Kazakhstan Medical Device Definition and Boundary Determination: A Three-Step Scoping Method

1. Key takeaways

Determining whether a product falls within the scope of medical device regulation in Kazakhstan follows three steps. Step one: examine whether the intended use falls within medical purposes such as prevention, diagnosis, treatment, rehabilitation, medical research, monitoring of physiological states and control of conception. Step two: examine whether the principal intended action is achieved by physical or mechanical means that are not pharmacological, immunological or metabolic in nature. Step three: check whether the legal texts place the product on the list of exemptions from registration. Only after all three steps point in the same direction does the product require state registration under Order No. ҚР ДСМ-16 or Union registration under the Eurasian Economic Union rules. The sequence matters: a product that fails the medical-purpose test at step one never reaches the registration question at all, while a product that passes steps one and two but appears on the exemption list at step three can circulate without registration under the conditions attached to that exemption. Documenting this analysis in writing at project initiation is the cheapest risk control available, because boundary mistakes discovered after submission are expensive to reverse. The determination also protects downstream decisions: marketing claims, tender documents and distribution agreements all inherit the scope conclusion, and a wrong inheritance multiplies the original error across every commercial document that references the product category.

2. Legal basis

3. Expert insights

Insight one: the mechanism of action is the watershed, not the use. Products whose principal intended action is achieved by pharmacological, immunological or metabolic means fall on the medicines track; products whose principal action is physical or mechanical fall on the device track. Products that contain a medicinal substance but whose principal action remains physical, such as drug-coated stents or dressings carrying an antimicrobial agent, are typical boundary cases. The dossier must argue the principal mode of action explicitly, supported by the product’s design characteristics and performance data, rather than leaving the assessor to infer it from the marketing description. GRZAN prepares this argument as a standalone section of the dossier so that the classification reasoning is visible and reviewable in one place.

Insight two: software is expressly brought within the device category. Dedicated software intended for device purposes, whether standalone or embedded, qualifies as a medical device within the Union legal framework, and this interpretation carries through into Kazakh classification and review practice. The boundary question for software is whether it serves a medical purpose, not whether it is installed on hardware. A mobile application that calculates a dosing recommendation is a device even though it runs on a consumer phone; the same code running as a hospital logbook is not. This practical estimate keeps software scoping decisions anchored to the intended use claim rather than to the platform.

Insight three: the exemption list is dynamic. Article 4 of the 2014 Agreement established the list of exemptions, and the protocol signed on February 9, 2026 added four categories: custom-made devices manufactured for an individual patient, devices imported under competent authority permission to save lives, devices manufactured in a member state exclusively for export, and combination packs and first-aid kits composed of registered devices with medicines. Whenever a scoping decision is made, the exemption list must be checked against its most recent version, because yesterday’s answer does not bind today’s protocol amendments.

Insight four: identify combination products early. Packs combining devices and medicines are already governed by dedicated rules at Union level, in Article 187 and Article 187(1) of Decision No. 78 of the Council of the Eurasian Economic Commission (added in 2025), which distinguish three situations. Because the Kazakhstan national register manages medicines and devices together, the registration pathway for a combination product must be fixed at project initiation, including which component is the lead track and how the subordinate components will be recorded.

4. Practical recommendations

1. At project initiation, issue a written definition determination memo of three to five paragraphs setting out the intended use, the mechanism of action, and whether the product falls on the exemption list, signed by the regulatory owner.
2. For boundary products, submit a written enquiry to the competent authority through the authorized representative before dossier submission, and keep the reply as an annex to the dossier.
3. Create a separate dossier structure for combination products, identifying the lead track (medicine or device) and the registration status of each subordinate component.
4. Re-verify the exemption list annually, and re-run the comparison once the protocol signed on February 9, 2026 enters into application.

5. Verification checklist

• □ The product’s intended use falls within the list of medical purposes
• □ The principal intended action is physical or mechanical (not pharmacological, immunological or metabolic)
• □ The latest version of the exemption list has been checked and the product is not exempt
• □ For combination products, the lead track and the registration status of subordinate components are defined
• □ For software, its medical purpose is confirmed and it is treated within the device category
• □ The definition determination memo is archived and attached to the registration dossier

GRZAN provides registration support in Kazakhstan for manufacturers, importers and authorized representatives, covering scope and boundary determination, dossier preparation and authority enquiries. For assistance, contact info@grzanglobal.com.

Regulatory information verified as of October 29, 2026.