Competent authority
authority.competent-authority
Ministry of Health / Committee for Medical and Pharmaceutical Control
Committee for Medical and Pharmaceutical Control · structured requirements
🇰🇿 Kazakhstan medical device regulatory data
Explore the medical device requirements currently available for Kazakhstan, organized by topic and linked to official sources.
5 facts5 dimensions2 official sourceslatest verification 2026-08-13
Legal basis & guidance
Which current law, regulation, guidance, and transition provisions apply?
Official legal and guidance surface
legal-basis.official-surface
- Authority
Ministry of Health / Committee for Medical and Pharmaceutical Control
- SubmissionSurface
Digital Government to e-Licensing portal
- VerifiedHighlights
- The official service covers registration, re-registration and dossier amendments.
- Its stated outputs include Kazakh- and Russian-language instructions, packaging and labels.
Official forms & portals
Which current form, portal, account, and submission package must be used?
Official form or portal surface
submission.official-form-or-portal-surface
- SubmissionSurface
Digital Government to e-Licensing portal
- VerifiedHighlights
- The official service covers registration, re-registration and dossier amendments.
- Its stated outputs include Kazakh- and Russian-language instructions, packaging and labels.
Registration pathways
Which registration, notification, listing, reliance, or conformity route applies?
Market-access route or official registration surface
registration.market-access-route
- SubmissionSurface
Digital Government to e-Licensing portal
- VerifiedHighlights
- The official service covers registration, re-registration and dossier amendments.
- Its stated outputs include Kazakh- and Russian-language instructions, packaging and labels.
Reliance & recognition
Which foreign decisions or evidence can be reused, with what effect and conditions?
EAEU common medical-device registration — common registration scope
reliance.reliance-edge-eaeu-common-registration-approval-eaeu-common-registration-kazakhstan
- Target
geo:kaz
- SourceApproval
EAEU common medical-device registration
- EdgeType
Common Registration Scope
- MarketAccessStrength
Direct If Target Selected
- RegulatoryLayer
Product Marketing
- LocalApplicationRequired
No
- TargetDecisionRetained
Yes
Conditions
- medical devices and IVDs subject to route-specific scope
- applicant selects reference state and one or more recognition states
- certificate scope is not assumed to include every member unless selected and recognized
Need to apply Kazakhstan's requirements to a product?
Confirm the current Committee for Medical and Pharmaceutical Control pathway, evidence, and local-role details for the actual device before filing.