Regulations Governing the Inspection of the Medical Device 
Quality Management System and the Issuance of  
the Manufacturing license (Draft)  
 
Article 1  
 The Regulations are enacted in accordance with Article 22 Paragraph 4 of the Medical 
Devices Act  (hereinafter referred to as this Act).  
 
Article 2  
 Applications for the inspection of the medical device quality management system 
shall be filed to the c entral competent authority , with fee payment and the requested  
documents and materials as set out in Appendix 1.  
 The applications in the preceding paragraph, if involving medical devices 
manufactured in and imported from foreign countries, shall be filed by the medical device 
import er to the central competent authority.  
 The documents or materi als submitted with applications in the preceding two 
paragraphs, if found incomplete but correct able, shall be corrected within a given time 
limit upon the notice of the central competent authority; failure to do so shall lead to the 
rejection of the applications.  
 The applications in the first paragraph, including the documents and materials 
submitted, shall be made in the Chinese or English languages; otherwise a Chinese or 
English translation shall be provided.  
 
Article 3  
 The central competent authority, upon receiving the application of the preceding 
Article  shall conduct the inspection  and having determined the compliance of the Medical 
Device Quality Management System Regulations , shall issue the manufacturing license of 
the medical device; the applicants whose cases in which compliance is not determined 
may sub mit an application for re -inspection within two months after receiving the written 
notice but the application for re -inspection is limited to once only.  
 
Article 4  
 In addition to the inspection  mentioned in the preceding Article , the central 
competent authority  may perform  routine or for-cause  inspections of the medical device 
quality management system.  When performing the inspection in the  preceding Article and  preceding paragraph, 
the municipal and county (city) health authorities may be notified to send staff to 
participate.  
 For-Cause inspections  in the first paragraph may be performed, without prior 
notification , at the premises of the medical device manufacturer.  
 
Article 5  
 The registration in the manufacturing license of the medical devices includes the 
following items:  
1. Name of the medical device manufacturer ; 
2.  Address of the medical device manufacturer ; 
3.  Authorized items and content of operations ; 
4. Domestically manufactured device, m anagement representative  of the medical 
device manufacturer;  
5.  Imported devices,  the medical device firm that is the agent for import ; 
6.  License number; and  
7. Validity.  
 Upon any changes of the regist ered items in the subparagraphs 1, 2, 4 and 5 of the 
preceding paragraph, application for change of registration shall be filed to the central 
competent authority within thirty ( 30) days after the actual happening of the occurrence, 
in one copy of application form, with fee payment and the requested  documents and 
materials as set out in Appendix 2.  
 The changes in subparagraph 2 of Paragraph 1 is limited to those resulted from street 
number reassignment; in cases of relocation, a new application shall be made in 
accordance with Article 2.  
 For the application for changes in subparagraph 3 of Paragraph  1, the provisions of 
Articles 2 and 3 shall  apply mutatis mutandis.  
 For changes in the second  paragraph s, the provisions of Article 2 Paragraph 2, 3 and 
4 shall apply mutatis mutandis , and for changes in the second and the preceding 
paragraphs , the original validity  will not be extended . 
 
Article 6  
 The validity of the manufacturing license of the medical devices is three years; 
applications for extension, if necessary, shall be made between six and twelve months 
prior to expiration, and each extension period is limi ted to three years; for the application and inspection procedures, the provisions of Articles 2 and 3 shall apply mutatis mutandis.  
 For applications for extension made within the period specified in the preceding 
paragraph which the central competent auth ority, for no reasons attributable to the 
medical device manufacturers, does not make a decision of approval or disapproval 
before the expiration of the original validity, the original validity will be extended to the 
date of approval or disapproval.  
 
Article 7  
 Inspectors, when performing inspection tasks, shall present identification documents 
and explain the purpose of inspection, and may take actions to preserve evidence against 
any violations defined in the Medical Device Quality Management System Regulations . 
 
Article 8  
 The central competent authority, for performing inspections of the  Regulations, may 
take samples of the products when necessary.  
 The sampling in the preceding paragraph is d one with no payment involved and on 
a random basis. The medical device manufacturers may not specify samples; and the 
amount of samples is limited to what is necessary for inspection.  
 
Article 9  
 The medical device firms who are approved of the manufacturi ng license may apply 
to the central competent authority, in a copy of application form, with fee payment and 
all the documents below to obtain license documents : 
1. Photocopy of manufacturing license of the medical devices.  
2. Photocopy of the medical device business permits.  
 
Article 10  
 The central competent authority, under any of the following circumstances, shall 
annulled or revoke all or a part of the manufacturing license of the medical devices:  
1. The business permit  of medical device manufacturer  has been canceled or 
revoked in accordance with laws;  
2. The business permit of medical device  import er has been canceled or revoked in 
accordance with law s; or 
3. Other matters that constitute reasons for annulation or revocation in accordance 
with the provisions of related  Act. 
 Article 11  
 A medical device firm, when and if its manufacturing license of the medical devices 
is annulled or revoked by the central competent authority, shall return the  license 
documents in its possession (if any) within fifteen (15) days from the date of notification; 
failure to do so will lead to their automatic cancellation.  
 
Article 12  
 A medica l device firm, when and if it suspends its business operation, shall hand in 
the original license documents in its possession to the municipal and county (city) health 
authorities   for custody and claim it when it resumes business operation.  
 A medical device firm, when and if it ceases its business operation, shall return the 
original license documents in its possession; failure to do so will lead to their cancellation 
by the centr al competent authorities.  
 
Article 13  
 The Regulations shall come into effect on the day when this Act takes effect.  Appendix  1 
 
Application   mode  
Requested  Manufacturer of Domestic Medical Devices  Manufacturer of Imported Medical Devices  
On-site inspection  Desktop inspection6 
(QSD review)  Overseas On-site 
inspection  
Basic information of the  manufacturer   O  
Certificate of compliance equivalent to medical device 
QMS certification (ISO13485)   O  
Document demonstrating that the manufacturer is a legal 
entity2   O 
A photocopy of the medical device business permit  O   
Evidentiary documents showing the manufacturer's 
registration3 O   
Letter of authorization and agreement from the original 
manufacturer5   O 
Manufacturer quality manual  O ▲1 O 
Document master list  O O O 
Quality system procedural documents   ▲1  
Medical device file list5 O O O 
Plant layout diagram  O O O 
Production area information for each type of product  O O O 
Main manufacturing equipment and main testing 
equipment  O O O 
Manufacturing process diagrams for each product item  O O O 
Organizational chart  O  O 
Suppliers of main raw materials and each component  O  O 
Note:  
1. ▲shows in the case of application s for extension only need to submit the parts of revisions, the manufacturing license and the letter of revisions from the manufacturer.  
2. The certification issued by medical device competent authority of the country where the manufacturer is located , ISO13485 c ertification  or other document demonstrating 
that the manufacturer is a legal entity.  3. Pursuant to the Factory Management Act, or if such manufacture, as approved by the central competent health authority, is for research and developmen t purposes are 
allowed exemption from factory registration . 
4. Should clearly states that the original manufacturer authorizes the pha rmaceutical firm in Taiwan to submit an application to the Food and Drug Administration, Ministry 
of Health and Welfare, R.O.C. (Taiwan), for overseas manufacturer inspection and related matters.  
5. The medical device file is  that established by manufacturer on the basis of  article 11 of the Medical Device Quality Management System Regulations.  
6. Medical device manufacturer falling with the scope of an agreement/established between other competent authorities with Taiwa n (R.O.C), the requested documents could 
be substit uted by  other documents announced by the central competent authority.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Appendix 2  
Registered  
 Item for change  
 
Request  Manufacturer of Domestic Medical Devices  Manufacturer of Imported Medical Devices  
Name of the manufacturer  Address of 
the 
manufacturer  Management 
representative  Name of the 
manufacturer  Address of the 
manufacturer  The domestic medical device 
firm 
Involving a 
transfer of 
ownership  Name  Involving a 
transfer of 
agent rights  Name  
A photocopy  of Manufacturing 
license O O O O O O O O 
A photocopy of the medical device 
business permit  O O     O O 
Evidentiary documents issued by the 
household/business registration 
agency or related official agency of 
the country where the manufacturer 
is located    O   O   
Evidentiary document showing 
appointment of the management 
representative     O     
The original letter of  declaration   
for change  from the manufacturer      O O   
The o riginal  certificate issued by the 
highest health authority in the country 
where the manufacturer is located      O    
The original agreement issued by the 
medical device firm for transfer of 
Manufacturing license  O      O  
The original letter of authorization 
from the manufacturer1 O      O  
Note:  1. Should clearly states that the termination of the registration of the first medical device firm's authorization and the subse quent authorization and registration of the second 
medical device firm; the matters authorized and the addresses of the first and second medical device firms shall be included, with a period of validity of 1 y ear.