G/TBT/N/MYS/79  
 
24 October 2018  
(18-6660) Page: 1/2 
Committee on Technical Barriers to Trade  Original: English  
 
  
NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6  
 
1. Notifying Member: MALAYSIA   
If applicable, name of local government involved (Article 3.2  and 7.2):   
2. Agency responsible:  
National Pharmaceutical Regulatory Agency (NPRA)  
Ministry of Health  
Lot 36, Jalan Universiti  
46200 Petaling Jaya  
Selangor  
Phone: (+603)78835400  
Fax: (+603)79581312  
Email: rosilawati.a@npra.gov.my   
Website: www.npra.gov.my   
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 n ational tariff 
heading. ICS numbers may be provided in addition, where applicable): 
Drug-Medical Device and Medical Device -Drug Combination products ; (ICS: 11.040, 
11.120).  
5. Title, number of pages and language(s) of the notified document: Guideline For  
Registration Of Drug -Medical Device And Medical Device -Drug Combination Products 
(33 page(s), in English; 3 page(s), in Malay)   
6. Description of content: This guideline serves as a guidance for the submission of 
registration application of drug -medical device/medical device -drug combination 
products.  
Combination products which has not been registered :  
- Guideline For Registration Of Drug -Medical Device And Medical Device -Drug 
Combination Products applicable for product registration application submitted  
on/after 1 July 2019.  
Combination products registration application submitted before 1 July 2019 and still in 
evaluation :  
- Guideline For Registration Of Drug -Medical Device And Medical Device -Drug 
Combination Products applicable during re -registration.  
Combination products which has been registered and available in market :  G/TBT/N/MYS/79  
 
- 2 - 
 
  - Guideline For Registration Of Drug -Medical Device And Medical Device -Drug 
Combination Products applicable during re -registration for product expired on/after 
1 July 2019.  
7. Objective and rationale, including the nature of urgent problems where 
applicable: Protection of human health or safety; To ensure safety, quality, efficacy and 
performance of combination products.  
8. Relevant documents:   
1. Sales of Drugs Act 1952  (Act 368)  
2. Medical Device Act 2012 (Act 737)  
3. Control of Drugs and Cosmetics Regulations 1984  
4. Drug Registration Guidance Document (DRGD) Second Edition, September 2016, 
Revised July 2018  
9. Proposed date of adoption: To be determined  
Proposed date of entry into force: 1 July 2019  
10. Final date for comments: 60 days from notification  
11. Texts available from: National enquiry point [X] or address, telephone and fax 
numbers and email and website addresses, if available, of other body:   
National Pharmaceutical Regulatory Agency (NPRA)  
Ministry of Health  
Lot 36, Jalan Universiti  
46200 Petaling Jaya  
Selangor  
Phone: (+603)78835400  
Fax: (+603)79581312  
Email: rosilawati.a@npra.gov.my  
Website:  www.npra.gov.my   
Guideline for Registration of Drug -Medical Device and Medical Device -Drug Combination 
Products can be downloaded at this link:  
http://npra.moh.gov.my/images/Guidelines_Central/MDC/Garis_Panduan_13.3.17.pdf   
https://members.wto.org/crnattachments/2018/TB T/MYS/18_5565_00_x.pdf  
https://members.wto.org/crnattachments/2018/TBT/MYS/18_5565_01_e.pdf  
https://members.wto.org/crnattachments/2018/TBT/MYS/18_5565_02_e.pdf