that a medical device
is likely to cause serious harm to the health of human body, it
shall immediately prohibit its manufacture or import, and may
cancel its medical device license or listing. As for such
medical device that has been manufactured or imported, its2020/3/23 Medical Devices Act - Article Content - Laws & Regulations Database of The Republic of China
https://law .moj.gov .tw/ENG/LawClass/LawAll.aspx?media=print&pcode=L0030106 15/26Article 55
Article 56export, sale, supply, transport, storage, brokerage, transfer,
or display with the intent to sell shall be prohibited for a
time period. Such medical device may be confiscated and
destroyed if necessary.
Regarding medical devices suspected to have not been registered
and approved or listed or to be defective medical devices, for
medical devices that have not been registered and approved or
listed, the municipal or county (city) competent authority shall
first place them in confinement at the site and take samples for
inspection or testing before taking further actions. For
defective medical devices, the authority may first place them in
confinement at the site and take samples for inspection or
testing before taking further actions. As for those which have
caused serious harm, they shall be confiscated and destroyed
after reporting for approval to the central competent authority.
The quantity of the samples set forth in the preceding paragraph
shall be limited to the extent sufficient for use in inspection
or testing, and receipts shall be given to business operators.
For medical devices set forth in Paragraph 1, the competent
authority may notify or announce the withdrawal, cessation of
use, or suspension of the manufacture, import, or sale thereof.
In the 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 their medical device licenses or listings,
medical device business permits, medical device manufacturing
licenses, 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 the case of repeated
violation, their business operations may be suspended.
3. For those that manufacture, import, sell, or display with the
intent to sell defective medical devices, in the case of a
serious violation or repeated violation, the original approving
authority may cancel all of their medical device licenses or
listings and medical device manufacturing licenses, or may
suspend their business operations.
The competent authority may announce the name, address, and
responsible person of firm or business subject to the
disciplinary actions set forth in the preceding paragraph, name
of medical devices, and circumstances of violation.2020/3/23 Medical Devices Act - Article Content - Laws & Regulations Database of The Republic of China
https://law .moj.gov .tw/ENG/LawClass/LawAll.aspx?media=print&pcode=L0030106 16/26Article 57
Article 58In case the defective medical 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 carrying out the modification within a
time period. Those that cannot be modified or are not modified
within the time period shall be confiscated and destroyed.
Imported defective medical devices shall be immediately placed
in confinement, and the municipal or county (city) competent
authority shall order the original importer to return and export
such devices within a time period. Those which are not returned
within the time period shall be confiscated and destroyed.
In case any defective medical device set forth in Subparagraph 6
of 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 time period according to the severity of its
circumstances.
The provisions of Paragraph 1 shall apply mutatis mutandis to
medical devices that have been determined to be manufactured or
imported without registration and market approval or listing.
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, other
medical device firms, and pharmacies, and shall recall and
handle marketed and stocked products within the specified time
period:
1. Where a license has been obtained or listing has been
completed, but its manufacture or import is prohibited by
announcement.
2. Where the medical device is defective or has not been
registered and approved or listed.
3. Where the finding after inspection, testing, or other risk
assessment is that there is likelihood to cause harm to the
health of human body for users.
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 manufacture or import of medical devices violates
the provisions of Articles 26, 32, or 33.
6. Other circumstances in which a necessary recall is announced
by the central competent authority.
When the medical device manufacturing or importing firm recalls
medical device of the preceding paragraph, medical institutions,
other medical device firms, and pharmacies shall give their
cooperation.
Regulations governing the classification, approaches for recall2020/3/23 Medical Devices Act - Article Content - Laws & Regulations Database of The Republic of China
https://law .moj.gov .tw/ENG/LawClass/LawAll.aspx?media=print&pcode=L0030106 17/26Article 59
Article 60
Article 61
Article 62operation, handling methods, and other matters to be complied
with in regard to medical devices required to be recalled of
Paragraph 1, shall be established by the central competent
authority.
The competent authority shall not only strictly keep
confidential the identity information of those reporting
defective medical devices that have been 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
Any person who manufactures or imports the defective medical
devices set forth in Subparagraph 1 of Article 8 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 knowingly 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 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 set forth in
Paragraph 1 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 commits the aforementioned offence set forth in
Paragraph 2 by negligence shall be subject to detention or a
fine of not more than NT$1,000,000.
Any person who uses, without authorization or as an
infringement, the name, instructions, or labels of another legal
medical device 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.
Any person who violates Paragraph 1 of Article 25 and
manufactures or imports medical devices without approval, or who
violates Paragraph 2 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$10,000,000.2020/3/23 Medical Devices Act - Article Content - Laws & Regulations Database of The Republic of China
https://law .moj.gov .tw/ENG/LawClass/LawAll.aspx?media=print&pcode=L0030106 18/26Article 63
Article 64
Article 65This 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.
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
60 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.
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.
Any person violating the provisions of Article 46 and labeling
or promoting non-medical devices as having therapeutic effects
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 40 and engaging in
advertising of medical devices without being a medical device
firm.
2. Violating the provisions of Paragraph 1 of Article 41 and
failing 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 41 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 specified in Article
44.
5. Where medical devices are advertised in any of the manners
set forth in the provisions of Article 45.
6. Where a medical device firm fails to give a notice or recall
medical devices within the specified time period under any of2020/3/23 Medical Devices Act - Article Content - Laws & Regulations Database of The Republic of China
https://law .moj.gov .tw/ENG/LawClass/LawAll.aspx?media=print&pcode=L0030106 19/26Article 66
Article 67the circumstances set forth in Subparagraphs 1 through 3 of
Paragraph 1 of Article 58.
Any mass media enterprise which violates the provisions of
Paragraph 1 of Article 42 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. For those who fail to stop publishing or
broadcasting, a consecutive sentence shall be imposed for each
violation until the said advertisements are no longer published
or broadcast.
Any mass media enterprise which violates the provisions of
Paragraph 2 of Article 42 and fails to preserve the information
of the firm that commissions the advertisement, or evades,
impedes, or refuses any request by the competent authority 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 also 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 competent authority of the
target business for handling in accordance with applicable
regulations.
In the 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, name
of the medical device, and circumstances of committing the
violation may be announced. In addition, the following
disciplinary actions shall be imposed according to the severity
of the violation:
1. Cancelling 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 times 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 approval that the business has obtained for all of
the medical device advertisements shall be cancelled, and no
advertisement applications shall be accepted within two years.
In the case of repeated violation after a punishment is imposed
in accordance with the preceding paragraph, an order may be
issued to terminate the business of the offender and cancel its2020/3/23 Medical Devices Act - Article Content - Laws & Regulations Database of The Republic of China
https://law .moj.gov .tw/ENG/LawClass/LawAll.aspx?media=print&pcode=L0030106 20/26Article 68
Article 69company, business, or factory registration or part of the
registered particulars.
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 by purchasing or
renting medical devices that have not been registered and
approved or listed, or medical devices supplied by those other
than medical device firms.
2. Violating the provisions of Paragraph 1 of Article 20 by
failing to meet the Establishment Standards for Medical Device
Manufacturers.
3. Where domestic medical device manufacturers violating the
provisions of Paragraph 1 of Article 22 by failing to comply
with the medical device quality management system regulations,
or violating the provisions of Paragraph 2 of Article 22 by
manufacturing medical devices without obtaining manufacturing
license.
4. Where medical device dealers importing medical devices that
have been manufactured in violation of the provisions of
Paragraph 3 of Article 22 as applied mutatis mutandis pursuant
to Paragraph 1 or Paragraph 2.
5. Violating the provisions of Paragraph 1 of Article 25 by
manufacturing or importing medical devices without applying for
registration and market approval or listing, or violating the
provisions of Paragraph 2 of Article 25 by applying for listing
instead of the required registration and market approval.
6. Violating the provisions of Paragraph 3 of Article 34 by
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, in addition to the punishments that
shall be imposed in accordance with the preceding paragraph, the
central competent authority may publicize the names of the
medical device firms and order them to make corrections within a
time period, during which their manufacture, import, and
business operations may be suspended in part or in whole. If no
corrections are made within the time period, extension of
medical device license in accordance with Article 27 shall not
be approved or annual declaration in accordance with Article 28
shall not be filed, 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, the central competent authority may also cancel all
or part of the medical device manufacturing licenses, licenses,
or listings.
In case a medical device firm uses false documents or
information to file applications in accordance with the2020/3/23 Medical Devices Act - Article Content - Laws & Regulations Database of The Republic of China
https://law .moj.gov .tw/ENG/LawClass/LawAll.aspx?media=print&pcode=L0030106 21/26Article 70provisions of this Act, a fine of not less than NT$60,000 but
not more than NT$2,000,000 shall be imposed. In the case of
serious violation, no application shall be allowed within two
years. The licenses or approvals that have been obtained shall
be cancelled.
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 of Article 13 by
engaging in the business activities of medical device firms
without being a medical device firm, or violating the provisions
of Paragraph 2 of Article 13 by failing to complete change
registration for any change in the particulars registered.
2. Violating the provisions of Paragraph 3 of Article 13 by
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 in accordance with
Article 18.
4. Violating the provisions of the regulations established in
accordance with Paragraph 4 of Article 22 in regard to
alteration.
5. Violating the provisions of Paragraph 1 of Article 23 by
authorizing the commissioning or accepting the commissioning to
manufacture medical devices without approval, or violating the
provisions of Paragraph 2 of Article 23 by manufacturing medical
devices.
6. Violating the provisions of Paragraph 1 of Article 24 by
failing to comply with the regulations for good distribution
practice of medical devices, or violating the provisions of
Paragraph 2 of Article 24 by engaging in wholesale, import, or
export of medical devices without obtaining a distribution
license.
7. Violating the provisions of Paragraph 1 of Article 25 by
selling, supplying, transporting, storing, engaging in brokerage
of, transferring, or displaying with the intent to sell medical
devices without applying for registration and market approval or
listing.
8. Violating the provisions of Article 26 by making alteration
to any of the original particulars of registration and market
approval or listing without approval.
9. Violating the provisions of Article 32 or 33 in regard to the
packaging, labels, and instructions of medical devices or the
particulars indicated thereof.
10. Violating the provisions of the regulations established in
accordance with Paragraph 2 of Article 35 in regard to
restrictions on supply and sale or return.
11. Violating the provisions of Paragraph 1 of Article 37 by
implementing a clinical trial without approval, or violating the2020/3/23 Medical Devices Act - Article Content - Laws & Regulations Database of The Republic of China
https://law .moj.gov .tw/ENG/LawClass/LawAll.aspx?media=print&pcode=L0030106 22/26Article 71provisions of Paragraph 2 of Article 37 by failing to obtain
consent from human subjects prior to implementing the clinical
trial.
12. Violating the provisions of Paragraph 1 of Article 48 by
failing to report to the central competent authority, or
violating the provisions of Paragraph 2 of Article 48 in regard
to the conditions, reporting methods, time period, and contents.
13. Violating the provisions of Article 51 by evading, impeding,
or refusing an inspection or random testing.
When the circumstances set forth in Subparagraph 6 of the
preceding paragraph occur, in addition to the punishments that
shall be imposed in accordance with the preceding paragraph, the
central competent authority may publicize the names of the
medical device firms and order them to make corrections within a
time period, during which their wholesale, retail, import, and
export may be suspended in part or in whole. For those who fail
to make corrections within the time period, a consecutive
sentence may be imposed for each violation until the corrections
are made.
A fine of not less than NT$20,000 but not more than NT$500,000
shall be imposed when any of the following circumstances occurs:
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 corrections
within the time period that has been ordered by the competent
authority in accordance with Paragraph 2 of Article 57.
2. Violating the provisions of Paragraph 1 of Article 15 by
failing to employ qualified technicians.
3. Violating the provisions of Paragraph 1 or 2 of Article 19,
or violating the provisions of the regulations established in
accordance with Paragraph 3 of Article 19 in regard to the
scope, methods for establishment and maintenance of data,
retention period, report contents and methods.
4. Violating the provisions of the regulations established in
accordance with Paragraph 3 of Article 24 in regard to
alteration.
5. Violating the provisions of the regulations established in
accordance with Paragraph 3 of Article 37 in regard to avoidance
of conflicts of interest, information disclosure, supervision
and administration, or inspection, or failing to make
corrections within the time period that has been ordered by the
competent authority in accordance with the provisions of the
said regulations.
6. Violating the provisions of Article 38 by failing to report
or report for recordation, or failing to report or report for
recordation within a time period.
7. Violating the provisions of Article 49 by failing to conduct
reporting or undertake corrective and preventive measures in2020/3/23 Medical Devices Act - Article Content - Laws & Regulations Database of The Republic of China
https://law .moj.gov .tw/ENG/LawClass/LawAll.aspx?media=print&pcode=L0030106 23/26Article 72
Article 73
Article 74accordance with the provisions.
8. Violating the provisions of Article 53 by evading, impeding,
or refusing a census.
9. Violating the provisions of Paragraph 3 of Article 55 by
failing to withdraw or suspend the manufacture, import, or sale.
10. Failing to give recall notices or recall medical devices
within a specified time period when any of the circumstances set
forth in Subparagraphs 4 through 6 of Paragraph 1 of Article 58
occurs.
11. Violating the provisions of Paragraph 2 of Article 58 by
failing to cooperate in recalling medical devices.
12. Violating the provisions of the regulations established in
accordance with Paragraph 3 of Article 58 in regard to the
approaches for recall operation and handling methods of medical
devices.
In case a person fined under this Act disagrees with the fine
imposed in accordance with the provisions of this Act, 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 authority 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 disagrees 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.
In the event that approval is not given to the application for
medical device clinical trial implementation, medical device
registration and market approval, or change or extension of a
license filed in accordance with this Act, the disagreeing
applicant may, within four months upon receipt of the notice of
disciplinary action, clearly state 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.
Unless otherwise provided, the punishments prescribed in this
Act shall be imposed by the municipal or county (city) competent2020/3/23 Medical Devices Act - Article Content - Laws & Regulations Database of The Republic of China
https://law .moj.gov .tw/ENG/LawClass/LawAll.aspx?media=print&pcode=L0030106 24/26Article 75
Article 76
Article 77
Article 78
Article 79authority, or may be imposed by the central competent authority
if necessary. However, the cancellation of the company
registration, business registration, factory registration, or
the registered particulars, in part or in whole, upon
confirmation of the order of business termination by the
municipal or county (city) competent authority, shall be
forwarded for execution by the industry or commerce competent
authority or its competent authority of the target business.
Chapter IX Supplementary Provisions
The enforcing authority may collect the necessary fees incurred
by confiscation and destruction under this Act from offenders.
Fees shall be paid when a person applies for or declares
permits, licenses, or other matters in accordance with this Act,
or makes formal inquiry about product registration and market
approval, listing, annual declaration, and relevant regulations
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.
When necessary, 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 testing of medical
devices. Regulations governing its designation, commissioning,
and related matters thereof shall be established by the central
competent authority.
The central competent authority may carry out accreditation of
the relevant agency (or institution), legal entity,
organization, or private institution commissioned to conduct
testing, as set forth in the preceding article. Regulations
governing their accreditation and management shall be
established by the central competent authority.
The central competent authority 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.
Regulations governing its designation, commissioning, and
related matters thereof shall be established by the central
competent authority.
The central competent authority may designate a subordinate
agency (or institution) or commission another agency (or
institution), or an accredited legal entity or organization to
carry out education and training of technicians, review of
registration and market approval of medical devices, issuance of2020/3/23 Medical Devices Act - Article Content - Laws & Regulations Database of The Republic of China
https://law .moj.gov .tw/ENG/LawClass/LawAll.aspx?media=print&pcode=L0030106 25/26Article 80
Article 81
Article 82certificates, review and inspection of clinical trials, review
of advertisements, reporting of serious adverse events, and
inspection or census of medical device firms.
With the exception of education and training, the commissioned
agency shall observe avoidance of conflicts of interest for
matters related to designation or commissioning set forth in the
preceding paragraph. Regulations governing its commissioning,
accreditation, avoidance of conflicts of interest, and other
related matters shall be established by the central competent
authority.
The central competent authority may designate a subordinate
agency or commission another agency (or institution) to carry
out the accreditation work as set forth in Paragraph 1.
Regulations governing its designation, commissioning, and
related matters shall be established by the central competent
authority.
The central competent authority and central industry competent
authority may provide incentives for research and development of
innovative medical device technologies.
Regulations governing the eligibility criteria, review
procedures of the incentives referred to in the preceding
paragraph, and other related matters may be jointly established
by the central competent authority and central industry
competent authority.
Due to the characteristics for use of medical devices, when
research institutions, medical institutions, or medical device
firms collect, process, or use personal data in accordance with
Subparagraph 6 of Paragraph 1 of Article 6 of the Personal Data
Protection Act, the central competent authority may announce
other methods of consent equivalent to the written consent.
In the event of violating the provisions set forth in Paragraph
1 or 2 of Article 8 and consequently resulting in occurrence of
damages arising from injury to the medical device end-user
patients or consumers, medical device manufacturers or importers
shall be liable for compensation. However, this shall not apply
if the medical device manufacturers or importers have no
negligence in regard to the manufacturing, packaging, labeling,
sterilization, or final inspection and release of the medical
devices, or the injury is not caused by the negligence, or has
exercised reasonable care to prevent such injury from occurring.
Even if the medical device end-user patients or consumers under
the circumstances of the preceding paragraph have suffered an
injury that is a non-pecuniary damage, they may claim for a
reasonable amount of monetary compensation.
For claims filed by the medical device end-user patients or
consumers set forth in the preceding two paragraphs, provisions2020/3/23 Medical Devices Act - Article Content - Laws & Regulations Database of The Republic of China
https://law .moj.gov .tw/ENG/LawClass/LawAll.aspx?media=print&pcode=L0030106 26/26Article 83
Article 84
Article 85of Articles 47 through 55 of the Consumer Protection Act may
apply mutatis mutandis for initiation of consumer litigation.
Under the circumstances identified in Paragraph 1 or 2, if it is
difficult or impossible for the medical device end-user patients
or consumers to prove the monetary value of the actual damage,
they may ask the court to award the compensation in the amount
of at least NT$1,000 per incident, per person based on the
severity of the damage.
In the event that the municipal governments or the county/city
governments receive multiple claims from 20 or more medical
device end-user patients or consumers due to the same incident,
they shall assist medical device end-user patients or consumers
to bring litigation in accordance with the provisions of Article
50 of the Consumer Protection Act.
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.
The Enforcement Rules of this Act shall be established by the
central competent authority.
The date for enforcing this Act shall be determined by the
Executive Yuan.
Web site： Laws & Regulations Database of The Republic of China