G/TBT/N/RUS/99  
21 February 2020  
(20-1343) 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:  RUSSIAN FEDERATION   
If applicable, name of local government involved (Article 3.2 and 7.2):   
2. Agency responsible:   
Eurasian Economic Commission  
Department for technical regulation and accreditation  
Tel: +7(495)669 -24-00 
Fax: +7(495)669 -24-15 
E-mail: dept_techregulation@eecommission.org  
Web-site: www.eurasiancommission.org , https://docs.eaeunion.org/ru -ru 
Name and address (including telephone and fax numbers , email and website 
addresses, if available) of agency or a uthority designated to handle comments 
regarding the notification shall be indicated if different from above:   
Russian Scientific and Technical Centre for Information on Standardization, Metrology and 
Conformity Assessment  
(Standartinform, National enquir y point for the TBT Agreement)  
Tel: +7(495) 531 -26-59  
E-mail: info@gostinfo.ru   
Website: www.gostinfo.ru   
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):  Wadding, 
gauze, bandages (dressings, adhesive plasters, poultices), impregnated or coated with 
pharmaceutical substances or in forms or packings for retail sale, for medical, surgical or 
veterinary use (HS 3005); Instruments and appliances used in medical, surgical, dental or 
veterinary sciences, including scintigraphic apparatus, other electro -medical apparatus and 
sight testing instruments (HS 9018); X -ray, alpha, beta, gamma radiation apparatus; 
x-ray tubes, x -ray generators, high tension generators, control panels and desks, screens, 
examination or treatment tables, chairs and the like (HS 9 022); Furniture; medical, 
surgical, dental or veterinary (e.g. operating tables, hospital beds, dentists' chairs) 
barbers' chairs; parts (HS 9402).  
5. Title, number of pages and language(s) of the notified document:  Draft 
amendments to the Rules for regis tration and examination of safety, quality and 
effectiveness of medical devices (104 page(s), in Russian)  
6. Description of content:  The Draft amendments to the Rules for registration and 
examination of safety, quality and effectiveness of medical devices  apply to medical 
devices issued for circulation in the territory of the Eurasian economic union and provide 
for the following:  
- clarification of terms and definitions;  
- clarification of the mechanism for implementing the procedure for approval by States of G/TBT/N/RUS/99  
 
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  the recognition of the expert opinion of the reference state;  
- determination of cases when changes are made to the registration dossier of medical 
devices in the not ification procedure;  
- clarification of the procedure for canceling the validity (cancellation) of the registration 
certificate of a medical device.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of human health or safety  
8. Relevant documents:   
• Draft amendments to the Rules for registration and examination of safety, quality 
and effectiveness of medical devices: https://docs.eaeunion.org/ria/ru -
ru/0103911/ria_18022020  
• Decision N° 46 of the Board of the Eurasian Economic Commission of 12 February 
2016: https://docs.eaeunion.org/docs/ru -ru/01410768/cncd_12072016_46  
9. Proposed date of adoption:  To be determined  
Proposed date of entry into force:  To be determined  
10. Final date for comments:  20 April 2020  
11. Texts available from:  National enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
Eurasian Economic Commission  
Department for technical regulation and accreditation  
Tel: +7(495)669 -24-00 
Fax: +7(495)669 -24-15 
E-mail: dept_techregulation@eecommission.org  
Web-site: www.eurasiancommission.org , https://docs.eaeunion.org /ru-ru 
https://docs.eaeunion.org/ria/ru -ru/0103911/ria_18022020  
https://docs.eaeunion.orq/docs/ru -ru/01410768/cncd_12072016_46