1 
 Draft Regulations Governing Issuance of Medical Device License, Listing and 
Annual Declaration  
Articles  
Chapter 1 General Provisions  
Article 1 The present regulations are stipulated in accordance with Article 29 of the Medical 
Devices Act (hereinafter referred to as "the Act").  
Article 2 Terms used in the present regulations shall have the following meanings:  
1. The manufacture and free sale certificates of the country of origin : refers to verifying documents 
issued by the highest health authority or agency of the country where the imported medical 
device is manufactured to prove that the medical device is manufactured and can be sol d 
freely in the country.  
2. A foreign original manufacturer authorization letter: refers to an authorized agent letter issued 
by a foreign original manufacturer of the imported medical device.  
3. In Vitro Diagnostic Device (hereafter referred to as IVD):  refers to a medical device such as 
diagnostic reagents, instruments, software or systems used to collect, prepare, and test 
specimens from human body in order to diagnose disease, determine the state of health or 
other conditions.  
4. Predicate product: r efers to a medical device that has obtained domestic licens e or listing and 
meets one of the following conditions:  
(1) the medical device has the same intended purpose and technical characteristics as another 
medical device intending to apply for license o r listing;   
(2) the medical device  other than the preceding Paragraph  has similar intended purpose with 
another medica l device intending to apply for  license or listing, but its technical 
characteristics are different; however, such differences will not af fect the product's safety 
and efficacy.  
Chapter 2 Registration and Market Approval of Medical Device and Issuance of License  
Article 3 Applicants who intend to apply for license  to manufacture medical devices, or registration 
and market approval for imported medical devices, shall prepare relevant documents and 
information  in accordance with Articles 4 and 5, pay the fees and submit the application to the 
central competent authority.  
With the exception of medical devices that are approved for export only, applicants whose 
application for registration and market approval, as mentioned in the preceding Paragra ph, 
requires testing in accordance with the provisions of the present regulations, shall follow the 
testing notice, pay the testing fees, and submit said medical devices to the examination process 
with adequate samples for examination by the designated dea dline.  
Items required for registration and market approval referred to in Paragraph 1 are as 
follows:  
1. Chinese and English product names;  2 
 2. Name of the medical device firm;  
3. Name and address of the medical device manufacturer;  
4. Efficacy, intended use, or  indications;  
5. Ingredients, materials, structures, specifications or model number of the medical device;  
6. Labeling, instructions and packaging.  
7. Other items designated for registration, as announced by the central com petent authority.  
Article 4 Applicants applying for registration and market approval to manufacture or import Class I 
medical devices shall submit  documents and information as specified in Attachment 1.  
The central competent authority may waive Items 5 and 6 of Paragraph 3 of the preceding 
Article for the aforementioned application.  
Article 5 To apply for registration and market approval to manufacture or import Class II or Class 
III medical devices, applicants shall submit  documents and information as  specified in 
Attachments 2 and 3.  
The central competent authority may waive items 5 and 6 of Paragraph 3 of Article 3 for the 
aforementioned of the product  manufactured for export only.  
Article 6 Upon receiving the applications, the central competent authority shall conduct formality 
examination to examine the documents and information.  
In the event that the central competent authority discovers that the application documents 
and information are not complete, the central competent authority shall notify the applicant who 
shall make corrections within four months. In the event that the applicant fails to make 
corrections before the designated deadline, the application shall be rejected.  
Article 7 Upon completing the aforementioned examination, the central competent authority shall 
conduct substantial examination.  
In the event that the central competent authority discovers that the application documents 
and information are incomplete during substa ntial examination and corrections may be made, the 
central competent authority shall notify the applicant who shall make corrections within three 
months. In the event that the applicant fails to make corrections before the designated deadline, 
the applicat ion shall be rejected.   
Article 8 If any of the following circumstances applies to the application, the applicant may submit  
relevant documents and information and apply for priority examination to the central competent 
authority:  
1. For the purpose of preventing, diagnosing, or treating life -threatening diseases or diseases 
causing severe disability, with no appropriate medication, medical device or appropriate 
alternative treatment available yet domestically;  
2. For the purpose o f preventing, diagnosing, or treating rare diseases as specified in Paragraph 1 
of Article 3 of The Rare Disease and Orphan Drug Act.  
3. The application has received priority support or subsidy from the central competent authority 
or other agency and has conducted or will conduct clinical trial domestically to verify its 3 
 safety and efficacy or the medical device is responding to public health emergencies or 
urgent medical demand;  
Article 9 In the event that any of the following circumstances matches the application upon 
substantial examination, the application shall not be approved:  
1. The applicant has not paid the prescribed application fee;  
2. The attached documents and information are incomplete, or are inconsistent with the contents 
of the application;  
3. The applicant has failed to submit samples for testing according to the regulations, or the 
samples submitted for testing do not meet re quirements;   
4. The medical device under application is more hazardous than beneficial to human health;   
5. Other circumstances that are inconsistent with laws, regulations or administrative directives.   
Article 1 0 The central competent authority shall in form the applicant the result of the examination; 
If a license  is granted after registration and market approval, the applicant shall, within three 
months after the arrival date of the notice, pay the fees for the license , and provide labels, 
instructions or packaging according to the approved content to the central competent authority to 
obtain the license.   
If the applicant fails to follow the preceding paragraph, or fails to obtain the license before 
the deadline, the central competent authority may revo ke the license.  
Article 1 1 The preliminary determination made by the central competent authority is that the 
product has the efficacy stated in the application;  does not present any major risk; and meets one 
of the following circumstances, the central competent authority  may ask the applicant to provide 
their plan to conduct safety monitoring or post -market surveillance before issuing a license  with 
shorter validity.  
1. For the purpose of preventing, diagnosing, or treating life -threatening diseases or diseases 
causing severe disability, with no appropriate medication, medical device or alternative 
treatment available yet domestically;   
2. The necessity of responding to public health emergencies or urgent medical demand;  
3. The product  is innovative or novel, and ha s significant clinical benefits, and are used to 
improve or assist medical diagnosis and treatment . 
If the applicant fails to conduct safety monitoring or post -market surveillance plan 
according to the preceding paragraph, the c entral competent authority may revoke the license.  
Chapter 3 Changer, an d re-issuance or replacement of  license.  
Article 1 2 If any of the following circumstance s applies to the content of the  license, labels, 
instructions or packaging, the applicant shall prepare documents and information listed in 
Attachment 4, pay the fees and submit the application to the central competent authority.  
1. Change of Chinese product name   
2. Change of English product  name  
3. Change of the original instructions, label, or packaging.  4 
 4. Change of ingredients, materials, structures, specifications or model number.  
5. Change of efficacy, intended use or indication.  
6. Change of the name of the manufacturer;  
7. Change of address of the manufacturer or country of origin;  
8. Change of the license holder;  
9. Change of the name of the  license holder;  
To apply for replacement or re -issuance of damaged or lost licenses, or approved 
documents of labels, instructions or packaging, the documents and information listed in 
Attachment 4 shall be submitted and relevant fees paid.  
Application for re -issuance or  replacement of license, as mentioned in the preceding 
Paragraph, the applicant shall, within three months after the arrival date of t he notice, pay the 
fees for the  license to the central competent authority to obtain the license. If the applicant fails 
to obtain the license before the deadline, the central competent authority may revoke the license.  
For applications referred to in Items 1 and 2, the central competent authority shall annotate 
changed registration items and changed date on the original license, then return the license with 
the stamp.  
Article 1 3 Under any of the following circumstances , manufacturers may, of their own accord, 
change labels, instructions or packaging, and the relevant changes shall be documented 
accordingly:  
1. No changes in the originally approved text:  
（1） Only changing the material, shape, graphic design or colors of labels,  instructions or 
outer box and the graphic design shall not be offensive, indecent or misleading;  
（2） 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. However, the font size of English text may not 
be larger than that of Chinese text;  
（4） Adding printings on outer boxes or using new outer boxes to replace the labels. The 
design of text and graphs shall be identical t o those approved;  
2. Changing the text without affecting the quality or safety of the medical device:  
（1） Only adding or changing bar -codes, recycling marks, “GMP” before the medical device 
manufacturer’s name, CE marks, the suggested retail price, customer ser vice telephone 
line, the manufacturer's telephone number, fax number and contact; copyright registration 
number or company trademark approved by Taiwan Intellectual Property Office, CNS 
mark or trademark registration number.  
（2） Adding or changing the distrib utor’s name or address. The font size of the distributor’s 
name may not be larger than that of the medical device manufacturer's (license  holder's) 
name.  
（3） Adding or changing the medical device firm's name, the manufacturer’s name or address 
as approved by the central competent authority;  5 
 （4） Adding, deleting or changing the name of the medical device firm adding to the changed 
Chinese and English product name, as approved by the central competent authority;  
Article 1 4 To apply for changes to Class I  medical devices, Article 4 shall be applied mutatis 
mutandis for preparation of the required documents and information.  
Article 1 5 To apply for changes to medical device manufactured exclusively for export, Article 5 
shall be applied mutatis mutandis fo r preparation of the required documents and information.  
Chapter 4 License Extension  
Article 1 6 To apply for license extension, applicants shall file the application with the following 
documents and information and pay the fees to the central competent authority within six 
months prior to the expiration date:  
1.  Original  license;  
2.  The manufacture and free sale certificate of the country of origin, unless the medical device 
is manufactured domestically;  
3. The foreign original manufacturer authorization letter, unless the medical device is 
manufactured domestically;  
4. Documents verifying that the medical device manufacturer has conformed with  the medical 
device quality management system regulations ;  
5.  If the  license issued in accordance with the provisions of Paragraph 1 of Article 1 1, the 
post-approval  study  reports shall be submitted;  
6. Other documents and information designated by the central competent authority.  
Artic le 17 To apply for extension of  license of Class I medical devices, Article 4 shall be applied 
mutatis mutandis for preparation of the required documents and information.  
Article 1 8 If the  license holder fails to file for extension before the expiration date in accordance 
with th e provisions of Article 1 6, the license holder shall re -apply for registration and market 
approval for re -issuance of the license  in accordance with Articles 4 and 5.  
However, in the case of Class II and Class III medical devices, and the re -application is 
submitted within six months after the expiration date of the original  license, the applicant shall 
prepare the following documents and information, without being  subjected to the restrictions set 
forth in Article 5:  
1. The medical device business permit ;  
2. The original  license;   
3. The original copy of the approved labels and form for attaching instruction of use stamped 
with tally impression of the central com petent authority.   
4. Drafts of the labels and instructions and both shall be attached on the forms for attaching 
labels and instructions.  
5. The manufacture and free sale certificate of the country of origin, unless the medical device is 
manufactured dom estically;  
6. The foreign original manufacturer authorization letter, unless the medical device is 6 
 manufactured domestically;  
7. Documents verifying that the medical device manufacturer has conformed with  the medical 
device quality management system regulations ;  
8. Other documents and information designated by the central competent authority.  
Once the application referred to in P aragraph 1 is approved, the new  license will be given a 
new number.  
Chapter 5 Listing and Annual Declaration  
Article 19 To apply for listing of medical device manufacturing or imported medical devices, the 
applicant shall file the application on the medical device listing system (hereinafter referred to as 
"the System") established by the central competent authority and pa y the fees to obtain the 
listing number:  
1 Chinese and English product names;  
2. Name of the medical device firm;  
3. Name and address of the manufacturer;  
4. Name and number  of the medical device classification ;  
5. Sterile conditions of the medical dev ice;  
6. Circumstances explaining that the medical device manufacturer has conformed with  the 
medical device quality management system regulations ;  
7. Other documents  and information  designated by the central competent authority.  
Article 2 0 With the exception of changes mentioned in Paragraph 4 of the preceding Article, all 
other changes to the listing shall be made on the system and relevant fees shall be paid.  
Changes to the name of the medical device firm mentioned in Paragraph 2 of the preceding 
Article shall be limited to those that do not involve transfer of rights.  
The name and number  of medical device  classification  mentioned in Paragraph 4 of the 
preceding Article shall not apply for changes of listing.  
Article 2 1 Those who have been listed for one full year shall conduct annual declaration on the 
listing system, confirm the following items and pay the fees annually in October:  
1. Chinese and English product names;  
2. Name of the medical device firm;  
3. Name and address of the m anufacturer;  
4. Name and number  of the medical device classification ;  
5. Circumstances explaining that the medical device manufacturer has conformed with  the 
medical device quality management system regulations ;  
6. Sterile conditions of the medical device;  
7. Other documents  and information  designated by the central competent authority.  
Article 2 2 Those who have been listed according to Paragraph 4 of Article 25 of the Act by the 
central competent authority shall follow the provisions of the preceding Article after the 
expiration date of the original  license. The same applies to who have been liste d by the central 7 
 competent authority for less than one year.  
Chapter 6 Supplementary Provisions  
Article 2 3 If the documents and information submitted with an application filed in accordance with 
this regulation  are not in traditional Chinese or English, a traditional Chinese or English 
translation shall be additionally provided.   
Article 2 4 If the application involves contract manufacturer, approval certificate obtained in 
accordance with medical device contrac t manufacturing operation guidelines.  
Article 2 5 The product name of a medical device shall comply with the following regulations:  
1. A product name shall not use the trademark or name of another medical device firm, unless 
the trademark has been awarded  or authorization has been obtained.  
2. A product name shall not be the same as or be similar with medical devices made by other 
firms, or cause confusion with medical devices made by other firms.  
3. A product name shall not involve any false or exaggerated statement, or leading people in 
improper association with medical device and/or efficacy or causing confusion.  
4. The Chinese product name shall not contain any character in any other language o r in 
numbers, unless phrases used contain meaning directly related, or English trademarks 
contains special meaning and approved by the central health competent authority.  
5. The Chinese and English names of medical devices exclusively for export shall not  be the 
same as those of domestically manufactured medical devices.  
The precedence of medical device names that are identical or similar shall be determined on 
the basis of the precedence of trademarks, company names, or other identifiable names.  
Articl e 26 This regulation shall be implemented on the date of promulgation of the Act.  
  
1 
 Attachment 1 : Documents  and information required to apply for  the 
manufacture and import Class I medical devices : 
Application Category  
Item Manufactur e Import  
1 Application form for Class I medical device registration and 
market approval  ○ ○ 
2 A photocopy of medical device business permit  ○ ○ 
3 Documents verifying th at medical device manufacturers  in 
conformity with medical device quality management system 
regulations  △ △ 
4 Instructions from the original manufacturer  △ △ 
5 Pre-clinical testing and the test specifications and methods, and 
the test reports  △ △ 
6 Other documents  and information  designated by the central 
competent authority  △ △ 
Explanation:  
I. ○: Documents of the item should be submitted. △：Depend ing on the case. ╳: Documents 
of the item is not required.  
II. A photocopy of  medical device business permit : 
(I) The Medical device  manufacturer shall submit  a photocop y of medical device 
manufacturer permit , and the medical device Importer shall submit  a photocopy of the 
medical device dealer permit  with the business item including  the "Import" . 
(II) For a domestically commissioned manufacture, the medical device business permit  of 
both the commissioner and the commissioned manufacturer should be submitted . 
III. Documents verifying that medical device manufacturers in  conformity with medical device 
quality management system regulations : The documents mentioned herein refer to the copy 
of the documents issued by the central competent authority to prove that the medical device 
manufacturer conforms to the Medical Devices Quality Management Systems Regulations . 
However, product items annou nced by the central competent authority shall not be required 
to obtain a manufacturing license, this document may be exempted.  
IV. Instructions from the original manufacturer : shall including the instruction for use , function, 
working principle, and compositi on (or ingredients) of the medical device, and the contents 
of which shall be sufficient to identify the medical product as meeting the identification of 
the Class I classification .  
2 
 V. Pre-clinical testing and the test specifications and methods, and the test  reports : The 
properties/specifications of the products are stipulated in the identification of the Class I 
classification or in accordance with the announcement pursuant to Article 30 of the Law of 
the Central Competent Authority . 
VI. The central  competent  authority may, depending on the circumstances of the case, request 
relevant  documents and  information be submitted : 
(I) If the product name  also bears  trademark, the product shall be accompanied by the 
relevant information for trademark registration. If the product name also bears the name 
or trademark of another manufacturer, the applicant shall attach a letter of consent from 
the company which its name or trademark has been added.  
(II) In line with the restricted import commodities and the Consolidated List of C ommodities 
Subject to Export Restriction and Commodities Assisted by Customs for Export 
Examination announced by the Bureau of Foreign Trade under the Ministry of Economic 
Affairs, for imported medical devices with China as the origin, importer of such med ical 
devices shall first obtain a certificate of export approval from the Bureau of Foreign 
Trade under the Ministry of Economic Affairs before applying for inspection and 
registration with the central competent authority.   
1 
 Attachment 2: Documents and information required to apply for the 
manufactur e and import  Class II and Class III medical devices : 
Application  
category  
 
 
Documents to be 
submitted  Class II Medical 
Devices  Class III Medical 
Devices  Same product with  
different product 
names  For 
export only  
Manufa
cture  Import  Manufact
ure Import  Manufact
ure Import  Manufactur
e 
1 Application 
form for medical 
device 
registration and 
market approval  ○ ○ ○ ○ ○ ○ ○ 
2 Two (2) copies 
of draft labels 
and instructions.  ○ ○ ○ ○ ○ ○ ╳ 
3 A photocopy of 
the medical 
device business 
permit  ○ ○ ○ ○ ○ ○ ○ 
4 The original 
copy of the 
manufacture and 
free sale 
certificate of the 
country of 
origin.  ╳ △ ╳ △ ╳ ○ ╳ 
5 The original 
copy of foreign 
original 
manufacturer 
authorization 
letter.  ╳ ○ ╳ ○ ╳ ○ ╳ 
6 Documents 
verifying that the 
medical device 
manufacturer 
has conformed 
with medical 
device quality 
management 
system 
regulations.  ○ ○ ○ ○ ╳ ╳ ○ 
7 Pre-clinical 
testing and the 
test 
specifications 
and methods, the 
original test 
records, and the 
test reports of △ △ ○ ○ ╳ ╳ ╳  
2 
 the quality 
control 
conducted by the 
original 
manufacturer.  
8 Relevant 
documents 
concerning 
product 
structure, 
materials, 
specifications, 
functions, 
intended uses, 
and drawings, 
etc. ○ ○ ○ ○ ╳ ╳ ╳ 
9 Clinical 
evidence  △ △ △ △ ╳ ╳ ╳ 
10 Radiation safety 
information for 
equipment 
generating 
ionizing 
radiation  △ △ △ △ ╳ ╳ ╳ 
11 Basic 
specifications 
and summary of 
technical 
documentation 
(STED) for the 
safety and 
efficacy of 
medical device  ╳ △ ○ ○ ╳ ╳ ╳ 
12 The original 
manufacturer's 
letter explaining 
that the product 
is the same 
product with 
different product 
names.  ╳ ╳ ╳ ╳ ○ ○ ╳ 
13 A photocopy of 
the approved 
labels and 
instructions 
stamped with 
tally impression 
of the central 
competent 
authority.  ╳ ╳ ╳ ╳ ○ ○ ╳ 
14 A photocopy of 
the original ╳ ╳ ╳ ╳ ○ ○ ╳  
3 
 approved 
medical device 
license  
15 Other documents 
and information 
designated by 
the central 
competent 
authority.  △ △ △ △ △ △ △ 
16 Samples for 
testing  ╳ ╳ △ △ ╳ ╳ ╳ 
Description:  
I. ○: Documents of the item should be submitted. △: Depending on the case. ╳: Documents 
of the item is not required  
II. Draft labels and instructions:  
1. Chinese instruction leaflet catalog, instructions, packaging, labeling, and draft color 
pictures of the physical appearance of product to be attached on the labels and outer 
box instruction.  
2. For those who imports medical devices, the original labels, packaging, instructions and 
draft detailed Chinese instructions.  
III. A photocopy of the medical device business permit  
1. Those who manufacture medical devices should attach a photocopy of the firm's 
license as a medical device manufacturer. Those who import medical devices should 
attach a photocopy of the license as a medical device dealer showing that the operating 
items include "importing medical devices".  
2. For domestic contract manufactur ing, both th e hiring firm and the contract 
manufacturer's medical device business permit shall be submitted.  
IV. Manufacture and free sale certificate of the country of origin : 
1. This document should record the following items:  
（1） The name, the specifications and model of the  medical device   
（2） The manufacturer’s name, address, the circumstances of manufacture, and the 
certification of approval for domestic sale in that country.   
2. This document may be replaced by document issued by other authorities or other 
documents in accordanc e with the following provisions:  
（1） If the medical device is not regulated by the highest health authority in the 
country of the manufacturer, said document may be issued by the local health 
agency or an organization approved by Taiwan's central health compet ent 
authority.   
（2） If the medical device is commissioned to be manufactured, said document may 
be issued by the highest health authority in the country where the hiring firm or 
the contract  manufacturer is located.   
（3） If the medical device is commissioned to be  manufactured, and it is not sold in 
the country where the contract manufacturer is located, said document may be  
4 
 replaced by a free sales certificate issued by the highest health authority in the 
country where the hiring firm is located, and a certificate  of manufacture issued 
by the country where the contract manufacturer is located.  
（4） Said document may be replaced by a manufacture certificate issued by the 
country of the manufacturer, and a free sale certificate issued by the highest 
health authority of the United States or EU member states.   
（5） If the medical device is a completely new device with no predicate  product , the 
on-site inspection reports provided by the central competent authority after 
conducting on -site inspection of foreign medical device manufacturer and 
medical device clinical trials reports carried out domestically shall be 
submitted. Manufacture and free sale certificate of the country of origin is not 
required.   
3. This document shall remain valid for two years after the date of issuance, and shall be 
notarized by Taiwan's embassy or consulate, representative office, other official office, 
or overseas o rganization in that country authorized by the Ministry of Foreign Affairs 
(hereafter referred to as the overseas representative organization of Taiwan). A 
Chinese or English translation shall be attached when the verifying documents are not 
in English, and  the translation shall also be notarized. However, certificates issued by 
the highest health authority of a country who has signed technical cooperation 
agreement for pre -market review of medical devices with Taiwan or certificates 
recognized by the centra l competent authority are exempt from notarization.   
V. Foreign original factory authorization letter:  
1. This document should record the following items:  
1、 The original manufacturer authorizes agents in Taiwan to apply for registration 
and market approval, and ag rees to work with agents in Taiwan to comply with 
relevant medical devices management regulations.  
2、 Specify the name and address of the medical device manufacturer commissioned 
or authorized to register and the name, specification and model of the medical 
device.  
2. This document may be replaced by other documents in accordance with the following 
provisions:  
（1） Authorized agent letter issued by a foreign original manufacturer of the 
imported medical devices to authorize the agent in Taiwan to apply for 
registrat ion and market approval. The content shall indicate the name and 
address of the manufacturer and the name and address of the commissioned or 
authorized medical device firm as well as the name, specification and model of 
the medical devices.  
（2） An authorizati on letter issued by the original manufacturer of the imported 
medical device to its foreign agent, and another authorization letter issued by 
the foreign agent that authorizes the importer in Taiwan to register, that shall  
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 explicitly state the name and add ress of the commissioned or authorized 
medical device firm, and the name, specifications, and model of the medical 
device.  
3. This document shall be valid within one year from its issuance date. If the document is 
not written in English, a Chinese or an Engl ish version of translation of the document 
shall be submitted as well.  
VI. Documents verifying that the medical device manufacturer has conformed with medical 
device quality management system regulations.  
1. This document refers to a photocopy of the certification document issued by the 
central competent authority stating that the medical device manufacturer has 
conformed with the medical device quality management system regulations.  
2. For firms that were originally regulated as pharmaceutical firms , the document may be 
replaced by photocopies of certification documents showing that the firm has 
conformed with the Pharmaceutical Good Manufacturing Practice Regulations within 
three years from the d ate of proclamation of listing change.  
VII. Pre-clinical testing and the test specifications and methods, the original test records, and the 
test reports of the quality control conducted by the original manufacturer:  
1. This document shall include information on safety and functional testing to ensure the 
claimed efficacy, structure, material, design and quality of the product.  
2. If predicate products have been approved by the central competent authority to be 
listed as Class II medical devices, the document can be  replaced by one of the 
following documents:  
（1） Market approval documents issued by the government of a country who has 
signed technical cooperation agreement for pre -market review of medical 
devices with Taiwan and basic specifications and summary of technic al 
documentation for the safety and efficacy of medical device.  
（2） An affidavit of pre -clinical testing document showing that the medical devices 
are product items announced by the central competent authority and predicate 
products produced by the manufactur er in the same classification and category 
have been approved for sale by the central competent authority.  
3. For Class II medical devices listed in Attachment 3, if the same manufacturer has 
predicate products of the same product that has been approved for sale by the central 
competent authority, and the license is still valid, said document may be replaced by 
Class II medical device product comparison and pre -clinical testing conformity 
affidavit.  
4. If the central competent authority has announced that the m edical device requires 
testing, two (2) copies of this document shall be attached.  
5. The commissioned laboratory responsible for biocompatibility, electrical safety, and 
electromagnetic compatibility (EMC) tests shall conform with any of the following:  
1、 Conf orms with the provisions of ISO/ IEC 17025.   
6 
 2、 Conforms with the provisions of Good Laboratory Practice for Nonclinical 
Laboratory Studies (GLP).  
VIII. The structure, materials, specifications, performance, usage, drawings and other related 
information of the pro duct: For instrument products, the operation manual and maintenance 
manual that cover this item can be replaced.  
IX. Clinical evidence:  
1. This document includes academic theoretical basis, relevant research reports and 
information, clinical evaluation reports or clinical trial reports.  
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 
Taiwan in light of the medical device product item, the case, and the materials 
submitted by the applicant.  
3. For medical devices with predicate products that have been approved by the central 
competent authority sale, unless it is necessary to verify the safety and effectiveness of 
the medical device with clinical evidence, this document may be exempted.  
4. For Class II medical devices without predicate products, unless otherwise specified, 
the cli nical trial report may be replaced with supporting data that meets all the 
following conditions:  
（1） There is no ethnic difference in the expected efficacy of this product.  
（2） There is no report of undesirable effect related to the claimed intended use or 
indica tions of such products in foreign countries and the products have not 
been required to be removed.  
（3） Pre-clinical data (including trial) can be used to verify that the difference 
between the product and products that have been approved to be sold 
domestical ly will not affect said product's safety and effectiveness; or provide 
market approval certification document showing that the product can be sold in 
the United States and the European Union and the applied indications do not 
exceed the scope approved by b oth the United States and the European Union.  
X. Radiation safety information for equipment generating ionizing radiation: Medical devices 
generating ionizing radiation shall submit this document.  
XI. Basic specifications and summary of technical documentation for the safety and efficacy of 
medical device:   
1. The format of this document shall be handled in accordance with the announcement of the 
central competent authority.  
2. If Class II medical device applied for is in the description VII.2 .(1) situation, this 
document shall be attached.  
XII. An explanatory letter from the original manufacturer explaining that the product is the same 
product with different names: The letter shall explain the product for which a new 
application has been made and t he originally -approved product are identical, and noting the 
license number of the originally -approved medical device license.   
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 XIII. 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 the applications co nforming 
to the announcement from the central health competent authority regarding the 
exemption from submitting the documentation in the preceding paragraph 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 the trademark, the applicant shall attach relevant materials 
related to trademark registration. If the product n ame bears the names or trademarks of 
another medical device firm, a consent letter issued by the medical device firm shall 
be attached.  
3. To comply with the consolidated list of commodities subject to import restriction and 
commodities assisted by customs f or import examination announced by the Bureau of 
International Trade of the Ministry of Economic Affairs, medical devices imported 
from China shall first obtain permit for import from the Bureau of International Trade 
of the Ministry of Economic Affairs be fore submitting to the central competent 
authority registration and market approval.  
4. For medical devices made for export only, the instructions, function, working principle, 
product composition (or ingredients) of the medical device should be attached, an d the 
content should be sufficient to determine that the product meets the identification of 
the application item.  
XIV. Samples for testing: The applicant shall, in accordance with the testing notice, pay the 
testing fee by the designated deadline, and submit said medical devices to the examination 
process with adequate samples for examination.  1 
 Attachment 3 : Applicable classifications of Class II Medical Devices Comparison 
and Preclinical Test Data Conformity Statement  
 Item Code  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 isoenzymes 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  
9 A.1660  Quality control material (assayed and un -assayed)  
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  
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  
 1 
 Attachment 4: Documents and information required to apply for change, transfer, and re -issuance or replacement of licenses  
Item to be changed  
 
 
 
 
Item Change of 
Chinese 
product 
name  Change of 
English 
product 
name  Change of 
the original 
instructions, 
labels, and  
packaging  Change of the i
ngredients, mater
ials, structures, s
pecifications or 
model number;  Change of e
fficacy, inten
ded use, or 
indications;  Change of the 
name of the 
manufacturer;  Change of the 
address of the 
manufacturer 
or country of 
origin  Change of 
the license 
holder  Change of 
the name of 
the license 
holder  Re-issuance or 
replacement of 
a lost or 
damaged 
license  
1 Application form for 
change in medical 
device license  ○ ○ ○ ○ ○ ○ ○ ○ 
Note 8  ○ ○ 
2 Application form for 
medical device 
registration and 
market approval  ╳ ╳ ╳ ╳ ╳ ╳ ╳ ╳ ╳ △ 
Note 12  
3 Original copy of the 
license.  ○ ○ ○ ○ ○ ○ ○ ○ ○ △ 
Note 13  
4 Original copy of the 
approved labels and 
instructions stamped 
with tally impression 
of the central 
competent authority.  ╳ ╳ ○ △ 
Note 2  
 ○ ╳ ╳ ╳ ╳ △ 
Note 14  
5 Two (2) copies of 
draft labels and 
instructions.  ╳ ╳   ○ △ 
Note 3  ○ ╳ ╳ ╳ ╳ △ 
Note 15  
6 A photocopy of 
medical device 
business permit.  ╳ ╳ ╳ ╳ ╳ △ 
Note 5  △ 
Note 5  ○ 
Note 9  ○ 
Note 11  ╳ 
7 The original copy of 
the manufacture and 
free sale certificate of 
the country of origin.  ╳ △ 
Note 1  ╳ △ 
Note 4  △ 
Note 4  △ 
Note 4  △ 
Note 6  ╳ ╳ ╳ 2 
 8 The original copy of 
foreign original 
manufacturer 
authorization letter.  ╳ ╳ ╳ △ 
Note 4  △ 
Note 4  △ 
Note 4  △ 
Note 4  △ 
Note 10  ╳ ╳ 
9 Documents verifying 
that the medical 
device manufacturer 
has conformed with 
medical device 
quality management 
system guidelines.  ╳ ╳ ╳ ╳ ╳ ○ ○ ╳ ╳ ╳ 
10 Pre-clinical testing 
and the test 
specifications and 
methods, the original 
test records, and the 
test reports of the 
quality control 
conducted by the 
original manufacturer.  ╳ ╳ ╳ △ 
Note 3  ○ ╳ △ 
Note 7  ╳ ╳ ╳ 
11 Relevant documents 
concerning product 
structure, materials, 
specifications, 
functions, intended 
uses, and drawings, 
etc. ╳ ╳ ╳ △Note 3  △ ╳ △ 
Note 7  ╳ ╳ ╳ 
12 Clinical evidence  ╳ ╳ ╳ △ 
Note 3  △ ╳ ╳ ╳ ╳ ╳ 
13 Radiation safety 
information for 
equipment generating 
ionizing radiation  ╳ ╳ ╳ ╳ 
Note 3  ╳ ╳ ╳ ╳ ╳ ╳ 3 
 14 Original 
manufacturer's 
covering letter that 
explains the change  ╳ ○ ○ △Note 3  ○ ○ ○ ╳ ╳ ╳ 
15 A comparison table of 
the change and the 
original approved 
content.  ╳ ╳ ○ △Note 3  ○ ╳ ╳ ╳ ╳ ╳ 
16 Assignment contract 
jointly issued by the 
assignor and the 
assignee.  ╳ ╳ ╳ ╳ ╳ ╳ ╳ ○ ╳ ╳ 
17 An affidavit from the 
medical device firm 
receiving agency 
rights (assignee) 
affirming responsible 
for the transferred 
medical device.  ╳ ╳ ╳ ╳ ╳ ╳ ╳ ○ ╳ ╳ 
18 One affidavit from 
the medical device 
firm after name 
change affirming 
responsible for every 
item on the changed 
license.  ╳ ╳ ╳ ╳ ╳ ╳ ╳ ╳ ○ ╳ 
19 One affidavit that 
claims no assignment 
of rights involved in 
this application for 
change in name of the 
medical device firm.  ╳ ╳ ╳ ╳ ╳ ╳ ╳ ╳ ○ ╳ 4 
 20 Other documents and 
information 
designated by the 
central competent 
authority.  △ △ △ △ △ △ △ △ △ △ 
Note 16  
21 Samples for testing  ╳ ╳ ╳ △ ╳ ╳ △ ╳ ╳ ╳ 
Description:  
I. ○: Documents of the item should be submitted. △: Depending on the case. ╳: Documents of the item is not required  
II. See description of Attachment 2 for regulations with regards to draft labels and instructions, photocopy of medical device bu siness permit, the manufacture and free sale certificate of the 
country of origin, foreign  original manufacturer authorization letter, documents verifying that the medical device manufacturer  has conformed with medical device quality management 
system guidelines, pre -clinical testing and the test specifications and methods, the original test re cords, and the test reports of the quality control conducted by the original manufacturer, 
relevant documents concerning product structure, materials, specifications, functions, intended uses, and drawings, etc., cli nical evidence, radiation safety informa tion for equipment 
generating ionizing radiation, other documents designated by the central competent authority, and relevant regulations regard ing samples for testing.  
Note:  
1. The manufacture and free sale certificate of the country of origin shall indicat e the changed product and the already approved product are in fact the same, unless the medical device is 
manufactured domestically.  
2. This does not apply if the change of specification does not involve the originally approved instructions, labels or packag ing.  
3. This does not apply if the change involves deletion of specifications.  
4. This does not apply for medical device manufactured domestically. This does not apply if the change involves deletion of spec ifications.  
5. Domestic medical device firm shall attac he a photocopy of the new firm's license as a medical device manufacturer. This does not apply if the firm only imports medic al devices.  
6. This does not apply for medical devices manufactured domestically. If change of the manufacturing factory address was due to house -numbering system change, this document may be 
exempted, but a certificate issued by government shall be submitted; in the case of imported medical devices, the certificate  shall be notarized by R.O.C (Taiwan) foreign affairs office.  
7. If necess ary, the central competent authority may order submission of technical documentation such as relevant documents concerning pr oduct structure, materials, specifications, 
performance, intended use, drawing and others, and documents of pre -clinical testing, a nd the test results of quality control of the original manufacturer. If the application for change 
involves a Class III IVD, this information shall be attached. If the central competent authority has announced that the medic al device requires testing, two (2) copies of this information 
shall be attached. The applicant shall, in accordance with the testing notice, pay the testing fee by the designated deadline , and submit said medical devices to the examination process 
with adequate samples for examination.  
8. Application for change of license holder shall be applied by the transferor and the transferee jointly.  
9. A photocopy of the transferee's license as a medical device dealer.  
10. The foreign original manufacturer authorization letter shall explain in detail ab out 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 addresses of assignor and assignee. This does not apply for medical device manufactured do mestically.  
11. Photo copy of the transferee's license as a medical device dealer after the name change.  
12. This information shall be attached when applying for re -issuance or replacement of a lost or damaged medical device license. This does not apply when applying for re -issuan ce or 
replacement of lost or damaged instructions, labels and packaging.  
13. This does not apply when applying for re -issuance of a lost license.  
14. This information shall be attached when applying for re -issuance or replacement of lost or damaged instructions,  labels and packaging. This does not apply when applying for re -issuance 
or replacement of a lost or damaged license, instructions, labels and packaging.  
15. This information shall be attached when applying for re -issuance or replacement of lost or damaged in structions, labels and packaging. This does not apply when applying for re -issuance 
of a lost or damaged license.  
16. When applying for re -issuance of a lost license, an affidavit stating that the original license indeed being lost must be attached. When appl ying for re -issuance or replacement of lost or 5 
 damaged instructions, labels and packaging, an affidavit stating that the original instructions, labels and packaging indeed being lost must be attached.