Competent authority
authority.competent-authority
Bulgarian Drug Agency (BDA)
BDA · structured requirements
🇧🇬 Bulgaria medical device regulatory data
Explore the medical device requirements currently available for Bulgaria, organized by topic and linked to official sources.
5 facts4 dimensions5 official sourceslatest verification 2026-08-13
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
BDA national forms plus EUDAMED shared layer
- VerifiedHighlights
- BDA publishes separate forms for manufacturer/device registration, notification and information submission.
- The official forms surface includes registration/change materials.
Registration pathways
Which registration, notification, listing, reliance, or conformity route applies?
Market-access route or official registration surface
registration.market-access-route
- SubmissionSurface
BDA national forms plus EUDAMED shared layer
- VerifiedHighlights
- BDA publishes separate forms for manufacturer/device registration, notification and information submission.
- The official forms surface includes registration/change materials.
Reliance & recognition
Which foreign decisions or evidence can be reused, with what effect and conditions?
EU CE under MDR/IVDR — single market validity
reliance.reliance-edge-eu-ce-to-eea30-approval-eu-ce-mdr-ivdr-bulgaria
- Target
geo:bgr
- SourceApproval
EU CE under MDR/IVDR
- EdgeType
Single Market Validity
- MarketAccessStrength
direct
- RegulatoryLayer
Product Marketing
- SameDeviceRequired
Yes
- LocalApplicationRequired
No
- TargetDecisionRetained
No
Conditions
- medical devices and IVDs subject to route-specific scope
- valid CE conformity route for the device
- country language, economic-operator, EUDAMED, and national vigilance obligations still apply
Türkiye CE under aligned MDR/IVDR — customs union free circulation
reliance.reliance-edge-turkiye-ce-to-eu27-approval-turkiye-ce-mdr-ivdr-bulgaria
- Target
geo:bgr
- SourceApproval
Türkiye CE under aligned MDR/IVDR
- EdgeType
Customs Union Free Circulation
- MarketAccessStrength
Direct With Local Obligations
- RegulatoryLayer
Product Marketing
- LocalApplicationRequired
No
- TargetDecisionRetained
No
Conditions
- medical devices and IVDs subject to route-specific scope
- certificate duly issued by a Turkish notified body under aligned MDR/IVDR rules
Need to apply Bulgaria's requirements to a product?
Confirm the current BDA pathway, evidence, and local-role details for the actual device before filing.