Competent authority
authority.competent-authority
National Medicines Regulatory Authority (NMRA)
NMRA · structured requirements
🇱🇰 Sri Lanka medical device regulatory data
Explore the medical device requirements currently available for Sri Lanka, 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
National Medicines Regulatory Authority (NMRA)
- SubmissionSurface
NMRA online pre-submission form plus physical dossier/checklists
- VerifiedHighlights
- NMRA's current hub publishes registration, variation, waiver, low-risk, forms, guidelines, fees and registered-device lists.
- Foreign manufacturers file through a Sri Lankan marketing authorization holder.
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
NMRA online pre-submission form plus physical dossier/checklists
- VerifiedHighlights
- NMRA's current hub publishes registration, variation, waiver, low-risk, forms, guidelines, fees and registered-device lists.
- Foreign manufacturers file through a Sri Lankan marketing authorization holder.
Registration pathways
Which registration, notification, listing, reliance, or conformity route applies?
Market-access route or official registration surface
registration.market-access-route
- SubmissionSurface
NMRA online pre-submission form plus physical dossier/checklists
- VerifiedHighlights
- NMRA's current hub publishes registration, variation, waiver, low-risk, forms, guidelines, fees and registered-device lists.
- Foreign manufacturers file through a Sri Lankan marketing authorization holder.
Reliance & recognition
Which foreign decisions or evidence can be reused, with what effect and conditions?
WHO Prequalification of IVDs — collaborative abridged registration
reliance.reliance-edge-who-pq-ivd-to-crp43-program-who-pq-ivd-sri-lanka
- Target
geo:lka
- SourceApproval
WHO Prequalification of IVDs
- EdgeType
Collaborative Abridged Registration
- MarketAccessStrength
facilitated
- RegulatoryLayer
Product Marketing
- LocalApplicationRequired
Yes
- TargetDecisionRetained
Yes
- TimeTargetDays
90
- TimeBasis
Working Days After Access To All Relevant Information
Conditions
- WHO-prequalified IVDs
- manufacturer opt-in and consent
- participating NRA
- same product in all essential features
- national requirements and fees remain
Need to apply Sri Lanka's requirements to a product?
Confirm the current NMRA pathway, evidence, and local-role details for the actual device before filing.