EAEU Decision No. 106 QMS Inspections for Kazakhstan: Report Validity, Inspection Cycles and Scope Reduction

1. Key takeaways

On the Union pathway, the quality management system is evaluated in the form of a production site inspection, governed by Decision No. 106 of the Board of the Eurasian Economic Commission dated November 10, 2017 (as amended by Decision No. 131 dated November 12, 2021). Three core figures define the rhythm: the inspection report is valid for 3 years from the date of issue; periodic inspections run in 3-year cycles; and the manufacturer may apply to the inspection body for a periodic inspection within 6 months before the previous report expires. Where the manufacturer has established a quality management system equivalent to ISO 13485, the inspection may be limited to design and development, production and release control, and consumer-related processes including post-market surveillance. These figures and qualifications together determine not only the initial registration schedule but the entire long-term compliance calendar of the site.

2. Legal basis

3. Expert insights

Insight one: the value of an ISO 13485 certificate is a narrower inspection scope, not an exemption. Under Decision No. 106, where the manufacturer has established a quality management system equivalent to ISO 13485 and can produce the certificate and audit reports, the inspection may be limited to design and development, production and release control, and consumer-related processes including post-market surveillance. This dramatically shortens the time on site, but it does not remove the inspection itself. Treating the certificate as a full exemption is a planning error that surfaces as an unplanned audit demand.

Insight two: the three time figures set the long-term compliance rhythm. The report is valid for 3 years, periodic inspections recur every 3 years, and the application may be filed 6 months before expiry. Once the first report is obtained, a rolling calendar should be built immediately, because a report that lapses interrupts lawful circulation until a new inspection is completed — an entirely avoidable commercial outage with fixed, known dates. The same calendar should track the certificates and audit reports supporting the reduced scope, since they must remain current for the reduction to hold.

Insight three: the Board recommendation of April 7, 2026 unified the inspection methodology. On April 7, 2026 the Board of the Eurasian Economic Commission adopted methodological recommendations for conducting production inspections of medical devices, giving the inspection bodies of the member states a single methodological baseline with a focus on sterilization processes and on production site inspections triggered by adverse event or complaint notifications. The document is advisory, yet in practice it defines the inspection standard across the Union, so preparing to it is the safest posture.

Insight four: unscheduled inspections have four trigger scenarios. A manufacturer may apply for an unscheduled inspection itself, in situations including a change to the list of production sites, confirmation that identified violations have been corrected, confirmation that the causes of non-conforming devices leaving the factory have been eliminated, and confirmation that the quality management system has been implemented. This provides a formal channel for restoring a demonstrable compliance status after major changes, which is far better than waiting for the next periodic cycle.

Insight five: national pathway exemptions coexist with Union pathway inspection duties. Under Order No. ҚР ДСМ-10, devices of potential risk class 1 and non-sterile class 2а are not inspected on the national pathway, and devices are likewise exempt where the same production site already has devices registered in Kazakhstan and entered in the national register. The inspection burden of the two pathways must therefore be estimated separately, project by project, before the pathway choice is finalized. A site with several devices on different routes needs one consolidated inspection calendar rather than a plan per device.

4. Practical recommendations

1. Assemble the ISO 13485 certificate and audit reports to narrow the inspection scope under Decision No. 106.
2. Maintain a rolling inspection calendar reflecting the 3-year validity and the 6-month application window before expiry.
3. Track the Board recommendation of April 7, 2026 and prepare evidence on sterilization processes and complaint handling first.
4. After major changes, restore demonstrable compliance through the formal channel of an unscheduled inspection.
5. For national pathway projects, verify the two exemptions (by risk class and by site registration history) at the outset.

5. Verification checklist

• □ ISO 13485 certificate and audit reports are prepared and can be used to narrow the inspection scope
• □ The 3-year validity of inspection reports is captured in the rolling calendar
• □ A reminder is set for the periodic inspection application (6 months before expiry)
• □ Evidence on sterilization and complaint handling is prepared against the recommendation of April 7, 2026
• □ The four trigger scenarios for unscheduled inspections are integrated into change management
• □ The two inspection exemptions on the national pathway have been verified

GRZAN provides registration support in Kazakhstan for manufacturers, importers and authorized representatives, covering QMS inspection preparation, Union pathway compliance and post-approval maintenance. For assistance, contact info@grzanglobal.com.

Regulatory information verified as of October 29, 2026.