G/TBT/N/RUS/104  
12 August 2020  
(20-5542) 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 availa ble) of agency or authority 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 (Standartinfor m, National enquiry 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 and similar products (bandaging material, adhesive pl asters,poultices), 
impregnated or coated with pharmaceutical substances or put up in forms or packings for 
retail sale for medical, surgical, dental or veterinary purposes (HS 3005); Instruments 
and appliances used in medical, surgical, dental or veterinar y 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,  examinationor 
treatment tables, chairs and the like (HS 9022); 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 conducting studies (tests) for evaluation of biological action 
of medical products (18 page(s), in Russian)  G/TBT/N/RUS/104  
 
- 2 - 
 
  6. Description of content:  The Draft amendments to the Rules for conducting studies 
(tests) fo r evaluation of biological action of medical products to medical devices issued 
for circulation in the territory of the Eurasian Economic Union and provide for the 
following:  
- clarification of the concepts;  
- determining the grounds for excluding testing laboratories (centers) from the unified 
register of authorized organizations that have the right to conduct research (testing) of 
medical devices for the purpose of their registration;  
- clarification of the form of the Protocol of studies (tests) for eval uation of biological 
action of medical products.  
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 conducting studies (tests) for evaluation of 
biological action of medical products to medical devices: 
https://docs.eaeunion.org/ria/ru -ru/0104121/ri a_20072020  
• Decision No.38 of the Council of the Eurasian Economic Commission of May 16, 
2016 
http://www.eurasiancommission.org/en/act/texnreg/deptexreg/LS1/Documents
/Rules%20for%20Studies%20%28Tests%29%20for%20Evaluation%20of%20Bi
ological%20Action_38.pdf  
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:   
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 
http://www.eurasiancommission.org/en/act/texnreg/deptexreg/LS1/Documents/Rules%
20for%20Studies%20%28Tests%29%20for%20Evaluation%20of%20Biological%20Acti
on_38.pdf  
https://docs.eaeunion.org/ria/ru -ru/0104121/ria_20072020