BDA market access

Bulgaria medical device registration resources

Research BDA registration records, classification, regulations, timelines, fees, and market updates — the stable entrance to every Bulgaria medical device resource.

4 free resourcesAug 2026 fees reviewed

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Everything we track for Bulgaria

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Additional certification and licence checker

Check whether product features may trigger separate radio, electrical, metrology, radiation, import, or other Bulgaria requirements.

Medical device regulation news

Follow recent Bulgarian Drug Agency (BDA) policy, guidance, safety, and compliance updates.

AI medical device classifier

Describe your device and get a preliminary BDA risk class with official rule references.

Government registration fees

Review current BDA application, review, and renewal fees.

Government fees

Full fee schedule (8 lines) →

BDA registration fees in EUR · reviewed 2026-08-25

Fee line	Amount	Provenance
Class I device registration (single device)	EUR 255.65	Verified
Class I device registration (group of devices)	EUR 281.21–1,227.10	Verified
Custom-made device registration (single device)	EUR 25.56	Verified
IVD List A/B registration (single device)	EUR 204.52	Verified

4 more fee lines on the full schedule · 8 of 8 rows source-verified

Latest regulation news

All Bulgaria regulation news →

Newest BDA-related headlines from the daily-refreshed feed — every row links to the publishing source.

Aug 26MGMedEnvoy GlobalWhat Is a Saudi Arabia Authorized Representative for Medical Devices?

Bulgaria Aug 26OSOperon StrategistSFDA Medical Device Establishment License (MDEL): Complete Compliance Guide

Bulgaria Aug 25MGMedEnvoy GlobalHow Does Mexico Classify Single-Use Versus Reusable Medical Devices?

Bulgaria Aug 25FLFDA Law BlogFDA Addresses Device Constituents in New Draft Guidance on Container Closure Systems

Bulgaria Aug 25PBPacific BridgeCan Foreign Clinical Data be Used to Get Your Medical Device Approved in Japan?

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Turn Bulgaria research into practical work

The target market is carried into each tool. Add the product, evidence, or regulatory change you want to assess.

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Build a reusable product master

Structure company, product, model, approval, certificate, and evidence facts before starting Bulgaria work.

Bulgaria market-launch workpaper

Connect the BDA route, evidence, labels, local role, timing, and dependencies to a wider launch plan.

Bulgaria dossier reuse and delta

Compare an existing authorization and evidence set against BDA administrative, testing, labeling, and dossier needs.

Bulgaria change notification workpaper

Map a product or manufacturing change to BDA evidence, notification, timing, and implementation questions.

Bulgaria regulatory change impact

Assess a current BDA update against one product and turn it into an owner-ready action workpaper.

Bulgaria cybersecurity evidence review

Review connected-device architecture, risks, SBOM, testing, lifecycle controls, and market-specific questions for Bulgaria (BDA).

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Local representation, BDA submissions, and lifecycle maintenance — handled with an expert.