G/TBT/N/RUS/134  
23 June  2022 
(22-4865) 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:   
Eurasiah 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/en -us 
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 a nd 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 u nder Article 2.9.2 [X], 2.10.1 [  ], 5.6.2 [X], 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 products (bandages, adhesive plasters, poultices) 
impregnated or coated with pharmaceutical substances or packaged in molds or packages 
for retail sale for medical, surgical, dental or veterinary purposes (HS 3005); Devices and 
devices  used in medicine, surgery, dentistry or veterinary medicine, including 
scintigraphic devices, other electromedical devices and vision testing devices (HS 9018); 
X-ray, alpha -, beta -, gamma -emitting devices; intended or not intended for medical, 
surgical, dental or veterinary use, including radiographic or radiotherapy equipment, X -
ray tubes and other X -ray generators, high voltage generators, shields and control panels, 
screens, tables, chairs and similar products for examination and treatment (HS 9022); 
Medical, surgical, dental or veterinary furniture (for example, operating tables, 
examination tables, hospital beds with mechanical devices, dental chairs) hairdressing 
chairs and similar chairs with devices for rotation and simultaneously for tilting and l ifting; 
parts of the above -mentioned products (HS 9402).  
5. Title, number of pages and language(s) of the notified document:  Draft 
amendments to the Rules for conducting clinical and clinical laboratory tests of medical 
devices; (75 page(s), in Russian)  G/TBT/N/RUS/134  
 
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  6. Description of content:  The draft amendments to the Rules for conducting clinical and 
clinical laboratory tests (studies) of medical devices apply to medical products put into 
circulation on the territory of the Eurasian Economic Union and envisage the following:  
clarification of the concepts;  
clarification of the conditions for obtaining clinical data for software that is a medical 
device;  
clarification of the conditions of comparability of medical devices when considering clinical 
data;  
clarification of the procedure for obtaining a permit for testing;  
clarification of test requirements;  
clarification of the grounds for excluding medical organizations from the unified register 
of authorized organizations authorized to conduct research (te sting) of medical devices 
for the purpose of their registration;  
definition of requirements for the technical file of the software that is a medical device; 
clarification of the form of test reports.  
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 clinical and clinical -laboratory tests 
of medical devices: https://docs.eaeunion.org/ria/ru -ru/0104092/ria_09072020  
• Decision No.29 of the Council of the Eurasian Economic Commission of February 
12, 2016: https://docs.eaeunion.org/ria/ru -ru/0105401/ria_08062022  
9. Proposed date of adoption:  To be determined  
Proposed date of entry into force:  To be determined  
10. Final date for comments:  18 September 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-mail: dept_techregulation@eecommission.org  
Web-site: www.eurasiancommission.org ,  
https://docs .eaeunion.org/en -us 
https://docs.eaeunion.org/ria/ru -ru/0104092/ria_09072020  
https://docs.eaeunion.org/ria/ru -ru/0105401/ria%2008062022