. /.  WORLD TRADE  
ORGANIZATION  G/TBT/N/THA/157 
23 August 2004 
 (04-3513) 
Committee on Technical Barriers to Trade Original:  English 
   
NOTIFICATION 
 
The following notification is being circ ulated in accordance with Article 10.6. 
 
1. Member to Agreement notifying:   THAILAND
 
If applicable, name of local government involved (Articles 3.2 and 7.2):         
2. Agency responsible:   Food and Drug Administration (FDA), Ministry of Public Health 
Name and address (including telephone and fax numbers, e-mail and web-site 
addresses, if available) of  agency or authority designated to handle comments 
regarding the notification shall be  indicated if different from above:    
Thai Industrial Standards Institute (TISI),  
Tel.:  (66 2) 2023512  
Fax.:  (66 2) 2478734  E-mail:  thaistan@tisi.go.th, stdinfo@tisi.go.th  Website address:   www.tisi.go.th 
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 equipment 
(HS: 9018, ICS:  11.040) 
5. Title, number of pages and langu age(s) of the notified document:   Draft Medical Device 
Act B.E.... (30 pages, available in Thai language) 
6. Description of content:   A modification to the Medical Device Act B.E. 2531(1988). The 
main amendments are as follows: 
- Withdrawing the Medical Device Act B.E. 2531(1988) 
- Including the provision of product liability for medical devices; 
- Including criteria for advertising; - Revising criteria for licensing and registration; - Revising sanctions for violations. 
7. Objective and rationale, including the na ture of urgent problems where applicable:  
Consumer protection. 
8. Relevant documents:    
Publication in which the notification is published when adopted: 
 - Government Gazette. G/TBT/N/THA/157 
Page 2   
 
9. Proposed date of adoption:   
Proposed date of entry into force:   }To be determined 
10. Final date for comments:   60 days from the circulation date. 
11. Texts available from:  National enquiry point [ X] or address, telephone and fax 
numbers, e-mail and web-site addresses, if available of the other body:   
http://www.fda.moph.go.th/fda-net/html/p roduct/other/kbs3/MdActupdate3.doc 
 