Medical device registration in Kazakhstan. With RedMed
- Obtaining a permanent Medical devices registration in Kazakhstan
- Updating existing Kazakhstani Registrations with new items
- An Authorized Representative in Kazakhstan service
- Business & State Procurement options consultancy
- Trademark registration within State Registry
- Selling your devices via leasing scheme thru a dedicated enterprise
The market
Foreign devices hold a 90% share in the state registry. The leading import partners are Russia, Belarus, China, Germany, India.
The system of compulsory medical insurance has been in effect since January 1, 2020. Due to its implementation, the state procurement for the healthcare sector has increased by more than 2 times. The state medical procurements in 2024 in Kazakhstan exceed 2.5 trillion tenge ($5.34 B).
A significant increase in the financing of health care at the expense of compulsory medical insurance has made it possible to improve the availability of medical care. Manufacturers and distributors of medical devices can participate in state procurements after the registration for the devices obtained.
Contact us
for more information via chat down the page, or by hello@red-med.ru
Registration process in brief:
1. Dossier creation:
techfile, IfU, risk management file
2. Payment of state fee for trials
in Regulator
3. Manufacturing
site audit
(for 1st-timers only)
4. Regulator issues
permanent
e-certificate
The state registration for medical devices in Kazakhstan conducted by National pharma and medical devices expertize center. The regulator`s website is www.ndda.kz.
We adhere to the following laws of the Republic of Kazakhstan in the regulation of medical devices:
- Order of the Minister of Health of the Republic of Kazakhstan No. ҚР ДСМ-16, dated 09.02.21 Approves the rules for state registration, re-registration (for Kazakhstan-made devices), and making changes to the registration dossier of a medicinal product or medical device.
- Rules for the Registration and Examination of the Safety, Quality, and Effectiveness of Medical Devices within the Eurasian Economic Union (EAEU). It establishes the procedure for conducting registration and examination of medical devices within the EAEU framework. National registration of medical devices has been extended until Dec. 31, 2025, allowing devices registered under national legislation to be marketed in Kazakhstan without re-registration under the EAEU Rules after January 1, 2026.
- Order of the Minister of Health of the Republic of Kazakhstan No. ҚР ДСМ-11, dated 27.01.21. Approves the rules for labeling and traceability of medicinal products and medical devices.
Frequently Asked Questions about the medical devices registration in Kazakhstan
Q: Do I need a local Authorized Representative (AR) to complete the registration?
A: Yes, a sole locally-established AR required to bear all regulatory responsibilities while the device is on the market. This entity will be stated in the Registration Certificate and will provide feedback to the Regulator`s requests. We offer Authorized Representative services in Kazakhstan for all clients.
Q: Is a manufacturing site inspection required during registration?
A: Currently, first-time market entrants are required to undergo a manufacturing site inspection. The Regulator sets the maximum price for the inspection, which is $7,000.
Q: How much time does the registration take, from A to Z?
A: All of works can fit in 4-6 months including dossier compilation and the regulatory reviewing.
Q: Is there any kind of express registration, for an FDA, UK, EU, Japan, Korea - registered devices?
A: So far, only regular registration process exists in Kazakhstani legislation.
Q: What is the samples import policy for trials?
A: If you hold a CE Full Quality Assurance certificate, or your device is AC-powered, then no samples are required for the Regulator`s review. However, all of "class 2b sterile", "class 3" devices will be requested in the absence of EC FQA. The samples then will be returned to the Authorized Representative.
Q: How long does it take to get an update to the existing Registration?
A: It usually takes 1 to 3 months for a full application of updates to existing certificate.
Q: What are the state fees for the registration like?
A: The fees consist of the Regulator review fee ($200 to $1200 per device + 25% for each modification), and the Registration fee (up to $90). The updates fee is $0, yet the Regulator review fees apply. For the full fee calculation please contact us today.
Q: If we obtain registration before January 1, 2026, will it remain valid after this date when the EAEU regulations come into force? Will this registration be valid across the entire EAEU?
A: According to the ruling of the EAEU Council, all national registrations will remain valid indefinitely in their respective countries. If you obtain registration in Kazakhstan before Dec., 31, 2025, it will remain valid permanently after January 1, 2026, but only within Kazakhstan. Registration certificates issued in any EAEU member state before January 1, 2026, will not allow the sale of medical devices in other member states. The EAEU members are: Russia, Kyrgyzstan, Belarus, Armenia, Kazakhstan.
Q: Should we wait until January 1, 2026, to obtain registration for medical devices across the entire EAEU? It sounds like a lucrative option.
A: The decision is yours. Currently, the cost of medical device registration in Kazakhstan typically falls within a $10,000–12,000 budget. In contrast, EAEU registration involves mandatory technical and toxicity testing, clinical trials, and approvals in each member state. Additionally, the state registration fee will be higher. Current 4-6 months for the registration will be 1,5-2 years with EAEU. Be prepared to spend approximately four times the cost of local Kazakhstani registration.
Q: What else should I know about the registration of medical devices in Kazakhstan?
A: The Regulator issues only e-certificates, no printed versions granted or distributed. Validity of the registration checked on the Regulator`s website. Please check here: http://register.ndda.kz/category/search_prep
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