G/TBT/N/TPKM/257  
 
6 December 2016  
(16-6651) Page: 1/3 
Committee on Technical Barriers to Trade  Original : English  
 
  NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6  
 
1. Notifying Member : THE SEPARATE CUSTOMS TERRITORY OF TAIWAN, PENGHU, KINMEN 
AND MATSU  
If applicable, name of local government involved  (Article 3.2 and 7.2) : 
2. Agency responsible:  
Food and Drug Administration  
Ministry of Health and Welfare  
No.161 -2, Kunyang St, Nangang District  
Taipei City 115 -61, Taiwan  
Tel.: (886-2) 2787 -7526  
Fax: (886-2) 2787 -8287  
Email : shoulder0705@fda.gov.tw   
Name and address (including telephone and fax numbers , email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification  shall be indicated if different from above : 
3. Notified under Article 2.9.2 [ X], 2.10.1 [  ], 5.6.2 [  ], 5.7.1 [  ], other : 
4. Products covered (HS or CCCN where applicable, otherwise national tariff heading. 
ICS numbers may be provided in addition, where applicable) : Medical devices  
5. Title, number of pages  and language(s)  of the notified document : General 
Information on Draft Partial Amendment to the Regulation for Registration of Medical Devices 
(41 pages, in English; 22 pages, in Chinese)  
6. Description of content : This Regulation was established in accord ance with Paragraph 3, 
Article 40 of the Pharmaceutical Affairs Act to meet the needs for registration and market 
approval of medical devices and management of permit licenses, and was promulgated 
and came into force as per the Decree of Wei -Shu-Yao-Zi No.  0930328238 on 
30 December 2004. This Regulation has undergone five amendments since then. In order 
to improve the registration and market approval process and ensure the safety and 
efficacy of medical devices on the market, a draft partial amendment to th e Regulation for 
Registration of Medical Devices has been formulated. The main points of the amendment 
are as follows:  
1. With the provisions of Paragraph 3 of Article 3 and Article 13 of the Regulations for 
Registration of Medicinal Products as reference, it  is stipulated that a Chinese or 
English translation shall be provided if the documents submitted are not made in 
Traditional Chinese or English (amendment to Article 3).  
2. Considering that the current relationship between the commissioning company and 
the commissioned manufacturing factory is not proved by a manufacture certificate 
but by a commissioning contract signed by the parties and other relevant documents 
in accordance with the Regulations for Medicament Contract Manufacture and 
Analysis, the relevan t provisions that require a clear description of the relationship 
between the commissioning company and the commissioned manufacturing factory 
in a manufacture and free sale certificate of the country of origin, as set forth in the G/TBT/N/TPKM/257  
 
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  latter part of Paragraph  3, are deleted (amendment to Article 7).  
3. To meet the needs for e -government, online application services have become 
available for Class I medical devices. The applicant may sign or affix their seal to 
confirm their identity if an application is submitted  in writing. However, if a 
registration application is submitted online, the identity of the applicant must be 
confirmed by means of electronic signature since the applicant is unable to sign or 
affix their seal. As a result, the latter part of the paragra ph explicitly stipulates that 
those submitting an application online shall do so with the IC card issued by the 
Certificate Authority of the Ministry of Economic Affairs (amendment to Articles 14 
and 16).  
4. Changes in the specifications or efficacy of a medi cal device shall be done after 
evaluated by the original designer or manufacturer of the product, so as to ensure 
the safety and efficacy of the product. Therefore, the amendment requires that the 
comparison and explanation of the changed specifications or  efficacy and the 
originally approved specifications or efficacy submitted for the purpose of applying 
for change of the specifications or efficacy on a permit license shall be issued by the 
original medical device manufacturer (amendment to Articles 24 an d 26).  
5. Paragraph 6 is added to prevent the change of the address of a medical device 
manufacturing factory from resulting in any inconsistency with its medical device 
previously approved for registration and market approval in terms of the quality, 
safety,  and efficacy. The central competent authority may order the applicant to 
submit relevant supporting documents to confirm the consistency with its medical 
device previously approved for registration and market approval (amendment to 
Article 28).  
6. To avoid o ther factors that affect the safety and efficacy of the product concerned 
due to extension or change of a permit license, the rights of the central health 
competent authority to order the applicant to submit relevant documents are 
reserved, thereby ensurin g the efficacy and safety of the product (amendment to 
Article 35).  
7. To collect complete information on the instructions of Class I medical devices and 
improve the management after launch to the market, it is explicitly stipulated that 
Class I medical devic e permit license holders shall upload the instructions, labels, 
and outer box documents to the information system specified by the central health 
competent authority within one (1) month after obtaining permit licenses or within 
six (6) months after the am endment to this Regulation comes into force if they 
obtain Class I medical device permit licenses before the amendment to this 
Regulation comes into force. Moreover, such uploading is listed as a requirement for 
applying for extension of Class I medical de vice permit licenses (amendment to 
Articles 35 and 36).  
8. Since the review process for medical devices exclusively for export is different from 
that for domestically manufactured medical devices, it is explicitly stipulated that the 
Chinese and English names  of medical devices exclusively for export shall not be the 
same as those of domestically manufactured medical devices. Thus, any confusion 
between medical devices exclusively for export and domestically manufactured 
medical devices can be avoided (amendme nt to Article 37).  
7. Objective and rationale , including the nature of urgent problems where 
applicable : Prevention of deceptive practices and consumer protection  
8. Relevant documents : The Pharmaceutical Affairs Act  
9. Proposed date of adoption : To be determined  
Proposed date of entry into force : To be determined   
10. Final date for comments : 60 days from notification  G/TBT/N/TPKM/257  
 
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  11. Texts available from : National enquiry point  [X] or address, telephone and fax 
number s and e mail and website address es, if availabl e, of other body:  
TPKM WTO/TBT Enquiry Point  
Bureau of Standards, Metrology and Inspection  
Ministry of Economic Affairs  
No. 4, Section 1, Jinan Road  
Zhongzheng District, Taipei City 100, Taiwan  
Tel.: (886-2) 2343 -191  
Fax: (886-2) 2343 -1804  
E-mail: tbtenq@bsmi.gov.tw  
http://members.wto.org/crnattachments/2016/TBT/TPKM/16_5006_00_e.pdf  
http://members.wto.org/crnattachments/2016/TBT/TPKM/16_5006_00_x.pdf