Registration of medical devices in Kazakhstan-bg

Registration of medical devices in Kazakhstan

The healthcare expenses in Kazakhstan are equal to 3,7% of the GDP, which is lower than average in countries with the same level of economic and social development. Nevertheless, over the last few years, budgets for the healthcare sector have been increased and the government has the mission to achieve a level of 5%-GDP-expenses by 2025.

Being a member of the EAEU since 2015, Kazakhstan has always had quite a difficult national registration procedure. 

The registration of medical devices is carried out mostly by 2 authorized bodies under the Ministry of Health: 

The National Center of Expertise for PP and MD (carries out the first stage of the registration procedure)

The Committee for Medical and Pharmaceutical Control (carries out the second stage of the registration procedure)

At the first stage, you will need to prepare the registration dossier, receive approval to import the samples, and submit everything to the Center at once. Depending on the risk class, you will receive the results of expertise in 90-160 days. The expertise is followed by the inspection of a production site, which takes up to 120 extra days. This procedure is harmonized with the EAEU regulations and applicable to all medical devices of 2a, 2b and 3 risk classes in case neither MD nor manufacturer’s production site were previously registered in Kazakhstan. 

At the second stage, you are required to submit all the positive results and approvals from the Center to the Committee, pay the registration and within 5 days, you will get the national registration certificate which has no expiry date.

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