1 General Information on Draft Partial Amendment to 
the Regulation for Registration of Medical Devices  
  This Regulation was established in accordance with Paragraph 3, Article 
40 of the Pharmaceutical Affairs Act to meet the needs for registration and 
market approval of medical d evices and management of permit licenses , and 
was promulgated and came into force as per the Decree  of Wei -Shu-Yao-Zi 
No. 093032823 8 on December 30, 2004. This Regulation has undergone five 
amendments since then.  In order to improve the registration and market 
approval process and ensure the safety and efficacy of medical devices on 
the market, a draft partial amendment to the Regulat ion for Registration of 
Medical Devices  has been formulated. The main points of the amendment 
are as follows:  
1. With the provisions of Paragraph 3 of Article 3 and Article 13 of the Regu-
lations for Registration of Medicinal Products  as reference, it is stipulated  
that a Chinese or English translation shall be provided if the documents 
submitted are not  made  in Traditional Chinese or English ( amendment to  
Article 3).  
2. Considering that the current relationship between the commissioning 
company and the co mmissioned manufacturing factory is not proved by a 
manufacture certificate but by a commissioning contract signed by the 
parties and other relevant documents in accordance with the Regulations 
for Medicament Contract Manufacture and Analysis, the relevant  prov i-
sions that require a clear description  of the relationship between the 
commissioning company and the commissioned manufacturing factory in 
a manufacture and free sale certificate of the country of origin , as set 
forth  in the latter part of Paragraph 3, are  deleted (amendment to Article 
7). 
3. To meet the needs for e -government, online application services have 2 become available for Class I medical devices . The applicant may  sign or 
affix their seal  to confirm their identity  if an application is submitted in 
writing. However, i f a registration application is submitted online, the 
identity of the applicant must be confirmed by means of electronic sign a-
ture since the applicant is unable to sign or affix their seal . As a result, 
the latter part of the paragraph explicitly stipulates that those submitting 
an application online shall do so with the IC card issued by the Certificate 
Authority of th e Ministry of Economic Affairs (amendment to Articles 14 
and 16).  
4. Change s in the specifications or efficacy of a medical device shall be done 
after evaluated by the original designer or manufacturer of the product, 
so as to ensure the safety and efficacy of the product. Therefore, the 
amendment requires that the comparison and explanation of the 
changed specifications or efficacy and the originally approved specific a-
tions or efficacy submitted for the purpose of applying for change of the 
specifications or efficacy on a permit license shall be issued by the orig i-
nal medical devi ce manufacturer (amendment to Articles 24 and 26).  
5. Paragraph 6 is added  to prevent the change of the address of a medical 
device manufacturing factory from resulting in any inconsistency with its 
medical device previously approved for registration and m arket approval 
in terms of the quality, safety, and efficacy . The central competent a u-
thority may order the applicant to submit relevant supporting documents 
to confirm the consistency with its  medical device previously approved 
for registration and market  approval  (amendment to Article  28). 
6. To avoid other factors that affect the safety and efficacy of the product 
concerned due to extension or change of a permit license, the rights of 
the central health competent authority to order the applicant  to submi t 
relevant documents  are reserved , thereby ensuring  the efficacy and saf e-
ty of the product  (amendment to Article  35). 
7. To collect complete information on the instructions of Class I medical 3 devices and improve the management after launch to the market, it is 
explicitly stipulated that Class I medical device  permit license holders 
shall  upload the instructions, labels, and outer box documents to the i n-
formation system specified by the central health competent authority 
within one (1) month  after obtaining  permit licenses or within six (6) 
months  after  the amendment to this Regulation comes into force if they 
obtain Class I medical device permit licenses  before the amendment to 
this Regulation comes into force . Moreover, such uploading is listed as a 
requir ement for applying for extension of Class I medical device permit 
licenses  (amendment to Article s 35 and 36) . 
8. Since the review process for medical devices exclusively for export is 
different from that for domestically manufactured medical devices, it is  
explicitly stipulated that the Chinese and English names of medical devi c-
es exclusively for export shall not be the same as those of domestically 
manufactured medical devices. Thus, any confusion between medical d e-
vices exclusively for export and domestic ally manufactured medical d e-
vices can be avoided  (amendment to Article  37). 
  4 Comparison Table of Provisions of the Draft Partial 
Amendment to the Regulation for Registration of 
Medical Devices  
Amended Provisions  Existing Provisions  Explanations  
Article 3  For all registr a-
tions mentioned in the 
preceding article, the 
applicant shall pay the 
application fee and su b-
mit completed applic a-
tion forms with all r e-
quired documents purs u-
ant to this Regulation to 
the central health comp e-
tent authority for app rov-
al. 
The application 
forms referred to in the 
foregoing Paragraph i n-
clude application form for 
the registration and ma r-
ket approval of medical 
devices, application form  
for change of registration, 
application form for e x-
tension of permit license 
validity, affida vit, form for 
attaching outer box i n-
struction label, and other 
form and document fo r-
mats associated with the 
application procedures.  
If the documents 
submitted for an applic a-
tion filed in accordance Article 3  For all registr a-
tions mentioned in the 
preceding article, the 
applicant shall pay  the 
application fee and su b-
mit completed applic a-
tion forms with all r e-
quired  documents purs u-
ant to this Regulation to 
the central health comp e-
tent authority for  appro v-
al. 
The application 
forms referred to in the 
foregoing Paragraph i n-
clude application  form for 
the registration and ma r-
ket approval of medical 
devices, application form   
for change of  registration, 
application form for e x-
tension of permit license  
validity, affidavit, form for 
attaching outer box i n-
struction label,  form for  
attaching permit license,  
and other form and do c-
ument formats associated 
with the  application pr o-
cedures.  1. The “form for attaching 
permit license s”, as pr e-
viously set forth in Par a-
graph 2, is provided for a 
manufacturer to attach 
its pharmaceutical firm 
permit license. However, 
the provisions governing 
the required application 
documents herein  have 
stipulated  that a  pharm a-
ceutical firm permit l i-
cense and other doc u-
ments shall be submi t-
ted. Therefore, an appl i-
cant shall directly submit 
a photocopy of its l i-
cense, and said form is 
deleted.  
2. Paragraph 3 is added to 
stipulate that a Traditio n-
al Chinese or English 
translation shall be pro-
vided if the documents 
submitted for an applic a-
tion filed in accordance 
with this Regulation are 
not in Traditional Chinese 
or English.  
 5 Amended Provisions  Existing Provisions  Explanations  
with this Regulation are 
not in Traditional Chinese 
or En glish, a Traditional 
Chinese or English tran s-
lation shall be provided.  
Article 7  The manufacture 
and free sale certificates 
of the country of origin 
referred to in this Regul a-
tion are verifying doc u-
ments issued by the hig h-
est health authority of 
the country where the 
imported medical device 
is manufactured. The 
content of such doc u-
ments shall state the 
name and the address of 
the manufacturing f acto-
ry, the name of the med i-
cal device, the specific a-
tions and model of the 
medical device, the ci r-
cumstances of manufa c-
ture, and the certification 
of approval for domestic 
sale in that country. If it is 
confirmed that the med i-
cal device is not regulated 
by the highest health 
authority in the country 
of the manufacturer, said 
manufacturing and sales 
approval documents may 
be issued by the local 
health agency or an o r-
ganization approved by Article 7  The manufacture 
and free sale certificates 
of the country of origin 
referred to in  this Regul a-
tion are verifying doc u-
ments issued by the hig h-
est health authority of  
the country where the 
imported medical device 
is manufactured. The 
content of such  docu-
ments shall state the 
name and the address of 
the manufacturing fact o-
ry, the name of the med i-
cal device, the specific a-
tions and model of the 
medical device, the  cir-
cumstances of manufa c-
ture, and the certification 
of approval for domestic 
sale in  that country. If it is 
confirmed that the med i-
cal device is not regulated 
by the  highest health 
authority in the country 
of the manufacturer, said 
manufacturing and  sales 
approval documents may 
be issued by the local 
health agency or an o r-
ganization  approved by Paragraph 3 is amended. 
The current  relationship 
between the commissioning 
company and  the commi s-
sioned manufacturing 
factory is proved by a 
commissioning contract . 
Thus, “t he documents shall 
provide clear description 
about the relationship 
between the commissioning 
company and commissioned 
manufacturing factory ” is 
deleted . 6 Amended Provisions  Existing Provisions  Explanations  
Taiwan's central health 
competent authority.  
With regard to the 
manuf acture and free 
sale certificates in the 
foregoing Paragraph, if an 
imported medical device 
is commissioned to ma n-
ufacture, and the device 
is not on sale in the cou n-
try of the commissioned 
manufacturing factory, a 
free sale certificate issued 
from the coun try’s hig h-
est competent health 
authority of the commi s-
sioning company and a 
manufacture certificate 
issued from the country’s 
competent authority of 
commissioned manufa c-
turing factory may be 
submitted instead of the 
foregoing manufacture 
and free sale cert ificate.  
If an imported med i-
cal device is commi s-
sioned to be manufa c-
tured, the manufacture 
and free sale certificates 
in Paragraph 1 are a l-
lowed to be issued by 
respective highest health 
competent authority of 
the country either of the 
commissioning compan y 
or of the commissioned Taiwan's central health 
competent authority.  
With regard to the 
manufacture a nd free 
sale certificates in the 
foregoing  Paragraph, if an 
imported medical device 
is commissioned to ma n-
ufacture, and the  device 
is not on sale in the cou n-
try of the commissioned 
manufacturing factory, a  
free sale certificate issued 
from the country ’s high-
est competent health 
authority  of the commi s-
sioning company and a 
manufacture certificate 
issued from the  country ’s 
competent authority of 
commissioned manufa c-
turing factory may be  
submitted instead of the 
foregoing manufacture 
and free sale cert ificate.  
If an imported med i-
cal device is commi s-
sioned to be manufa c-
tured, the manufacture  
and free sale certificates 
in Paragraph 1 are a l-
lowed to be issued by 
respective  highest health 
competent authority of 
the country either of the 
commissioning  company 
or of the commissioned 7 Amended Provisions  Existing Provisions  Explanations  
manufacturing factory.  
The manufacture 
and free sale certificates 
in Paragraph 1 is allowed 
to be substituted by a 
certificate of manufacture 
issued by the government 
of the country where the 
imported medical device 
is manufactured  and a 
certificate of free sale 
issued by the highest 
health competent autho r-
ity of the United States of 
America, or any member 
state of the European 
Union.  
The verifying doc u-
ments in the four prece d-
ing paragraphs shall r e-
main valid for two years 
after the  date of issuance, 
and shall be notarized by 
Taiwan's embassy or co n-
sulate, representative 
office, other official o f-
fice, or overseas organiz a-
tion in that country a u-
thorized by the Ministry 
of Foreign Affairs (herea f-
ter referred to as the 
overseas represen tative 
organization of Taiwan). A 
Chinese or English tran s-
lation shall be attached 
when the verifying do c-
uments are not in English, manufacturing factory. 
The documents shall 
provide  clear description 
about the relationship 
between the commissio n-
ing company and  com-
missioned manufacturing 
factory.  
   The manufacture and 
free sale certificates in 
Paragraph 1 is allowed to 
be substituted by a certi f-
icate of manufacture 
issued by the government 
of the country  where the 
imported medical device 
is manufactured and a 
certificate of free sale  
issued by the highest 
health competent autho r-
ity of the United States of  
America, or  any memb er 
state of the European 
Union.  
    The verifying doc u-
ments in the four prece d-
ing paragraphs shall r e-
main valid for two  years 
after the date of issuance, 
and shall be notarized by 
Taiwan's embassy or  con-
sulate, representative 
office, o ther official office, 
or overseas organization 
in that country authorized 
by the Ministry of Foreign 
Affairs (hereafter referred 8 Amended Provisions  Existing Provisions  Explanations  
and the translation shall 
also be notarized.  to as  the overseas repr e-
sentative organization of 
Taiwan). A Chinese or 
English  translation shall 
be attached when the 
verifyin g documents are 
not in English, and  the 
translation shall also be 
notarized.  
Article 14  For application 
of registration and market 
approval of domestically 
manufactured Class 1 
medi cal devices, the fo l-
lowing documents shall 
be submitted for review:  
1. Application form for 
Class 1 medical device 
registration  and market 
approval and original 
copy of affidavit.  
2.A photocopy of pharm a-
ceutical firm permit l i-
cense as a medical d e-
vice manu facturer.  
3.Documents  verifying 
that the manufactory in 
conformity with the 
Good Manufacturing 
Practices for Medical 
Devices in accordance 
with the Part 3 of the 
Pharmaceutical Good 
Manufacturing Practice 
Regulations (hereafter 
referred to as GMP for 
Medical Devices). Pro d-Artic le 14 For application 
of registration and market 
approval of domestically 
manufactured  Class 1 
medical devices, the fo l-
lowing documents shall 
be submitted for review:  
1. Application form for 
Class 1 medical device 
registration and market 
approval and  original 
copy of affidavit.  
2.A photocopy of pharm a-
ceutical firm permit l i-
cense as a medical d e-
vice manufacturer.  
3.Documents verifying 
that the manufactory in 
conf ormity with the 
Good Manufacturing  
Practices for Medical 
Devices in accordance 
with the Part 3 of the 
Pharmaceutical  Good 
Manufacturing Practice 
Regulations (hereafter 
referred to as GMP for 
Medical  Devices). Pro d-Paragraph 5 is added. 
Online application  becomes 
available to meet the needs 
for e -government. In 
addition, it is explicitly 
stated that the applicant 
shall sign or affix their seal  if 
an application is submitted 
in writing. I f a registration 
application is submitted 
online, the identity of the 
applicant must be con-
firmed by means of ele c-
tronic signature since the 
applicant is unable to sign 
or affix their seal . As a 
result, the latter part of the 
paragraph explicitly stip u-
lates that those submitting 
an application online shall 
do so with the IC card 
issued by the Certificate 
Authority of the Ministry of 
Economic Affairs . Moreover, 
the pharmaceutical firm 
permit licenses of those 
submitting an application 
online  may be inspected on 9 Amended Provisions  Existing Provisions  Explanations  
uct items in accordance 
with the Article 4 A p-
pendix II of the Regul a-
tions for Governing the 
Management of Medical 
Device are exempted 
from this subparagraph.  
In the event of the 
pharmaceutical firm a p-
plying for registration 
different from the man u-
facturer, it shall be 
deemed as commission 
manufacturing.  
The medical device 
applying for registration is 
commissioned to man u-
facture or analysis, it shall 
be in conformity with the 
Regulations for Medic a-
ment Contract Manufa c-
ture and Analysis.  
The medical device 
applyi ng for registration 
in Paragraph 1 shall be in 
conformity with procl a-
mations of the central 
health competent autho r-
ity; and the technical 
documentation of the 
device shall be kept in the 
manufactory for inspe c-
tion, which including: the 
Chinese instruction leaf-
let, instruction for use, 
packaging, labels of the 
medical device, and do c-uct items in accordance 
with the Article 4 Ap-
pendix II of the  Regul a-
tions for Governing the 
Management of Medical 
Device are exempted 
from this  subparagraph.  
  In the event of the 
pharmaceutical firm a p-
plying for registration 
different from the  man u-
facturer, it shall be 
deemed as commission 
manufac turing.  
  The medical device 
applying for registration is 
commissioned to man u-
facture or  analysis, it shall 
be in conformity with the 
Regulations for Medic a-
ment Contract  Manufa c-
ture and Analysis.  
  The medical device 
applying for registration in 
Paragraph 1 shall be in 
conformity  with proclam a-
tions of the central health 
competent authority; and 
the technical  document a-
tion of the device shall be 
kept in the manufactory 
for inspection, which  
including: the Chinese 
instruction leaflet, instru c-
tion for use, pac kaging, 
labels  of the medical 
device, and documents the system. Therefore, the 
applying pharmaceutical 
firms are not r equired to 
provide said documents.  10 Amended Provisions  Existing Provisions  Explanations  
uments with the product 
information such as co n-
struction, material, spec i-
fication, efficacy, purpose, 
drawing and others, and 
documents of pre -clinical 
trial, and inspection r e-
sults of quality control of 
original manufacturer. 
The central health co m-
petent authority may 
order its submission if 
necessary.  
The registration and 
market approval applic a-
tion filed in accordance 
with Paragraph 1 may be 
submitted in writing or 
online. In t he case of 
submission in writing, the 
applying pharmaceutical 
firm shall sign or affix 
their seal  to the applic a-
tion form. In the case of 
submission online, the IC 
card issued by the Certif i-
cate Authority of the 
Ministry of Economic 
Affairs  shall be used, and 
the documents set forth 
in Subparagraphs 1 and 2 
of Paragraph 1 are not 
required.  with the product info r-
mation such as  constru c-
tion, material, specific a-
tion, efficacy, purpose, 
drawing and others, and  
documents of pre -clinical 
trial, and inspection r e-
sults of quality control of  
original manufacturer. The 
central health competent 
authority may order its  
submission if necessary.  
Article 15   For application 
of registration and market 
approval for domestically 
manufactured Class 2 or Article 15   For application 
of registration and market 
approval for domestically 
manufactured  Class 2 or 1. The text in Subparagraph 
2 of Paragraph 2 is 
amended.  
2. Paragraph 7 is amended. 
For medical devices that 11 Amended Provisions  Existing Provisions  Explanations  
Class 3 medical devices, 
the following documents 
shall be submitted for 
review:  
1.One  copy each of the 
original and photocopy 
of the medical device 
registration and market 
approval application 
form.  
2.Two copies of each of 
the following items: the 
form for attaching outer 
box instruction label 
with all Chinese instru c-
tion leaflet catalog 
packaging, and labeling, 
instructions for use, and 
color pictures of the 
physical appearance of 
product.  
3.A photocopy of pharm a-
ceutical firm permit l i-
cense as a medical d e-
vice manufacturer.  
4.Affidavit (A)  
5.Documents verifying 
that the domestic ma n-
ufactur ing factory is in 
conformity with  the 
GMP for Medical Devi c-
es. 
6.One copy of each of the 
follwing items: pre -
clinical testing and the 
test specifications and 
methods, the original Class 3 medical devices, 
the following documents 
shall be submitted for  
review:  
1.One copy each of the 
original and photocopy 
of the medical device 
registration and  market 
approval application 
form.  
2.Two copies of each of 
the following items: the 
form for attaching outer  
box instruction label 
with all Chinese instru c-
tion leaflet catalog 
packaging, and  labeling, 
instructions for use, and 
color pictures of the 
physical appearance of  
product.  
3.A photocopy of pharm a-
ceutical firm permit l i-
cense as a medical d e-
vice manufacture r. 
4.Affidavit (A)  
5.Documents verifying 
that the domestic ma n-
ufacturing factory is in 
conformity with   the 
GMP for Medical Devi c-
es. 
6.One copy of each of the 
follwing items: pre -
clinical testing and the 
test specifications and 
methods, the original require submission for 
testing, two (2) copies  of 
the documents stating 
the test specifications 
and methods for pre -
clinical testing and qual i-
ty control conducted by 
the original manufactu r-
er, the original test rec-
ords, and the test result 
reports shall be submi t-
ted. 12 Amended Provisions  Existing Provisions  Explanations  
test records, and the 
test reports of the qual i-
ty control conducted by 
the original manufa c-
turer.  
7.One copy of each of the 
relevant documents 
concerning product 
structure, materials, 
specifications, perfo r-
mance, intended uses, 
and drawings, etc. For 
instrument products, an 
operation manual or a 
service manual covers 
all of the a bove -
mentioned items may 
be a substitution.  
8.Theoretical basis and 
relevant research r e-
ports and data.  
9.Clinical trial reports.  
10.Two copies of radiation 
safety information for 
equipments generating 
ionizing radiation.  
Documents of the 
Subparagraphs 5 in the 
preceding paragraph, in 
accordance with any of 
the followings, may be 
substituted with phot o-
copies of documents 
verifying compliance with 
the Good Manufacturing 
Practices for Pharmace u-
ticals in accordance with test records, and the 
test reports of the  qual i-
ty control conducted by 
the original manufa c-
turer.  
7.One copy of each of the 
relevant documents 
concerning product 
structure,  materials, 
specifications, perfo r-
mance, intended uses, 
and drawings, etc. For  
instrument  products, an 
operation manual or a 
service manual covers 
all of the  above -
mentioned items may 
be a substitution.  
8.Theoretical basis and 
relevant research r e-
ports and data.  
9.Clinical trial reports.  
10.Two copies of radiation 
safety information for 
equipm ents generating 
ionizing  radiation.  
Documents of the 
Subparagraphs 5 in the 
preceding paragraph, in 
accordance with any  of 
the followings, may be 
substituted with phot o-
copies of documents 
verifying  compliance with 
the Good Manufacturing 
Practices for Pharm aceu-
ticals in accordance  with 13 Amended Provisions  Existing Provisions  Explanations  
the Part 2 of the Pharm a-
ceutical Good M anufa c-
turing Practice Regul a-
tions (hereafter referred 
to as GMP for Pharm a-
ceuticals):  
1.The medical device 
applying for registration 
and market approval 
was regulated as pha r-
maceutical product b e-
fore. This rule applies 
within three years from 
the date of p roclam a-
tions of listing change.  
2.The medical device was 
regulated as a pharm a-
ceutical product before 
January 1, 2013 . This 
rule applies within three 
years from the promu l-
gation date of the  Sep-
tember 5, 2014 
amendment to this 
Regulation.  
The central health  
competent authority shall 
determine or announce 
whether the medical 
device applying for regi s-
tration and market a p-
proval requires clinical 
trials in Taiwan in light of 
the medical device pro d-
uct item, the case, and 
the materials submitted.  
In the event of  al-the Part 2 of the Pharm a-
ceutical Good Manufa c-
turing Practice Regul a-
tions  (hereafter referred 
to as GMP for Pharm a-
ceuticals):  
1.The medical device 
applying for registration 
and market approval 
was regulated as  phar-
maceutical pr oduct b e-
fore. This rule applies 
within three years from 
the date of  proclam a-
tions of listing change.  
2.The medical device was 
regulated as a pharm a-
ceutical product before 
January 1,  2013. This 
rule applies within three 
years from the promu l-
gation date of t he Sep-
tember 5, 2014 
amendment to this 
Regulation.  
The central health 
competent authority shall 
determine or announce 
whether the  medical 
device applying for regi s-
tration and market a p-
proval requires clinical  
trials in Taiwan in light of 
the medical device  prod-
uct item, the case, and 
the materials submitted.  
In the event of a l-14 Amended Provisions  Existing Provisions  Explanations  
ready a product in the 
market similar to the 
medical device applying 
for registration, except 
where other regulations 
apply, the documents 
specified in Subpar a-
graphs 8 and 9 of Par a-
graph 1 may be waived. 
However, the applicant 
shall additionally attach a 
domestic clinical trial 
report when clinical trials 
in Taiwan are required in 
accordance with the for e-
going Paragraph.  
In the event of a p-
plying for registration and 
market approval of Class 
2 medical devices with no 
predicate product prev i-
ously approved to market 
by the central health 
competent authority, the 
documents specified in 
Subparagraphs 9 of Par a-
graph 1 may be waived if 
the medical device is in 
conformity with the r e-
lated simplified rules or 
regulations announced by 
the central health comp e-
tent a uthority. However, a 
domestic clinical trial 
report shall be submitted 
when a domestic clinical 
trial is required according ready a product in the 
market similar to the 
medical device  applying 
for registration, except 
where other regulations 
apply, the documents  
specified in Subpar a-
graphs 8 and 9 of Par a-
graph 1 may be waived. 
However, the  applicant 
shall additionally attach a 
domestic clinical trial 
report when clinical  trials 
in Taiwan are required in 
accordance with the for e-
going Paragraph.  
In the event of a p-
plying for registration and 
market approval o f Class 
2 medical  devices with no 
predicate product prev i-
ously approved to market 
by the central  health 
competent authority, the 
documents specified in 
Subparagraphs 9 of Par a-
graph  1 may be waived if 
the medical device is in 
conformity with the r e-
lated sim plified  rules or 
regulations announced by 
the central health comp e-
tent authority. However, a  
domestic clinical trial 
report shall be submitted 
when a domestic clinical 
trial is  required according 15 Amended Provisions  Existing Provisions  Explanations  
to Paragraph 3.  
In the event of a p-
plying for registration of 
medical devices exclusiv e-
ly for export, submissions 
for testing are not  re-
quired, and documents 
required by Subpar a-
graphs 6 to 10 of Par a-
graph 1 shall be exemp t-
ed. 
The registration and 
market approval of IVDs 
shall be in conformity 
with the preceding six 
paragraphs and an-
nouncements  by the 
central health competent 
authority . For t he IVD s 
listed as Class III accor d-
ing to the Regulations for 
Governing the Manag e-
ment of Medical Device 
and required to undergo 
testing, as announced by 
the central health comp e-
tent authority , two (2) 
copies of the documents 
specified in Subparagraph 
6 of Paragraph 1 shall be 
submitted , and  subm is-
sion for testing  is r e-
quired , except for  prod-
ucts exclusively for e x-
port.  
The medical devices 
applying for Class III regi s-to Paragraph 3.  
In the event of a p-
plying for registration of  
medical devices exclusiv e-
ly for export,  submissions 
for testing are not r e-
quired, and documents 
required by Subpar a-
graphs 6  to 10 of Par a-
graph 1 shall be exemp t-
ed. 
IVD applying for re g-
istration and market a p-
proval shall be in co n-
formity with the  prece d-
ing six paragraphs and 
proclamations by the 
central health competent  
authority; the IVDs listed 
as Class III according to 
the Regulations for Go v-
erning  the Management 
of Medical Device and 
announced by the central 
health competent  autho r-
ity for the requiremen t of 
testing shall also submit 
for testing, except  prod-
ucts exclusively for e x-
port.  
The medical devices 
applying for Class III regi s-
tration and market a p-
proval, except  products 
exclusively for export, 
shall also submit doc u-
ments of Essential Princ i-16 Amended Provisions  Existing Provisions  Explanations  
tration and market a p-
proval, except products 
exclusively for export, 
shall also submit docu-
ments of Essential Princ i-
ples (EP) and Summary of 
Technical Documentation 
(STED) in accordance with 
Appendix.  
In the event of the 
pharmaceutical firm a p-
plying for registration and 
market approval different 
from the manufacturer, it 
shall be deemed as c om-
mission manufacturing.  
In the event of the 
medical device applying 
for registration and ma r-
ket approval is commi s-
sioned to manufacture or 
testing, the device shall 
be in conformity with the 
preceding nine par a-
graphs and the Regul a-
tions for Medicament 
Contract Manufacture 
and Analysis.  
The medical device 
applying for registration 
in Paragraph 1 and Par a-
graph 6 shall be in co n-
formity with related rules 
or regulations announced 
by the central health 
competent authority, and 
the documents exempted ples (EP) and Summary of 
Technical Documentation 
(STED) in accordance with 
Appendix.  
In the event of the 
pharmaceutical firm a p-
plying for registration and 
market  approval different 
from the manufacturer, it 
shall be deemed as co m-
mission  manufacturing.  
In the event  of the 
medical device applying 
for registration and ma r-
ket approval is  commi s-
sioned to manufacture or 
testing, the device shall 
be in conformity with the  
preceding nine par a-
graphs and the Regul a-
tions for Medicament 
Contract Manufacture  
and Analysis.  
The m edical device 
applying for registration 
in Paragraph 1 and Par a-
graph 6 shall be  in co n-
formity with related rules 
or regulations announced 
by the central health  
competent authority, and 
the documents exempted 
from submission shall be 
kept in the  manufacturi ng 
factory. The central 
health competent autho r-
ity may order its  submi s-17 Amended Provisions  Existing Provisions  Explanations  
from submis sion shall be 
kept in the manufacturing 
factory. The central 
health competent autho r-
ity may order its submi s-
sion when necessary.  sion when necessary.  
 
Article 16   For application 
of regist ration and market 
approval for imported 
Class I medical device, the 
following documents shall 
be submitted:  
1.Application form for 
Class I medical device 
registration and market 
approval and original 
copy of affidavit.  
2.A photocopy of pharm a-
ceutical firm permit l i-
cense as a medical d e-
vice dealer.  
3.Certificate of in co n-
formity with the GMP 
for Medical Devices. 
Product items in a c-
cordance with the Art i-
cle 4 Appendix II of the 
Regulations for Gover n-
ing the Management of 
Medical Device are e x-
empted from this sub-
paragraph.  
If the medical device 
applying for registration 
and market approval is 
commissioned to man u-
facture or analysis, it shall Article 16   For application 
of registration and market 
approval for imported 
Class I medical  device,  the 
following documents shall 
be submitted:  
1.Application form for 
Class I medical device 
registration and market 
approval and  original 
copy of affidavit.  
2.A photocopy of pharm a-
ceutical firm permit l i-
cense as a medical d e-
vice dealer.  
3.Certificate  of in co n-
formity with the GMP 
for Medical Devices. 
Product items in  ac-
cordance with the Art i-
cle 4 Appendix II of the 
Regulations for Gover n-
ing the  Management of 
Medical Device are e x-
empted from this su b-
paragraph.  
If the medical device 
applying for registr ation 
and market approval is 
commissioned  to man u-
facture or analysis, it shall Paragraph 4 is added. 
Online application becomes 
available to meet the needs 
for e -government. I n 
addition, it is explicitly 
stated that the applicant 
shall sign or affix their seal  if 
an application is submitted 
in writing. If a registration 
application is submitted 
online, the identity of the 
applicant must be co n-
firmed by means of ele c-
tronic signa ture since the 
applicant is unable to sign 
or affix their seal . As a 
result, the latter part of the 
paragraph explicitly stip u-
lates that those submitting 
an application online shall 
do so with the IC card 
issued by the Certificate 
Authority of the Ministry  of 
Economic Affairs . 18 Amended Provisions  Existing Provisions  Explanations  
be in conformity with the 
Regulations for  Medi c-
ament Contract Manufa c-
ture and Analysis.  
The medical device 
applying for registration 
in the Paragraph 1 shall 
be in conformity with 
related rules or regul a-
tions announced by the 
central health competent 
authority, and the follo w-
ing technical document a-
tion of the device shall be 
kept in the manufacturing 
factory for inspection:  
instruction leaflets, the 
original instruction for 
use with a copy of its 
Chinese translation, 
packaging, labels of the 
medical device, and do c-
uments with the info r-
mation of the product 
such as structure, mater i-
als, specifications, pe r-
formance, intended u se, 
drawing and others, and 
documents of pre -clinical 
testing, and the testing 
results of quality control 
of the original manufa c-
turer. The central health 
competent authority may 
order its submission 
when necessary.  
The registration and be in conformity with the 
Regulations for   Medi c-
ament Contract Manufa c-
ture and Analysis.  
The medical device 
applying for registration 
in the Paragraph 1 shall 
be in  conformity w ith 
related rules or regul a-
tions announced by the 
central health  competent 
authority, and the follo w-
ing technical document a-
tion of the device shall  be 
kept in the manufacturing 
factory for inspection: 
instruction leaflets, the  
original instruction for 
use with a copy of its 
Chinese translation, 
packaging,  labels of the 
medical device, and do c-
uments with the info r-
mation of the product 
such  as structure, mater i-
als, specifications, pe r-
formance, intended use, 
drawing and  others, and 
documents of pre -clinical 
testing, and the testing 
results of quality  control 
of the original manufa c-
turer. The central health 
competent authority may  
order its submission 
when necessary.  19 Amended Provisions  Existing Provisions  Explanations  
market approval app lica-
tion filed in accordance 
with Paragraph 1 may be 
submitted in writing or 
online. In the case of 
submission in writing, the 
applicant  shall sign or 
affix their seal  to the 
application form. In the 
case of submission 
online, the IC card issued 
by the Cer tificate Author i-
ty of the Ministry of Ec o-
nomic Affairs shall be 
used, and the documents 
set forth in Subpar a-
graphs 1 and 2 of Par a-
graph 1 are not required . 
Article 17   For application 
of registration and market 
approval for imported 
Class II or Class III medical 
devices, the following 
document shall be su b-
mitted for review:  
1.One copy of each of the 
original and photocopy 
of the medical  device 
registration and market 
approval application 
form.  
2.Two copies of each of 
the following items: the 
affixed or stapled to the 
label attachment form 
of instructions and 
manual with detailed Article 17   For application 
of registration and market 
approval for imported 
Class II or Class  III medical 
devices, the following 
document shall be su b-
mitted for review:  
1.One copy of each of the 
original and photocopy 
of the medical device 
registration  and market 
approval application 
form.  
2.Two copies of each of 
the following items: the 
affixed or sta pled to the 
label  attachment form 
of instructions and 
manual with detailed 1. The text in Subparagraph 
2 of Paragraph 2 is 
amended.  
2. Paragraph 6 is amended. 
For medical devices that 
require submission for 
testing, two (2) copies  of 
the documents stating 
the test specifications 
and methods for pre -
clinical testing and qual i-
ty control conducted by 
the original manufactu r-
er, the original test rec-
ords , and the test result 
reports shall be submi t-
ted. 20 Amended Provisions  Existing Provisions  Explanations  
Chinese translations, 
packaging, labels and 
color pictures of the 
physical appearance of 
product.  
3.A photocopy of pharm a-
ceutical firm permit l i-
cense as a medical d e-
vice dealer.  
4.Affidavit (A)  
5.The original copy of the 
manufacture and free 
sale certificate of the 
country of origin.  
6.The  original copy of the 
foreign original man u-
facturer authorization 
letter.  
7.Documents verifying 
that the domestic ma n-
ufacturing factory in 
conformity with the 
GMP for Medical Devi c-
es. 
8.One copy of each of the 
following  items: pre -
clinical testing and the 
test specifications and 
methods, the original 
test records, and the 
test reports of the qual i-
ty control conducted by 
the original manufa c-
turer.  
9.One copy of each of the 
relevant documents 
concerning product Chinese translations,  
packaging, labels and 
color pictures of the 
physical appearance of 
product.  
3.A photocopy of pharm a-
ceutical firm permit l i-
cense as a medical d e-
vice dealer.  
4.Affidavit (A)  
5.The original copy of the 
manufacture and free 
sale certificate of the 
country of  origin.  
6.The original copy of the 
foreign original man u-
facturer authorization 
letter.  
7.Documents verifying 
that the domestic ma n-
ufacturing factory in 
conformity with the  
GMP for Medical Devi c-
es. 
8.One copy of each of the 
following  items: pre -
clinical testing and the 
test specifications and 
methods, the original 
test records, and the 
test reports of the  qual i-
ty control conducted by 
the original manufa c-
turer.  
9.One copy of each of the 
relevant documents 
concerning product 21 Amended Provisions  Existing Provisions  Explanations  
structure, materials, 
specifications, perfo r-
manc e, intended uses, 
and drawings, etc. For 
instrument product, an 
operation manual or a 
service manual covers 
all of the aboveme n-
tioned items may be a 
substitution.  
10.Theoretical basis and 
relevant research r e-
ports and data.  
11.Clinical trial reports.  
12.Tw o copies of radiation 
safety information for 
equipment generating 
ionizing radiation.  
Documents of the 
Subparagraphs 7 in the 
preceding paragraph, in 
accordance with any of 
the followings, may be 
substituted with phot o-
copies of documents 
verifying complian ce with 
the GMP for Pharmace u-
ticals:  
1.The medical device 
applying for registration 
and market approval 
was regulated as pha r-
maceutical product b e-
fore. This rule applies 
within three years from 
the date of proclam a-
tions of listing change.  structure,  materials, 
specifications, perfo r-
mance, intended uses, 
and drawings, etc. For  
instrument product, an 
operation manual or a 
service manual covers 
all of the aboveme n-
tioned  items may be a 
substitution.  
10.Theoretical basis and 
relevant research r e-
ports and data.  
11.Clinical trial reports.  
12.Two copies of radiation 
safety information for 
equipment generating 
ionizing  radiation.  
Documents of the 
Subparagraphs 7 in the 
preceding p aragraph, in 
accordance with any  of 
the followings, may be 
substituted with phot o-
copies of documents 
verifying  compliance with 
the GMP for Pharmace u-
ticals:  
1.The medical device 
applying for registration 
and market approval 
was regulated as  phar-
maceutical p roduct b e-
fore. This rule applies 
within three years from 
the date of  proclam a-
tions of listing change.  22 Amended Provisions  Existing Provisions  Explanations  
2.The  medical device was 
regulated as a pharm a-
ceutical product before 
January 1,  2013. This 
rule applies within three 
years from the promu l-
gation date of the Sep-
tember 5, 2014  
amendment to this 
Regulation.  
The central health 
competent authority shall 
determine or announce 
whether the medical 
device applying for regi s-
tration and market a p-
proval requires clinical  
trials in Taiwan in light of 
the medical device pro d-
uct item, the case, and 
the materials submitted.  
In the event of a l-
ready a product in the 
market simi lar to the 
medical device applying 
for registration, except 
where other regulations 
apply, the documents 
specified in Subpar a-
graphs 10 and 11 of Par a-
graph 1 may be waived. 
However, the applicant 
shall additionally attach a 
domestic clinical trial 
report wh en clinical trials 
in Taiwan are required in 
accordance with the for e-2.The medical device was 
regulated as a pharm a-
ceutical product before 
January 1,  2013. This 
rule applies within three 
years from the promu l-
gation date of the Se p-
tember 5, 2014 
amendment to this 
Regulation.  
The central health 
competent authority shall 
determine or announce 
whether the  medical 
device applying for regi s-
tration and market a p-
proval requires clinical  
trials in Taiwan in light of 
the medical devic e pro d-
uct item, the case, and 
the materials submitted.  
In the event of a l-
ready a product in the 
market similar to the 
medical device  applying 
for registration, except 
where other regulations 
apply, the documents  
specified in Subpar a-
graphs 10 and 11 of Par a-
graph 1 may be waived. 
However, the  applicant 
shall additionally attach a 
domestic clinical trial 
report when clinical  trials 
in Taiwan are required in 
accordance with the for e-23 Amended Provisions  Existing Provisions  Explanations  
going Paragraph.  
In the event of a p-
plying for registration and 
market approval of Class 
2 medical devices with no 
predicate product prev i-
ously approved to market 
by the central health 
com petent authority, the 
documents specified in 
Subparagraphs 11 of 
Paragraph 1 may be 
waived if the medical 
device is in conformity 
with the related simpl i-
fied rules or regulations 
announced by the central 
health competent autho r-
ity. However, a domestic 
clinical trial report shall 
be submitted when a 
domestic clinical trial is 
required according to 
Paragraph 3.  
The registration and 
market approval of IVDs 
shall be in conformity 
with the preceding five 
paragraphs and a n-
nouncements by the 
central health compete nt 
authority. For the IVDs 
listed as Class III accor d-
ing to the Regulations for 
Governing the Manag e-
ment of Medical Device 
and required to undergo going Paragraph.  
In the event of a p-
plying for registration and 
market approval o f Class 
2 medical  devices with no 
predicate product prev i-
ously approved to market 
by the central  health 
competent authority, the 
documents specified in 
Subparagraphs 11 of 
Paragraph  1 may be 
waived if the medical 
device is in conformity 
with the related si mpli-
fied rules or regulations 
announced by the central 
health competent autho r-
ity. However, a  domestic 
clinical trial report shall 
be submitted when a 
domestic clinical trial is  
required according to 
Paragraph 3.  
IVD applying for re g-
istration and market a p-
proval shall be in co n-
formity with the  prece d-
ing five paragraphs and 
proclamations by the 
central health competent  
authority; IVDs listed as 
Class III according to the 
Regulations for Governing 
the Management of Me d-
ical Device and a n-
nounced as the item r e-24 Amended Provisions  Existing Provisions  Explanations  
testing, as announced by 
the central health comp e-
tent authority, two (2) 
copies  of the documents 
specified in  Subparagraph 
8 of Paragraph 1 shall be 
submitted , and submi s-
sion for testing is r e-
quired.  
The Class III medical 
device applying for regi s-
tration and market a p-
proval, shall submit do c-
uments of Essential Pri n-
ciples (EP) and Summary 
of Technical Document a-
tion (STED) in accordance 
with Appendix.  
In the event of the 
medical device applying 
for registration is co m-
missioned to manufa c-
ture or analysis, in add i-
tion to conformity with 
the preceding seven pa r-
agraphs, conformity with 
the Regulations for M e-
dicament Con tract Man u-
facture and Analysis shall 
also be required.  
The medical device 
applying for registration 
according to the Par a-
graph 1 shall be in co n-
formity with related rules 
or regulations announced 
by the central health quired testing by the  
central health competent 
authority shall also su b-
mit for testing.  
The Class III medical 
device applying for regi s-
tration and market a p-
proval, shall  submit do c-
uments of Essential Pri n-
ciples (EP) and Summary 
of Technical Document a-
tion (STED) in accordance 
with Appendix.  
In the event of the 
medical device applying 
for registration is co m-
missioned to  manufa c-
ture or analysis, in add i-
tion to conformity with 
the preceding seven  par-
agraphs, conformity with 
the Regulations for M e-
dicament Contract Man u-
facture and  Analysis shall 
also be required.  
The medical device 
applying for registration 
according to the Par a-
graph 1 shall be  in co n-
formity with related rules 
or regulations announced 
by the central health  
competent authority; 
document exemp ted 
from submission shall be 
kept at the  manufacturing 
factory for possible i n-25 Amended Provisions  Existing Provisions  Explanations  
competent authority; 
document exempted  
from submission shall be 
kept at the manufacturing 
factory for possible i n-
spection, The medical 
device applying for regi s-
tration and market a p-
proval in the Paragraph 1 
shall be in conformity 
with related rules or reg u-
lations announced by the 
central healt h competent 
authority, and documents 
exempted from submi s-
sion shall be kept. The 
central health competent 
authority may order its 
submission when nece s-
sary.  spection, The medical 
device applying for  regis-
tration and market a p-
proval in the Paragraph 1 
shall be in conformity 
with  related rules or reg u-
lations announced by the 
central he alth competent 
authority,  and documents 
exempted from submi s-
sion shall be kept. The 
central health competent  
authority may order its 
submission when nece s-
sary.  
Article 24  The following 
documents shall be a t-
tached when applying for 
change of the specific a-
tions on a medical device 
permit license:  
1.Application form for 
change in medical d e-
vice permit license.  
2.Original copy of the 
medical device permit 
license.  
3.Original copy of the 
already approved i n-
struction leaflet 
stamped with tally i m-
pression of the central Article 24   The following 
documents shall be a t-
tached when applying for 
change of the  specific a-
tions on a medical device 
permit license:  
1.Application form for 
change in medical d e-
vice permit license.  
2.Original copy of the 
medical device permit 
license.  
3.Original copy of the 
already approved i n-
struction leaflet 
stamped with tally  im-
pression of the central 1. Subparagraph 7 of 
Paragraph 1 is amended. 
Any change in the spec i-
fications of a medical 
device (such as new 
availability of contact 
lenses in different diam e-
ters or colors) shall be 
done after evaluated by 
the original designer or 
manufacturer of the 
product, so as to ensure 
the safety and efficacy of 
the product. Therefore, 
the amendment requires 
that the comparison and 
explanation of the 26 Amended Provisions  Existing Provisions  Explanations  
health competent a u-
thority.  
4.Two copies of each of 
the following items: the 
affixed or stapled t o the 
label attachment form 
of instructions and 
manual with detailed 
Chinese translations, 
packaging, labels and 
color pictures of the 
physical appearance of 
product.  
5.One copy of each of the 
following items: pre -
clinical testing and the 
test specificatio ns and 
methods, the original 
test records, and the 
test reports of the qual i-
ty control conducted by 
the original manufa c-
turer.  
6.One copy of each of the 
relevant documents 
concerning product 
structure, materials, 
specifications, perfo r-
mance, intended uses,  
and drawings, etc. For 
instrument product, an 
operation manual or a 
service manual covers 
all of the aboveme n-
tioned items may be a 
substitution.  
7.The original copy  of the health competent a u-
thority.  
4.Two copies of each of 
the following items: the 
affixed or stapled to the 
label  attachment form 
of instructions and 
manual with detailed 
Chinese translations,  
packaging, labels and 
color pictures of the 
physical appearance of 
product.  
5.One copy of each of the 
following items: pre -
clinical testing and the 
test specifications and 
methods, the original 
test records, and the 
test reports of the  qual i-
ty control conducted by 
the original manufa c-
turer.  
6.One copy of each of the 
relevant documents 
concerning product 
structure,  materials, 
specifications, perfo r-
mance, intended uses, 
and drawings, etc. For  
instrument product, an 
operation manual or a 
service manual covers 
all of the aboveme n-
tioned  items may be a 
substitution.  
7.A comparison table of changed specificatio ns 
and the originally a p-
proved specifications 
submitted for the pu r-
pose of applying for 
change of the specific a-
tions on a permit license 
shall be issued by the 
original medical device 
manufacturer.  
2. The text in Paragraph 3 is 
slightly amended. The 
previo us provisions stip u-
late that for Class III IVDs, 
compliance with the pr e-
ceding two paragraphs is 
required, and an original 
covering letter issued by 
the original manufacturer 
shall be submitted. When 
necessary, stability test 
results and other relevant 
data shall also be provi d-
ed. However, “stability 
test results and other 
relevant data” are part of 
“pre -clinical testing” set 
forth in Subparagraph 5 
of Paragraph 1. The “ori g-
inal manufacturer’s co v-
ering letter” is a redu n-
dancy of the “original 
copy of the co mparison 
and explanation of the 
changed specifications 
and the originally a p-
proved specifications 27 Amended Provisions  Existing Provisions  Explanations  
comparison and expl a-
nation of the change d 
specifications  and the 
original ly approve d 
specification s issued by 
the original manufa c-
turer ; 
8.The original copy of the 
manufacture and free 
sale certificate of the 
country of origin.  
9.The original copy of 
foreign original man u-
facturer authorization 
letter.  
10.Two  copies of radiation 
safety information for 
equipment generating 
ionizing radiation.  
The documents in 
The documents in Su b-
paragraphs 8 and 9 of the 
foregoing Paragraph may 
be waived when applying 
to change a domestically -
manufactured medical 
device permit license.  
The application for 
change of the specific a-
tions of a medical device  
shall be in conformity 
with the preceding two 
paragraphs if such a d e-
vice is a Class III IVD . 
Moreover, if  the IVD is 
required to undergo tes t-
ing, as announced by the the change and the ori g-
inal specification with 
explanation.  
8.The original copy of the 
manufacture and free 
sale certificate of the 
country of  origin.  
9.The  original copy of 
foreign original man u-
facturer authorization 
letter.  
10.Two copies of radiation 
safety information for 
equipment generating 
ionizing  radiation.  
The documents in 
Subparagraphs 8 and 9 of 
the foregoing Paragraph 
may be waived when  
applying t o change a 
domestically -
manufactured medical 
device permit license.  
When the medical 
device for which an appl i-
cation to add specific a-
tions has been made  is a 
Class III IVD, in addition to 
the preceding two par a-
graphs, original copy of  
the original manufact urer 
covering letter shall be 
submitted, when nece s-
sary, attach  stability test 
results and other relevant 
data; when the type of 
device is announced  as issued by the original 
manufacturer” set forth 
in the amended Subpar a-
graph 7 of Paragraph 1. 
Thus, said text is deleted. 
Moreover, for medical 
devices that are required 
to undergo testing, two 
(2) copies  of the doc u-
ments stating the test 
specifications and met h-
ods for pre -clinical testing 
and quality control co n-
ducted by the original 
manufacturer, the orig i-
nal test records, and the 
test result reports shall 
be submitted . 28 Amended Provisions  Existing Provisions  Explanations  
central hea lth competent 
authority, two (2) copies  
of the documents spec i-
fied in Subparagraph 5 of 
Paragraph 1 shall be 
submitted , and submi s-
sion for testing is r e-
quired.  
The medical device 
applying for registration 
in Paragraph 1 shall be in 
conformity with related 
rules or regulations a n-
nounced by the central 
health competent autho r-
ity, and the documents 
exempted from submi s-
sion shall be kept in the 
manufacturing factory. 
The central health co m-
petent authority may 
order its submission 
when necessary.  the one required testing 
by the central health 
competent authority shall 
also submit for testing.  
The medical device 
applying for registration 
in Paragraph 1 shall be in 
conformity  with related 
rules or regulations a n-
nounced by the central 
health competent  autho r-
ity, and the documents 
exempted from submi s-
sion shall be kept in the  
manufacturing factory. 
The central health co m-
petent authority may 
order its  submission 
when necessary.  
Article 26   The following 
documents shall be a t-
tached when applying for 
change in medical device 
efficacy, indication, pe r-
formance, instruction for 
use, or dosage on a med i-
cal device permit, the 
following do cuments shall 
be submitted:  
1.Application form for 
change in medical d e-
vice permit license.  
2.Original copy of the Article 26   The following 
documents  shall be a t-
tached when applying for 
change in medical device  
efficacy, indication, pe r-
formance, instruction for 
use, or dosage on a med i-
cal device permit,  the 
following documents shall 
be submitted:  
1.Application form for 
change in medical d e-
vice permit license.  
2.Original copy of the Subparagraph 11 of Par a-
graph 1 is added . Any 
change in the efficacy  of a 
medical device ( for exa m-
ple, the graft materials 
previously for dental 
purposes only may also be 
used for other bone defects ) 
shall be done after evalua t-
ed by the original designer 
or manufacturer of the 
product, so as to ensure the 
safety and effica cy of the 
product. Therefore, the 29 Amended Provisions  Existing Provisions  Explanations  
medical device permit 
license.  
3.Original copy of the 
already approved i n-
struction leaflet 
stamped with tally i m-
pression of the central 
healt h competent a u-
thority.  
4.Two copies of each of 
the following items: the 
affixed or stapled to the 
label attachment form 
of instructions and 
manual with detailed 
Chinese translations, 
packaging, labels and 
color pictures of the 
physical appearance of 
produc t. 
5.One copy of the follo w-
ing items: pre -clinical 
testing and the test 
specifications and 
methods, the original 
test records, and the 
test reports of the qual i-
ty control conducted by 
the original manufa c-
turer.  
6.One copy of each of the 
relevant documents 
concerning product 
structure, materials, 
specifications, fun c-
tions, intended uses, 
and drawings, etc. For medical device permit 
license.  
3.Original copy of the 
already approved i n-
struction leaflet 
stamped with tally  im-
pression of the central 
health competent a u-
thority.  
4.Two copies of each of 
the following items: the 
affixed or stapled to the 
label  attachment form 
of instructions and 
manual with detailed 
Chinese translations,  
packaging, labels and 
color pictures of the 
physical app earance of 
product.  
5.One copy of the follo w-
ing items: pre -clinical 
testing and the test 
specifications  and 
methods, the original 
test records, and the 
test reports of the qual i-
ty control  conducted by 
the original manufa c-
turer.  
6.One copy of each of the 
relevant documents 
concerning product 
structure,  materials, 
specifications, fun c-
tions, intended uses, 
and drawings, etc. For  comparison and explanation 
of the changed efficacy  and 
the originally approved 
efficacy  submitted for the 
purpose of applying for 
change of the efficacy  on a 
permit license shall be 
issued by the original 
medical device ma nufactu r-
er. 30 Amended Provisions  Existing Provisions  Explanations  
instrument product, an 
operation manual or a 
service manual covers 
all of the aboveme n-
tioned items may be a 
substitution.  
7.The original copy of the 
manufacture and free 
sale certificate of the 
country of origin.  
8.The original copy of 
foreign original man u-
facturer authorization 
letter.  
9.Theoretical basis and 
relevant research r e-
ports and data.  
10.Clinical trial reports.  
11. The o riginal copy of 
the comparison and e x-
planation of the 
changed particulars  and 
the originally approved 
particulars  issued by the 
original manufacturer.  
 In the event of 
applying for change of a 
domestically manufa c-
tured medical device, 
Subparagraph 7 and 8 
and of the preceding  
paragraph shall be e x-
empted.  
In the event of a l-
ready a product in the 
market similar to the 
medical device applying instrument product, an 
operation manual or a 
service manual covers 
all of the aboveme n-
tioned  items may be a 
substitution.  
7.The origi nal copy of the 
manufacture and free 
sale certificate of the 
country of  origin.  
8.The original copy of 
foreign original man u-
facturer authorization 
letter.  
9.Theoretical basis and 
relevant research r e-
ports and data.  
10.Clinical trial reports.  
In the event o f applying 
for change of a domest i-
cally manufactured med i-
cal device,  Subparagraph 7 
and 8 and of the prece d-
ing paragraph shall be 
exempted.  
In the event of a l-
ready a product in the 
market similar to the 
medical device  applying 
for changes of Paragraph 
1, the documents spec i-
fied in Subparagraphs 9 
and 10 of Paragraph 1 
may be waived.  
The medical device 
applying for registration 
in Paragraph 1 and Par a-31 Amended Provisions  Existing Provisions  Explanations  
for changes of Paragraph 
1, the documents spec i-
fied in Subparagraphs 9 
and 10 of Paragraph 1 
may be waived.  
The medical device 
applying for  registration 
in Paragraph 1 and Par a-
graph 3 shall be in co n-
formity with related rules 
or regulations announced 
by the central health 
competent authority, and 
the documents exempted 
from submission shall be 
kept in the manufacturing 
factory. The central 
health competent autho r-
ity may order its submi s-
sion when necessary.  graph 3 shall be  in co n-
formity with related rules 
or regulations announced 
by the central health  
competent au thority, and 
the documents exempted 
from submission shall be 
kept in the  manufacturing 
factory. The central 
health competent autho r-
ity may order its  submi s-
sion when necessary.  
Article 28   The following 
documents shall be a t-
tached when applying for 
change in address of 
manufacturing factory 
(including the country of 
origin):  
1.Application form for 
change in medical d e-
vice permit license.  
2.Original copy of the 
medica l device permit 
license.  
3.Original manufacturer 
covering letter that e x-
plains the change in 
manufacturing factory Article 28   The following 
documents shall be a t-
tached when applying for 
change in address of  
manufacturing factory 
(including the country of 
origin):  
1.Application form for 
change in medical de-
vice permit license.  
2.Original copy of the 
medical device permit 
license.  
3.Original manufacturer 
covering letter that e x-
plains the change in 
manufacturing  factory 1. Paragraph 5 is amended. 
For the  change of the 
address of the manufa c-
turing factory of Class III 
IVDs , documents regar d-
ing pre-clinical testing 
and quality control co n-
ducted by the original 
manufacturer  are r e-
quired  in accordance 
with Article 12, to verify 
the safety and functiona l-
ity of the products. 
Therefore, new contents 
are added to the original 
provisions to avoid any 
doubts during reviews 32 Amended Provisions  Existing Provisions  Explanations  
address.  
4.Photocopy of pharm a-
ceutical firm permit l i-
cense of the manufa c-
turing factory with the 
new address.  
5.Original copy of the 
manufact ure and free 
sale certificate of the 
country of origin.  
6.The original copy of 
foreign original man u-
facturer authorization 
letter.  
7.Documents verifying 
that the manufacturing 
factory in conformity 
with the GMP for Med i-
cal Devices.  
In the event of a p-
plying for change in ma n-
ufacturing factory name 
for an imported medical 
device, Subparagraph 4 of 
the preceding paragraph 
shall be exempted.  
In the event of a p-
plying for change in ma n-
ufacturing factory name 
for a domestically man u-
factured medical device, 
Subpara graph 5 and 6 of 
Paragraph 1 shall be e x-
empted.  
If change of the 
manufacturing factory 
address was due to address.  
4.Photocopy of pharm a-
ceutical firm permit l i-
cense of the manufa c-
turing factory w ith the 
new address.  
5.Original copy of the 
manufacture and free 
sale certificate of the 
country of  origin.  
6.The original copy of 
foreign original man u-
facturer authorization 
letter.  
7.Documents verifying 
that the manufacturing 
factory in conformity 
with t he GMP for  Med i-
cal Devices.  
In the event of a p-
plying for change in ma n-
ufacturing factory name 
for an imported  medical 
device, Subparagraph 4 of 
the preceding paragraph 
shall be exempted.  
In the event of a p-
plying for change in ma n-
ufacturing factory name 
for a domestically  man u-
factured medical device, 
Subparagraph 5 and 6 of 
Paragraph 1 shall be e x-
empted.  
If change of the 
manufacturing factory 
address was due to and be consistent with 
the current review r e-
quirements.  
2. Paragraph 6 is added. To 
prevent the  change of 
the address of a medical 
device manufact uring 
factory  from resulting in 
any inconsistency with its 
medical device previously 
approved for registration 
and market approval in 
terms of the quality, saf e-
ty, and efficacy , the ce n-
tral health competent 
authority  may order the 
applicant to submit do c-
uments regarding pre-
clinical testing and qual i-
ty control conducted by 
the original manufacturer  
to verify the safety and 
functionality of the pro d-
uct. 33 Amended Provisions  Existing Provisions  Explanations  
house -numbering system 
change, document for 
Subparagraph 5 of Par a-
graph 1 may be exemp t-
ed, a certificate issued by 
government shall be 
submitted; in the case of 
imported medical devi c-
es, the certificate shall be 
notarized by R.O.C (Ta i-
wan) foreign affairs office.  
In the case of a Class 
III IVD, t he application for 
change shall be in co n-
formity with the prece d-
ing four paragraphs. 
Moreover, two (2) copie s 
of the documents stating 
the test specifications and 
methods for pre -clinical 
testing and quality co n-
trol conducted by the 
original manufacturer , 
the original test records, 
and the test result reports 
shall be submitted. I f the 
IVD is required to unde r-
go testing, as announced 
by the central health 
competent authority, 
submission for testing is 
also required.  
For medical device s 
for which an application 
for change of the address 
of the manufacturing 
factory  is submitt ed in house -numbering system  
change, document for 
Subparagraph 5 of Par a-
graph 1 may be exemp t-
ed, a certi ficate  issued by 
government shall be 
submitted; in the case of 
imported medical devi c-
es, the certificate shall be 
notarized by R.O.C (Ta i-
wan) foreign affairs office.  
When the medical 
device for which an appl i-
cation to change man u-
facturing factory  address 
has been made is a Class 
III IVD, in addition to the 
preceding 4 paragraphs,  
two copy of each of the 
following items, including 
pre-clinical testing and 
the test  specifications and 
methods, the original test 
records, and the test 
reports of the  quality 
cont rol conducted by the 
original manufacturer, 
shall be submitted. When 
the type of device is a n-
nounced as the one r e-
quired testing by the 
central health  competent 
authority, the applicant 
shall also submit for tes t-
ing. 34 Amended Provisions  Existing Provisions  Explanations  
accordance with Par a-
graph  1, the central 
health competent autho r-
ity may , if necessary,  
order submission of tech-
nical documentation such 
as relevant documents 
concerning product stru c-
ture, materials, specific a-
tions, performance, i n-
tended use, and dra w-
ings, pre -clinical testing 
documents, a nd test 
results of quality control 
by the original manufa c-
turer.  
Article 35  The following 
documents shall be a t-
tached when applying for 
extension of the validity 
period of a medical d e-
vice permit license:  
1.A medical device permit 
license validity period 
extension application 
form approved by the 
special municipality, 
county and city health 
competent authority of 
the pharmaceutical 
company's locality.  
2.Original copy of t he 
medical device permit 
license.  
3.The original copy of the 
manufacture and free 
sale certificate of the Article 35   The following 
documents shall be a t-
tached when applying for 
extension of the  validity 
period of a medical d e-
vice permit license:  
1.A medical device permit 
license validity period 
extension application 
form approved by the 
special municipality, 
county and city health 
competent authority of  
the pharmaceutical 
company's locality.  
2.Original copy of the 
medical device permit 
license.  
3.The original copy of the 
manufacture and free 
sale certificate of the 1. Paragraph 4 is added. To 
strengthen the manag e-
ment of Class I medical 
device s, the uploading of  
the instructions, labels, 
and outer box es of Class I 
medical device s has b e-
come a requirement for 
applying for extension.  
2. The text in Subparagraph 
2 of Paragraph 6 is 
amended.  
3. Paragraph 7 is added. If 
there are doubts about 
the safety and efficacy of 
the product concerned 
by the application for 
extension, the central 
health competent a u-
thority may order the 
manufacturer to submit 35 Amended Provisions  Existing Provisions  Explanations  
country of origin.  
4.Original copy of foreign 
original manufacturer 
continual authorization 
letter.  
5.Certificate of in co n-
formity with the GMP 
for Me dical Devices. 
Product items in a c-
cordance with the Art i-
cle 4 Appendix II of the 
Regulations for Gover n-
ing the Management of 
Medical Device are e x-
empted from this su b-
paragraph.  
The medical device 
applying for foregoing 
paragraph application is 
commissioned  to man u-
facture or analysis, it shall 
be in conformity with the 
Regulations for Medic a-
ment Contract Manufa c-
ture and Analysis.  
In the event of a p-
plying for extension of 
the validity period of a 
medical device permit 
license for a domestically 
manufactured m edical 
device, the applicant is 
exempted from submi t-
ting documents specified 
in Subparagraph 3 and 4 
of Paragraph 1.  
In the event  of a p-country of  origin.  
4.Original copy of foreign 
original manufacturer 
continual authorization 
letter.  
5.Certificate of in co n-
formity with the GMP 
for Medical Devices. 
Product items in  ac-
cordance with the Art i-
cle 4 Appendix II of the 
Regulations for Gover n-
ing the Management of 
Medical Device are e x-
empted from this su b-
paragraph.  
The medical device 
applying for foregoing 
paragraph application is 
commissioned to  man u-
facture or analysis, it shall 
be in conformity with the 
Regulations for  Medic a-
ment Contract Manufa c-
ture and Analysis.  
In the event of a p-
plying for extension of 
the validity period of a 
medical device  permit 
license for a domestically 
manufactured medical 
device, the applicant is  
exempted from submi t-
ting documents specified 
in Subparagraph 3 and 4 
of Pa ragraph 1.  
In the event of a p-relevant documents, so 
as to ensure the efficac y 
and safety of the pro d-
uct. 36 Amended Provisions  Existing Provisions  Explanations  
plying for extension of a 
Class I medical device 
permit license, this article 
shall apply, and the i n-
structions, labels, and 
outer box shall first be 
uploaded to the info r-
mation system specified 
by the central health 
competent authority.  
In the event of a p-
plying extension of the 
validity period of a med i-
cal device permit license 
of a Class I medical d e-
vice, in addition to co m-
plying this article, Articles 
14 and 16 shall be applied 
mutatis mutandis.  
If meeting one of the 
following circumstances, 
documents of the Su b-
paragraphs 5 in the Par a-
graph 1 may be substitu t-
ed with photocopies of 
documents verifying 
compliance with GMP fo r 
Pharmaceuticals:  
1.The medical device 
applying for registration 
was regulated as a 
pharmaceutical product 
before. This rule applies 
within three years from 
the date of proclam a-
tions of listing change.  
2.The medical device was plying extension of the 
validity period of a med i-
cal device permit  license 
of a Class I medical d e-
vice, in addition to co m-
plying this article, Articles  
14 and 16 shall be applied 
mutatis mutandis.  
If meeting one of the 
followin g circumstances, 
documents of the Su b-
paragraphs 5 in  the Par a-
graph 1 may be substitu t-
ed with photocopies of 
documents verifying  
compliance with GMP for 
Pharmaceuticals:  
1.The medical device 
applying for registration 
was regulated as a 
pharmaceutical  produc t 
before. This rule applies 
within three years from 
the date of proclam a-
tions  of listing change.  
2.The medical device was 
regulated as a pharm a-
ceutical product before 
January 1,  2013. This 
rule applies within three 
years from the promu l-
gation date of the  Sep-
tember 5, 2014 
amendment to this 
Regulation. The man u-
facturing factory with 
valid  medical device l i-37 Amended Provisions  Existing Provisions  Explanations  
regulated as a pharm a-
ceutical product before 
January 1,  2013. This 
rule applies within three 
years from the promu l-
gation date of the  Sep-
tember 5, 2014 
amendment to this 
Regulation. The man u-
facturing factory with 
valid  medical device l i-
cense shall not be a p-
proved for extension if it 
fails to conform to  the 
GMP for medical device.  
For the application 
for extension of a permit 
license in accordance 
with Paragraph 1, the 
central health competent 
authority may order 
submission of relevant 
documents if there are 
doubts about the safe ty 
and efficacy of the pro d-
uct concerned . cense shall not be a p-
proved for extension if it 
fails to conform to  the 
GMP for medical device.  
Article 36   Publication of 
medical device instru c-
tion leaflet, labeling and 
packaging, in addition to 
conformity with Article 75 
of the Act and related 
proclamations made by 
the central health comp e-
tent authority, applicant 
shall modify, supplement 
or resend related doc u-Article 36   Publication of 
medical device instru c-
tion leaflet, labeling and 
packaging, in  addition to 
conformity with Article 75 
of the Act and related 
proclamations made by  
the central health comp e-
tent authority, applicant 
shall modify, suppleme nt 
or resend  related doc u-Paragraphs 5 and 6 are 
added. To collect complete 
information on the  instru c-
tions of Class I medical 
devices and improve the 
management after launch  to 
the market , permit license 
holders are required to 
upload the instructions, 
labels, and outer box 
documents to the info r-38 Amended Provisions  Existing Provisions  Explanations  
ments under the request 
of central health comp e-
tent authority.  
Medical device i n-
struction leaflet shall 
publicize all contraindic a-
tion, warning, side e f-
fects, and other notices, 
in red, red box, or bold 
type fon ts. Font type in a 
Chinese instruction leaflet 
shall not be smaller than 
7-pt font.  
Domestic medical 
device labeling, instru c-
tion leaflet, and packa g-
ing shall mainly publicize 
in Chinese characters. 
Characters in any other 
language shall be smaller 
than Ch inese ones.  
For imported med i-
cal device, in addition to 
mandatary Chinese i n-
struction leaflet, labeling 
and packaging shall publ i-
cize product name, med i-
cal device permit license 
number, the name and 
address of the pharm a-
ceutical firm as the i m-
porter shall all be in Ch i-
nese characters. Man u-
facturing date and expir a-
tion date shall be in Ch i-
nese characters as well, 
or understood habitually; ments under the request 
of central health comp e-
tent authority.  
Medical device i n-
struction leaflet shall 
publicize all contraindic a-
tion, warning,  side e f-
fects, and other notices, 
in red, red box, or bold 
type fonts. Font type in a  
Chinese instruction leaflet 
shall not be smaller than 
7-pt font.  
Domestic medical 
device labeling, instru c-
tion leaflet, and packa g-
ing shall mainly  publicize 
in Chinese characters. 
Characters in any other 
language shall be smaller  
than Chinese ones.  
For imported med i-
cal device, in addition to 
mandatary Chinese i n-
struction leaflet,  labeling 
and packaging shall publ i-
cize product name, med i-
cal device permit license  
number, the name and 
address of the pharm a-
ceutical firm as the i m-
porter shall all be  in Ch i-
nese characters. Man u-
facturing date and expir a-
tion date shall be in Ch i-
nese  characters as well, 
or understood habitually; mation system specified by 
the central health comp e-
tent authority within one (1) 
month  after obtaining 
permit licenses or within six 
(6) months  from the date of 
promulgation of the 
Amendment to this Regul a-
tion if they have obtained 
permit licenses.  39 Amended Provisions  Existing Provisions  Explanations  
Characters in any other 
language shall be smaller 
than Chinese ones.  
Holder s of permit l i-
cense s for approved and 
launched Class I medical 
device s shall, within one 
(1) month  after obtaining 
the permit license s, up-
load the instructions, 
labels, and outer box es to 
the information system 
specified by the central 
health competent autho r-
ity. Permit licen se holder s 
shall assume the oblig a-
tions to ensure the au-
thenticity of all uploaded 
contents, including the 
names of the uploaded 
documents, labels, i n-
structions, packaging, 
trademarks, and dra w-
ings.  
Permit license hol d-
ers who obtain  Class I 
medical device permit 
licenses before  the 
amendment to this Reg u-
lation comes into force 
shall, within six (6) 
months  from the date of 
promulgation of the ○○○ 
Amendment to this Reg u-
lation, upload the instru c-
tions, labels, and outer 
boxes in accordance with Characters in any other 
language shall  be smaller 
than Chinese ones.  40 Amended Provisions  Existing Provisions  Explanations  
the preceding p aragraph.  
Article 37   The product 
name of a medical device 
shall comply with the 
following regulations:  
1.A product name shall 
not use pharmaceutical 
name, trademark, or 
name of manufacturer 
from others, unless 
trademark awarded or 
authorization obtained.  
2.A product name shall 
not be the same as ot h-
er medical device, o r 
involved in counterfei t-
ing or insinuation.  
3.Product name shall not 
involve in misreprese n-
tation, overstatement, 
or leading people in i m-
proper association with 
medical device and/or 
efficacy.  
4.Chinese product name 
shall not contain any 
character in any other 
language or in numbers, 
unless phrases used 
contain meaning direc t-
ly related, or English 
trademarks contains 
special meaning and 
approved by the central 
health competent a u-
thority.  
5.The Chinese and English Article 37   The product 
name of a medical device 
shall comply with the 
following regulations:  
1.A product name shall 
not use pharmaceutical 
name, trademark, or 
name of  manufacturer 
from others, unless 
trademark awarded or 
authorization obtain ed. 
2.A product name shall 
not be the same as ot h-
er medical device, or 
involved in  counterfei t-
ing or insinuation.  
3.Product name shall not 
involve in misreprese n-
tation, overstatement, 
or leading  people in i m-
proper association with 
medical device and/or 
efficacy.  
4.Chinese product name 
shall not contain any 
character in any other 
language or in  numbers, 
unless phrases used 
contain meaning direc t-
ly related, or English 
trademarks  contains 
special meaning and 
approved by the central 
health competent a u-
thority.  
5.A product name shall Subparagraph 5 of Par a-
graph 1 is added. Since the 
review process for medical  
devices exclusively for 
export is different from that 
for domestically manufa c-
tured medical devices, it is 
explicitly stipulated  that the 
Chinese and English names 
of medical devices excl u-
sively for export shall not be 
the same as those of 
domestically ma nufactured 
medical devices . Thus, any 
confusion between medical 
devices exclusively for 
export and domestically 
manufactured medical 
devic es can be avoided.  41 Amended Provisions  Existing Provisions  Explanations  
names of medical d e-
vices exclusively for e x-
port shall not be the 
same as those of d o-
mestically manufa c-
tured medical devices.  
6.A product name shall 
not be in other impro p-
er situations as a name 
of medical device.  
The precedence of 
medical device names 
that are identical or sim i-
lar shall be determined 
on the basis of the prec e-
dence of trademarks, 
company names, or other 
identifiable names.  
The central health 
competent authority may 
review the name of a 
medical device already 
approved for sale in a c-
cordance with regulations 
of the foregoing tw o pa r-
agraphs.  not be in other impro p-
er situations as a name 
of medical  device.  
The precedence of 
medical device names 
that are identical or sim i-
lar shall be  determined 
on the basis of the prec e-
dence of trademarks, 
company names, or other  
identifia ble names.  
The central health 
competent authority may 
review the name of a 
medical device  already 
approved for sale in a c-
cordance with regulations 
of the foregoing two  par-
agraphs.