Regulatory Documentation for Medical Devices in Kazakhstan

A medical device is intended by the manufacturer for diagnosis, prevention or treatment of disease, as well as for patient rehabilitation.

Article 1 of the Code of the Republic of Kazakhstan dated 7 July 2020 No. 360-V “On Public Health and Healthcare System” states:

Subparagraph 161) — medical devices (MD):

“medical devices – medical-purpose products and medical equipment”.

Subparagraph 186) — medical-purpose products:

“medical-purpose products – materials, products, solutions, reagents, kits and sets used to provide medical care in accordance with their intended function and the manufacturer’s instructions”.

Subparagraph 189) — medical equipment:

“medical equipment – devices, instruments, equipment, complexes and systems used separately or in combination to provide medical care in accordance with the functional purpose and operating characteristics established by the manufacturer”.

In short:

MD = medical-purpose products + medical equipment.
Medical-purpose products are mainly materials, solutions, reagents, kits and sets.
Medical equipment includes devices, instruments, equipment, complexes and systems.

The decisive factors are the product’s intended purpose, claimed characteristics, instructions for use and method of application. If an equivalent product is already registered in Kazakhstan, the product under review is likely to be considered a medical device as well.

If the regulatory status of the product is unclear, an official expert procedure can be carried out by the authorized state body to obtain an Expert Conclusion on whether the product is classified as a medical device.

For an initial assessment, it is usually sufficient to provide:

• product name and description;
• manufacturer information;
• intended purpose and field of application;
• instructions for use;
• photographs of the product, packaging and labeling;
• evidence of registration in the country of manufacture or a letter from the competent authority of that country confirming that the product is not classified as a medical device.

A complete dossier is not required at the first stage. We review the available materials and advise which documents are missing.

The timeline depends on the risk class, type of device, completeness of the documentation, the need for testing, manufacturing inspection and the time required to respond to comments from the expert organization.

Registration timelines are generally shorter for medical equipment because laboratory testing is not performed. For medical devices of safety class IIb and above, registration usually takes longer because a manufacturing inspection is required.

Indicative service timelines from the date of submission to the authorized body:

• Medical device registration without inspection: 6–8 months;
• Medical device registration with inspection: 10–12 months;
• Expert determination of medical device status: 15 business days;
• Medical device conformity certificate: 5 business days.

After the preliminary review, we prepare an indicative work plan and explain which stages may affect the overall duration.

The fee is calculated individually and depends on:

• the type and risk class of the device;
• the number of models and versions;
• the volume and quality of the available documentation;
• the need for translation and document revision;
• the number of required tests;
• the need for a manufacturing inspection;
• the need to revise existing documents or prepare missing documentation.

Registration services start from KZT 1.5 million / approximately USD 3,500, including translations and fees payable to the authorized body, and may reach KZT 10 million / approximately USD 21,000 or more when manufacturing inspection, translations and regulatory fees are included.

After the preliminary assessment, the client receives a clear scope of work and a cost estimate.

A final decision of a government authority or expert organization cannot be guaranteed in advance.

We can guarantee professional document preparation, dossier review, procedural support, timely preparation of responses to comments and transparent communication of identified risks.

Before starting the project, we assess its prospects. If we identify serious obstacles to registration, we inform the client in advance.

Missing documents do not always mean that registration or regulatory-status expertise is impossible. We first determine which materials are missing, which documents can be prepared or restored, and which tests may be required.

After the review, the client receives a list of missing documents and a step-by-step plan for further action.

For manufacturers in Kazakhstan, registration may be possible even with a minimal initial set of documentation.

For foreign manufacturers, the availability of a Registration Certificate, Certificate of Free Sale, Export Certificate, or an Expert Conclusion from the competent authority confirming that the product is not classified as a medical device is critical. These documents must be apostilled.