On Ratification of the Protocol on Amendments to the Agreement on Common Principles and Rules for the Circulation of Medical Devices (Medical Devices and Medical Equipment) within the Framework of the Eurasian Economic Union dated December 23, 2014

Home / RLA / On Ratification of the Protocol on Amendments to the Agreement on Common Principles and Rules for the Circulation of Medical Devices (Medical Devices and Medical Equipment) within the Framework of the Eurasian Economic Union dated December 23, 2014

On Ratification of the Protocol on Amendments to the Agreement on Common Principles and Rules for the Circulation of Medical Devices (Medical Devices and Medical Equipment) within the Framework of the Eurasian Economic Union dated December 23, 2014

The Law of the Republic of Kazakhstan dated February 6, 2023 No. 191-VII SAM.

To ratify the Protocol on Amendments to the Agreement on Common Principles and Rules for the Circulation of Medical Devices (Medical Devices and Medical Equipment) within the Framework of the Eurasian Economic Union dated December 23, 2014, signed in Moscow on December 30, 2021.

President

Republic of Kazakhstan

K. TOKAEV

protocol on amendments to the Agreement on Common Principles and Rules for the Circulation of Medical Devices (Medical Devices and Medical Equipment) within the Framework of the Eurasian Economic Union dated December 23, 2014

The Member States of the Eurasian Economic Union, hereinafter referred to as the Member States,

based on the Treaty on the Eurasian Economic Union of May 29, 2014,

have agreed on the following:

Article 1

Amend article 11 of the Agreement on Common Principles and Rules for the Circulation of Medical Devices (Medical Devices and Medical Equipment) within the Framework of the Eurasian Economic Union dated December 23, 2014, stating it as follows:

"Article 11 Transitional period

Until December 31, 2021, an application for examination or registration of a medical device may be submitted in accordance with the procedure provided for by the legislation of the Member State. If an application for examination or registration of a medical device is submitted in accordance with the procedure provided for by the legislation of a Member State before December 31, 2021, registration of a medical device may be carried out in accordance with the procedure provided for by the legislation of the Member State.

A medical device registered in accordance with the procedure provided for by the legislation of a Member State is put into circulation in the territory of that Member State before the expiration of the validity period of the documents confirming its registration, and is circulated only in the territory of that Member State.

A medical device registered in accordance with the procedure provided for by the legislation of a Member State (with the exception of a medical device for which an indefinite document confirming registration has been issued) may be re-registered (a document confirming registration has been reissued) in accordance with the procedure provided for by the legislation of a Member State, if the relevant application is submitted before December 31, 2026.

It is allowed to make changes to the registration documents of a medical device registered in accordance with the procedure provided for by the legislation of a member state (with the exception of changes requiring new registration in accordance with the procedure provided for in paragraph 2 of Article 4 of this Agreement), if the Relevant application is submitted before December 31, 2026."

Article 2

This Protocol shall be applied temporarily by the Member States from January 1, 2022, and for a Member State whose legislation does not provide for the possibility of temporary application of international treaties, this Protocol shall apply from the date on which such Member State completes the internal procedures necessary for the entry into force of this Protocol, but not earlier than January 1, 2022.

This Protocol shall enter into force on the date of receipt by the depositary, through diplomatic channels, of the last written notification on the completion by the Member States of the internal procedures necessary for the entry into force of this Protocol.

Done in Moscow on December 30, 2021, in one original copy in the Russian language.

The original copy of this Protocol shall be kept in the Eurasian Economic Commission, which, as the depositary of this Protocol, will send a certified copy to each Member State.

For the Republic

Armenia

For the Republic

Belarus

For the Republic of Kazakhstan

For the Kyrgyz Republic

For the Russian Federation

I hereby certify that this text is a complete and authentic copy of the Protocol on Amendments to the Agreement on Common Principles and Rules for the Circulation of Medical Devices (Medical Devices and Medical Equipment) within the Framework of the Eurasian Economic Union dated December 23, 2014, signed on December 30, 2021 in Moscow.:

for the Republic of Armenia - Deputy Prime Minister of the Republic of Armenia Mikhail Grigoryan;

for the Republic of Belarus - Minister of Health of the Republic of Belarus D. L. Pinevich;

for the Republic of Kazakhstan - First Deputy Prime Minister of the Republic of Kazakhstan - A. A. Smailov;

for the Kyrgyz Republic - First Deputy Chairman of the Cabinet of Ministers of the Kyrgyz Republic A. O. Kozhoshev;

for the Russian Federation - Deputy Chairman of the Government of the Russian Federation - A. L. Overchuk.

The original copy is kept at the Eurasian Economic Commission.

Director

Legal Department

Eurasian Economic Commission

commissions

V. I. Taraskin

President

Republic of Kazakhstan

Constitution Law Code Standard Decree Order Decision Resolution Lawyer Almaty Lawyer Legal service Legal advice Civil Criminal Administrative cases Disputes Defense Arbitration Law Company Kazakhstan Law Firm Court Cases