Kazakhstan Medical Device Post-Market Surveillance: Order ҚР ДСМ-320/2020 Compliance Guide

1. Key takeaways

Post-market surveillance of medical devices in Kazakhstan is governed by Order No. ҚР ДСМ-320/2020 of the Minister of Health, which approves the Rules for Monitoring the Safety, Quality and Effectiveness of Medical Devices. The surveillance system should be established before certification is granted rather than assembled afterwards, because surveillance obligations arise as soon as a product enters circulation and require an authorized entity located in Kazakhstan to carry them out. Products registered under the Union pathway are additionally subject to Decision No. 174 of the Eurasian Economic Commission dated December 22, 2015. Where a portfolio contains products on both pathways, the authorized representative must be conversant with both sets of rules at the same time, and the surveillance system must be able to demonstrate compliance under either regime when the regulator asks for evidence.

2. Legal basis

3. Expert insights

Insight 1: surveillance obligations require a Kazakhstan-based entity to carry them out. Foreign manufacturers must appoint an entity located in Kazakhstan to perform local adverse event monitoring and other post-market activities. This means a surveillance system cannot be solved by running one setup at headquarters and sharing it across markets; collection, evaluation and reporting steps must be localized so that information reaches the regulator in the required form. The appointment agreement should define these outputs and their deadlines explicitly, so that the local partner knows exactly what it is accountable for. In practice this entity also becomes the addressee of regulator requests, so its responsiveness directly affects how quickly the company can answer official inquiries.

Insight 2: surveillance and risk management documentation are two sides of the same system. The risk management file makes an acceptability judgment on residual risk before the product reaches the market; surveillance verifies after market entry whether that judgment still holds. The interface between the two is the surveillance focus, which is derived from the residual risk conclusions in the risk management file. When building the system, read the risk management file first and then define the surveillance plan, so that every monitoring activity has a documented rationale behind it. A surveillance plan that ignores the risk file produces monitoring activity without justification, a gap that inspectors identify quickly.

Insight 3: two pathways mean two rule sets, and the representative must master both. Products registered under national rules are subject to Order No. ҚР ДСМ-320/2020, while products registered under Union rules are subject to Decision No. 174. Companies whose portfolio combines both pathways face a correspondingly higher capability requirement for their representative. This is an easily overlooked hidden requirement when selecting an authorized representative, and it should be verified before appointment rather than discovered after an inspection finding. Confirming this capability during selection costs little; discovering the gap during an event costs far more.

Insight 4: surveillance data must be traceable back to the risk management file. Each adverse event evaluation should be compared against the risk management file: is this a known risk, an acceptable risk, or an emerging risk. The conclusion of that comparison determines whether corrective action is initiated. This closed loop is what makes a surveillance system genuinely effective, as opposed to a system that merely collects data without connecting it to any documented risk judgment or documented decision on follow-up measures. Reconciling the event ledger against the risk file at fixed intervals keeps this loop alive rather than merely formal.

Insight 5: the surveillance system must produce verifiable records. Ledgers, evaluation records, report records and corrective action records together form the evidence of the system. During supervisory inspections, the regulator examines these records rather than the system documents themselves. A system that is well documented on paper but poorly evidenced in records will not withstand scrutiny, so record-keeping discipline should be treated as part of the system design from the outset, with responsibilities and retention periods assigned in writing. Records that cannot be retrieved quickly are treated by inspectors the same way as records that were never made, so retrieval discipline matters as much as creation discipline.

4. Practical recommendations

1. Establish the surveillance system before certification and connect it to the residual risk conclusions of the risk management file.
2. Identify the Kazakhstan-based carrying entity, and state the outputs and deadlines of surveillance duties in the appointment agreement.
3. Where both pathways coexist in the portfolio, confirm that the representative is familiar with both Order No. ҚР ДСМ-320/2020 and Decision No. 174.
4. Build a closed-loop process from event to evaluation to action to record, with evaluation conclusions traced back to the risk management file.
5. Manage system documents and records separately: documents describe how work is done, records prove that it was done.

5. Verification checklist

• □ The surveillance system has been established before certification
• □ The surveillance focus has been derived from the residual risk conclusions of the risk management file
• □ The Kazakhstan-based carrying entity has been identified, with obligations and deadlines written into the agreement
• □ The representative is familiar with Order No. ҚР ДСМ-320/2020 and Decision No. 174
• □ A closed-loop process from event to evaluation to action to record has been established
• □ Ledgers, evaluation records, report records and corrective action records can be retrieved at any time

Regulatory information verified as of October 29, 2026.

GRZAN provides registration and post-market compliance support for medical device manufacturers, importers and authorized representatives in Kazakhstan, including surveillance system setup, adverse event management and inspection preparation. For inquiries, contact info@grzanglobal.com.