DECISION OF BOARD OF THE EURASIAN ECONOMIC COMMISSION

of February 18, 2025 No. 18

About modification of Rules of classification of medical products depending on potential risk of application

According to item 4 of article 4 of the Agreement on the single principles and rules of the address of medical products (products of medical appointment and medical equipment) within the Eurasian Economic Union of December 23, 2014 and Item 23 of appendix No. 2 to the Regulations of work of the Eurasian economic commission approved by the Decision of the Supreme Eurasian economic council of December 23, 2014 No. 98, Board of the Eurasian economic commission SOLVED:

1. In Rules of classification of the medical products depending on potential risk of application approved by the Decision of Board of the Eurasian economic commission of December 22, 2015 No. 173:

a) add Item 19 with words "(except for napkins of hands of medical personnel, operational and injection fields, antiseptic for processing, which belong to the class 2a)";

b) in line item 42 appendices No. 1 to the specified Rules in column 3 of the word "especially for providing" to replace with the word "for".

2. Determine that changes, the stipulated in Item 1 this Decision, do not extend to the legal relationship connected with registration of medical products if statements for holding procedures of registration and examination, modification of the registration file (including in notifying procedure) or about carrying out approval of the expert opinion on the registered medical product were submitted by the applicant before the date of entry into force of this Decision.

3. This Decision shall enter into force upon the expiry of 30 calendar days from the date of its official publication.

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