Labeling and control: The Ministry of Health presented a pilot project for traceability of medical devices.
The Ministry of Health has prepared a draft order to conduct a pilot project on labeling and traceability of medical products registered in the Republic of Kazakhstan.
The project provides for the introduction of a new mechanism for monitoring the circulation of medical devices (MD) registered in the Republic of Kazakhstan.
The proposed approach will ensure transparency in the movement of medical products at all stages – from the manufacturer and supplier to medical organizations and the end consumer, the ministry explained.
The main objective of the pilot project is to create additional tools to confirm the quality, safety, and effectiveness of medical devices used in the healthcare system.
The document defines specific types of medical devices that will be included in the monitoring system. The selection was based on the classification of the Commodity Nomenclature of Foreign Economic Activity (CN VED), taking into account international experience and the requirements of the supranational legislation of the Eurasian Economic Union.
The implementation of the project is expected to have a positive impact on the development of the pharmaceutical and medical market.
Implementation of monitoring will allow:
increase transparency in the circulation of medical products; promptly identify low-quality, counterfeit or adulterated products on the market; to strengthen the efficiency of the work of the pharmaceutical inspectorate and authorized bodies. Furthermore, monitoring data will be used as a tool for further analytical and control work. Deviations identified at specific stages of medical device circulation will serve as the basis for additional audits, checks, and inspections within the framework of current legislation.
In the long term, the implementation of the system will lead to a reduction in costs associated with the circulation of defective products, and will also improve the efficiency of monitoring and managing medical device inventories, the Ministry believes.
The project is open for public discussion on the Open NPA portal until April 3, 2026, at the link: https://legalacts.egov.kz/npa/view?id=15787611