Registration of Medicinal Products and Devices under National Rules - FCHAIN

Registration of Medicinal Products and Devices under National Rules

The Ministry of Health of the Republic of Kazakhstan has submitted for public discussion a draft Resolution “On the Draft Law of the Republic of Kazakhstan ‘On the Ratification of the Protocol on Amendments to the Agreement on Uniform Principles and Rules for Circulation of Medical Devices within the Eurasian Economic Union dated December 23, 2014.’”

The document provides for the extension of the transition period from national registration rules for medical devices to the unified rules of the Eurasian Economic Union (EAEU).

 

What Changes Are Proposed

The draft Law proposes to:

• extend the deadline for submitting applications under the national procedure for examination and registration of medical devices until December 31, 2027;
• extend the deadline for re-registration of medical devices until December 31, 2028;
• set the deadline for submitting applications for amendments to registration documents until December 31, 2028.

Thus, manufacturers, importers, and distributors will retain the opportunity to operate under the national regulatory framework for several more years.

 

Why the Transition Period Is Being Extended

The extension aims to ensure the stability of the domestic medical device market and prevent supply disruptions.

The transition to the unified EAEU rules requires significant business adaptation — from revising technical documentation to undergoing conformity assessment procedures under new regulatory requirements.

The additional time will allow:

• healthcare organizations to ensure uninterrupted supply;
• suppliers to systematically prepare for EAEU requirements;
• manufacturers to develop registration strategies aligned with the new regulatory environment.

 

What This Means for Market Participants

Extending the transition period reduces short-term regulatory risks and allows market participants to:

• optimize their portfolio of registration certificates;
• determine priorities for transitioning to EAEU procedures;
• distribute financial and administrative workload;
• minimize risks of product circulation suspension.

At the same time, postponing the transition does not eliminate the need for strategic preparation for the full implementation of unified EAEU medical device circulation rules.

 

Public Discussion

The public discussion of the draft will continue until February 25, 2026. Comments and suggestions can be submitted through the “Open NPAs” portal.

 

FChain – Expert Support for the Pharmaceutical Industry

FChain provides professional legal and accounting support to pharmaceutical companies, helping them build secure and sustainable operating models in a complex and constantly evolving regulatory environment. We advise on legislative matters and support businesses in accounting, tax, and HR administration, ensuring protection of their interests and mitigation of legal and tax risks.

Our comprehensive approach enables companies to minimize regulatory risks and maintain business stability amid ongoing legislative changes.

 

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