G/TBT/N/RUS/183

3 June 2026

(26-4089)

Committee on Technical Barriers to Trade

Original: English

1.

Notifying Member: RUSSIAN FEDERATION

If applicable, name of local government involved (Articles 3.2 and 7.2):

2.

Agency responsible:

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

Website: www.gostinfo.ru

3.

Notified under Article 2.9.2 [X], 2.10.1 [ ], 5.6.2 [X], 5.7.1 [ ], 3.2 [ ], 7.2 [ ], Other:

4.

Products covered (HS codes or national tariff lines. ICS numbers may be provided in addition, where applicable): Cotton wool, gauze, bandages and similar articles (for example, bandages, Band-Aids, poultices), im pregnated or coated with pharmaceutical substances or packaged in forms or packages for retail sale, intended for use in medicine, surgery, dentistry or veterinary medicine (HS 3005);

Devices and instruments used in medicine, surgery, dentistry or veterinary m edicine, including scintigraphic equipment, other electro-medical equipment and vision testers (HS 9018);

Equipment based on the use of X-ray, alpha, beta or gamma radiation, intended or not intended for medical, surgical, dental or veterinary use, including X-ray 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 or treatment (HS 9022);

Medical, surgical, dental or veterinary furniture (for example, operating tables, examination tables, hospital beds with mechanical devices, dental chairs); barber chairs and similar chairs with devices for rotating and simultaneously for tilting and lifting; parts of the above-mentioned products (HS Code 9402).

5.

Details of notified document(s) (title, number of pages and languages, means of access): Draft amendments to the Rules for registration and examination of safety, quality and effectiveness of medical devices; (2 page(s), in Russian)

Link to notified document(s) and/or contact details for agency or authority which can provide copies upon request:

6.

Description of content: The draft amendments to the Rules for registration and examination of safety, quality and effectiveness of medical devices provides for the possibility of suspending the validity of the marketing authorization in the event that there is no valid report on the results of inspection in the marketing authorization application of a medical device in order to prevent the release into circulation of a poor quality medical product.

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://regulation.eaeunion.org/orv/3481/

Decision of the Council of the Eurasian Economic Commission No. 46 of February 12, 2016

https://eec.eaeunion.org/en/comission/department/deptexreg/ls1/MD_acts.php

9.

Proposed date of adoption: To be determined

Proposed date of entry into force: To be determined

10.

Provision of comments

Final date for comments: Not Applicable

[ ] 60 days from notification

Contact details of agency or authority designated to handle comments regarding the notification: