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 Regulations Governing Issuance of Medical Device License, Listing and Annual Declaration  
Chapter 1 General Provisions  
Article  1 The Regulations are stipulated in accordance with Article 29 of the Medical Devices Act 
(hereinafter referred to as "the Act "). 
Article  2 The t erms used in the Regulations are defined as follows : 
1. Manufacture and free sale certificate  of the country of origin : refers to a certification 
document issued by the highest health authority or agency of the country where an 
imported medical device is manufactured that verifies the medical device is 
manufactured and sold freely in that country.  
2. Foreign original manufacturer authorization letter: refers to an authorized agent letter 
issued by the foreign original manufacturer of an imported medical device.  
3. In Vitro Diagnostic Device (IVD): refers to a reagent, instrument, software , or system 
used t o collect, prepare, or test specimens from human body in order to diagnose disease, 
determine the state of health or other conditions.  
4. Predicate  device : refers to a medical device that has obtained domestic license or listing 
and meets one of the following  conditions:  
(1) It has the same intended use and technical characteristics as the proposed medical 
device apply ing for license or listing . 
(2) It is a medical device other than  the one referred to in  the preceding subparagraph, 
has the same intended use as the proposed medical device apply ing for license or 
listing, and has different technical characteristics but which do not affect product 
safety and efficacy . 
Chapter 2 Registration and Market Approval of Medical Device and Issuance of License  
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 no tice issued by the central competent authority, 
pay the testing fee  by the designated deadline, and submit sufficient samples necessary for 2 
 testing to conduct testing procedures. However, this does not apply to those exclusively for 
export . 
Registration pa rticulars for the license ref erred 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. Other registration particulars that have been designated by the central compe tent 
authority.  
Article 4 The product name of a medical device referred to in the preceding article shall comply with 
the following  provisions : 
1. It shall not use the medical device trademark or firm name of  others.  However, this shall 
not apply when said product has obtained the trademark or the use has been  authorized . 
2. It shall not be the same as or similar to the medical device product name of other firms, 
thereby causing confusion with the medical devices of other firms.  
3. It shall not involve any false or exaggerated statement s, or lead people to have improper 
associa tion or confusion on the intended use and effectiveness  of medical device.  
4. The Chinese product name shall not contain any character s in other language or any 
numbers. However, this shall not apply when the central competent authority deems that 
they have direct meaning or the English trademark has special meaning.  
5. The Chinese and English product names of medical devices exclusively for export shall 
not be the same as the Chinese and English product names of medical devices  that are 
sold domestica lly. 
The determination of medical device product names being the same or similar shall be 
decided based on the precedence of trademarks, company names, or other identifiable 
names.  
Article 5 For an application of registration and market approval to manufac ture or import Class  1 
medical devices, the documents and information that shall be submitted are specified in 3 
 Appendix 1. 
For the application  set forth in the preceding paragraph,  the central competent authority 
may waive approval of registration particulars specified in Subparagraphs 5 and 6 of 
Paragraph 3 of Article  3. 
Article  6 For an application of registration and market approval to manufacture or import Class  2 or 
Class 3 medical devices, except as stipulated in the provisions of Paragraph 2 of Article 19, 
the documents and information that shall be submitted are specified in Appendix 2 and 
Appendix 3. 
For the application  set forth in the preceding paragraph,  the central competent authority 
may waive  approval of registration particular s specified in S ubparagraphs 5 and 6 of 
Paragraph 3 of Article 3 if the  products  are exclusively for export . 
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 four months. Failure to make 
corrections by the designated deadline  shall subject  the application to reject ion. 
Article 8 After completing the formality review set forth in the preceding article, the central 
competent authority shall conduct a substantial review . 
If the substantial review set forth in the preceding paragraph finds application documents 
and information are not compl ete or sufficient such that corrections can be made , the central 
competent authority shall notify the applicant to make corrections within three months. 
Failure to make corrections by the designated deadline  shall subject  the application to 
reject ion. 
Article 9 If any of the following circumstances applies to an application, the applicant may submit 
supporting documents and information to apply for priority review with the central 
competent authority : 
1. For use in the prevention, diagnosis, or treatment of life-threatening diseases or diseases 
causing severe disability, with no appropriate medication, medical device , or suitable 
alternative treatment available yet domestically.  
2. For use in the prevention, diagnosis, or treatment of rare diseases as specified in 4 
 Paragraph 1 of Article 3 of the Rare Disease and Orphan Drug Act.  
3. Having received priority assistance in accordance with government policies,  been 
subsid ized for research and development from the central competent authority or other  
authority,  and condu cting or will be conduct ing clinical trial domestically to verify 
product safety and efficacy , or meeting the domestic public health or urgent medical  
needs . 
Article 10 If any of the following circumstances occurs in an application after substantial review, the 
application shall be disapproved : 
1. Payment of the fee does not meet the provisions.  
2. Documents and information submitted are not ready  or are inconsistent with regard to 
the contents of application . 
3. Testing procedures have not been conducted in a ccordance with the provisions  or 
submitted  samples have been found to be noncompliant after the testing.  
4. The medical device under application is such that its risk of harming the health  of human 
body is greater than the benefit.  
5. Other circumstances that do not comply with the provisions of laws and regulations.  
Article  11 The central  competent authority shall notify the applicant of the application review result; 
if a license is  approved and issued , the applicant shall, within three months after the arrival  
date of the notice, pay the license  fee and prepare labels, instructions , or packaging 
according to the approved content to the central competent authority in order to obtain the 
license.  
If the applicant fails to obtain the license in accordance with the provisions of the preceding 
paragraph, the central competent authority may  cancel  its license.  
Article  12 If the preliminary determination made by the central competent authority with regard to an 
application is that the product has the  effectiveness  stated in the application , does not 
present any significant risks, and meets one of the following circumstances, the central 
competent authority may request the applicant to provide a plan to conduct safety 
surveillance or post-approval study . After revie w, a license with shorter validity  period may 
be issued : 
1. For use in the prevention, diagnosis, or treatment of life -threatening diseases or diseases 
causing severe disability, with no appropriate medication, medical device , or suitable 5 
 alternative treatmen t available yet domestically.  
2. Meeting the domestic public health or urgent medical  needs . 
3. Being innovative or novel  and having  significant clinical benefits , with the potential of 
being used to enhance or support medical diagnosis and treatment . 
If the app licant fails to conduct safety surveillance or post-approval study in accordance 
with the plan referred to in the preceding paragraph, the central competent authority may  
cancel its license.  
Chapter 3 Change, Re -issuance , or Replacement of License.  
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 submitted and  fee shall be paid for  submi ssion 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 packag ing is lost or 
damaged,  documents and information in Appendix 4 shall b e 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 reject ion. 
For application s 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 6 
 the deadline  may subject its license to cancellation by  the central competent authority.  
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 stamp ing. 
Article  14 Under any  of the following circumstances, license holder s may, of their own accord, 
change labels, instructions , or packaging  of the medical device s, and such  changes shall be 
documented accordingly:  
1. No changes in the text  content : 
(1) Only changing the material, shape, graphic design , color  or luster  of labels, 
instructions , or outer box and the graphic  design not be ing 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 
labels, and their design of text and graphs being identical to those in the originally 
approved labels . 
2. Chang es of  the following text content that do not relate to the quality and safety of 
medical device s: 
(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 trademar k approved by Taiwan 
Intellectual Property Office, CNS mark or trademark registration number.  
(2) Adding or ch anging 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 . 7 
 (4) Adding, deleting, or changing the name of medical device firm that has been 
approved for change by the central competent authority and that constitutes part 
of the Chinese and English product names . 
Article  15 For those apply ing for a change o f Class  1 medical device, the provisions of Article 5 shall 
apply mutatis mutandis to the submission of their documents and information . 
Article 16 For those apply ing for a change o f medical device  exclusively for export , the provisions 
of Article 6 shall apply mutatis mutandis to the submission of their documents and 
information . 
Chapter 4 License Extension  
Article  17 Applicants who apply for a license extension shall fill out and submit an application form 
within six months prior to the expiration date , submit the following documents and 
information , and pay the fee to the central competent authority  for submission : 
1. Original license.  
2. Manufacture and free sale certificate of the country of origin, which is not required for 
those manufactured domestically.  
3. Foreign original manufacturer authorization let ter, which is not required for those 
manufactured domestically.  
4. Document verifying that manufacturer conform s to the Medical Device Quality 
Management System  Regulations . 
5. For a license issued in accordance with the provisions of Paragraph 1 of Article 12, 
safety surveillance or post -approval study report shall be submitted.  
6. Other documents and information designated by the central competent authority.  
If the central competent authority finds that documents and information of the preceding 
paragraph are not  ready  such that corrections can be made , the central competent authority 
shall notify the applicant to make corrections within three months. Failure to make 
corrections by the designated deadline  shall subject  the application to reject ion. 
Article  18 For those apply ing for a license extension of Class  1 medical device, the provisions of 
Article 5 shall apply mutatis mutandis to the submission of their documents and 
information . 
Article  19 Those that fail to apply for a license extension before the expiration date in accordance 
with the provisions of Article 17 shall re -apply for registration and market approval in 8 
 accordance with Articles 5 and 6 for a license to be issued. 
If the application is for a Class  2 or Class  3 medical device  license  and it is re-applied 
within six months after the expiration date of original license, the following documents and 
information  shall be submitted  without being subjected to the restrictions in the provisions 
of Article 6 : 
1. Business permit of the medical device firm . 
2. Original license . 
3. Originally approved labels, instruction s, or packaging stamped with tally impression of 
the central competent authority.  
4. Draft of labels, instructions , or packaging.  
5. Manufacture and free sale certificate of the co untry of origin, which is not required for 
those manufactured domestically . 
6. Foreign original manufacturer authorization letter, which is not required for those 
manufactured domestically . 
7. Document verifying that manufacturer conform s to the Medical Device Quality 
Management System  Regulations.  
8. Other documents and information designated by the central competent authority.  
After approval of the application set forth in Paragraph 1, the license is issued with a new 
number.  
Chapter 5 Listing and Annual Declarat ion 
Article  20 Applicants who apply for a listing to manufactur e or import medical devices shall list the 
following document s and information in the medical device listing system (hereinafter 
referred to as "the 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 n ame 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 . 9 
 7. Other documents and information designated by the central competent authority.  
The provisions of Article 4 shall apply mutatis mutandis to  the product names of medical 
devices in the preceding paragraph.  
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 S ystem and pay the fee. 
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 in 
Subparagraph 4 of Paragraph 1 of the preceding article shall not apply for a listing  change . 
Article  22 Those who have been listed for one full year shall file an annual declaration in the Listing 
System in October  of each year , confirm the listing status of the following  particulars,  and 
pay the fee : 
1. Chinese and English product names . 
2. Name of the medical device firm . 
3. Name and address of the manufacturer . 
4. Item n ame and number of the medical device classification . 
5. Status of the manufacturer in conforming to the Medical Device Quality Management 
System Regulations . 
6. Sterility condition of the medical device . 
7. Other documents and information designated by the central competent authority.  
Article 2 3 For t hose that have been listed directly in accordance with Paragraph 4 of Article 25 of the 
Act by the central competent authority , medical device firms  shall file a declaration in 
accordance with the provisions of the preceding article  after the expiration date of original 
license . 
Chapter 6 Supplementary Provisions  
Article 24 If the documents and information submitted with an application filed in accordance with 
the Regulations  are not in traditional Chinese or English, a traditional Chinese or E nglish 
translation shall be provided . 
Article 25 If the application involves contract manufacturer, approval certificate obtained in 
accordance with the Regulations Governing Contract Manufacturing  of Medical Devices  10 
 shall be submitted by the applicant . 
Article 26 The Regulations  shall be implemented on May 1, 2021 .