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Kazakhstan Medical Device Registration

Kazakhstan Medical Device Regulations

Definitive Guide to Medical Device Registration in Kazakhstan: NDDA, Regulations, and Market Dynamics

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:

  1. State registration within the frame of the national registration procedure conducted according to the local legislation of each country of registration.
  2. State registration within the frame of the procedure conducted according to the regulations of the EAEU.

Classification: Class I, IIa, IIb and III

Listing or Registration Requirements:

  • To register a device, submit the registration documents in electronic format (including the registration fee payment receipt), translated into Russian, at the National Center for the Expertise of Drugs and Medical Devices which will review the documentation. The latter will carry out a detailed examination through a primary, analytical analysis (only for some devices) and a special analysis of the documentation and sample of the device submitted.
  • An inspection is planned by the Regulatory Authority to the manufacturer in case of device first placing on the market and devices requiring special installation and maintenance conditions (MRI, X-Ray).
  • In case of a successful outcome, a registration certificate will be issued and within ten days the approved instructions for use of the device and medical equipment in Russian and national language will be delivered, as well as approved packaging and labelling design.
  • Registered medical devices are posted on the National Center for Expertise of Drugs and Medical Devices web page.

Documents Required for Registration:

  • On-Site Audit: The manufacturing site inspection is required only for the registration of sterile class IIa, IIb, and III medical devices whose manufacturer has never been registered before in Kazakhstan or devices that require special maintenance and installation such as MRI and X-Ray machines. Class I and IIa non-sterile medical devices are exempted from this stage.
  • Local Tests/Permit: In-country local testing is required for all types of devices which include technical, biological, and measuring device testing.
  • Clinical Evaluation or Studies: Clinical studies are required for any type of medical device except Class 1 IVDs. The decision to conduct clinical studies is based on the recommendation of the expert organization.

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:

  • Medical Device – 5 Years
  • Medical Equipment – 7 years

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:

  • Manufacturer
  • Authorised Representative

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

  • Act as your Authorised representative

Why Choose Us

  • Working towards client satisfaction
  • Cost effective solutions
  • Project completion before deadline
  • Quality Regulatory affairs solutions

Contact us for free consultation: [email protected]

 

 

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