G/TBT/N/RUS/135  
11 July 2022  
(22-5310) 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   
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:   
Russian Scientific and Technical Center for Information  
on Standardization, Metrology and Conformity Assessment (Standartinform, National 
enquiry point for the TBT Agreement)  
Tel: +7(495) 531 -26-59 
E-mail: info@gostinfo.ru  
Web-site: www.gostinfo.ru   
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 similar articles (for example, dressings, adhesive plasters, 
poultices), impregnated or coated with pharmaceutica l substances or put up in forms or 
packings for retail sale for medical, surgical, dental or veterinary purposes. (HS code(s): 
3005); Instruments and appliances used in medical, surgical, dental or veterinary 
sciences, including scintigraphic apparatus, ot her electro -medical apparatus and sight -
testing instruments. (HS code(s): 9018); Apparatus based on the use of X -rays or of 
alpha, beta or gamma radiations, whether or not for medical, surgical, dental or veterinary 
uses, including radiography or radiother apy apparatus, X -ray tubes and other X -ray 
generators, high tension generators, control panels and desks, screens, examination or 
treatment tables, chairs and the like. (HS code(s): 9022); Medical, surgical, dental or 
veterinary furniture (for example, ope rating tables, examination tables, hospital beds with 
mechanical fittings, dentists' chairs); barbers' chairs and similar chairs, having rotating 
as well as both reclining and elevating movements; parts of the foregoing articles. (HS 
code(s): 9402)  
5. Title, number of pages and language(s) of the notified document:  Draft 
amendments to the Rules of classification of medical devices depending on the potential 
risk of use; (39 page(s), in Russian)  G/TBT/N/RUS/135  
 
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  6. Description of content:  The Draft amendments to the Rules of classification of medical 
devices depending on the potential risk of use apply to medical devices and provide for 
the following:  clarification of the concepts; clarification of classification criteria for medical 
devices for in vitro diagnostics; establ ishment of criteria and conditions for the 
classification of software that is a medical device; clarification of classification of medical 
devices.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Consumer information, labelling; Protection of human health or safety  
8. Relevant documents:   
• Draft amendments to the Rules of classification of medical devices depending on 
the potential risk of use https://docs.eaeunion.org/ria/ru -
ru/0105470/ria_29062022  
• Decision № 173 of th e Board of the Eurasian Economic Commission of December 
22, 2015 https://docs.eaeunion.org/docs/ru -ru/0149288/clcd_30122015_173  
9. Proposed date of adoption:  To be determined  
Proposed date of entry into force:  To be determined  
10. Final date for comments:  4 October 2022  
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-maii: dept_techregulation@eecommission.org  
Web-site: www.eurasiancommission.org