General description of draft amendments on partial 
articles of “Regulations Governing Issuance of Medical 
Device License, Listing and Annual Declaration ” as 
well as Appendix 1 of Article 5, Appendices 2 and 3 of 
Article 6  
The Regulations Governing Issuance of Medical Device License, Listing and 
Annual Declaration (hereinafter referred to as the Regulations) were released 
on April 29, 20 21 with Wei -Shou -Shi-Tzu No. 1101603144  order of the 
Ministry of Health and Welfare . Considering the rapid advancement of medical 
devices, to harmonize with international regulations, to improve Taiwan ’s 
practical management of medical devices, and to improv e administrative 
efficiency, draft amendment of partial articles of the Regulations as well as 
Appendix 1 of Article 5, Appendices 2 and 3 of Article 6 have been  prepared . 
Key points of the amendment are listed below:  
I. Added registration particulars of medi cal device licenses and amended 
regulations on medical devices that need to submit samples for testing.  
(Amended Article 3)  
II. Amended the designated deadline  to make corrections after the formality 
review of applications of medical device registration and market approval. 
(Amended  Article 7)  
III. Added change of particulars to medical device licenses and amended the 
documents and information  to be submitted for applications of changes of 
particulars. (Amended Article 13)  
IV. Newly added a mutatis mutandis provision on applications for change of 
particulars of medical device licenses  that require submission of samples 
for testing . (Amended Article 13 -1) 
V. Added and amended the regulations to stipulate when medical device 
license holders can make changes of their own accord. (Amended Article 
14) 
VI. Amended the regulations governing the application for listing of medical devices and change of listing of medical devices, and added Appendix 5 
to list the documents and information  that should be uploaded for 
reference. (Amend ed Article s 20 and 21) 
VII. Documents and information  that shall be submitted for an application of 
registration and market approval to manufacture or import Class 1 medical 
devices  have been added . (Amended provisions in Appendix 1 of Article 
5 of the Regulati ons) 
VIII. Amended documents and information that shall be submitted for an 
application of registration and market approval to manufacture or import 
Class 2 or Class 3 medical devices and relevant instructions . (Amended 
provisions in Appendix 2 of Article 6 of t he Regulations)  
IX. Amended the title of Appendix 3 and a dded applicable product items for 
Class 2 medical device product comparison and preclinical test data 
conformity statement. (Amended provisions in Appendix 3 of Article 6 of 
the Regulations)  
 
  Comparison Table of Original and Amended Provisions 
in “the Regulations Governing Issuance of Medical 
Device License, Listing and Annual Declaration .” 
Amended articles  Original articles  Description  
Article 3 Applicants who 
apply for a license 
issued by the 
registration and market 
approval to manufacture 
or import medical 
devices shall submit 
documents and 
information in 
accordance with the 
provisions of Articles 5 
and 6 and pay the fee to 
the central  competent 
authority for 
submission.  
To apply for the 
registration and market 
approval referred to in 
the preceding paragraph 
for items announced by 
the central competent 
authority, applicant s 
shall follow the testing 
notice issued by the 
central competen t 
authority, pay the 
testing fee by the 
designated deadline, and 
submit sufficient 
samples necessary for 
testing to conduct 
testing procedures. 
However, this does not Article 3 Applicants who 
apply for a license 
issued by the 
registration and market 
approval to manufacture 
or import medical 
devices shall submit 
documents and 
information in 
accordance with the 
provisions of Articles 5 
and 6 and pay the fee to 
the central  competent 
authority for 
submission.  
Applicants whose 
application of 
registration and market 
approval, as referred to 
in the preceding 
paragraph and needed to 
conduct testing in 
accordance with the 
provisions of the 
Regulations,  shall 
follow the testing n otice 
issued by the central 
competent authority, 
pay the testing fee by 
the designated deadline, 
and submit sufficient 
samples necessary for 
testing to conduct 1. Paragraph 2 has been 
amended to clarify that 
testing is required for 
items announced by 
the central competent 
authority  when 
applying for 
registration and market 
approval to 
manufacture or import 
medical devices . 
2. The manufacturing 
license number has 
been added as one of 
the particulars to be 
included  in the 
registration particulars 
of medical device 
licenses.  apply to those 
exclusively for export.  
Registration 
particulars for the 
license referred  to in 
Paragraph 1 are as 
follows:  
1. Chinese and English 
product names.  
2. Name of the medical 
device firm.  
3. Name and address of 
the medical device 
manufacturer.  
4. Effectiveness, 
intended use, or 
indication.  
5. Ingredients, materials, 
structures, 
specifications, or 
model number of the 
medical device.  
6. Labels, instructions, 
or packaging.  
7. Manufacturing license 
number.  
8. Other registration 
particulars that have 
been designated by 
the central competent 
authority.  testing procedures. 
However, this does not 
apply to those 
exclusively for export.  
Registration 
particulars for the 
license referred to in 
Paragraph 1 are as 
follows:  
1. Chinese and English 
product names.  
2. Name of the medical 
device firm.  
3. Name and address of 
the medical device 
manufacturer.  
4. Effectiveness, 
intended use, or 
indication.  
5. Ingredients, mat erials, 
structures, 
specifications, or 
model number of the 
medical device.  
6. Labels, instructions, 
or packaging.  
7. Other registration 
particulars that have 
been designated by 
the central competent 
authority.  Article 7 After receiving 
an application of 
registration and market 
approval, the central 
competent authority 
shall conduct a 
formality review of 
application documents 
and information.  
If the formality 
review set forth in the 
preceding paragraph 
finds application 
documents and 
information are not 
ready such that 
corrections can be 
made, the central 
competent authority 
shall notify the 
applicant to make 
corrections within one 
month. Failu re to make 
corrections by the 
designated deadline 
shall subject the 
application to rejection.  Article 7 After receiving 
an application of 
registration and market 
approval, the central 
competent authority 
shall conduct a 
formality review of 
application docu ments 
and information.  
If the formality 
review set forth in the 
preceding paragraph 
finds application 
documents and 
information are not 
ready such that 
corrections can be 
made, the central 
competent authority 
shall notify the 
applicant to make 
corrections  within four 
months. Failure to make 
corrections by the 
designated deadline 
shall subject the 
application to rejection.  The provision on the 
formality review of 
applications of registration 
and market approval of 
medical devices has been 
amended to improve the 
review efficiency , to 
prevent manufacturers 
from submitting 
applications before all 
required documents and 
information  are complete, 
and to avoid wasting 
reviewers ’ effort  review ing 
applications with 
incomplete documents and 
information .  
Article 13 If registration 
particulars of the 
license, labels, 
instructions, or 
packaging are changed 
relating to any of the 
following 
subparagraphs, 
documents and 
information in 
Appendix 4 shall be Article 13 If registration 
particulars of the 
license, labels, 
instructions, or 
packaging are changed 
relating to any of the 
following 
subparagraphs, 
documents and 
information in 
Appendix 4 shall be As the manufacturing 
license number has been 
added as one of the 
particulars to be included 
in the registration 
particulars of medical 
device licenses  in Article 
3, it has been added as one 
of the particulars to be 
included in applications 
for change of particulars submitted and fee shall 
be paid for submission 
of an appl ication to the 
central competent 
authority:  
1. Chinese product 
name.  
2. English product 
name.  
3. Labels, 
instructions , or 
packaging.  
4. Ingredients, 
materials, 
structures, 
specifications , or 
model number.  
5. Effectiveness, 
intended use, or 
indication.  
6. Name of the 
manufacturer.  
7. Address of the 
manufacturer or 
country of 
manufacture.  
8. License holder.  
9. Name of the 
license holder.  
10. Manufacturing 
license number.   
When the approved 
document of license or 
labels, instructions, or 
packaging is lost or 
damaged, d ocuments 
and information in 
Appendix 4 shall be submitted and fee shall 
be paid for submission 
of an application to the 
central competent 
authority:  
1. Chinese product 
name . 
2. English product 
name.  
3. Labels, 
instructions , or 
packaging.  
4. Ingredients, 
materials, 
structures, 
specifications , or 
model number.  
5. Effectiveness, 
intended use, or 
indication.  
6. Name of the 
manufacturer.  
7. Address of the 
manufacturer or 
country of 
manufacture .  
8. License holder.  
9. Name of the 
license holder  
When the approved 
document of license or 
labels, instructions, or 
packaging is lost or 
damaged, documents 
and information in 
Appendix 4 shall be 
submitted and fee shall 
be paid to apply for of medical device licenses.  submitted and fee shall 
be paid to apply for 
replacement or re -
issuance.  
If the central 
competent authority 
finds that documents 
and information referred 
to in the preceding two 
paragraphs are not ready 
such that corrections 
can be made, it shall 
notify the applicant to 
make corrections within 
three months. Failure to 
make corrections by the 
designated deadline 
shall subject the 
application to rejection.  
For applications of 
re-issuance or 
replacement of lice nse 
as referred to in 
Paragraph 2, the 
applicant shall, within 
three months after the 
arrival date of the 
notice, pay the license 
fee and obtain the 
license from the central 
competent authority. 
Failure to obtain the 
license by the deadline 
may subject its  license 
to cancellation by the 
central competent 
authority.  replacement or re -
issuance.  
If the central 
competent authority 
finds that documents 
and information referred 
to in the preceding two 
paragraphs are not ready 
such that corrections 
can be made, it shall 
notify the applicant to 
make corrections within 
three months. Failure to 
make corrections by the 
designated deadline 
shall subject the 
application to rejection.  
For applications of 
re-issuance or 
replacement of license 
as referred to in 
Paragraph  2, the 
applicant shall, within 
three months after the 
arrival date of the 
notice, pay the license 
fee and obtain the 
license from the central 
competent authority. 
Failure to obtain the 
license by the deadline 
may subject its license 
to cancellation by the  
central competent 
authority.  
For applications 
referred to in 
Paragraphs 1 and 2, the For applications 
referred to in 
Paragraphs 1 and 2, the 
central competent 
authority shall annotate 
the original license with 
the changed registration 
particulars and date, and 
return it after st amping.  central competent 
authority shall annotate 
the original license with 
the changed registration 
particulars and date, and 
return it after stamping.  
Article 13 -1 For items 
announced by the 
central competent 
authority to apply for 
the change referred to in 
Subparagraph 4 or 7 of 
Paragraph 1 of the 
preceding article, the 
provisions of Paragraph 
2 of Article 3 shall 
apply mutatis mutandi s.  1. This Article is newly 
added.  
2. To specify that testing 
is required for items 
announced by the 
central competent 
authority when 
apply ing for the 
change referred to in 
Subparagraph 4 or 7 of 
Paragraph 1 of Article 
13. 
Article 14 Under any of 
the following  
circumstances, license 
holders may, of their 
own accord, change 
labels, instructions, or 
packaging of the 
medical devices, and 
such changes shall be 
documented 
accordingly:  
1. No changes in the 
text content:  
(1)  Only changing 
the material, 
shape, graphic 
design,  color or Article 14 Under any of 
the following 
circumstances, license 
holders may, of their 
own accord, change 
labels, instructions, or 
packaging of the 
medical devices, and 
such changes shall be 
documented 
accordingly:  
1. No changes in the 
text content:  
(1)  Only changing 
the material, 
shape, graphic 
design, color or 1. As all items listed in 
Subparagraph 2 are no t 
related to the quality 
and safety of medical 
devices, the wording 
has been changed to 
remove the restriction 
and for clarity of the 
regulations.  
2. As the management of 
medical device  
manufacturer s has 
been changed from 
Good Manufacturing 
Practice (GMP) to 
Quality Management 
System ( QMS ), it has luster of labels, 
instructions, or 
outer box and 
the graphic 
design not being 
offensive, 
indecent, or 
misleading.  
(2)  Due to different 
packaging 
quantities, 
resizing the 
approved 
graphic design 
or text to fit a 
different size of 
packaging, or 
reposi tioning the 
approved 
graphic design 
or text.  
(3)  Changing the 
fonts of the 
approved text, 
and its font size 
of English text 
not being larger 
than that of 
Chinese text for 
the product 
name.  
(4)  Adding printings 
on outer boxes 
or using new 
outer boxes to 
replace t he 
affixed labels, 
and their design luster  of labels, 
instructions, or 
outer box and 
the graphic 
design not being 
offensive, 
indecent, or 
misleading.  
(2)  Due to different 
packaging 
quantities, 
resizing the 
approved 
graphic design 
or text to fit a 
different size of 
packaging, or 
repositioning the 
approved 
graphic design 
or text.  
(3)  Changing the 
fonts of the 
approved text, 
and its font size 
of English text 
not being larger 
than that of 
Chinese text for 
the product 
name.  
(4)  Adding printings 
on outer boxes 
or using new 
outer boxes to 
replace the 
affixed label s, 
and their design been added in Item 1 
of Subparagraph 2, so 
manufacturers can 
change the wording of 
QMS of their own 
accord on the 
condition that the 
manufacturing license 
has been obtained ; 
information about 
representatives in other 
countries or areas has 
been added as an item 
that can be changed by 
manufacturers of their 
own accord.  
3. Considering 
international 
regulations on the 
labeling of medical 
devices, Item 5 of 
Subparagraph 2 is 
newly  added. On the 
condition that such 
particulars comply 
with regulations for the 
approval and 
registration of the 
license, international 
labeling symbols 
representing the 
particulars can be 
changed by 
manufacturers of their 
own accord to 
facilitate complianc e. 
4. The central competent 
authority may, based of text and 
graphs being 
identical to those 
in the originally 
approved labels.  
2. Changes of the 
following text 
content : 
(1)  Adding or 
changing 
barcode, 
recycling mark, 
“QMS/ GMP ” 
characters of a 
medical device 
QMS/ GMP 
manufacturer, 
CE mark, 
suggested retail 
price, customer 
service 
telephone line, 
manufacturer ’s 
telephone 
number, fax 
number, contact 
office, copyright 
registration 
number or 
company 
trademark 
approved by 
Taiwan 
Intellectual 
Property Office, 
CNS mark or 
trademark 
registration of text and 
graphs being 
identical to those 
in the originally 
approved labels.  
2. Changes of the 
following text 
content  that do not 
relate to the quality 
and safety of 
medical devices:  
(1)  Adding or 
changing 
barcode, 
recycling mark, 
“GMP ” 
characters of a 
medical device 
GMP 
manufacturer, 
CE mark, 
suggested retail 
price, customer 
service 
telephone line, 
manufacturer ’s 
telephone 
number, fax 
number, contact 
office, copyright 
registration 
number or 
company 
trademark 
approved by 
Taiwan 
Intellectual 
Property Office, on the discovery of 
new facts and to 
protect the health and 
interests of the public, 
require the addition, 
deletion, or change of 
text on labels, 
instructions, or 
packaging of medical 
devices. For rapid and 
effective transmission 
of information, 
Subparagraph 3 is 
added . number, 
information of  
representative in 
other countries 
or areas . 
(2)  Adding or 
changing 
distributor ’s 
name or address, 
and the font size 
of distributor ’s 
name not larger 
than that of 
medical device 
manufacturer ’s 
(license 
holder ’s) name.  
(3)  Adding or 
changing the 
name of medical 
device firm, or 
the name or 
address of 
manufacturer 
that has been 
approved for 
change by the 
central 
competent 
authority.  
(4)  Adding,  
deleting, or 
changing the 
name of medical 
device firm that 
has been 
approved for 
change by the CNS mark or 
trademark 
registration 
number.  
(2)  Adding or 
changing 
distributor ’s 
name or address, 
and the font s ize 
of distributor ’s 
name not larger 
than that of 
medical device 
manufacturer ’s 
(license 
holder ’s) name.  
(3)  Adding or 
changing the 
name of medical 
device firm, or 
the name or 
address of 
manufacturer 
that has been 
approved for 
change by the 
central 
competent 
authority.  
(4)  Adding, 
deleting, or 
changing the 
name of  medical 
device firm that 
has been 
approved for 
change by the 
central  central 
competent 
authority and 
that constitutes 
part of the 
Chinese and 
English product 
names.  
(5) Adding, deleting 
or changing 
international 
symbols 
representing 
approval and 
registration 
particulars on 
the license.  
3. Adding, deleting or 
changing the 
content according 
to the 
announcements 
made in 
accordance with 
Subparagraph 10, 
Paragraph 1, 
Article 13 of the 
Act. competent 
authority and 
that constitutes 
part of the 
Chinese and 
English product 
names.  
Article 20 Applicants who 
apply for a listing to 
manufacture or import 
medical devices shall 
list the following 
documents and 
information in the 
medical device listing 
system  (hereinafter 
referr ed to as “the Article 20 Applicants who 
apply for a listing to 
manufacture or import 
medical devices shall 
list the following 
documents and 
information in the 
medical device listing 
system (hereinafter 
referred to as “the To improve the 
management of the 
medical device listing 
system, the regulations on 
uploading documents and 
information  for reference 
when applying for a listing 
to manufacture or import 
medical devices has been 
amended. Appendix 5 Listing System ”) 
established by the 
central competent 
authority,  upload 
relevant documents and 
information as 
stipulated in Appendix 5  
and pay the fee to 
obtain a listing number:  
1. Chinese and 
English product 
names.  
2. Name of the 
medical device 
firm.  
3. Name and address 
of the 
manufacturer.  
4. Item name and 
number of the 
medical device 
classification.  
5. Sterility condition 
of the medical 
device.  
6. Status of the 
manufacturer in 
conforming to the 
Medical Device 
Quality 
Manageme nt 
System 
Regulations.  
7. Other documents 
and information 
designated by the 
central competent 
authority.  Listing System ”) 
established by the 
central competent 
authority and pay the  
fee to obtain a listing 
number:  
1. Chinese and 
English product 
names.  
2. Name of the 
medical device 
firm.  
3. Name and address 
of the 
manufacturer.  
4. Item name and 
number of the 
medical device 
classification.  
5. Sterility condition 
of the medical 
device.  
6. Status of the 
manufacturer in 
conforming to the 
Medical Device 
Quality 
Management 
System 
Regulations.  
7. Other documents 
and information 
designated by the 
central competent 
authority.  
The provisions of 
Article 4 shall apply 
mutatis mutandis to the have been added to 
explicitly list the 
documents and 
information  that should be 
uploaded when applying 
for a listing of a medical 
device.  The provisions of 
Article 4 shall apply 
mutatis mutandis to the 
product names of 
medical devices in the 
preceding paragraph.  product names of 
medical devices in the 
preceding paragraph.  
Article 21 With the 
exception of 
Subparagraph 4, those 
that change the listing 
particula rs of any 
subparagraph referred to 
in Paragraph 1 of the 
preceding article shall 
apply for the change in 
the Listing System and 
pay the fee.  
For the 
aforementioned 
application of change, 
the previous Article 
shall appl y mutatis 
mutandis for applicants 
to upload the documents 
and information.   
Changes to name 
of the medical device 
firm referred to in 
Subparagraph 2 of 
Paragraph 1 of the 
preceding article shall 
be limited to those that 
do not involve transfer 
of rights.  
Changes to item 
name and number of the 
medical device 
classification referred to Article 21 With the 
exception of 
Subparagraph 4, those 
that change the listing 
particulars of any 
subparagraph referred to 
in Paragraph 1 of the 
preceding article shall 
apply for the change in 
the Listing System and 
pay the fee.  
Changes to name 
of the medical device 
firm referred to in 
Subparagraph 2 of 
Paragraph 1 of the 
preceding ar ticle shall 
be limited to those that 
do not involve transfer 
of rights.  
Changes to item 
name and number of the 
medical device 
classification referred to 
in Subparagraph 4 of 
Paragraph 1 of the 
preceding article shall 
not apply for a listing 
change.  Paragra ph 2 has been 
added in accordance with 
Article 20 to specify that 
to apply for a change of a 
listing of a medical device, 
the previous Article shall 
be applied mutatis 
mutandis and applicants 
shall upload the 
documents and 
information.  in Subparagraph 4 of 
Paragraph 1 of the 
preceding article shall 
not apply for a listing 
change.  
Article 26 The Regu lations 
shall be implemented on 
May 1, 2021.  
Amendments to the 
Regulations shall be 
implemented on the date 
of promulgation.   Article 26 The Regulations 
shall be implemented on 
May 1, 2021.  
 Paragraph 2 is added to 
specify the effective date 
of the amendments of the 
Regulations.   
 
 
 
 Comparison Table of O riginal and Amended Provisions in Appendix 1 of Article 5  
Amended provisions  Original provisions  Description  
Appendix 1: Documents and information that shall be 
submitted  for an application of registration and market 
approval to manufacture or import Class 1 medical devices  
   Application Category  
Item Manufacture  Import  
1 Application form for Class 1 
medical device registration 
and market approval  ○ ○ 
2 Copy of the medical device 
business permit  ○ ○ 
3 Document verifying that 
medical device manufacturer 
conforms to the Medical 
Device Quality Management 
System Regulations  △ △ 
4 Instructions of product from 
the original manufacturer  △ △ 
5 Test specifications and 
methods for preclinical  
testing and the test reports  △ △ Appendix 1: Documents and information that shall be 
submitted for an application of registration and market 
approval to manufacture or import Class 1 medical devices  
Application Category  
Item Manufacture  Import  
1 Application form for Class 1 
medical device registration 
and market approval  ○ ○ 
2 Copy of the  medical device 
business permit  ○ ○ 
3 Document verifying that 
medical device manufacturer 
conforms to the Medical 
Device Quality Management 
System Regulations  △ △ 
4 Instructions of product from 
the original manufacturer  △ △ 
5 Test specifications and 
methods for preclinical  
testing and the test reports  △ △ Change of 
wording of 
Section 6 of 
the 
Instructions 
and relevant 
documents and 
information 
that should be 
submitted have 
been added for 
clarity and for 
applicants to 
follow.  6 Other documents and 
information designated  by the 
central competent authority  △ △ 
 
Instructions:  
1. ○: Indicates document for this item shall be submitted.  
△: Indicates it would be dependent on the case.  
2. Copy of the medical device business permit : 
(1)  Those who manufacture medical devices shall 
attach a copy of the medical device 
manufacturing permit. Those who import 
medical devices  shall  attach a copy of the 
medical device dealer permit showing that the 
business category includes “medical device 
import .”  
(2)  For domestic contract manufacturing, both the 
contract party and the contract manufacturer ’s 
medical device business permits shall be 
submitted.   
3. Document verifying that medical device manufacturer 
conforms to the Medical Device Quality Management 
System Regulations: This document refers to a copy of  
the certification document issued by the central 
competent authority stating that the me dical device 
manufacturer conforms to the Medical Device Quality 6 Other documents and 
information designated by the 
central competent authority  △ △ 
 
Instructions:  
1. ○: Indicates document for this item shall be submitted.  
△: Indicates it would  be depend ent on the case.  
2. Copy of the medical device business permit : 
(1)  Those who manufacture medical devices shall 
attach a copy of the medical device 
manufactur ing permit . Those who import 
medical devices shall  attach a copy of the 
medical device dealer permit showing that the 
business category  includes “medical device 
import .”  
(2)  For domestic contract manufacturing, both the 
contract party and the contract manufacturer ’s 
medical device business permits shall be 
submitted.   
3. Document verifying that medical device manufacturer 
conforms to the Medical Device Quality Management 
System Regulations: This document refers to a copy of  
the certification document issued by the central 
competent authority stating that the medical device 
manufacturer conforms to the Medical Device Quality Management System Regulations. However, this shall 
not be required for items that, as product items 
announced by the central competent authority, do not 
need to obtain  manufacturing license.   
4. Instructions of product from the original manufacturer: 
They shall include the instructions for use, function, 
working principle, explanation of product composition 
(or ingredients), and the contents of which shall be 
sufficient to determine that the medi cal product meets 
the identification of Class 1 classification.   
5. Test specifications and methods of preclinical testing 
and the test reports: These documents shall be submitted 
if the product performance/specifications have been 
described in the identifica tion provisions of Class 1 
medical device product items or announced by the 
central competent authority pursuant to Article 30 of the 
Act.  
6. Other documents and information designated by the 
central competent authority : 
(1)  If the product name bears a trademark, relevant 
information related to trademark registration shall 
be submitted. If the product name bears the name 
or trademark of another firm, a consent letter 
issued by the firm shall be submitted.  Management System Regulations. However, this shall 
not be required for items that, as product items 
announc ed by the central competent authority, do not 
need to obtain manufacturing license.   
4. Instructions of product from the original manufacturer: 
They shall include the instructions for use, function, 
working principle, explanation of product composition 
(or in gredients), and the contents of which shall be 
sufficient to determine that the medical product meets 
the identification of Class 1 classification.   
5. Test specifications and methods of preclinical testing 
and the test reports: These documents shall be submi tted 
if the product performance/specifications have been 
described in the identification provisions of Class 1 
medical device product items or announced by the 
central competent authority pursuant to Article 30 of the 
Act.  
6. The central competent authority may, depending on the 
circumstances of the case, request relevant documents 
and information be submitted : 
(1)  If the product name bears a trademark, relevant 
information related to trademark registration 
shall be submitted. If the product name bears the 
name or trademark of another firm, a consent 
letter issued by the firm shall be submitted.   (2)  In line with the Con solidated List of 
Commodities Subject to Import Restriction and 
Commodities Assisted by Customs for Import 
Examination announced by the Bureau of Foreign 
Trade of the Ministry of Economic Affairs, 
medical devices imported from China shall first 
obtain perm it for import from the Bureau of 
Foreign Trade of the Ministry of Economic 
Affairs before applying for registration and 
market approval from the central competent 
authority.  
(3) If the name of the product bears a proper noun for 
performance/specification of a specific country or 
international organization standards, supporting 
documents issued by the country or the region, a 
third -party validation agency, or the international 
organization should be attached.  (2)  In line with the Con solidated List of 
Commodities Subject to Import Restriction and 
Commodities Assisted by Customs for Import 
Examination announced by the Bureau of 
Foreign Trade of the Ministry of Economic 
Affairs, medical devices imported from China 
shall first obtain perm it for import from the 
Bureau of Foreign Trade of the Ministry of  
Economic Affairs before applying for 
registration and market approval from the central 
competent authority.   
  
 Comparison Table of Original and Amended Provisions in Appendix 2 of Article 6  
Amended provisions  Original provisions  Description  
Appendix 2 Documents and information that shall be submitted 
for an application of registration and market approval to 
manufacture or import Class 2 or Class 3 medical devices  
 
   Application  
     Category  
 
 
 
 
 
 
Documents and 
Information to 
be Submitted  Class 2  
Medical 
Devices  Class 3  
Medical 
Devices  Same 
Product 
with 
Different 
Product 
Names  Exclusively 
for Export  
Manufacture  Import  Manufacture  Import  Manufacture  Import  Manufacture  
1 Application 
form for 
medical device 
registration 
and market 
approval  ○ ○ ○ ○ ○ ○ ○ 
2 Two copies of 
draft labels, 
instructions or 
packaging  ○ ○ ○ ○ ○ ○ ╳ 
3 Copy of the 
medical device 
business 
permit  ○ ○ ○ ○ ○ ○ ○ Appendix 2 Documents and information that shall be submitted 
for an application of registration and market approval to 
manufacture or import Class 2 or Class 3 medical devices  
 
   Application  
     Category  
 
 
 
 
 
 
Documents and 
Information to 
be Submitted  Class 2  
Medical 
Devices  Class 3  
Medical 
Devices  Same 
Product 
with 
Different 
Product 
Names  Exclusively 
for Export  
Manufacture  Import  Manufacture  Import  Manufacture  Import  Manufacture  
1 Application 
form for 
medical device 
registration 
and market 
approval  ○ ○ ○ ○ ○ ○ ○ 
2 Two copies of 
draft labels, 
instructions or 
packaging  ○ ○ ○ ○ ○ ○ ╳ 
3 Copy of the 
medical device 
business 
permit  ○ ○ ○ ○ ○ ○ ○ 1. Following the 
amendment of 
the provision 
of Paragraph 2 
of Article 3 on 
product s that 
require testing, 
Item 16 of 
“Documents 
and 
information 
that shall be 
submitted ” has 
been amended.  
2. Change of 
wording of 
Item 3, 
Subp aragraph 
2, Section 4 of 
the 
Instructions.  
3. Added new 
applicable 
items in 
accordance 
with Appendix 
3. For practical 
management, 4 Original of the 
manufacture 
and free sale 
certificate of 
the country of 
origin  ╳ △ ╳ △ ╳ ○ ╳ 
5 Original of the 
foreign 
original 
manufacturer 
authorization 
letter  ╳ ○ ╳ ○ ╳ ○ ╳ 
6 Documen t 
verifying that 
medical device 
manufacturer 
conforms to 
the Medical 
Device Quality 
Management 
System 
Regulations  ○ ○ ○ ○ ╳ ╳ ○ 
7 Test 
specifications 
and methods of 
preclinical 
testing and 
quality control 
conducted by 
the original 
manufacturer, 
the original △ △ ○ ○ ╳ ╳ ╳ 4 Original of the 
manufacture 
and free sale 
certificate of 
the country of 
origin  ╳ △ ╳ △ ╳ ○ ╳ 
5 Original of the 
foreign 
original 
manufacturer 
authorization 
letter  ╳ ○ ╳ ○ ╳ ○ ╳ 
6 Document 
verifying that 
medical device 
manufacturer 
conforms to 
the Medical 
Device Quality 
Management 
System 
Regulations  ○ ○ ○ ○ ╳ ╳ ○ 
7 Test 
specifications 
and methods of 
preclinical 
testing and 
quality control 
conducted by 
the original 
manufacturer, 
the original △ △ ○ ○ ╳ ╳ ╳ the provisions 
of 
Subp aragraph 
3 of Section 7 
of the 
Instructions 
have been 
amended.  
4. Section 13 of 
the 
Instructions 
added other 
documents and 
information  
designated by 
the central 
competent 
authority.  
5. Amended 
Section 14 of 
the 
Instructions to 
clearly specify 
that products 
that require 
testing are 
items 
announced in 
accordance 
with Paragraph 
2 of Article 3.  test records, 
and the test 
reports  
8 Documents 
relating to 
product 
structures, 
materials, 
specifications, 
functions, 
intended uses, 
and drawings  ○ ○ ○ ○ ╳ ╳ ╳ 
9 Clinical 
evidence 
information  △ △ △ △ ╳ ╳ ╳ 
10 Radiation 
safety 
information for 
equipment 
generating 
ionizing 
radiation  △ △ △ △ ╳ ╳ ╳ 
11 Essential 
Principles (EP) 
of Safety and 
Performance 
of Medical 
Devices and 
Summary 
Technical 
Documentation 
(STED)  ╳ △ ○ ○ ╳ ╳ ╳ test records, 
and the test 
reports  
8 Documents 
relating to 
product 
structures, 
materials, 
specifications, 
functions, 
intended uses, 
and drawings  ○ ○ ○ ○ ╳ ╳ ╳ 
9 Clinical 
evidence 
information  △ △ △ △ ╳ ╳ ╳ 
10 Radiation 
safety 
information for 
equipment 
generating 
ionizing 
radiation  △ △ △ △ ╳ ╳ ╳ 
11 Essential 
Principles (EP) 
of Safety and 
Performance 
of Medical 
Devices and 
Summary  
Technical 
Documentation 
(STED)  ╳ △ ○ ○ ╳ ╳ ╳ 12 Original of the 
manufacturer’s 
letter 
explaining that 
the product is 
the same 
product with 
different 
product names  ╳ ╳ ╳ ╳ ○ ○ ╳ 
13 Copy of the 
originally 
approved 
labels, 
instructions, or 
packaging 
stamped with 
tally 
impression of 
the central 
competent 
authority  ╳ ╳ ╳ ╳ ○ ○ ╳ 
14 Copy of the 
originally 
approved 
medical device 
license  ╳ ╳ ╳ ╳ ○ ○ ╳ 
15 Other 
documents and 
information 
designated by 
the central △ △ △ △ △ △ △ 12 Original of the 
manufacturer’s 
letter 
explaining that 
the product is 
the same 
product with 
different 
product names  ╳ ╳ ╳ ╳ ○ ○ ╳ 
13 Copy of the 
originally 
approved 
labels, 
instructions, or 
packaging 
stamped with 
tally 
impression of 
the central 
competent 
authority  ╳ ╳ ╳ ╳ ○ ○ ╳ 
14 Copy of the 
originally 
approved 
medical device 
license  ╳ ╳ ╳ ╳ ○ ○ ╳ 
15 Other 
documents and 
information 
designated by 
the central △ △ △ △ △ △ △ competent 
authority  
16 Samples for 
testing  △ △ △ △ ╳ ╳ ╳ 
 
Instructions:  
1. ○: Indicates document for this item shall be submitted.  △: 
Indicates it would be dependent on the case . X: Indicates 
document for this item shall not be required for submission.   
2. Draft labels, instructions or packaging:  
(1)  For those who manufacture medical devices, the 
Chinese labels, instructions, or packaging and draft 
color pictures of the actual product appearance.   
(2)  For those who import medical devices, the original 
labels, instructions, or packaging, the draft detailed 
Chinese instructions and draft color pictures of the 
actual product appearance.   
3. Copy of the medical device business permit : 
(1)  Those who manufacture medical devices shall attach a 
copy of the medical device manu factur ing permit . Those 
who import medical devices should attach a copy of the 
medical device dealer permit showing that the business 
category includes “medical device import .” competent 
authority  
16 Samples for 
testing  ╳ ╳ △ △ ╳ ╳ ╳ 
 
Instructions:  
1. ○: Indicates document for this item shall be submitted.  △: 
Indicates it would be dependent on the case  X: Indicates 
document for this item shall not be required for submission.   
2. Draft labels, instructions or packaging:  
(1)  For those who manufacture medical devices, the 
Chinese labels, instructions, or packaging and draft 
color pictures of the actual product ap pearance.   
(2)  For those who import medical devices, the original 
labels, instructions, or packaging, the draft detailed 
Chinese instructions and draft color pictures of the 
actual product appearance.   
3. Copy of the medical device business permit : 
(1)  Those who manufacture medical devices shall attach a 
copy of the medical device manufactur ing permit . Those 
who import medical devices should attach a copy of the 
medical device dealer permit showing that the business 
category includes “medical device impo rt.” (2)  For domestic contract manufacturing, both the contract 
party and the contract manufacturer's  medical device 
business permits  shall be submitted.   
4. Manufacture and free sale certificate of the country of origin : 
(1)  This document shall record the following particulars:  
① Name and specifications and/or model number of 
the medical device.   
② Manufacturer ’s name, address, manufacturing 
status, and actual status for domestic sale as 
approved in that country.   
(2)  This document may be replaced by a document issued 
by other authorities or another document in accordance 
with the following provisions:  
① If the medical  device is not regulated by the highest 
health authority in manufacturer ’s country, this 
document may be issued by the local health agency 
or an organization approved by the central 
competent authority of the Republic of China 
(Taiwan).   
② If th e medical device is commissioned to be 
manufactured, this document may be issued by the 
highest health authority in the country where the 
contract party or the contract manufacturer is 
located.   (2)  For domestic contract manufacturing, both the contract 
party and the contract manufacturer's  medical device 
business permits shall be submitted.   
4. Manufacture and free sale certificate of the country of origin:  
(1)  This document shall record the following particulars:  
① Name and specifications and/or model number of 
the medical device.   
② Manufacturer ’s name, address, manufacturing 
status, and actual status for domestic sale as 
approved in that country.  
(2)  This document may be replaced by a document issued 
by other authorities or another document in accordance 
with the following provisions:  
① If the medical device is not regulated by the highest 
health authority in manufacturer ’s country, this 
document may be issued by the local health agency 
or an organization a pproved by the central 
competent authority of the Republic of China 
(Taiwan).  
② If the medical device is commissioned to be 
manufactured, this document may be issued by the 
highest health authority in the country where the 
contract party or the contract man ufacturer is 
located.  ③ If the medical device involves contract 
manufacturing and it is not sold in the country 
where the contract manufacturer is located, this 
document may be replaced by a free sale certificate 
issued by the highest health authority in the 
country where the contract party is located, and a 
manufacture certificate issued by the government 
of the country where the contract manufacturer is 
located.  
④ This document may be replaced by a manufacture 
certificate issued by the government of 
manufacturer ’s country and a free sale certificate 
issued by the highest health authority of  the United 
States of America or of a European Union Member 
State.   
⑤ If the medical device is a world ’s first product with 
no predicate, a report from the central competent 
authority after conducting an on -site inspection of 
the foreign medical device manuf acturer and a 
report of medical device clinical trials carried out 
in the Republic of China (Taiwan) shall be 
submitted for the exemption from submitting the 
manufacture and free sale certificate of the country 
of origin.   ③ If the medical device involves contract 
manufacturing and it is not sold in the country 
where the contract manufacturer is located, this 
document may be replaced by a free sale certificate 
issued by the highest health authority in th e 
country where the contract party is located, and a 
manufacture certificate issued by the government 
of the country where the contract manufacturer is 
located.  
④ This document may be replaced by a manufacture 
certificate issued by the government of the 
manu facturer ’s country and a free sale certificate 
issued by the highest health authority of the United 
States of America or of a European Union Member 
State.  
⑤ If the medical device is a world ’s first product with 
no predicate, a report from the central compet ent 
authority after conducting an on -site inspection of 
the foreign medical device manufacturer and a 
report of medical device clinical trials carried out 
in the Republic of China (Taiwan) shall be 
submitted for the exemption from submitting the 
manufactur e and free sale certificate of the country 
of origin.  (3)  This document shall remain valid for two years from the 
date of issuance, and shall be notarized by the Republic 
of China ’s (Taiwan ’s) overseas embassy or consulate, 
representative office, other official office stationed in 
the region, or overseas organization authorized by the 
Ministry of Foreign Affairs (hereafter referred to as the 
ROC overseas representative office). If the certification 
document is not issued in English, a Chinese or English 
translation shall be submitted at the same time and the 
translation shall be notarized. Howev er, those issued by 
the highest health authority of a country that has 
established technical cooperation agreement with the 
Republic of China (Taiwan) for the premarket review of 
medical devices or those recognized by the central 
competent authority are ex empt from notarization.   
5. Foreign original manufacturer authorization letter:  
(1)  This document shall record the following particulars:  
① The original manufacturer authorizes an agent in 
the Republic of China (Taiwan) to apply for 
registration and market approval  and agrees to 
coordinate with the agent in the Republic of China 
(Taiwan) to comply with relevant medical device 
regulatory requirements.   
② It specifies the name and address of medical device 
firm commissioned or authorized to register, as (3)  This document shall remain valid for two years from the 
date of issuance, and shall be notarized by Republic of 
China ’s (Taiwan ’s) overseas embassy or consulate, 
representative office, other official office stationed in 
the region, or overseas organization authorized by the 
Ministry of Foreign Affairs (hereafter referred to as the 
ROC overseas representative office). If the certification 
document is not issued in English, a Chinese or English 
translati on shall be submitted at the same time and the 
translation shall be notarized. However, those issued by 
the highest health authority of a country that has 
established technical cooperation agreement with the 
Republic of China (Taiwan) for the premarket rev iew of 
medical devices or those recognized by the central 
competent authority are exempt from notarization.   
5. Foreign original manufacturer authorization letter : 
(1)  This document shall record the following particulars:  
① The original manufacturer authorizes an agent in 
the Republic of China (Taiwan) to apply for 
registration and market approval and agrees to 
coordinate with the agent in the Republic of China 
(Taiwan) to comply with relevant medical device 
regulatory requir ements.  
② It specifies the name and address of medical device 
firm commissioned or authorized to register, as well as the name  and specifications and/or model 
number of medical device.   
(2)  This document may be replaced by other documents in 
accordance with the following provisions:  
① A certification document for authorized agent 
issued by the headquarter company of the imported 
medica l devices that authorizes the agent in the 
Republic of China (Taiwan) to apply for 
registration and market approval. Its contents 
explicitly state the name and address of 
manufacturer and specify the name and address of 
medical device firm commissioned or authorized 
to register, as well as the name and specifications 
and/or model number of medical device.   
② The original manufacturer of imported medical 
devices issues a certification document stating its 
foreign agent, and then the foreign agent issues a 
certification document for authorized agent, which 
authorizes the agent in the Republic of China 
(Taiwan) to apply for registration and market 
approval and explicitly states the name and address 
of medical device firm commissioned or 
authorized to register, as  well as the name and 
specifications and/or model number of medical 
device.   well as the name and specifications and/or model 
number of medical device.  
(2)  This document may be replaced by other documents in 
accordance with the  following provisions:  
① A certification document for authorized agent 
issued by the headquarter company of the imported 
medical devices that authorizes the agent in the 
Republic of China (Taiwan) to apply for 
registration and market approval. Its contents 
explicitly state the name and address of   
manufacturer and specify the name and address of  
medical device firm commissioned or authorized 
to register, as well as the name and specifications 
and/or model number of medical device.  
② The original manufacturer of imported medical 
devices issues a certification document stating its 
foreign agent, and then the foreign agent issues a 
certification document for authorized agent, which 
authorizes the agent in the Republic of China 
(Taiwan) to apply for registration a nd market 
approval and explicitly states the name and address 
of medical device firm commissioned or 
authorized to register, as well as the name and 
specifications and/or model number of medical 
device.  (3)  This document shall remain valid for one year from the 
date of issuance. If it is not issued in English, a Chinese 
or English translation shall also be submitted at the same 
time.   
6. Document verifying that medical device manufacturer 
conforms to the Medical Device Quality Management 
System Regulations:  
(1)  This document refers to the certification document 
issued by the central competent authority stating that the 
medical device manufac turer conforms to the Medical 
Device Quality Management System Regulations.   
(2)  For medical devices that were originally regulated as 
pharmaceuticals and within three years from the date of 
announcing the regulatory change to medical devices, 
this document ma y be replaced by a copy of the 
certification document showing conformance to the 
Good Manufacturing Practices for Pharmaceuticals.   
7. Test specifications and methods of preclinical testing and 
quality control conducted by the original manufacturer, the 
origi nal test records, and the test reports:  
(1)  This document shall include information on safety and 
performance testing that has been conducted to ensure 
the claimed efficacy, structure, materials, design, and 
quality of the product.   (3)  This document shall remain valid for one year from t he 
date of issuance. If it is not issued in English, a Chinese 
or English translation shall also be submitted at the same 
time.  
6. Document verifying that medical device manufacturer 
conforms to the Medical Device Quality Management 
System Regulations:  
(1)  This document refers to the certification document 
issued by the central competent authority stating that the 
medical device manufacturer conforms to the Medical 
Device Quality Management System Regulations.   
(2)  For medical devices that were originally regulated as 
pharmaceuticals and within three years from the date of 
announcing the regulatory change to medical devices, 
this document may be replaced by a copy of the 
certification document showing conformance to the 
Good Manufacturing Practices for Pharmaceutical s.  
7. Test specifications and methods of preclinical testing and 
quality control conducted by the original manufacturer, the 
original test records, and the test reports:  
(1)  This document shall include information on safety and 
performance testing that has been conducted to ensure 
the claimed efficacy, structure, materials, design, and 
quality of the product.   (2)  For Class 2 medical devices  with predicate device(s) 
that have been approved for marketing by the central 
competent authority, this document may be replaced by 
one of the following documents:  
① Marketing approval certification document issued 
by the government of a country that has established 
technical cooperation agreement with the Republic 
of China (Taiwan) for the premarket review of 
medical devices, as well as Essential Principles 
(EP) of Safety and Performance of Medical 
Devices and Summary Technical Documentation 
(STED).   
② Affidavit of preclinical testing conformity for  
medical device that is a product announced by the 
central competent authority whose manufacturer 
has a predicate device of the same classification 
and approved for marketing by the centra l 
competent authority.   
(3)  For Class 2 medical devices in Appendix 3,  if the 
applicant has obtained the license  showing that the  same 
medical device manufacturer has manufactured a 
predicate device of the same item  and the license is still 
within the validity period, this document m ay be 
replaced by the Class 2 medical device product 
comparison and preclinical test data conformity (2)  For Class 2 medical devices with predicate device(s) 
that have been approved for marketing by the central 
competent authority, this document may be replaced by 
one of the following documents:  
① Marketing approval certification document issued 
by the government of a country that has established 
technical  cooperation agreement with the Republic 
of China (Taiwan) for the premarket review of 
medical devices , as well as Essential Principles 
(EP) of Safety and Performance of Medical 
Devices and Summary Technical Documentation 
(STED).  
② Affidavit of preclinical testing conformity for  
medical device that is a product announced by the 
central competent authority whose manufacturer 
has a predicate device of the same classification 
and approved for marketing by the central 
competent authority.  
(3)  For Class 2 medical devices in Appendix 3, if the same 
manufacturer  has a predicate device approved for 
marketing by the ce ntral competent authority that has 
the same product classification and its license is still 
within the validity period, this document may be 
replaced by the Class 2 medical device product statement,  with the exception of medical devices 
containing medicine.  
(4)  For medical devices that require testing as announced by 
the central competent authority, two copies of this 
document shall be submitted.  
(5)  Commissioned laboratories that conduct the 
biocompatibility, electrical safety, and electromagnetic 
compatibility (EMC) testing shall conform to any of the 
following requirements:  
① Conform to the pr ovisions of ISO/IEC 17025.   
② Conform to the provisions of Good Laboratory 
Practice for Nonclinical Laboratory Studies (GLP).   
8. Documents relating to product structures, materials, 
specifications, functions, intended uses, and drawings: For 
instrument product s, the operation manual and maintenance 
manual that cover these documents may replace them.   
9. Clinical evidence information : 
(1)  This document includes:  
① Academic and theoretical bases, relevant research 
reports and data.   
② Clinical evaluation report or clinical trial report.   
(2)  The central competent authority shall determine or 
announce whether or not the medical device applying 
for registration and market approval requires clinical 
trials in the Republic of China (Taiwan) by considering comparison and preclinical test data conformity 
statement.   
(4)  For medi cal devices that require testing as announced by 
the central competent authority, two copies of this 
document shall be submitted.  
(5)  Commissioned laboratories that conduct the 
biocompatibility, electrical safety, and electromagnetic 
compatibility (EMC) testin g shall conform to any of the 
following requirements:  
① Conform to the provisions of ISO/IEC 17025.  
② Conform to the provisions of Good Laboratory 
Practice for Nonclinical Laboratory Studies (GLP).  
8. Documents relating to product structures, materials, 
specifi cations, functions, intended uses, and drawings: For 
instrument products, the operation manual and maintenance 
manual that cover these documents may replace them.   
9. Clinical evidence information:  
(1)  This document includes:  
① Academic and theoretical bases, relevant research 
reports and data.  
② Clinical evaluation report or clinical trial report.  
(2)  The central competent authority shall determine or 
announce whether or not the medical device applying 
for registration and market ap proval requires clinical 
trials in the Republic of China (Taiwan) by considering the medical device product item, individual case, and 
data submitted by applicant.   
(3)  For medical devices with predicate device(s) that have 
been approved for marketing by the central competent 
authority, unless it is necessary to verify their safety and 
effectiveness with clinical ev idence, this document may 
be exempt from submission.   
(4)  For Class 2 medical devices without predicate device, 
unless otherwise specified, the clinical trial report may 
be replaced by supporting data that meets all the 
following conditions:  
① There are no ethni c differences in the expected 
effectiveness of this product.   
② There are no serious adverse reports related to the 
claimed intended use or indication for such type of 
product in foreign countries, and the product has 
not been required to be removed from the  market.   
③ Preclinical data (including trial) may be used to 
demonstrate that the differences between the 
product and domestic products that have been 
approved for marketing will not affect the 
product ’s safety and effectiveness; or marketing 
approval certification documents of the United 
States of America and the European Union may be 
provided and the indication under application does the medical device product item, individual case, and 
data submitted by applicant.  
(3)  For medical devices with predicate device(s) that have 
been approved for marketing by the c entral competent 
authority, unless it is necessary to verify their safety and 
effectiveness with clinical evidence, this document may 
be exempt from submission.  
(4)  For Class 2 medical devices without predicate device, 
unless otherwise specified, the clinical  trial report may 
be replaced by supporting data that meets all the 
following conditions:  
① There are no ethnic differences in the expected 
effectiveness of this product.  
② There are no serious adverse reports related to the 
claimed intended use or indication  for such type of 
product in foreign countries, and the product has 
not been required to be removed from the market.  
③ Preclinical data (including trial) may be used to 
demonstrate that the differences between the 
product and domestic products that have bee n 
approved for marketing will not affect the 
product ’s safety and effectiveness; or marketing 
approval certification documents of the United 
States of America and the European Union may be 
provided and the indication under application does not exceed the scope approved by the United States 
of America and the  European Union.   
10. Radiation safety information for equipment generating 
ionizing radiation: For medical devices generating ionizing 
radiation, this document shall be submitted.   
11. Essential Principles (EP) of Safety and Performance of 
Medical Devices and Sum mary Technical Documentation 
(STED):  
(1)  The format of this document shall follow the 
announcement  of the central competent authority.   
(2)  For Class 2 medical devices under application with 
the circumstances in Paragraph (2) ① of Section 7, 
this document shall be  submitted.   
12. Manufacturer's letter explaining that the product is the same 
product with different product names: It shall explain that the 
product for which a new application has been made and the 
originally approved product are identical products, and 
indicate clearly the medical device license number that was 
originally approved.  
13. Other documents and information designated by the central 
competent authority:  
(1)  For medical devices using bovine or ovine/hircine 
tissues, an explanation of animal raw material  source 
control procedures and proof of raw material source 
from the original manufacturer shall be submitted in not exceed the s cope approved by the United States 
of America and the European Union.  
10. Radiation safety information for equipment generating 
ionizing radiation: For medical devices generating ionizing 
radiation, this document shall be submitted.   
11. Essential Principles (EP)  of Safety and Performance of 
Medical Devices and Summary Technical Documentation 
(STED):  
(1)  The format of this document shall follow the 
announcement of the central competent authority.   
(2)  For Class 2 medical devices under application with 
the circumstances in  Paragraph (2) ① of Section 7, 
this document shall be submitted.   
12. Manufacturer ’s letter explaining that the product is the same 
product with different product names: It shall explain that the 
product for which a new application has been made and the 
origin ally approved product are identical products, and 
indicate clearly the medical device license number that was 
originally approved.  
13. Other documents and information designated by the central 
competent authority:  
(1)  For medical devices using bovine or ovine/hircine 
tissues, an explanation of animal raw material source 
control procedures and proof of raw material source 
from the original manufacturer shall be submitted in order to verify that the processes associated with the 
medical device and the ultimate finished product do 
not use any bovine or ovine/hircine product from the 
bovine spongiform encephalopathy (BSE) epidemic 
areas announced by the Council of Agriculture, 
Executive Yuan, and have not been contaminated by 
BSE pathogens. However, for applications 
conforming to the announcement from the central 
compe tent authority regarding the exemption from 
submitting the aforementioned documentation after 
considering the international regulatory guidelines for 
controlling bovine or ovine/hircine tissues in 
accordance with the risk of contamination of the 
tissues by  BSE pathogen, this provision shall not 
apply.   
(2)  If the product name bears a trademark, relevant 
information related to trademark registration shall be 
submitted. If the product name bears the name or 
trademark of another medical device firm, a consent 
letter issued by the firm shall be submitted . 
(3)  In line with the Consolidated List of Commodities 
Subject to Import Restriction and Commodities 
Assisted by Customs for Import Examination 
announced by the Bureau of Foreign Trade of the 
Ministry of Economic Affairs, medical devices order to verify that the processes associated w ith the 
medical device and the ultimate finished product do 
not use any bovine or ovine/hircine product from the 
bovine spongiform encephalopathy (BSE) epidemic 
areas announced by the Council of Agriculture, 
Executive Yuan, and have not been contaminated b y 
BSE pathogens. However, for applications 
conforming to the announcement from the central 
competent authority regarding the exemption from 
submitting the aforementioned documentation after 
considering the international regulatory guidelines for 
controllin g bovine or ovine/hircine tissues in 
accordance with the risk of contamination of the 
tissues by BSE pathogen, this provision shall not 
apply.   
(2)  If the product name bears a trademark, relevant 
information related to trademark registration shall be 
submitted . If the product name bears the name or 
trademark of another medical device firm, a consent 
letter issued by the firm shall be submitted .  
(3)  In line with the Consolidated List of Commodities 
Subject to Import Restriction and Commodities 
Assisted by Customs for Import Examination 
announced by the Bureau of Foreign Trade of the 
Ministry of Economic Affairs, medical devices imported from China sha ll first obtain permit for 
import from the Bureau of Foreign Trade of the 
Ministry of Economic Affairs before applying for 
registration and market approval from the central 
competent authority.   
(4)  For medical devices exclusively  for export, the 
instructions  for use , function, working principle, and 
explanation of product composition (or ingredients) 
shall be submitted, and the content s of which shall be 
sufficient to determine that th is product meets the 
identification of the product item under application.  
(5) If the name, the label, instructions or packaging of 
the product bears a proper noun for 
performance/specification of a specific country or 
international organization standards, supporting 
documents issued by the country or the region, a 
third -party validat ion agency, or the international 
organization should be attached.   
14. Samples for testing : For items announced in Paragraph 2 
of Article 3,  the applicant shall  follow the testing notice, 
pay the testing fee by the designated deadline, and submit 
sufficient  samples for testing to conduct testing 
procedures.  imported from China sha ll first obtain permit for 
import from the Bureau of Foreign Trade of the 
Ministry of Economic Affairs before applying for 
registration and market approval from the central 
competent authority.   
(4)  For medical devices exclusively for export , the 
instructions  for use , function, working principle,  and 
explanation of product composition (or ingredients) 
shall be submitted, and the content s of which shall be 
sufficient to determine that th is product meets the 
identification of the product item under application.   
14. Samples for testing: The applicant shall follow the testing 
notice, pay the testing fee by the designated deadline, and 
submit sufficient samples for testing to conduct testing 
procedures.  Comparison Table of Original and Amended Provisions in Appendix 3 of Article 6  
Amended title  Original title  Description  
Appendix 3: “Applicable Product Items for Class 2 Medical 
Device Product Comparison and Preclinical Test Data 
Conformity Statement ” mentioned in Section 7 of the 
Instructions in Appendix 2  Appendix 3: Applicable Product Items for Class 2 Medical 
Device Product Comparison and Preclinical Test Data 
Conformity Statement  Slight revision of 
the title of 
Appendix 3 for 
clarity  
Amended provisions  Original title  Description  
 
 Item Number  Name  
1 A.1020  Acid phosphatase (total or 
prostatic) test system  
2 A.1025  Adrenocorticotropic hormone 
(ACTH) test system  
3 A.1035  Albumin test system  
4 A.1050  Alkaline phosphatase or isozymes 
test system  
5 A.1070  Amylase test  system  
6 A.1110  Bilirubin (total or direct) test 
system  
7 A.1150  Calibrator  
8 A.1155  Human chorionic gonadotropin 
(HCG) test system   
 Item Number  Name  
1 A.1020  Acid phosphatase (total or 
prostatic) test system  
2 A.1025  Adrenocorticotropic hormone 
(ACTH) test system  
3 A.1035  Albumin test system  
4 A.1050  Alkaline phosphatase or isozyme s 
test system  
5 A.1070  Amylase test system  
6 A.1110  Bilirubin (total or direct) test 
system  
7 A.1150  Calibrator  
8 A.1345  Glucose test system  Added applicable 
product items.  9 A.1215  Creatine phosphokinase/creatine 
kinase or isoenzymes test system  
10 A.1345  Glucose test system  
11 A.1660  Quality control material (assayed 
and unassayed)  
12 A.1675  Blood specimen collection device  
13 B.5400  Coagulation instrument  
14 B.5425  Multipurpose system for in vitro 
coagulation studies  
15 B.7470  Glycosylated hemoglobin assay  
16 B.8625  Hematology quality control 
mixture  
17 C.0002  Dengue virus serological reagents  
18 C.2410  Culture medium for pathogenic 
Neisseria spp  
19 C.3305  Herpes simplex virus serological 
reagents  
20 C.3390  Neisseria spp. Direct serological  
test reagents  
21 C.3860  Trichomonas vaginalis nucleic acid 
assay  9 A.1660  Quality control material (assayed 
and unassayed)  
10 C.5510  Immunoglobulins A, G, M, D, and 
E immunological test system  
11 D.5630  Nebulizer  
12 E.1130  Noninvasive blood pressure 
measurement system  
13 E.2340  Electrocardiograph  
14 E.2700  Oximeter  
15 F.3200  Resin tooth bonding agent  
16 F.3590  Preformed plastic denture tooth  
17 F.3660  Impression material  
18 F.4850  Ultrasonic scaler  
19 F.6070  Ultraviolet activator for   
polymerization  
20 F.6660  Porcelain powder for clinical use  
21 H.5470  Ureteral dilator  
22 I.0006  Medical protective clothing  22 C.5100  Antinuclear antibody 
immunological test system  
23 C.5270  C-reactive protein immunological 
test system  
24 C.5510  Immunoglobulins A, G, M, D, and 
E immunological test system  
25 C.5750  Radioallergosorbent  (RAST) 
immunological test system  
26 C.5775  Rheumatoid factor immunological 
test system  
27 D.5630  Nebulizer  
28 D.5710  Electrically powered oxygen tent  
29 D.5730  Tracheal tube  
30 D.5800  Tracheostomy tube and tube cuff  
31 D.5915  Manual emergency ventilator  
32 E.0005  Percutaneous transluminal 
coronary angioplasty (PTCA)   
catheter  
33 E.1130  Noninvasive blood pressure 23 I.4370  Surgical drape and drape 
accessories  
24 I.4495  Stainless steel suture  
25 I.4580  Surgical lamp  
26 J.2800  Sterilization process indicator  
27 J.2910  Clinical electronic thermometer  
28 J.5440  Intravascular administration set  
29 J.5570  Hypodermic single lumen needle  
30 J.5860  Piston syringe  
31 J.6850  Sterilization wrap  
32 M.5918  Rigid gas permeable contact lens 
care products  
33 M.5928  Soft (hydrophilic) contact lens care 
products  
34 O.5500  Infrared lamp  
 measurement system  
34 E.1200  Diagnostic intravascular catheter  
35 E.1210  Continuous flush catheter  
36 E.1220  Electrode recording  catheter or 
electrode recording probe  
37 E.1280  Steerable catheter  
38 E.1310  Vessel dilator for percutaneous 
catheterization  
39 E.1330  Catheter guide wire  
40 E.1340  Catheter introducer  
41 E.2340  Electrocardiograph  
42 E.2360  Electrocardiograph electrode  
43 E.2700  Oximeter  
44 E.2900  Patient transducer and electrode 
cable (including connector)  
45 E.3450  Vascular graft prosthesis  
46 E.4450  Vascular clamp  
47 E.5150  Embolectomy catheter  
48 E.5900  Thermal regulation system  49 F.1745  Laser fluorescence caries detection 
device  
50 F.1800  Extraoral source x -ray system  
51 F.1810  Intraoral source x -ray system  
52 F.3060  Gold based alloys and precious 
metal alloys for clinical use  
53 F.3200  Resin tooth bonding agent  
54 F.3275  Dental cement  
55 F.3590  Preformed plastic denture tooth  
56 F.3630  Endosseous dental implant 
abutment  
57 F.3660  Impression material  
58 F.3690  Tooth shade resin material  
59 F.3765  Pit and fissure sealant and 
conditioner  
60 F.3820  Root canal filling resin  
61 F.4760  Bone plate  
62 F.4850  Ultrasonic scaler  
63 F.6070  Ultraviolet activator for 
polymerization  
64 F.6660  Porcelain powder for clinical use  
65 G.4250  Ear, nose, and throat electric or 
pneumatic surgical drill  66 H.1075  Gastroenterology -urology biopsy 
instrument  
67 H.1500  Endoscope and accessories  
68 H.4620  Ureteral stent  
69 H.5010  Biliary catheter and accessories  
70 H.5130  Urological  catheter and accessories  
71 H.5470  Ureteral dilator  
72 H.5540  Blood access device and 
accessories  
73 H.5630  Peritoneal dialysis system and 
accessories  
74 H.5820  Hemodialysis system and 
accessories  
75 H.5980  Gastrointestinal tube and 
accessories  
76 I.0003  Ultrasonic surgical instrument  
77 I.0006  Medical protective clothing  
78 I.4010  Tissue adhesive  
79 I.4014  Nonresorbable gauze/sponge for 
external use  
80 I.4018  Hydrophilic wound dressing  
81 I.4020  Occlusive wound/burn dressing  82 I.4022  Hydrogel wound dressing and burn 
dressing  
83 I.4370  Surgical drape and drape 
accessories  
84 I.4400  Electrosurgical cutting and 
coagulation device and accessories  
85 I.4493  Absorbable poly(glycolide/L -
lactide) surgical suture  
86 I.4495  Stainless steel suture  
87 I.4580  Surgical lamp  
88 I.4780  Power suction pump  
89 I.4810  Laser surgical instrument for  use in 
general and plastic surgery and in 
dermatology  
90 I.4830  Absorbable surgical gut suture  
91 I.4840  Absorbable polydioxanone surgical 
suture  
92 I.5000  Nonabsorbable poly (ethylene 
terephthalate) surgical suture  
93 I.5010  Nonabsorbable polypropylene 
surgical suture  
94 I.5020  Nonabsorbable polyamide surgical 
suture  95 I.5030  Natural nonabsorbable silk surgical 
suture  
96 I.5035  Nonabsorbable expanded 
polytetrafluoroethylene surgical 
suture  
97 J.2800  Sterilization process indicator  
98 J.2910  Clinical electronic thermometer  
99 J.5090  Liquid bandage  
100 J.5200  Intravascular catheter  
101 J.5240  Medical adhesive tape and 
adhesive bandage  
102 J.5440  Intravascular administration set  
103 J.5570  Hypodermic single lumen needle  
104 J.5700  Neonatal phototherapy unit  
105 J.5860  Piston syringe  
106 J.5965  Subcutaneous, implanted, 
intravascular infusion port and 
catheter  
107 J.5970  Percutaneous, implanted, long -term 
intravascular catheter  
108 J.6850  Sterilization wrap  109 K.4305  Powered compound cranial drills, 
burrs, trephines, and their  
accessories  
110 K.4310  Powered simple cranial drills, 
burrs, trephines,  and their 
accessories  
111 K.4360  Electric cranial drill motor  
112 K.4370  Pneumatic cranial drill motor  
113 K.4840  Manual rongeur  
114 L.1690  Hysteroscope and accessories  
115 L.1720  Gynecologic laparoscope and 
accessories  
116 L.1730  Laparoscopic insufflator  
117 L.4150  Bipolar endoscopic coagulator -
cutter and accessories  
118 L.6100  Assisted reproduction needles  
119 L.6110  Assisted reproduction catheters  
120 L.6130  Assisted reproduction microtools  
121 M.1120  Ophthalmic camera  122 M.1570  Ophthalmoscope  
123 M.1850  AC-powered slitlamp 
biomicroscope  
124 M.4150  Vitreous aspiration and cutting 
instrument  
125 M.4670  Phacofragmentation system  
126 M.4790  Ophthalmic sponge  
127 M.5918  Rigid gas permeable contact lens 
care products  
128 M.5925  Soft (hydrophilic) contact lens  
129 M.5928  Soft (hydrophilic) contact lens care 
products  
130 N.1100  Arthroscope  
131 N.3027  Polymethylmethacrylate (PMMA) 
bone cement  
132 N.3045  Resorbable calcium salt bone void 
filler device  
133 N.3050  Spinal interlaminal fixation 
orthosis  
134 N.3060  Spinal intervertebral body fixation 
orthosis  135 N.3070  Pedicle screw spinal system  
136 O.0001  Static electric therapy apparatus  
137 O.3860  Powered wheelchair  
138 O.5500  Infrared lamp  
139 P.1570  Diagnostic ultrasonic transducer  
 Comparison Table of Amended and Original Provisions in Appendix 4, Article 13  
Amended provisions  Original provisions  Description  
Appendix 4 : Documents and information that shall be submitted for an 
application of  change, re -issuance , or replacement of medical device 
license  
Item to be  
Changed  
 
 
 
 
 
 
 
 
 
 
 
Documents  
and 
Information to 
be Submitted  Chinese product name  English product name  Labels, Instructions, or Packaging  Ingredients, Materials, Structures, Specifications, or Model number  Effectiveness, Intended Use, or Indication  Name of the Manufacturer  Address of the Manufacturer or Country of Manufacture  License Holder  Name of the License Holder  Re-issuance or  Replacement of a Lost or Damaged License  Manufacturing license number  Appendix 4: Documents and information that shall be submitted for an 
application of change, re -issuance , or replacement of medical device 
license  
Item to be  
Changed  
 
 
 
 
 
 
 
 
 
 
 
Documents  
and 
Information to 
be Submitted  Chinese product name  English product name  Labels, Instructions, or Packaging  Ingredients, Materials, Structures, Specifications, or Model number  Effectiveness, Intended Use, or Indication  Name of the Manufacturer  Address of the Manufacturer or Country of Manufacture  License Holder  Name of the License Holder  Re-issuance or Replacement of a Lost or Damaged License  1. As Article 13 
has added the 
manufacturin
g license 
number to be 
one of the 
registratio n 
particulars of 
medical 
device license 
registration, it 
has been 
added to the 
documents 
and 
information 
that shall be 
submitted for 
an application 
of change of 
medical 
device 1 Application 
form for 
change of 
medical 
device 
license  ○ ○ ○ ○ ○ ○ ○ ○ 
Note 
9 ○ ○ ○ 
2 Application 
form for 
medical 
device 
registration 
and market 
approval  ╳ ╳ ╳ ╳ ╳ ╳ ╳ ╳ ╳ △ 
Note 
13 ╳ 
3 Original 
license  ○ ○ ○ ○ ○ ○ ○ ○ ○ △ 
Note 
14 ○ 
4 Copy of the 
originally 
approved 
labels,  
instructions
, or 
packaging 
stamped 
with tally ╳ ╳ ○ △ 
Note 
2 ○ ╳ ╳ ╳ ╳ △ 
Note 
15 ╳ 1 Application 
form for 
change of 
medical 
device 
license  ○ ○ ○ ○ ○ ○ ○ ○ 
Note 
8 ○ ○ 
2 Application 
form for 
medical 
device 
registration 
and market 
approval  ╳ ╳ ╳ ╳ ╳ ╳ ╳ ╳ ╳ △ 
Note 
12 
3 Original 
license  ○ ○ ○ ○ ○ ○ ○ ○ ○ △ 
Note 
13 
4 Copy of the 
originally 
approved 
labels, 
instructions
, or 
packaging 
stamped 
with tally ╳ ╳ ○ △ 
Note 
2 ○ ╳ ╳ ╳ ╳ △ 
Note 
14 license.  
2. Change of 
wording of 
Section 2 of 
the 
Instructions.  
3. To be more 
specific, the 
content of 
Note 7 has 
been changed. 
Partial 
content of the 
original Note 
7 has been 
listed in Note 
8 and Note 1 8 
and the serial 
number  has 
been adjusted . impression 
of the 
central 
competent 
authority  
5 Two copies 
of draft 
labels, 
instructions
, or 
packaging  ╳ ╳ ○ △ 
Note 
3 ○ ╳ ╳ ╳ ╳ △ 
Note 
16 ╳ 
6 Copy of the 
medical 
device 
business 
permit  ╳ ╳ ╳ ╳ ╳ △ 
Note 
5 △ 
Note 
5 ○ 
Note 
10 ○ 
Note 
12 ╳ ╳ 
7 Original of 
the 
manufactur
e and free 
sale 
certificate 
of the 
country of 
origin  ╳ △ 
Note 
1 ╳ △ 
Note 
4 △ 
Note 
4 △ 
Note 
4 △ 
Note 
6 ╳ ╳ ╳ ╳ impression 
of the 
central 
competent 
authority  
5 Two copies 
of draft 
labels, 
instructions
, or 
packaging  ╳ ╳ ○ △ 
Note 
3 ○ ╳ ╳ ╳ ╳ △ 
Note 
15 
6 Copy of the 
medical 
device 
business 
permit  ╳ ╳ ╳ ╳ ╳ △ 
Note 
5 △ 
Note 
5 ○ 
Note 
9 ○ 
Note 
11 ╳ 
7 Original of 
the 
manufactur
e and free 
sale 
certificate 
of the 
country of 
origin  ╳ △ 
Note 
1 ╳ △ 
Note 
4 △ 
Note 
4 △ 
Note 
4 △ 
Note 
6 ╳ ╳ ╳ 8 Original of 
the foreign 
original 
manufactur
er 
authorizatio
n letter  ╳ ╳ ╳ △ 
Note 
4 △ 
Note 
4 △ 
Note 
4 △ 
Note 
4 △ 
Note 
11 ╳ ╳ ╳ 
9 Document 
verifying 
that 
medical 
device 
manufactur
er conforms 
to the 
Medical 
Device 
Quality 
Manageme
nt System 
Regulations  ╳ ╳ ╳ ╳ ╳ ○ ○ ╳ ╳ ╳ ○ 
10 Test 
specificatio
ns and 
methods of ╳ ╳ ╳ △ 
Note 
3 ○ ╳ △ 
Note 
8 ╳ ╳ ╳ ╳ 8 Original of 
the foreign 
original 
manufactur
er 
authorizatio
n letter  ╳ ╳ ╳ △ 
Note 
4 △ 
Note 
4 △ 
Note 
4 △ 
Note 
4 △ 
Note 
10 ╳ ╳ 
9 Document 
verifying 
that 
medical 
device 
manufactur
er conforms 
to the 
Medical 
Device 
Quality 
Manageme
nt System 
Regulations  ╳ ╳ ╳ ╳ ╳ ○ ○ ╳ ╳ ╳ 
10 Test 
specificatio
ns and 
methods of ╳ ╳ ╳ △ 
Note 
3 ○ ╳ △ 
Note 
7 ╳ ╳ ╳ preclinical 
testing and 
quality 
control 
conducted 
by the 
original 
manufactur
er, the 
original test 
records, 
and the test 
reports  
11 Documents 
relating to 
product 
structures, 
materials, 
specificatio
ns, 
functions, 
intended 
uses, and 
drawings  ╳ ╳ ╳ △ 
Note 
3 ○ ╳ △ 
Note 
8 ╳ ╳ ╳ ╳ preclinical 
testing and 
quality 
control 
conducted 
by the 
original 
manufactur
er, the 
original test 
records, 
and the test 
reports  
11 Documents 
relating to 
product 
structures, 
materials, 
specificatio
ns, 
functions, 
intended 
uses, and 
drawings  ╳ ╳ ╳ △ 
Note 
3 ○ ╳ △ 
Note 
7 ╳ ╳ ╳ 12 Clinical 
evidence 
information  ╳ ╳ ╳ △ 
Note 
3 △ ╳ ╳ ╳ ╳ ╳ ╳ 
13 Radiation 
safety 
information 
for 
equipment 
generating 
ionizing 
radiation  ╳ ╳ ╳ △ 
Note 
3 ╳ ╳ ╳ ╳ ╳ ╳ ╳ 
14 Original of 
the 
manufactur
er’s letter 
that 
explains the 
change  ╳ ○ ○ △ 
Note 
3 ○ ○ ○ ╳ ╳ ╳ ╳ 
15 Compariso
n table of 
changed 
and 
originally 
approved 
content  ╳ ╳ ○ △ 
Note 
3 ○ ╳ ╳ ╳ ╳ ╳ ╳ 12 Clinical 
evidence 
information  ╳ ╳ ╳ △ 
Note 
3 △ ╳ ╳ ╳ ╳ ╳ 
13 Radiation 
safety 
information 
for 
equipment 
generating 
ionizing 
radiation  ╳ ╳ ╳ △ 
Note 
3 ╳ ╳ ╳ ╳ ╳ ╳ 
14 Original of 
the 
manufactur
er’s letter 
that 
explains the 
change  ╳ ○ ○ △ 
Note 
3 ○ ○ ○ ╳ ╳ ╳ 
15 Compariso
n table of 
changed 
and 
originally 
approved 
content  ╳ ╳ ○ △ 
Note 
3 ○ ╳ ╳ ╳ ╳ ╳ 16 Transfer 
statement 
co-signed 
by the 
transferor 
and 
transferee  ╳ ╳ ╳ ╳ ╳ ╳ ╳ ○ ╳ ╳ ╳ 
17 Statement 
from the 
medical 
device firm 
receiving 
the 
transferred 
license 
(transferee) 
affirming 
the 
responsibili
ty for the 
transferred 
medical 
device  ╳ ╳ ╳ ╳ ╳ ╳ ╳ ○ ╳ ╳ ╳ 16 Transfer 
statement 
co-signed 
by the 
transferor 
and 
transferee  ╳ ╳ ╳ ╳ ╳ ╳ ╳ ○ ╳ ╳ 
17 Statement 
from the 
medical 
device firm 
receiving 
the 
transferred 
license 
(transferee) 
affirming 
the 
responsibili
ty for the 
transferred 
medical 
device  ╳ ╳ ╳ ╳ ╳ ╳ ╳ ○ ╳ ╳ 18 Statement  
from the 
medical 
device firm 
after name 
change 
affirming 
the 
responsibili
ty for every 
item on the 
changed 
license  ╳ ╳ ╳ ╳ ╳ ╳ ╳ ╳ ○ ╳ ╳ 
19 Statement 
claiming 
that change 
in the name 
of a 
medical 
device firm 
holding the 
medical 
device 
license  
does not ╳ ╳ ╳ ╳ ╳ ╳ ╳ ╳ ○ ╳ ╳ 18 Statement  
from the 
medical 
device firm 
after name 
change 
affirming 
the 
responsibili
ty for every 
item on the 
changed 
license  ╳ ╳ ╳ ╳ ╳ ╳ ╳ ╳ ○ ╳ 
19 Statement 
claiming 
that change 
in the name 
of a 
medical 
device firm 
holding the 
medical 
device 
license  
does not ╳ ╳ ╳ ╳ ╳ ╳ ╳ ╳ ○ ╳  
Instructions:  
I. ○: Indicates document for this item shall be submitted. △: 
Indicates it would be dependent on the case. ╳: Indicates 
document for this item shall not be required for submission.  
II. Please refer to the instructions of Appendix 2 for relevant 
regulations on: draft labels, instructions, or packaging; copy of the 
medical device business permit ; manufacture and free sale 
certificate of the country of origin; forei gn original manufacturer involve 
transfer of 
rights  
20 Other 
documents 
and 
information 
designated 
by the 
central 
competent 
authority  △ △ △ △ △ △ △ △ △ △ 
Note 
17 △ 
 
21 Samples 
for testing  ╳ ╳ ╳ △ 
Note 
18 ╳ ╳ △ 
Note 
18 ╳ ╳ ╳ ╳  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Instructions:  
I. ○: Indicates document for this item shall be submitted. △: 
Indicates it would be dependent on the case. ╳: Indicates 
document for this item shall not be required for submission.  
II. Please refer to the instructions of Appendix 2 for relevant 
regulations on: draft labels, instructions, or packaging; copy of the 
medical device business permit ; manufacture and free sale 
certificate of the country of origin; foreign original manufacturer involve 
transfer of 
rights  
20 Other 
documents 
and 
information 
designated 
by the 
central 
competent 
authority  △ △ △ △ △ △ △ △ △ △ 
Note 
16 
21 Samples 
for testing  ╳ ╳ ╳ △ ╳ ╳ △ ╳ ╳ ╳ authorization letter; document verifying that medical device 
manufacturer conforms to the Medical Device Quality 
Management System Regulations; test specifications and methods 
of preclinical testing and quality control conducted by  the original 
manufacturer; original test records and test reports; documents 
relating to product structure, materials, specifications, functions, 
intended uses, and drawings; clinical evidence  information; 
radiation safety information for equipment genera ting ionizing 
radiation; other documents designated by the central competent 
authority; and samples for testing.  
 
Notes:  
1. The manufacture and free sale certificate of the country of origin 
shall be able to indicate that the changed product and the originally 
approved product are the same. For domestically manufactured 
medical devices, it is exempt from submission.  
2. This is exempt from submission if the change of specifications does 
not involve changing the originally approved labels, instructions, or  
packaging.  
3. This is exempt from submission for deletion of specifications.  
4. For domestically manufactured medical devices, this is exempt 
from submission. For deletion of specifications, this is exempt from 
submission.  
5. For domestically manufactured medica l devices, a copy of new 
firm's medical device manufacturing permit shall be submitted. For authorization letter; document verifying that medical device 
manufacturer conforms to the Medical Device Quality 
Management System Regulations; test specifications and methods 
of preclinical testing and quality control conducted by the original 
manufacture r; original test records and test reports; documents 
relating to product structure, materials, specifications, functions, 
intended uses, and drawings; clinical evidence  information; 
radiation safety information for equipment generating ionizing 
radiation; other documents designated by the central competent 
authority; and samples for testing.  
 
Notes:  
1. The manufacture and free sale certificate of the country of origin 
shall be able to indicate that the changed product and the originally 
approved product are t he same. For domestically manufactured 
medical devices, it is exempt from submission.  
2. This is exempt from submission if the change of specifications does 
not involve changing the originally approved labels, instructions, or 
packaging.  
3. This is exempt from submission for deletion of specifications.  
4. For domestically manufactured medical devices, this is exempt 
from submission. For deletion of specifications, this is exempt from 
submission.  
5. For domestically manufactured medical devices, a copy of new 
firm's m edical device manufacturing permit shall be submitted. For imported medical devices, this is exempt from submission.  
6. For domestically manufactured medical devices, this is exempt 
from submission. If the change of manufactur er's address was due 
to house numbering system change, this document may be exempt 
but certificate document issued by a government agency shall be 
submitted; in the case of imported medical devices, it shall be 
notarized by ROC overseas representative offi ce. 
7. If the application for change involves a Class 3 IVD, this 
information shall be attached. For applications for change of other 
products,  the central competent authority may, when necessary, 
order  submission of this document.  
8. For medical devices that require testing as announced by the central 
competent authority, two copies of this document shall be 
submitted.  
9. The change of license holder shall be applied jointly by the 
transferor and transferee.  
10. This refers to a copy of the transferee's medical devi ce business 
permit.  
11. The foreign original manufacturer authorization letter shall explain 
in detail about termination of the rights of the transferor, and 
bestowing of such rights to the transferee, and shall state the 
product name and the names and addres ses of transferor and 
transferee. For domestically manufactured medical devices, it is 
exempt from submission.  
12. This refers to a copy of the transferee's medical device business imported medical devices, this is exempt from submission.  
6. For domestically manufactured medical devices, this is exempt 
from submission. If the change of manufacturer's address was due 
to house numbering system change, this document may be exempt 
but certificate document issued by a government agency shall be 
submitted; in the case of imported medical devices, it shall be 
notarized by ROC overseas representative office.  
7. When necessary, the centra l competent authority may order 
submission of technical documents relating to product structures, 
materials, specifications, functions, intended uses, drawings, and 
technical documents of preclinical testing and quality control test 
data of the original ma nufacturer. If the application for change 
involves a Class 3 in vitro diagnostic medical device, this 
information shall be submitted. For medical devices that require 
testing as announced by the central competent authority, two 
document copies shall be sub mitted. The applicant shall follow the 
testing notice, pay the testing fee by the designated deadline, and 
submit sufficient samples for testing to conduct testing procedures.  
8. The change of license holder shall be applied jointly by the 
transferor and tra nsferee.  
9. This refers to a copy of the transferee's medical device business 
permit.  
10. The foreign original manufacturer authorization letter shall explain 
in detail about termination of the rights of the transferor, and 
bestowing of such rights to the trans feree, and shall state the permit after name change.  
13. This document shall be submitted when applying for r e-issuance or 
replacement of a lost or damaged license. It is exempt from 
submission when applying for re -issuance or replacement of lost or 
damaged labels, instructions, or packaging.  
14. This is exempt from submission when applying for re -issuance of a 
lost license.  
15. This document shall be submitted when applying for replacement 
of damaged labels, instructions, or packaging. It is exempt from 
submission when applying for re -issuance or replacement of a lost 
or damaged license and re -issuance of lost labels, i nstructions, or 
packaging.  
16. This document shall be attached when applying for re -issuance or 
replacement of lost or damaged labels, instructions, or packaging. 
It is exempt from submission when applying for re -issuance or 
replacement of a lost or damaged l icense.  
17. When applying for re -issuance of a lost license, a statement 
declaring that the original license has indeed been lost shall be 
submitted. When applying for re -issuance or replacement of lost or 
damaged labels, instructions, or packaging, a stateme nt declaring 
that the original labels, instructions, or packaging has indeed been 
lost shall be submitted.  
18. The applicant shall follow the testing notice, pay the testing fee by 
the designated deadline, and submit sufficient samples for testing 
to conduct t esting procedures.  product name and the names and addresses of transferor and 
transferee. For domestically manufactured medical devices, it is 
exempt from submission.  
11. This refers to a copy of the transferee's medical device business 
permit after n ame change.  
12. This document shall be submitted when applying for re -issuance or 
replacement of a lost or damaged license. It is exempt from 
submission when applying for re -issuance or replacement of lost or 
damaged labels, instructions, or packaging.  
13. This i s exempt from submission when applying for re -issuance of a 
lost license.  
14. This document shall be submitted when applying for replacement 
of damaged labels, instructions, or packaging. It is exempt from 
submission when applying for re -issuance or replacemen t of a lost 
or damaged license and re -issuance of lost labels, instructions, or 
packaging.  
15. This document shall be attached when applying for re -issuance or 
replacement of lost or damaged labels, instructions, or packaging. 
It is exempt from submission whe n applying for re -issuance or 
replacement of a lost or damaged license.  
16. When applying for re -issuance of a lost license, a statement 
declaring that the original license has indeed been lost shall be 
submitted. When applying for re -issuance or replacement of lost or 
damaged labels, instructions, or packaging, a statement declaring 
that the original labels, instructions, or packaging has indeed been lost shall be submitted.  
 Comparison Table of Original and Amended Provisions in Appendix 5 of Article 20  
Amended provisions  Original provisions  Description  
Appendix 5 Documents and information that shall be uploaded for 
an application for a listing to manufacture or import Class 1 medical 
device s. 
 
Instructions:  
I. ○: Indicates document for this item shall be submitted. △: 
Indicates it would be dependent on the case.   
Item Upload 
1 Copy of the medical device business 
permit  ○ 
2 Document verifying that medical device 
manufacturer conforms to the Medical 
Device Quality Management System 
Regulations . △ 
3 Instructions of product from the original 
manufacturer  △ 
4 Test specifications and methods for 
preclinical test ing and the test reports  △ 
5 Other documents and information 
designated by the central competent 
authority  △  1. Newly added 
appendix . 
2. This appe ndix is 
added to list 
documents and 
information that 
shall be uploaded 
for an application 
for a listing in 
accordance with 
the amended 
Article 20.  II. Copy of the medical device business permit :  
(1) Those who manufacture medical devices shall  upload a 
copy of the medical device manufactur ing permit . Those 
who import medical devices shall upload a copy of medical 
device dealer permit showing that the business category 
includes “medical device import ”. 
(2) For domestic contract manufacturing, both the contract 
party and the contract manufacturer's medical  device 
business permits shall be uploaded.  
III. Document verifying that medical device manufacturer conforms 
to the Medical Device Quality Management System Regulations: 
This document refers to the certification document issued by the 
central competent authority stating that the medical device 
manufacturer conforms to the Medical Device Quality 
Management System Regulations.  However, this is not required 
for items that, according to product items announced by the 
central competent authority, do not need to obtain manufacturing 
license . 
IV. Instructions of product from the original manufacturer: They 
shall include the instructions for use, function, working principle, 
explanation of product composition (or ingredients), and the 
contents of which shall be suffi cient to determine that the medical 
product meets the identification of Class 1 classification. For 
items designated by the listing system, this document should be uploaded.  
V. Test specifications and methods of preclinical testing and the test 
reports: Th ese document s shall be uploaded for identification of 
Class 1 medical device items or if the performance /specifications 
of the products have been announced by the central competent 
authority pursuant to Article 30 of the Act.  
VI. Other documents and information designated by the central 
competent authority : 
(1)  If the product name bears a trademark, relevant information 
related to trademark registration shall be uploaded. If the 
product name bears the name or trademark of another firm, 
a consent letter issued by the firm shall be uploaded.  
(2)  In line with the Consolidated List of Commodities Subject 
to Import Restriction and Commodities Assisted by 
Customs for Import Examination announced by the Bureau 
of Foreign Trade of the Ministry of Economic Affairs, 
medical devices  imported from China shall first obtain 
permit for import from the Bureau of Foreign Trade of the 
Ministry of Economic Affairs before applying for a listing 
from the central competent authority.  
(3)  If the name of the product bears a proper noun for 
performanc e/specification of a specific country or 
international organization standards, supporting documents 
issued by the country or the region, a third -party validation agency, or the international organization should be 
uploaded.