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.

5 free resources24/25 requirements coveredAug 2026 fees reviewed

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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

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Government registration fees

Review current BDA application, review, and renewal fees.

Registration timeline

Compare the statutory notified-body conformity assessment clock under Regulation (EU) 2026/977 with realistic CE marking times by device class.

Structured regulatory requirements

Explore all 38 source-linked facts →

24 of 25 research dimensions currently covered · 19 official sources · latest verification 2026-09-07

Market entry

D01

Authority & regime

Verified

Competent authority: Bulgarian Drug Agency (BDA, ИАЛ — Изпълнителна агенция по лекарствата) is the competent authority for medical devices and IVDs in Bulgaria: it carries out registration under Chapter Two of…
Market-surveillance authority: Market surveillance on the territory of the Republic of Bulgaria is carried out by ИАЛ (Bulgarian Drug Agency) through inspectors and experts.

2 source-linked facts

Checked 2026-08-25

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D02

Legal basis & guidance

Verified

National framework law: National framework: Law on Medical Devices (Закон за медицинските изделия, ЗМИ), promulgated SG No. 46 of 12.06.2007, in force from 12.06.2007, last amended SG No. 41 of 10.05.2024. ЗМИ rem…

1 source-linked fact

Checked 2026-08-25

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D03

Device definition & scope

Verified

Device definition covers software: The ЗМИ definition of 'medical device' expressly includes software — an instrument, apparatus, device, software, material or other article used alone or in combination, including software.

1 source-linked fact

Checked 2026-08-25

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D04

Classification rules

Verified

EU MDR classes I, Is, Im, Ir, IIa, IIb and III: Class I, Class Is, Class Im, Class Ir, Class IIa, Class IIb, Class III

1 maintained scheme

Checked 2026-08-26

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D05

Registration pathways

Verified

Market-access route or official registration surface: submissionSurface: BDA national register under ЗМИ Chapter Two (чл. 27 devices; чл. 28 IVDs), plus EUDAMED as the EU shared layer (BDA feeds it under чл. 118 ЗМИ) · verifiedHighlights: Clas…
Class I / custom-made / systems registration deadline: Manufacturers of Class I devices, custom made device manufacturers and persons under ЗМИ Art. 21 22 (systems/procedure packs, pre use sterilisation) must file an application for registratio…

4 source-linked facts

Checked 2026-08-25

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D06

Reliance & recognition

Verified

EU CE under MDR/IVDR — single market validity: target: geo:bgr · sourceApproval: EU CE under MDR/IVDR · edgeType: single market validity · marketAccessStrength: direct · regulatoryLayer: product marketing · sameDeviceRequired: Yes · loc…

1 source-linked fact

Checked 2026-08-25

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D07

Economic-operator roles

Verified

Economic operator roles (MDR Chapter III): Chapter III of Regulation (EU) 2017/745 assigns the core obligations: manufacturers (Art. 10), authorised representatives (Art. 11, including the mandate and minimum list tasks of Art. 12),…

1 source-linked fact

Checked 2026-08-29

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D08

Establishment, import & distribution

Verified

Wholesale-trade permit requirement: Wholesale trade in medical devices in Bulgaria requires a wholesale trade permit (разрешение за търговия на едро) from ИАЛ (BDA) or another document certifying the right to trade medical de…
Wholesale-permit application content: The wholesale permit application to BDA includes: the company unified identification code (ЕИК); a list of device categories according to the БДС EN ISO 15225 nomenclature system; a declara…

2 source-linked facts

Checked 2026-08-25

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D09

Dossier requirements

Verified

Device registration attachments: The device registration application (ЗМИ Art. 27) must attach: the company unified identification code (ЕИК); the name and description of the device; and a document for the fee paid per the…
IVD registration attachments: The IVD registration application (ЗМИ Art. 28) must attach: ЕИК; technical and analytical characteristics; for List A/B and self testing devices also the name, type and model of the device…

2 source-linked facts

Checked 2026-08-25

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D10

Official forms & portals

Verified

Official form or portal surface: submissionSurface: BDA national forms plus EUDAMED shared layer · verifiedHighlights: BDA publishes separate forms for manufacturer/device registration and change (ЗМИ Art. 27(1)/(3); IVD f…

1 source-linked fact

Checked 2026-08-25

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Submission & evidence

D11

Label, IFU & language

Verified

IFU must be in Bulgarian: The instructions for use must also be drawn up in Bulgarian (national language requirement for devices placed on the market in Bulgaria).
IFU exemption for certain class I/IIa devices: An instructions for use document is not required for general medical devices of class I and IIa which, in the manufacturer's judgement, can be used safely without an IFU.

2 source-linked facts

Checked 2026-08-25

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D12

QMS, audit & inspection

Verified

QMS certificate for Class I sterile/measuring registration: For registration of Class I sterile and Class I measuring function devices (and pre use sterilisation systems/sets), BDA requires a valid manufacturer quality system certificate among the a…

1 source-linked fact

Checked 2026-08-25

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D13

Standards, testing & ancillary approvals

Verified

MDR electrical safety in place of the Low Voltage Directive: Electrical safety
MDR electromagnetic compatibility in place of the EMC Directive: EMC
Наредба за съществените изисквания и оценяване съответствието на радиосъоръженията: Wireless / radio

8 maintained overlays

Checked 2026-09-07

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D14

Fees

Verified

Class I device registration (single device): EUR 255.65
Class I device registration (group of devices): EUR 281.21–1,227.10

8 maintained fee lines · 2 related facts

Checked 2026-08-25

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D15

Review clocks

Unresolved

Class I · Self-declaration (no notified body): 0 days

1 maintained pathway · 3 related facts

Checked 2026-08-29

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D16

Approval validity & renewal

Verified

Registration certificate validity: The BDA registration certificate (удостоверение за регистрация/промяна) is issued valid until a change in the device or other changes in the declared data occur — no fixed expiry date and n…

1 source-linked fact

Checked 2026-08-25

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Lifecycle & post-market

D17

Change control

Verified

Changes filed as registration-change application: Changes to a registered device or applicant data are filed as an application for change in the registration (промяна в регистрацията) on the official BDA form under ЗМИ Art. 27(3) (devices)…

1 source-linked fact

Checked 2026-08-25

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D18

UDI, listing & traceability

Verified

BDA duty to feed EUDAMED: ИАЛ (BDA) must transmit to the European database (EUDAMED), immediately upon receipt and in a standardised format, the enumerated data — including registration data on manufacturers and aut…
Batch/serial number on packaging (wholesale): Wholesale traders must, where applicable, have a batch or serial number affixed on the packaging of the medical devices.

3 source-linked facts

Checked 2026-08-25

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D19

Clinical investigation & performance

Verified

Clinical investigation permit for high-risk devices: Clinical investigations of class III, implantable and long term invasive class IIa/IIb devices and active implantable devices may start only after a permit from the Executive Director of ИА…
Final clinical-investigation report due in 90 days: Within 90 days after completion of the clinical investigation, the sponsor must submit to BDA a final report on the investigation.

2 source-linked facts

Checked 2026-08-25

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D20

Special access & derogation

Verified

Minister-of-Health exceptional use permit: The Minister of Health may, by an exceptional order (заповед по изключение), permit a medical device to be put into use even where the conditions of ЗМИ Art. 8 are not met.

1 source-linked fact

Checked 2026-08-25

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D21

Manufacturer PMS

Verified

Manufacturer safety-tracking system: The manufacturer must create and maintain a documented system for tracking the safety of the medical devices it has placed on the market.

1 source-linked fact

Checked 2026-08-25

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D22

Vigilance & incident reporting

Verified

Manufacturer initial incident report 10/30 days: The manufacturer must file with BDA an initial report on the official form within 10 days of receiving information about an incident that caused death or serious deterioration of health, an…
Final incident report within 3 months: Within three months of filing the initial report under Art. 106, the manufacturer must prepare and submit to BDA a final report on the form approved by the Executive Director.

2 source-linked facts

Checked 2026-08-25

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D23

Recall, FSCA & market surveillance

Verified

Serious incident and FSCA reporting (Art. 87(1)): Manufacturers of devices made available on the Union market, other than investigational devices, must report to the relevant competent authorities any serious incident involving devices mad…

1 source-linked fact

Checked 2026-08-29

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D24

Advertising, claims & promotion

Verified

Misleading claims prohibition (Art. 7): In the labelling, instructions for use, making available, putting into service and advertising of devices it is prohibited to use text, names, trade marks, pictures and figurative or other…

1 source-linked fact

Checked 2026-08-29

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D25

Submission communications & appeal

Verified

Refusals appealable under the APC: Refusals under ЗМИ (e.g. refusal of a clinical investigation application) are appealable under the Administrative Procedure Code (Административнопроцесуален кодекс).
Appeals do not suspend execution: Appeals against BDA market surveillance orders do not suspend execution of the contested order.

2 source-linked facts

Checked 2026-08-25

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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