Is there a transition to the Eurasian Economic Commission (EAEU) unified registration system for devices?

Yes, national registration procedure remains available currently, but from January 1, 2027 registration under the EAEU unified procedure will be required for entering new medical devices to the markets across EAEU countries (unless the transition period is extended further).

What language requirements apply to documents required to be submitted for national registration of medical devices in Kazakhstan?

Translation of almost all of the required documents into Russian is sufficient. Translation into both Russian and Kazakh of the following documents is required only: IFU, description of the package, letter on the type of the medical device, information about the manufacturer, validation reports on software and some original administrative legalized documents.

Are there any exemptions when registration of medical devices is not required in Kazakhstan?

Yes, e.g., custom-made devices for individual patients, devices manufactured only for export, exhibition samples without sale rights.

Is it possible for a medical device already registered in the EU or US to avoid providing the samples for testing within registration procedure in Kazakhstan?

Yes, laboratory studies of samples are not required for national registration of medical devices manufactured at the production sites located in the countries of the European Union and (or) Great Britain, USA, Canada, Japan or Switzerland and approved for circulation by the regulatory authorities of said countries.

What happens if manufacturer change the labeling text, packaging or manufacturing site after approval of registration of medical device in Kazakhstan — do I need to declare such changes?

Yes, any significant change (e.g., packaging, labeling text, manufacturing site) must be reported and may require submission of amendments to the registration dossier to the Authority of Kazakhstan.

Who can act as an Authorized Representative for a foreign medical device manufacturer in Kazakhstan?

Only a local legal entity registered in Kazakhstan can serve as an Authorized Representative of the foreign legal manufacturer. At the discretion of the manufacturer, a distributor, or a representative office, or a third party may act as an authorized representative of the manufacturer. In case of appointment of our company as the authorized representative, it will be possible to have several distributors selling medical devices.

Can a foreign legal manufacturer change its Authorized Representative after approval of registration of medical device?

Yes, the manufacturer may change the Authorized Representative, but an official notification to the Authority and amendment to the Registration Certificate are required to be submitted and approved by the Authority of Kazakhstan.

How long is the validity of Registration Certificate on a medical device in Kazakhstan?

Under national registration procedure in Kazakhstan the Registration Certificate on a medical device is issued for unlimited term.

Registration of medical devices in Kazakhstan

Following recent amendments to the Eurasian Economic Union (EAEU) regulations on registration of medical devices, the transitional period, during which applicants may submit medical device registration dossiers either under the EAEU unified procedure or in accordance with the national legislation of individual member states, has been extended until December 31, 2027.

Choosing the national registration pathway in Kazakhstan also offers several advantages. Notably, applicants are not required to conduct local studies within the EAEU territory that are often both expensive and time-consuming. Instead, existing clinical data from the applicant’s side may be accepted, significantly reducing both the time and cost of the registration process. Upon successful completion of the registration procedure manufacturers are granted Registration Certificates with an unlimited validity period.

State registration of medical devices and equipment in Kazakhstan is regulated by the Ministry of Health of the Republic of Kazakhstan. Only after state registration and inclusion in the state register of the Republic of Kazakhstan medical devices and equipment can be allowed for use.

Registration procedure

In order to carry out the procedure of the state registration, it is necessary to pass the following steps:

1. Conclusion of the Agreement with the Authority and payment of the official invoice for the registration procedure.

2. Submission of the application form, registration dossier and samples of a medical device (if applicable) to the competent authority.

3. Examination of the safety, quality and effectiveness of medical devices that includes:

preliminary expertise;
specialized expertise;
inspection of the manufacturing site* (if required)
laboratory studies of the samples*** (if required).

4. Issuance of a conclusion regarding the safety, quality and effectiveness of a medical device.

5. Payment of the state fee for registration of a medical device or equipment, introducing data to the state register and issuing the Registration Certificate.

* Inspection is not carried out in the following cases:

for medical devices of classes 1 and 2 (non-sterile) of the potential risk;
other medical devices produced at the same manufacturing site have already been registered in Kazakhstan and included into the official state register (subject to the availability of a report on the inspection of the manufacturing site by the Kazakh Authority).

** Exceptions for laboratory studies of the samples:

registration of a medical equipment;
availability of a document from a notified body regarding the full compliance of the production of a medical device and the product quality control system with the requirements of the Directives of the European Commission on medical devices or MDR (Medical Device Regulation);
examination of a medical device manufactured at the production sites located in the countries of the European Union and (or) Great Britain, USA, Canada, Japan or Switzerland and approved for circulation by the regulatory authorities of said countries;
re-registration of a medical device;
accelerated examination of a medical device.

Pay attention

According to Kazakh regulations a foreign manufacturer must have an authorized representative with a registered office in Kazakhstan. Each medical device or equipment may be assigned to only one authorized representative. The authorized representative in Kazakhstan serves as the link between regulatory authorities, consumers, and the manufacturer, ensuring post-marketing supervision. They act based on the Power of Attorney issued by the manufacturer. If you do not have such a representative, we will be pleased to provide said service.

What is required for registration

In order to register a medical device or equipment it is necessary to provide the following to the National Centre for Expertise of Medicines and Medical Devices of the Republic of Kazakhstan:

1) Application form with the legalized Power of Attorney from the manufacturer to the representative in respect of Regulatory Affairs actions;

2) Registration dossier according to the current requirements of the Republic of Kazakhstan;

3) Information confirming the payment by the applicant of the official fee for conducting the expert examination;

4) Samples of a medical device and standard samples (if applicable)* in an amount required for conducting triple tests and with a residual shelf-life of at least six (6) months, complying with storage and transport conditions.

Timeframe

According to the Kazakh legislation, the procedure of the state registration of a medical device or equipment should be conducted not more than 110 working days (approx. 5 months, for medical device requiring laboratory studies) depending on the class of the potential risk of the medical device or 70 working days (approx. 3 months, for medical device or equipment not requiring laboratory studies) without consideration of the time for preparation of responses to the remarks (if any). The term for organization and conducting the inspection of the manufacturing site (if required) is not included in the total period of examination and should not exceed 90 working days (approx. 4 months) after receipt of the notification. However, in accordance with the usual practice, depending on the completeness of the provided materials, and scope of documentation, number of requests of the competent authority and other factors, the procedure of the state registration of a medical device in Kazakhstan lasts within about 4 to 6 months without consideration of the time for preparation of responses to the remarks (if any).

Validity term

The Certificate on the state registration of a medical device or equipment in the Republic of Kazakhstan is valid on the permanent basis.

Frequently asked questions

Is there a transition to the Eurasian Economic Commission (EAEU) unified registration system for devices? +

Yes, national registration procedure remains available currently, but from January 1, 2027 registration under the EAEU unified procedure will be required for entering new medical devices to the markets across EAEU countries (unless the transition period is extended further).
What language requirements apply to documents required to be submitted for national registration of medical devices in Kazakhstan? +

Translation of almost all of the required documents into Russian is sufficient. Translation into both Russian and Kazakh of the following documents is required only: IFU (User Manual), description of the package, letter on the type of the medical device, information about the manufacturer, validation reports on software and some original administrative legalized documents.
Are there any exemptions when registration of medical devices is not required in Kazakhstan? +

Yes, e.g., custom-made devices for individual patients, devices manufactured only for export, exhibition samples without sale rights.
Is it possible for a medical device already registered in the EU or US to avoid providing the samples for testing within registration procedure in Kazakhstan? +

Yes, laboratory studies of samples are not required for national registration of medical devices manufactured at the production sites located in the countries of the European Union and (or) Great Britain, USA, Canada, Japan or Switzerland and approved for circulation by the regulatory authorities of said countries.

What happens if manufacturer change the labeling text, packaging or manufacturing site after approval of registration of medical device in Kazakhstan — do I need to declare such changes? +

Yes, any significant change (e.g., packaging, labeling text, manufacturing site) must be reported and may require submission of amendments to the registration dossier to the Authority of Kazakhstan.
Who can act as an Authorized Representative for a foreign medical device manufacturer in Kazakhstan? +

Only a local legal entity registered in Kazakhstan can serve as an Authorized Representative of the foreign legal manufacturer. At the discretion of the manufacturer, a distributor, or a representative office, or a third party may act as an authorized representative of the manufacturer. In case of appointment of our company as the authorized representative, it will be possible to have several distributors selling medical devices.
Can a foreign legal manufacturer change its Authorized Representative after approval of registration of medical device? +

Yes, the manufacturer may change the Authorized Representative, but an official notification to the Authority and amendment to the Registration Certificate are required to be submitted and approved by the Authority of Kazakhstan.
How long is the validity of Registration Certificate on a medical device in Kazakhstan? +

Under national registration procedure in Kazakhstan the Registration Certificate on a medical device is issued for unlimited term.

For more detailed information, including costs associated with registration of medical devices or equipment in Kazakhstan, list of documents required for submission, etc., please contact our specialists directly.