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 Intellectual Property 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 US, Korea and Turkey.
The system of compulsory medical insurance has been in effect since January 1, 2020. Due to its implementation, the state hospitals increased procurement volumes by more than 2 times since 2020. The healthcare funding in 2025 in Kazakhstan exceed 2.5 trillion tenge ($5.34 B).
Private clinics and hospitals keep buying imported medical devices substantially, the amount spent exceeds $0,5B.
A demand for innovative medical devices, IVD and SaMD in Kazakhstan has never been higher than now.
Contact us
for more information via chat down the page, or by hello@red-med.ru
Registration process in brief:
1. We create techfile, risk management file, markings, IFU in Kazakh and Russian
2. State fees for registration and testing payable to the Regulator
3. Mandatory QMS audit for 1st-timers. Skipped for class 1, 2a NS & CE holders
4. Regulator issues
permanent
e-certificate within
90 days maximum
Validity: permanent
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, 2027, allowing devices registered under national legislation to be marketed in Kazakhstan without re-registration under the EAEU Rules after January 1, 2028.
- 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.
- Order of the Acting Minister of Health of the Republic of Kazakhstan No.ҚР ДСМ-7, dated 20.01.2021 Enacts State fees for the registration, update of the registration dossier of medical devices and its modifications - the main instrument in counting the state fee for our customers.
Once obtained, the Registration certificate is valid permanently.
The manufacturer, acting thru a local Authorised representative, is able to amend, update the Registration: adding manufacturing sites or updating its addresses; adding new items` sizes, new models, updating colors, names of the devices; changing AR, packaging variants.
Ask us for more info on this service.
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 and end customers` requests. We offer Authorized Representative services in Kazakhstan for all clients.
Q: Who is a Holder of the Registration Certificate in Kazakhstan?
A: The Manufacturer remains a holder, a 'manager' of the Registration in Kazakhstan - yet there is a legal requirement to appoint The Authorized entity for monitoring adverse events on the territory of the Republic of Kazakhstan, and The Authorized representative (AR) of the manufacturer to perform post-marketing activities, as well as to be mentioned in IfU and markings. We are experienced in performing these kinds of services and good to be you representatives in Kazakhstan. This role doesn`t involve any commercial activities` participation and doesn`t affect the manufacturer`s agreements with distributors.
Q: Is a manufacturing site inspection required during registration?
A: Yes, a QMS inspection of the manufacturing site is mandatory for most risk classes, regardless of whether the registration follows a fast-track or a standard pathway.
This requirement applies to all manufacturers entering the Kazakhstani market for the 1st time with devices of the respective risk class.
A QMS inspection is mandatory for:
- Class IIa sterile devices
- Class IIb devices
- Class III devices
A QMS inspection is not required when registering:
- Class I devices
- Class IIa non-sterile, non-measuring devices
However, on-site travel for the inspection may be waived at the regulator’s discretion and replaced by a remote (electronic/tele-inspection) format - a rare occasion, though.
The Regulator sets a maximum inspection fee (currently up to USD 7,000 per site) + travel expenses due. These sums are paid in advance.
The inspection report is valid for 3 years, after which re-inspection is required.
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: This kind of simplified (not exactly express one) expertise exists, and can be applied to devices holding recognized foreign approvals, such as:
- CE by NB certificates (Class Is / Im / Ir, IIa+), and/or
- Marketing authorization from EMA, FDA, Australia, Japan, Korea or Switzerland (this is a closed list - we regret to inform that no other certificates accepted).
Laboratory examination is mandatory for such devices. Physico-chemical, technical properties and, if necessary, microbiological parameters are checked as well, and within the Regulator. Specific laboratory fees apply, in addition to a device-specific registration fee.
Your Clinical evaluation report can be accepted as a substitute for local clinical trials. Other tests reports, obtained in another countries, will be added to the dossier, yet won`t affect decision on the registration speed much.
At the same time:
- CE Class I (self-declared)
- FDA Class I (registration and listing only)
do not qualify for fast-track registration and do not exempt the device from local testing.
Q: What is the samples import policy for trials?
A: If you hold a CE Full Quality Assurance certificate, or your device is powered from electricity (AC, battery), 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. If your devices do not hold a CE FQA, the samples will be required (2 items at least).
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. Specific state fees apply - please consult with our team member for exact budget and documents set.
Q: What are the state fees for the registration like?
A: Kazakhstan`s Regulator publishes a catalogue of state fees, from which we derive exact fee. There is no dependency on the risk class, rather on complexity and number of items - ask us today for exact amount, we are here to help. In addition, a specific flat state fee for the registration initiation applies.
Q: If we obtain registration before January 1, 2028, 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. National-level registration certificates issued in any EAEU member state before January 1, 2027, will not allow the sale of medical devices in another member state (as it currently is). The EAEU members are: Russia, Kyrgyzstan, Belarus, Armenia, Kazakhstan.
Q: Should we wait until January 1, 2028, to obtain registration for medical devices across the entire EAEU? It sounds like a lucrative option, to invest into a 5-countries certificate at once.
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, QMS Inspection and approvals in each member state. Additionally, the state registration fee is higher. Current 4-6 months for the registration will be 1,5-2 years with EAEU - as well you can`t launch marketing activities without the Regulatory approval in hand.
We always recommend our customers to follow national pathways in each of 5 members of the EAEU: Russia, Armenia, Kyrgyzstan, Belarus and Kazakhstan. This helps to save budgets and save months of waiting, as well allows to start sales faster.
Q: What else should I know about the registration of medical devices in Kazakhstan?
A: The Regulator to issue e-certificates, with no printed versions granted or distributed. Validity of the registration checked on the Regulator`s website: https://register.ndda.kz/#/reestr
hello@red-med.ru
red-med.ru
