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BDA · official source index

Bulgaria medical device regulatory sources

Start with the competent authority, submission surface, official forms, and source coverage we have verified for Bulgaria.

5 dimensions sourced5 official sources2026-08-13 reviewed
Review official sourcesAll countries
Official starting point

Bulgarian Drug Agency (BDA)

BDA national forms plus EUDAMED shared layer

Coverage boundary

This is an official-source spine, not a completed market-access rulebook. It identifies where to begin and shows which dimensions still need detailed extraction.

Structured coverage

Nine regulatory research dimensions

Each status is source-bound. A located page is useful for research, but it does not turn adjacent requirements into verified facts.

Official

Competent authority

National authority responsible for medical-device oversight.

2 linked sources
Research needed

Legislation & guidance

Primary law, regulation, or official implementation guidance.

0 linked sources
Official

Registration & submission

Official route used to register an operator or submit a device.

4 linked sources
Official

Official forms

Current authority forms, filing templates, or online form surface.

3 linked sources
Research needed

Label, IFU & language

Official surface for labeling, instructions for use, and language rules.

0 linked sources
Research needed

UDI & traceability

Official UDI, device identification, or traceability surface.

0 linked sources
Research needed

Post-market & vigilance

Incident reporting, vigilance, safety action, and recall surface.

0 linked sources
Official

Import & establishment

Importer, local operator, establishment, or market-entry surface.

3 linked sources
Official

Renewal & change

Renewal, variation, amendment, transfer, or discontinuation surface.

3 linked sources
Source highlights

What the reviewed surfaces indicate

  • BDA publishes separate forms for manufacturer/device registration, notification and information submission.
  • The official forms surface includes registration/change materials.
Primary evidence

Official sources

Reviewed 2026-08-13
European Commission

Medical devices — national competent-authority contacts

Current EU competent-authority discovery and contact spine.

Open source
EUR-Lex

Regulation (EU) 2017/746 on in vitro diagnostic medical devices

Shared EU/EEA IVD rule layer; national implementation deltas remain separate.

Open source
EUR-Lex

Regulation (EU) 2017/745 on medical devices

Shared EU/EEA medical-device rule layer; national implementation deltas remain separate.

Open source
European Commission

EUDAMED information centre

Shared EUDAMED layer; mandatory use of the first four modules began 28 May 2026.

Open source
Bulgarian Drug Agency (BDA)

Medical devices — forms

Current official surface used as a bounded starting point; it is not a complete rule table.

Open source
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