Amendments to the regulations on registration of medical devices in Kazakhstan that significantly reduce expenses for regulatory procedures

In accordance with the Order of the Minister of Health of the Republic of Kazakhstan No. 83, dated August 25, 2025, coming into force on September 9, 2025, amendments have been introduced to the rules for conducting the examination of medicinal products and medical devices.

The main change concerns the cancellation of the mandatory requirement to compile and submit the full set of documents for regulatory procedures related to registration of medical devices with translation into both Russian and Kazakh. This measure is expected to reduce financial and time-related costs for entering to the market of Kazakhstan.

More detailed information regarding the registration procedure on medical devices in Kazakhstan is available via the link here

For more detailed information on associated costs, lists of required documents, etc. please contact our specialists from the Regulatory Affairs Department.