Updated on 26/01/24
Regulatory Authority: National Centre for Medicines, Medical Devices, and Medical Equipment Expertise
The Republic of Kazakhstan’s Republican State Enterprise of the Medical and Pharmaceutical Control Committee is a state-level organization that focuses on the circulation of medicinal products and medical products. Established in 1997, it has a vertical structure with accredited testing laboratories and a European quality directorate. Its main functions include examining medicines, conducting preclinical research, conducting bioequivalence tests, providing information, and consulting services, translating pharmaceutical and medical terminology, analyzing, and assessing pharmaceutical product registration documents, implementing production conditions and quality assurance systems, and supplying medicinal preparations to pharmacies.
The organization is a full member of the US Pharmacopoeia Convention, an official observer of the European Pharmacopoeia Commission, and a member of the WHO international program for drug side effects monitoring.
Link for Regulatory Authority: https://www.ndda.kz/
Local Regulations: Kazakhstan is a member state of the Eurasian Economic Union (the EAEU) and according to the current legislation, until December 31, 2025, two possible ways of state registration of medical devices in the member states of the Eurasian Economic Union (Russia, Belarus, Kazakhstan, Kyrgyzstan, and Armenia) may be used, namely:
Classification: Class I, IIa, IIb and III
Listing or Registration Requirements:
Documents Required for Registration:
Registration Timeline: Registration time frames vary from 4 months for Class I devices to 10 months for Class III devices
Registration Fee: According to Resolution No. 771/2015, the evaluation and/or registration fees vary depending on the authority (from a minimum of 48,000 KZT per unit until 577,000 KZT for complex capital equipment). This is determined right upon the medical device’s online submission
License Validity:
License Renewal: Before 6 months at least
Language Requirements: All documents must be in Russian, IFU must be both in Russian and Kazak
Who should make this communication:
When to make this communication: Before placing a medical device into the Saudi Arabia market.
Additional Information:
In August 2022, the Eurasian Commission suggested prolonging the transition period for the shift from national regulatory frameworks to the enforcement of Eurasian Union regulations:
The adoption of the unified EAEU procedure has been extended until January 2026.
As of now, Kazakhstan has formally endorsed the protocol, allowing submissions under the national procedure until December 31, 2025.
How OMC Medical can assist you with the process
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Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
To launch a medical device in a country, medical devices must comply with the local country’s regulatory requirements. Let us be your trusted partner in bringing your medical devices to the Global market. Contact us today to learn more about how we can assist you in every step of the way.