Kazakhstan Medical Device Registration Dossier Composition: Required Documents and Review Logic

1. Key takeaways

The composition of the national registration dossier for medical devices in Kazakhstan is defined by Order No. ҚР ДСМ-16 of the Minister of Healthcare (dated February 9, 2021, registered with the Ministry of Justice under No. 22175). At its core the dossier contains the application form, information on the applicable regulatory and technical documents, the manufacturer’s technical documentation, the summary of technical documentation or technical specifications, risk management documentation, manufacturer’s reports and qualification test reports, operating documentation, technical test reports, toxicological study results, type-approval test reports for measuring instruments where applicable, and documentation proving clinical effectiveness and safety. The dossier is submitted in Russian, while the instructions for use, packaging descriptions, device type descriptions, manufacturer information, software validation reports and certain certified administrative documents must be provided bilingually in Russian and Kazakh. Reading the list carefully shows that it is not a random folder of papers: every item exists because an expert reviewer performs a specific verification action against it, and a dossier that mirrors those actions is materially easier to approve on the first pass.

2. Legal basis

3. Expert insights

Insight one: the dossier is organized around review actions, not around corporate departments. The list in Order No. ҚР ДСМ-16 maps onto three types of verification performed by the reviewer: verification of identity and authorization (application form, authorization documents, manufacturer information), verification of technical conformity (technical documentation, risk management, test reports), and verification of clinical value (documents on clinical effectiveness and safety). Archiving by these three categories, rather than by the internal R&D, quality and clinical departments of a manufacturer, makes it far easier for the reviewer to locate evidence and far more likely that the formal screening is passed in a single round.

Insight two: the information on applicable regulatory and technical documents is a distinctive Kazakh dossier item. The checklist singles out information on the applicable regulatory and technical documents, which must state the standards and technical specifications the product is built to. In dossiers prepared by Chinese manufacturers this section is the one most often weakened or reduced to a bare list of standards. Yet it is precisely the first entry point a reviewer uses to judge what the product was manufactured to, and a thin section here invites a request for supplementation that costs weeks.

Insight three: the bilingual document list is enumerated precisely, so neither expand it nor omit from it. The documents that require Russian and Kazakh are the instructions for use, packaging descriptions, device type descriptions, manufacturer information, software validation reports, and certain certified or notarized original administrative documents. Everything else may remain in Russian. Translating the entire dossier into Kazakh adds cost and, more importantly, multiplies the surfaces on which the two language versions can diverge, creating inconsistency risks that reviewers actively look for.

Insight four: documentation for measuring instruments is a parallel track, not a sub-item of the dossier. When a product qualifies as a measuring instrument, the type-approval test report forms part of the registration dossier, but the type approval itself follows a separate procedure under the law on ensuring the uniformity of measurements. The parameters recorded in the two tracks must be reconciled before submission; otherwise the classic finding of a registration certificate that does not match the metrology certificate will surface, and correcting it late in the process is disproportionately expensive.

Insight five: dossier quality determines the number of deficiency rounds, and the number of rounds determines the timeline. After the one-window consolidated service compressed the total statutory timeline to 100 working days in 2026, the time consumed by deficiency responses and inspections became the main variable in project planning. The marginal return on every additional week invested in dossier quality before submission is therefore dramatically amplified, and a disciplined pre-submission self-check is the cheapest schedule protection available.

4. Practical recommendations

1. Archive the dossier under the three categories of identity and authorization, technical conformity, and clinical value, so that formal screening can be passed in one round.
2. Dedicate a standalone section to the information on applicable regulatory and technical documents, spelling out standard numbers and technical specifications.
3. Follow the enumerated bilingual list strictly and avoid expanding translation beyond it.
4. Cross-check the type-approval documents of measuring instruments against the registration dossier so that the parameters agree exactly.
5. Run a completeness self-check before submission to minimize the risk of deficiency letters and to protect the overall timeline.

5. Verification checklist

• □ Application form, authorization documents and manufacturer information are complete and valid
• □ Information on applicable regulatory and technical documents is presented as a separate section with standard numbers stated
• □ Technical documentation, risk management documentation and technical specifications are complete
• □ Technical test reports and toxicological study results are attached where applicable
• □ Type-approval test report for measuring instruments is attached where applicable
• □ Documentation proving clinical effectiveness and safety is attached
• □ The bilingual document list has been followed exactly, without expanded translation

GRZAN provides registration support in Kazakhstan for manufacturers, importers and authorized representatives, covering dossier assembly, expert review liaison, bilingual documentation and post-approval maintenance. For assistance, contact info@grzanglobal.com.

Regulatory information verified as of October 29, 2026.