[Blog] Transforming healthcare: The evolution of medical devices rules in CIS countries (part 1)
In recent years, a remarkable transformation and substantial growth have been witnessed in the pharmaceutical industry of the Commonwealth of Independent States (CIS).
Countries such as Uzbekistan, Kazakhstan, and Kyrgyzstan have made diligent efforts and executed strategic actions to modernize their pharmaceutical sectors.
In 2015, a subgroup of CIS countries, came together to establish the Eurasian Economic Union (EAEU) and subsequently entered into a free trade agreement. The primary objectives behind the formation of this agreement were to foster increased economic cooperation and enhance the quality of life for the member states and their respective populations. Presently, these nations are actively engaged in initiatives aimed at implementing elevated standards and stringent requirements for medical devices, with the ultimate goal of improving healthcare provisions for their respective citizenries.
However, each of them has its own rules for these devices and does things differently in healthcare. Understanding the intricate web of regulatory requirements in this diverse and evolving region becomes imperative for manufacturers, healthcare professionals, and stakeholders alike.
Knowing and following these rules is crucial for people and companies who want to help improve healthcare in these countries while making sure medical devices are safe and work well.
In this article we will explain the evolution of the medical devices rules in Uzbekistan, Kazakhstan, and Kyrgyzstan.
The regulatory authority in Kazakhstan is the National Centre for Medicines, Medical Devices, and Medical Equipment Expertise.
In August 2022, the Eurasian Commission proposed an extension of the transition period, pushing the shift from national regulatory frameworks to Eurasian Union regulation enforcement to January 2026.
The Kazakh government introduced a draft decree aiming to achieve full serialization by 2025. By July 1, 2025, over-the-counter drugs and medical devices must be traceable and labelled.
Moreover, foreign manufacturers are required to designate a legal entity within Kazakhstan through a legalized Power of Attorney. This representative oversees their interests and ensures the safety, quality, and effectiveness of medical devices in Kazakhstan.
It is important to know that Kazakhstan employs a classification system for Medical Devices and IVDs, categorizing them into Classes 1, 2a, 2b, and 3.
The regulatory authority responsible for overseeing medical devices in Kyrgyzstan is the Department of Pharmaceutical Supply and Medical Equipment, which operates under the Ministry of Health of the Kyrgyz Republic.
In August 2022, the Eurasian Commission proposed an extension to the transition period to switch from the national regulatory frameworks to the Eurasian Union regulation enforcement. The implementation of the EAEU unified procedure is extended to January 2026.
Authorized representation is required, and medical devices are classified into risk-based categories of Classes I, IIa, IIb, and III.
Uzbekistan’s Cabinet of Ministers introduced Resolution No. 149 on April 2, 2022, establishing mandatory digital labelling for medicines and medical devices. The resolution outlines specific deadlines:
- Medicines and medical devices for orphan diseases must have mandatory labelling starting from March 1, 2023.
- Medical devices listed by the Ministry of Health will commence labelling from February 1, 2025.
This labelling process involves participants in the distribution of these products. They are responsible for independently labelling medicines and medical devices and reporting the use of digital identification tools to the NIS MPT. The digital labelling process includes the application of digital identification tools directly to the production line before storage, ensuring they cannot be separated from consumer packaging during the product’s entire shelf life. These codes adhere to ISO/IEC 16022-2008 standards.
In the upcoming article, we will pay attention to medical devices rules changes within the countries – Belarus, Ukraine and Russia.