G/TBT/N/RWA/818  
22 February 2023  
(23-1266) 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:  RWANDA  
If applicable, name of local government involved (Article 3.2 and 7.2):   
2. Agency responsible:   
Rwanda Food and Drugs Authority (Rwanda FDA)  
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:   
Rwan da Food and Drugs Authority (Rwanda FDA)  
info@rwandafda.gov.rw  
Nyarutarama Plaza, KG 9 Avenue  
Toll-free: 9097  
3. Notified under Article 2.9.2 [X], 2.10.1 [  ], 5.6.2 [  ], 5.7.1 [  ], 3.2 [  ], 7.2 [  ], 
other :  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  Wadding, 
gauze, bandages and the like, e.g. dressings, adhesive plasters, poultices, impregnated 
or covered wit h pharmaceutical substances or put up for retail sale for medical, surgical, 
dental or veterinary purposes (HS code(s): 3005); - Other : (HS code(s): 30069)  
5. Title, number of pages and language(s) of the notified document:  Regulations, 
No.: DFAR/HMDAR/T RG/002 Rev_2, Governing Registration of Medical Devices including 
In Vitro Diagnostics; (13 page(s), in English)  
6. Description of content:  The purpose of these regulations is to enforce the legal 
framework to ensure effective and efficient registration o f human and veterinary Medical 
Devices including In Vitro Diagnostics, and to provide an open, transparent and non -
discriminatory process for the registration of Medical Devices including In Vitro 
Diagnostics.  
7. Objective and rationale, including the nat ure of urgent problems where 
applicable:  Consumer information, labelling; Prevention of deceptive practices and 
consumer protection; Protection of human health or safety; Protection of animal or plant 
life or health; Quality requirements; Harmonization; Re ducing trade barriers and 
facilitating trade; Cost saving and productivity enhancement  
8. Relevant documents:   
Law No 47/2012 of 14/01/2013 relating to the regulation and inspection of food and 
pharmaceutical products  G/TBT/N/RWA/818  
 
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  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  
11. Texts available from:  National enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
Mr. Johnny Uwimana Hassan  
WTO/TBT Enquiry point  
Rwanda Standards Board  
KK 15 Rd, 49  
Kigali  
Tel: Hotline: 3250; +(250) 788636510  
Fax: +(250)788303492  
Email: info@rsb.gov.rw ; johnny.uwimana@rsb.gov.rw  
Website: http://www.rsb.gov.rw  
Mr. James D. TAYEBWA  
WTO Notification Officer  
Ministry of Trade and Industry  
Department of Trade and Investment  
Kigali  
Tel: +(250) 788 636 406  
Email: jtayebwa@minicom.gov.rw ; dyebwa@gmail.com  
Website: http://www.minicom.gov.rw  
Ms. Beatrice UWUMUKIZA  
Ministry of Agriculture and Animal Resources  
WTO/Plant Health Enquiry Point  
Tel: +(250) 788 84 84 10  
Email: infoinspection@minagri.gov.rw ; buwumukiza@minagri.gov.rw  
Dr. Isidore Gafarasi Mapendo  
Director of Veterinary and Laboratory Services  
Rwanda Agriculture Board (RAB)  
Animal Health Enquiry Point  
Tel: +(250) 788503589  
Email: info@rab.gov.rw ; igafarasi@gmail.com  
Ms. MUKAMUNANA Alphonsine  
Ministry of Health  
Department of Environmental Health Desk  
Tel: +(250) 788673500  
We notified both the Regulations and Guidelines b ecause the Guidelines have all the 
necessary details for the Regulations  
https://members.wto.org/crnattachments/2023/TBT/RWA/23_1281_00_e.pdf  
https://members.wto.org/crnattachments/2023/TBT/RWA/23_1281_01_e.pdf  
https://me mbers.wto.org/crnattachments/2023/TBT/RWA/23_1281_02_e.pdf