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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.

39 facts23 dimensions8 official sourceslatest verification 2026-09-15

Advertising, claims & promotion

Which claims, audiences, channels, approvals, and restrictions apply?

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Misleading claims prohibition (Art. 7)

advertising.misleading-claims-art-7
Fact-level verified

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 signs that may mislead the user or the patient with regard to the device's intended purpose, safety and performance by: ascribing functions and properties to the device which the device does not have; creating a false impression regarding treatment or diagnosis; failing to inform the user or patient of a likely risk associated with the use of the device in line with its intended purpose; or suggesting uses for the device other than those stated to form part of the intended purpose for which the conformity assessment was carried out.

Conditions
  • EU-wide rule under Regulation (EU) 2017/745, which applies directly in the member state; national implementing or administrative details are not covered by this fact.

Effective from 2021-05-26

Approval validity & renewal

What expires, what is retained periodically, and when must renewal start?

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Registration certificate validity

approval.registration-certificate-validity
Fact-level verified

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 no periodic renewal.

Conditions
  • National BDA registration under ЗМИ Art. 27/28.

Changes trigger a change application under ЗМИ Art. 27(3)/28(7) with a tariff fee.

Authority & regime

Which authority and binding regime govern this product, task, and date?

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Competent authority

authority.competent-authority
Fact-level verified

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 the Law on Medical Devices (ЗМИ), issues clinical-investigation and wholesale-trade permits, conducts market surveillance and maintains the national vigilance system.

Conditions
  • Applies to all device classes and IVDs under the national ЗМИ regime; EU-level authority roles under MDR/IVDR remain with the EU framework.

ЗМИ = Закон за медицинските изделия (Law on Medical Devices). Art. 6(1) also assigns clinical-trial permits (pt. 3), wholesale permits (pt. 4), market surveillance (pt. 5) and the vigilance system (pt. 7) to ИАЛ.

Market-surveillance authority

authority.market-surveillance-authority
Fact-level verified

Market surveillance on the territory of the Republic of Bulgaria is carried out by ИАЛ (Bulgarian Drug Agency) through inspectors and experts.

Conditions
  • National market-surveillance regime under ЗМИ Chapter Six.

BDA inspectors may block devices and order withdrawal; appeals are governed by чл. 97 ЗМИ.

Change control

Does the event require internal documentation, notice, prior approval, transfer, or a new application?

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Changes filed as registration-change application

change-control.registration-change-application
Fact-level verified

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) / Art. 28(7) (IVDs); a change fee per the tariff applies, and address changes are notified within 14 days.

Conditions
  • Already-registered manufacturers/devices under ЗМИ Art. 27/28; device-data changes require a new application, address changes a 14-day notification.

Clinical investigation & performance

Which clinical or IVD performance evidence or study is required and accepted?

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Clinical investigation permit for high-risk devices

clinical.high-risk-permit-ethics
Fact-level verified

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 ИАЛ (BDA), issued upon receipt of a positive opinion of the Ethics Committee for Clinical Trials; other investigations require notification only.

Conditions
  • Class III and implantable devices; long-term invasive class IIa/IIb; AIMD. Other investigations: notification procedure under Art. 45(2).

Ethics-committee opinion is a precondition; BDA assesses the application within 60 days (Art. 51(1)).

Device definition & scope

Is the product a device, IVD, accessory, software, or borderline product locally?

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Device definition covers software

device-definition.includes-software
Fact-level verified

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.

Conditions
  • Defines the scope of the national ЗМИ regime (registration, wholesale, surveillance); the autonomous EU definition in MDR/IVDR Art. 2 governs CE-marked devices.

Dossier requirements

Which evidence, local deltas, formats, and signatures are required?

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IVD registration attachments

dossier.registration-attachments-ivd
Fact-level verified

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 and results of the performance evaluation; instructions for use in Bulgarian; and a document for the paid fee.

Conditions
  • National registration of IVDs under ЗМИ Art. 28(1) and (3); Bulgarian IFU applies to List A/B and self-test devices.

Economic-operator roles

Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?

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Economic operator roles (MDR Chapter III)

operator.roles-mdr-chapter-iii
Fact-level verified

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), importers (Art. 13) and distributors (Art. 14); Art. 16 sets the cases in which those obligations shift to other operators.

Conditions
  • EU-wide rule under Regulation (EU) 2017/745, which applies directly in the member state; national implementing or administrative details are not covered by this fact.

Effective from 2021-05-26

Establishment, import & distribution

Which establishment licences, importer permissions, and distribution controls apply?

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Wholesale-permit application content

establishment.wholesale-permit-application-content
Fact-level verified

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 declaration covering the storage premises and the responsible manager; and a document for the paid fee.

Conditions
  • Application for a Bulgarian wholesale-trade permit under ЗМИ Art. 78.

Wholesale-trade permit requirement

establishment.wholesale-permit-required
Fact-level verified

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 devices issued by the competent authority of the relevant (EEA) state; Bulgarian manufacturers trading their own products are exempt.

Conditions
  • Applies to wholesale traders of medical devices in Bulgaria; own-product trade by BG manufacturers exempt under Art. 77(2); EEA-established traders may instead notify under Art. 78а.

Fees

What regulator fee applies to this class, route, event, and date?

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Fee payment timing and refund rule

fees.payable-at-submission-nonrefundable
Fact-level verified

Tariff fees are payable upon submission of the application/request for the service or inspection; if a started procedure is terminated, the paid fee is not refunded. From 01.01.2026 the tariff fees are denominated in euro; during the dual-circulation period payment in BGN cash is allowed at the official fixed rate.

Conditions
  • All fees under the ЗМИ tariff; euro denomination applies to the tariff as amended by ДВ бр. 115/30.12.2025, in force 01.01.2026.

Effective from 2011-12-16

Label, IFU & language

Which label and IFU elements, languages, symbols, and translation controls apply?

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IFU must be in Bulgarian

label-ifu.ifu-bulgarian-language
Fact-level verified

The instructions for use must also be drawn up in Bulgarian (national language requirement for devices placed on the market in Bulgaria).

Conditions
  • Devices within the ЗМИ regime placed on the market/into service in Bulgaria; national layer in addition to MDR Art. 10(11) / Annex I language rules.

Bulgarian IFU is also an attachment to IVD registration (Art. 28(2) pt. 4 ЗМИ) and is listed in BDA registration documents.

IFU exemption for certain class I/IIa devices

label-ifu.ifu-exemption-class1-2a
Fact-level verified

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.

Conditions
  • Devices under ЗМИ Art. 2(1) pt. 3 of class I and IIa; manufacturer's safe-use judgement.

Manufacturer PMS

Which PMS plan, report, PMCF or PMPF, trend, and lifecycle-update duties apply?

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Official forms & portals

Which current form, portal, account, and submission package must be used?

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Official form or portal surface

submission.official-form-or-portal-surface
Fact-level verified
Submission Surface

BDA national forms plus EUDAMED shared layer

Verified Highlights
  • BDA publishes separate forms for manufacturer/device registration and change (ЗМИ Art. 27(1)/(3); IVD form under Art. 28(1)/(3)/(7)) and for class IIa-III device information/notification (ЗМИ Art. 30).
  • The official forms surface includes registration/change materials.

Baseline URL pointed to the English forms category page; the reviewed Bulgarian forms page (180-forms) shows the current downloadable application forms (F_9001-01/02) with their ЗМИ legal bases.

QMS, audit & inspection

Which QMS, audit, inspection, and certificate scope is accepted or required?

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QMS certificate for Class I sterile/measuring registration

qms.qms-certificate-for-sterile-measuring-class1
Fact-level verified

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 application documents; the document list also includes the declaration of conformity, a valid EC certificate where applicable, and label and IFU in Bulgarian.

Conditions
  • National registration with BDA for Class I sterile / Class I measuring devices, custom-made devices, systems and procedure packs.

Recall, FSCA & market surveillance

Which recall, FSCA, notice, and authority-coordination duties apply?

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Serious incident and FSCA reporting (Art. 87(1))

recall.serious-incident-fsca-art-87-1
Fact-level verified

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 made available on the Union market and any field safety corrective action taken in respect of such devices, including any field safety corrective action carried out to prevent a risk of serious incident, in accordance with Articles 92(5) and (7).

Conditions
  • EU-wide rule under Regulation (EU) 2017/745, which applies directly in the member state; national implementing or administrative details are not covered by this fact.

Effective from 2021-05-26

Registration pathways

Which registration, notification, listing, reliance, or conformity route applies?

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Class I / custom-made / systems registration deadline

registration.class1-registration-14-days
Fact-level verified

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 registration on the official form to the Executive Director of ИАЛ (BDA) no later than 14 days after placing the device on the market and/or into service in Bulgaria.

Conditions
  • Class I devices (incl. sterile and measuring-function), custom-made devices, systems and procedure packs, pre-use sterilisation systems.

Attachments under Art. 27(2): ЕИК, device name and description, paid-fee document.

Class IIa-III: data on request instead of registration

registration.class2a-3-data-request
Fact-level verified

For class IIa, IIb and III devices (including active implantable devices) put into service in Bulgaria, ИАЛ (BDA) may request device-identifying data, the label and the instructions for use; there is no national registration duty for these classes.

Conditions
  • Devices under ЗМИ Art. 2(1) pt. 2 and pt. 3 of class IIa, IIb or III.

BDA publishes a corresponding notification form for class II/III devices placed on the market.

IVD registration deadline

registration.ivd-registration-14-days
Fact-level verified

Applications for registration of IVDs under ЗМИ Art. 28(1) and (3) (List A, List B, self-testing and other in-vitro diagnostic devices) must be filed with BDA within 14 days of placing on the market and/or into service in Bulgaria.

Conditions
  • IVDs within the national registration scope of ЗМИ Art. 28.

Market-access route or official registration surface

registration.market-access-route
Fact-level verified
Submission Surface

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)

Verified Highlights
  • Class I manufacturers (incl. sterile/measuring), custom-made-device makers and systems/procedure-pack assemblers, and IVD List A/B and self-test manufacturers, must apply for BDA registration within 14 days of placing on the market/into service in Bulgaria (ЗМИ Art. 27(1), Art. 28(6)).
  • For class IIa, IIb and III devices (incl. active implantable) there is no national registration duty; BDA may request device-identifying data, label and IFU (ЗМИ Art. 30).
  • Where the manufacturer is not established in the EU/EEA, the authorised representative files the registration (ЗМИ Art. 29).
Conditions
  • Applies to the national Bulgarian registration layer on top of CE marking; CE-marked devices otherwise circulate freely under MDR/IVDR.

Corrected from baseline that cited EUR-Lex as locator; the national registration duty is established by ЗМИ Art. 27/28, not by the EU regulation.

Reliance & recognition

Which foreign decisions or evidence can be reused, with what effect and conditions?

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Existing records include acceptance, restrictions and evidence reuse. The applicable product scope and conditions are preserved below; a reference does not by itself confer market access.

Bulgaria approvals and evidence in other markets (0 records)

No linked record is currently maintained. This does not establish that a pathway is unavailable.

Prior approvals and evidence for Bulgaria (3 records)

BulgariaUS FDA

Prior approval / evidence record

FDA 510(k)/PMA

Authority

FDA 510(k)/PMA

Accepted

No

Benefit

No substitute for EU MDR conformity assessment; useful as predicate documentation in the technical file

Commission Implementing Regulation (EU) 2026/977, Art. 2 — maximum notified-body conformity assessment timelines (30 + 120/90 parallel + 20 days)EUR-Lex Regulation (EU) 2017/745 (MDR)EUR-Lex MDR consolidated text — Annex IX §5.1 (expert-panel clinical evaluation consultation: 21/60 days) and §5.2(d) (ancillary medicinal-substance opinion: 210 days)

Maintained reference · planning ranges remain estimates · reviewed 2026-08-29

BulgariaNMPA

Regulatory reference

NMPA certificate does not replace EU conformity assessment

reliance.china-nmpa-no-recognition-route
Fact-level verified
Statement

For ordinary market placement under MDR/IVDR, a Chinese approval does not replace conformity assessment under MDR Article 52 or IVDR Article 48. The applicable EU class and procedure must be established independently; lower-risk devices may self-declare, while other devices require notified-body assessment. This is a finding about the ordinary conformity route, not a ban on Chinese devices or their technical evidence.

Source Jurisdiction Id

china

Source Authority Id

nmpa

Source Approval

China NMPA medical device registration certificate (Class II/III) or Class I filing record

Target Jurisdiction Id

bulgaria

China Classes In Scope

All NMPA classes (I filing, II, III) -> all EU MDR/IVDR classes

Edge Type

No Reliance Route

Market Access Strength

none

Regulatory Layer

Product Marketing

Local Application Required

null

Target Decision Retained

null

Conditions
  • Determine the local class independently; NMPA Class III is not an automatic EU class assignment.
  • A local regulatory application/decision is not universal: MDR Article 52(7) and IVDR Article 48(10) permit specified self-declaration routes.
  • Clinical, performance and technical evidence must meet the applicable EU requirements; the certificate alone does not replace them.
  • Special-purpose, investigational, custom-made and derogation regimes require separate assessment.
MDR consolidated text, 19 July 2026IVDR consolidated text, 10 January 2025

Independent review of current EUR-Lex consolidations supports this bounded ordinary-route conclusion. It does not establish the absence of every special route.

BulgariaEU conformity assessment

Prior approval / evidence record

EU CE under MDR/IVDR — single market validity

reliance.reliance-edge-eu-ce-to-eea30-approval-eu-ce-mdr-ivdr-bulgaria
Fact-level verified
Target

geo:bgr

Source Approval

EU CE under MDR/IVDR

Edge Type

Single Market Validity

Market Access Strength

direct

Regulatory Layer

Product Marketing

Same Device Required

Yes

Local Application Required

No

Target Decision Retained

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

EU-level source confirms the single-market validity of CE marking; national Bulgarian layer (ЗМИ registration for class I route, Bulgarian IFU, wholesale permits, vigilance) still applies as conditions state.

Review clocks

What review, validation, and applicant stop-clock rules apply?

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Clinical-investigation assessment stop-clock

review-clocks.clinical-investigation-stop-clock
Fact-level verified

Where BDA requests missing documentation during the clinical-investigation assessment, the 60-day assessment clock stops until the requested documentation is submitted.

Conditions
  • Clinical-investigation authorisation procedure under ЗМИ Art. 50-51.

Base clock: BDA assesses the documentation within 60 days of submission (Art. 51(1)).

Special access & derogation

Is an emergency, compassionate, custom, humanitarian, or other exceptional path available?

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Minister-of-Health exceptional use permit

special-access.ministerial-exemption
Fact-level verified

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.

Conditions
  • Exceptional cases; ЗМИ Art. 8 = conditions for placing on the market/into service (conformity).

Submission communications & appeal

How are deficiencies answered, clocks handled, and decisions escalated or appealed?

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UDI, listing & traceability

Which UDI, device listing, database, and traceability duties apply?

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BDA duty to feed EUDAMED

traceability.eudamed-feed
Fact-level verified

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 authorised representatives under Art. 29 and on devices registered under Chapter Two.

Conditions
  • National registration data collected by BDA under ЗМИ Chapter Two.

Vigilance & incident reporting

What is reportable, by whom, where, in what format, and by what deadline?

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Manufacturer initial incident report 10/30 days

vigilance.initial-report-10-30-days
Fact-level verified

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, and within 30 days for potential incidents; incidents involving third-country devices are also reportable.

Conditions
  • Incidents under ЗМИ Art. 105; 10-day for death/serious injury, 30-day for potential incidents (Art. 106(2)); third-country devices per Art. 106(3)-(4).

Related structured datasets

Classification systems · 1 record
Open EU MDR classes I, Is, Im, Ir, IIa, IIb and III →
Id

bulgaria:medical-device

Jurisdiction Id

bulgaria

Domains
  • medical-device
Name

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

Description

National projection of the directly applicable EU MDR classification. The canonical class axis and rules are maintained in eu:medical-device; national references describe only administration or local deltas.

Classes
  • Id

    i

    Label

    Class I

    Normalized Risk Level

    low

  • Id

    is

    Label

    Class Is

    Normalized Risk Level

    low

  • Id

    im

    Label

    Class Im

    Normalized Risk Level

    low

  • Id

    ir

    Label

    Class Ir

    Normalized Risk Level

    low

  • Id

    iia

    Label

    Class IIa

    Normalized Risk Level

    medium

  • Id

    iib

    Label

    Class IIb

    Normalized Risk Level

    high

  • Id

    iii

    Label

    Class III

    Normalized Risk Level

    highest

Regulator

BDA

Official Domains
  • bda.bg
  • eur-lex.europa.eu
  • europa.eu
Source Status

official-source-verified

Reference Sources
  • Title

    чл. 2, ал. 4 ЗМИ (Art. 2(4))

    Url

    https://lex.bg/bg/laws/ldoc/2135555444

    Reviewed On

    2026-08-25

    Supports

    Bulgaria applies the EU classification rules under MDR/IVDR; national delta: where the manufacturer and the notified body hold different views when applying the classification rules, the Bulgarian Drug Agency (ИАЛ) decides (ЗМИ Art. 2(4)).

Inherited From Scheme Id

eu:medical-device

Source Title

Regulation (EU) 2017/745, Art. 51 and Annex VIII

Source Url

https://eur-lex.europa.eu/eli/reg/2017/745/oj

Verified On

2026-08-26

Source Supports
  • class-axis
  • classification-rules
Registration pathways, prior approvals and planning · 1 record
Open Bulgaria registration →
Country

Bulgaria

Jurisdiction Id

bulgaria

Country Code

BG

Flag

🇧🇬

Regulator

Bulgarian Drug Agency

Regulator Abbrev

BDA

Region

europe

Tier

3

Risk Classification

4-class (I, IIa, IIb, III) — EU MDR

Classes
  • Id

    class-i

    Class Name

    Class I

    Risk Level

    low

    Pathway

    Self-declaration (no notified body)

    Official Timeline
    Min

    0

    Max

    0

    Unit

    days

    Verification Status

    official-verified

    Official Source
    Title

    EUR-Lex Regulation (EU) 2017/745 (MDR)

    Url

    https://eur-lex.europa.eu/eli/reg/2017/745/oj

    Accessed Date

    2026-08-25

    Realistic Timeline
    Min

    6

    Max

    9

    Unit

    months

    Notes
    • MDR Art. 52(7): non-sterile, non-measuring, non-reusable-surgical Class I devices are self-declared, so no authority or notified body reviews the file and there is no review clock
    • Elapsed time is Eudamed actor and device registration, which has no guaranteed processing time, plus any national registration duty
    Clinical Trial Required

    No

    Local Testing Required

    No

    Gmp Required

    Yes

Key Requirements
  • EU Authorized Representative (for non-EU manufacturers)
  • Class I national registration application due within 14 days of placing on the market (Art. 27(1) ЗМИ); IVD registration within 14 days (Art. 28(6)); changes within 14 days (Art. 28(7))
  • Clinical investigation authorisation assessed within 60 days (Art. 51(1)) with stop-clock (51(3)); tacit start if no decision (51(8)); refused applications remediable within 30 days (51(5)); final report within 90 days of completion (Art. 57(1))
  • Wholesale permit decided within 30 days (Art. 79(2)) with stop-clock (79(3)); EEA trader entries 7 days (79(4))
Prior Approvals
  • Authority

    FDA 510(k)/PMA

    Accepted

    No

    Benefit

    No substitute for EU MDR conformity assessment; useful as predicate documentation in the technical file

Local Rep Required

Yes

Local Rep Name

EU Authorized Representative

Mdsap Accepted

No

Mdsap Benefit

ISO 13485 accepted as QMS evidence

Registration Validity

5 years (CE certificate)

Last Updated

2026-08-29

Verification Status

partially-verified

Official Sources
  • Title

    Commission Implementing Regulation (EU) 2026/977, Art. 2 — maximum notified-body conformity assessment timelines (30 + 120/90 parallel + 20 days)

    Url

    https://eur-lex.europa.eu/eli/reg_impl/2026/977/oj

    Effective Date

    2027-02-25

    Accessed Date

    2026-08-29

  • Title

    EUR-Lex Regulation (EU) 2017/745 (MDR)

    Url

    https://eur-lex.europa.eu/eli/reg/2017/745/oj

    Accessed Date

    2026-08-25

  • Title

    EUR-Lex MDR consolidated text — Annex IX §5.1 (expert-panel clinical evaluation consultation: 21/60 days) and §5.2(d) (ancillary medicinal-substance opinion: 210 days)

    Url

    https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:02017R0745-20250110

    Accessed Date

    2026-08-29

Reviewed On

2026-08-29

Process
Template Id

default

Status

planning-template

Usage Rule

Maintained planning steps and estimates, not verified regulator deadlines.

Steps
  • Step

    1

    Title

    Pre-Submission Preparation

    Description

    Gather technical documentation, quality management system (QMS) records, and clinical data required by BDA. Appoint a EU Authorized Representative.

    Duration

    1-3 months

    Icon

    📋

  • Step

    2

    Title

    Application Submission

    Description

    Submit complete registration dossier to BDA including device description, risk analysis, and testing reports.

    Duration

    1-2 weeks

    Icon

    📤

  • Step

    3

    Title

    Administrative Review

    Description

    BDA reviews application for completeness. May request additional documents or clarifications.

    Duration

    2-4 weeks

    Icon

    🔍

  • Step

    4

    Title

    Technical Evaluation

    Description

    In-depth technical assessment of device safety and performance. BDA may issue questions.

    Duration

    0 days

    Icon

    ⚙️

  • Step

    5

    Title

    Registration Approval

    Description

    Upon successful review, BDA issues Bulgaria market authorization certificate.

    Duration

    1-2 weeks

    Icon

    ✅

Government fee schedules · 1 record
Open Bulgaria fees →
Jurisdiction Id

bulgaria

Country

Bulgaria

Country Code

BG

Authority

BDA

Low Risk Local
Min

255.65

Max

255.65

Currency

EUR

Per Product

Yes

High Risk Local
Min

255.65

Max

255.65

Currency

EUR

Per Product

Yes

Details
  • Id

    class-i-registration

    Item

    Class I device registration (single device)

    Currency

    EUR

    Amount Local

    255.65

    Amount Local Formatted

    EUR 255.65

    Frequency

    Per device

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.bda.bg/images/stories/documents/regulations/Тарифа%20медицински%20изделия.pdf

    Source Title

    Bulgarian Drug Agency tariff for medical devices (effective 1 January 2026)

    Source Effective Date

    2026-01-01

    Verified On

    2026-08-25

  • Id

    class-i-group-registration

    Item

    Class I device registration (group of devices)

    Currency

    EUR

    Amount Local

    281.21

    Amount Local Min

    281.21

    Amount Local Max

    1227.1

    Amount Local Formatted

    EUR 281.21–1,227.10

    Frequency

    Per group

    Notes

    Rises with the number of devices in the group up to EUR 1,227.10.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.bda.bg/images/stories/documents/regulations/Тарифа%20медицински%20изделия.pdf

    Source Title

    Bulgarian Drug Agency tariff for medical devices (effective 1 January 2026)

    Source Effective Date

    2026-01-01

    Verified On

    2026-08-25

  • Id

    custom-made-registration

    Item

    Custom-made device registration (single device)

    Currency

    EUR

    Amount Local

    25.56

    Amount Local Formatted

    EUR 25.56

    Frequency

    Per device

    Notes

    Groups: EUR 102.26 up to EUR 766.94.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.bda.bg/images/stories/documents/regulations/Тарифа%20медицински%20изделия.pdf

    Source Title

    Bulgarian Drug Agency tariff for medical devices (effective 1 January 2026)

    Source Effective Date

    2026-01-01

    Verified On

    2026-08-25

  • Id

    ivd-list-a-b-registration

    Item

    IVD List A/B registration (single device)

    Currency

    EUR

    Amount Local

    204.52

    Amount Local Formatted

    EUR 204.52

    Frequency

    Per device

    Notes

    Applies to immunological and molecular-biology IVDs; other IVDs: EUR 51.13 single, groups EUR 255.65–1,124.84.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.bda.bg/images/stories/documents/regulations/Тарифа%20медицински%20изделия.pdf

    Source Title

    Bulgarian Drug Agency tariff for medical devices (effective 1 January 2026)

    Source Effective Date

    2026-01-01

    Verified On

    2026-08-25

  • Id

    class-i-change

    Item

    Change to a registered Class I device

    Currency

    EUR

    Amount Local

    127.82

    Amount Local Formatted

    EUR 127.82

    Frequency

    Per change

    Notes

    IVD changes: EUR 102.26.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.bda.bg/images/stories/documents/regulations/Тарифа%20медицински%20изделия.pdf

    Source Title

    Bulgarian Drug Agency tariff for medical devices (effective 1 January 2026)

    Source Effective Date

    2026-01-01

    Verified On

    2026-08-25

  • Id

    clinical-investigation-permit

    Item

    Clinical-investigation permit assessment

    Currency

    EUR

    Amount Local

    1533.88

    Amount Local Formatted

    EUR 1,533.88

    Frequency

    Per application

    Notes

    Change to a permit: EUR 76.69.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.bda.bg/images/stories/documents/regulations/Тарифа%20медицински%20изделия.pdf

    Source Title

    Bulgarian Drug Agency tariff for medical devices (effective 1 January 2026)

    Source Effective Date

    2026-01-01

    Verified On

    2026-08-25

  • Id

    wholesale-certificate

    Item

    Wholesale-activity certificate

    Currency

    EUR

    Amount Local

    1533.88

    Amount Local Formatted

    EUR 1,533.88

    Frequency

    Per certificate

    Notes

    Change: EUR 76.69.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.bda.bg/images/stories/documents/regulations/Тарифа%20медицински%20изделия.pdf

    Source Title

    Bulgarian Drug Agency tariff for medical devices (effective 1 January 2026)

    Source Effective Date

    2026-01-01

    Verified On

    2026-08-25

  • Id

    wholesale-permit

    Item

    Wholesale permit (import/export/distribution)

    Currency

    EUR

    Amount Local

    2556.46

    Amount Local Formatted

    EUR 2,556.46

    Frequency

    Per permit

    Notes

    Change: EUR 127.82.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.bda.bg/images/stories/documents/regulations/Тарифа%20медицински%20изделия.pdf

    Source Title

    Bulgarian Drug Agency tariff for medical devices (effective 1 January 2026)

    Source Effective Date

    2026-01-01

    Verified On

    2026-08-25

Notes
  • Amounts follow the BDA tariff effective 1 January 2026.
Last Updated

2026-08-25

Verification Status

official-verified

Official Sources
  • Title

    Bulgarian Drug Agency tariff for medical devices (effective 1 January 2026)

    Url

    https://www.bda.bg/images/stories/documents/regulations/Тарифа%20медицински%20изделия.pdf

    Effective Date

    2026-01-01

    Accessed Date

    2026-08-25

Reviewed On

2026-08-25

Amount Status

exact-current

Range Available

Yes

Additional certifications and licences · 1 record
Open Bulgaria certifications →
Slug

bulgaria

Market

Bulgaria

Confidence

high

Schemes
  • Id

    lvd-medical-exclusion-mdr-electrical-safety

    Name

    MDR electrical safety in place of the Low Voltage Directive

    Category

    Medical Electrical Safety

    Status

    Included In Medical Registration

    Object

    Finished Device

    Note

    Annex II of Directive 2014/35/EU places electrical equipment for radiology and medical purposes outside the Low Voltage Directive, so there is no separate national electrical-safety certificate for a medical device. Electrical safety is assessed inside the MDR conformity assessment against MDR Annex I, with the harmonised IEC/EN 60601 series carrying the presumption of conformity.

    Source Urls
    • https://eur-lex.europa.eu/eli/dir/2014/35/oj
    Source Binding

    candidate

  • Id

    emc-directive-disapplied-by-mdr

    Name

    MDR electromagnetic compatibility in place of the EMC Directive

    Category

    emc

    Status

    Included In Medical Registration

    Object

    Finished Device

    Note

    Article 2(3) of Directive 2014/30/EU switches the EMC Directive off where other Union legislation lays the same essential requirements down more specifically, which MDR Annex I sections 18.5 and 18.6 do for medical devices. EMC is therefore dossier evidence inside the CE route and not a separate national EMC conformity step.

    Source Urls
    • https://eur-lex.europa.eu/eli/dir/2014/30/oj
    Source Binding

    candidate

  • Id

    naredba-pms-90-2016-radio-conformity

    Name

    Наредба за съществените изисквания и оценяване съответствието на радиосъоръженията

    Category

    Radio Spectrum

    Status

    Mandatory If Feature

    Object

    Radio Equipment

    Note

    Приета с ПМС № 90 от 19.04.2016 г. (ДВ, бр. 32 от 2016 г., in force 13 June 2016, last amended ДВ, бр. 103 от 2023 г.) transposes Directive 2014/53/EU and sets the essential requirements, conformity-assessment procedures and economic-operator duties for radio equipment; nothing in it creates a Bulgarian type approval, and чл. 4(2) forbids restricting the market access of compliant radio equipment. чл. 10, т. 1 is the point that matters for a connected device: the safety objectives of the low-voltage ordinance (ПМС № 47 от 2016 г.) are imported into the radio ordinance but without the voltage limit, and чл. 10, т. 2 imports the EMC ordinance level, so a wireless module below the LVD voltage floor is still assessed against those objectives. чл. 5 adds that putting radio equipment into service in Bulgaria may also be subject to requirements under the Закон за електронните съобщения, which is where spectrum authorisation lives.

    Source Binding

    unresolved

  • Id

    naredba-pms-55-2013-rohs

    Name

    Наредба за пускане на пазара на ЕЕО във връзка с ограниченията за употреба на определени опасни вещества

    Category

    Environmental And Batteries

    Status

    Evidence Only No Separate Certificate

    Object

    Electrical Electronic Medical Device

    Note

    Приета с ПМС № 55 от 06.03.2013 г. (ДВ, бр. 24 от 2013 г., last amended ДВ, бр. 30 от 2016 г.). чл. 2(1) bans placing on the market electrical and electronic equipment, cables and repair, reuse, upgrade or capacity-increase spare parts containing the приложение № 1 substances above the concentration limits, and чл. 1(2) does not restate the categories but points at чл. 21е, ал. 2 ЗЗВВХВС, with the exclusions in ал. 3. §3(1) of the transitional provisions carries the Bulgarian-specific dates: the DEHP, BBP, DBP and DIBP restrictions in т. 7–10 apply from 22 July 2019 generally but only from 22 July 2021 to medical devices, in vitro diagnostics and monitoring and control instruments, and §3(2) leaves devices placed on the market before that date outside them. Exemptions are not granted nationally: чл. 3 sends the application to the European Commission, and the minister of environment and water then records the outcome by order under чл. 21д, ал. 3 ЗЗВВХВС. Directive 2011/65/EU Annex I category 8 covers medical devices, Article 4(3) has bound medical devices since 22 July 2014 and in vitro diagnostic medical devices since 22 July 2016, and Article 2(4)(h) excludes active implantable medical devices.

    Source Binding

    unresolved

  • Id

    iaos-eeo-producer-register

    Name

    ИАОС register of persons placing electrical and electronic equipment on the market

    Category

    Environmental And Batteries

    Status

    Mandatory If Feature

    Object

    Producer Or Authorised Representative

    Note

    Наредба за излязлото от употреба електрическо и електронно оборудване (ПМС № 256 от 13.11.2013 г., ДВ, бр. 100 от 2013 г.) чл. 48(1) obliges everyone who places EEE on the Bulgarian market, including at a distance, or their authorised commercial representative, to ask to be entered in the register under чл. 45, ал. 1, т. 3 ЗУО; чл. 48(2) sets a one-month deadline running from the start of the placing-on-the-market activity and requires the filing to be made electronically on the ИАОС website, listing the name and ЕИК, the trade marks used in the country, the correspondence address, the contact person, the equipment categories and whether obligations are met individually or through a recovery organisation. чл. 49 puts the same one-month deadline on notifying changes and on asking to be struck off when the activity stops. Medical devices are named inside categories 4 and 5 of приложение № 3 (large and small appliances by external dimension), so an in-scope device is registrable, while чл. 4, т. 11 keeps out devices expected to be infective before end of life and active implantable devices. Directive 2012/19/EU Article 2(4)(g) excludes devices expected to be infective before end of life and active implantable devices; other medical devices are in scope, and Article 16 requires each Member State to keep a producer register.

    Source Urls
    • https://eur-lex.europa.eu/eli/dir/2012/19/oj
    Source Binding

    candidate

  • Id

    iaos-battery-producer-register

    Name

    ИАОС battery and accumulator producer register

    Category

    Environmental And Batteries

    Status

    Mandatory If Feature

    Object

    Battery Producer Or Authorised Representative

    Note

    Наредба за батерии и акумулатори и за негодни за употреба батерии и акумулатори (ПМС № 351 от 27.12.2012 г., ДВ, бр. 2 от 2013 г.) чл. 54(1) covers everyone placing batteries and accumulators on the market including those built into appliances, and чл. 54(2) again gives one month from the start of the activity to file electronically with ИАОС, naming the battery type as portable, automotive or industrial and the individual or collective compliance route; чл. 55 gives the ИАОС executive director 10 days to act on the filing. чл. 6(3) bans portable batteries above 0.002 % cadmium by weight, including built-in ones, but чл. 6(4), т. 2 exempts portable batteries intended for medical equipment. The version published by the environment ministry is consolidated only to ДВ, бр. 51 от 2013 г. and contains no reference to Regulation (EU) 2023/1542, so the national ordinance still rests on the repealed Directive 2006/66/EC and no Article 55 designation has been made in it; the Regulation applies directly in the meantime. Article 11(2)(b) of Regulation (EU) 2023/1542 lets professional medical imaging and radiotherapy devices and in vitro diagnostic medical devices restrict portable-battery replacement to independent professionals, and Article 11(3) lifts the removability duty where continuity of supply is needed for safety or data integrity.

    Source Binding

    unresolved

  • Id

    produktova-taksa-or-recovery-organisation

    Name

    Продуктова такса, avoidable through individual compliance or a recovery organisation

    Category

    Environmental And Batteries

    Status

    Mandatory If Feature

    Object

    Producer Or Authorised Representative

    Note

    The register entry is only the visible half of the obligation; the money sits in Наредба за определяне на реда и размера за заплащане на продуктова такса (ПМС № 120 от 30.05.2008 г., ДВ, бр. 53 от 2008 г., last amended ДВ, бр. 100 от 2013 г.). чл. 1(1) makes everyone placing on the Bulgarian market products that become mass-spread waste after use liable for the product fee, and чл. 1(2) defines those persons as producers, importers and persons bringing the products into the territory. The fee is what an EEE producer avoids by meeting the collection and recovery targets, and чл. 3(5) provides that missing the WEEE collection target makes the full product fee payable on the entire quantity of equipment placed on the market in the previous year, with чл. 3(6) charging the full fee per приложение category for a missed recovery or reuse and recycling target. For a device manufacturer the practical consequence is that the ИАОС registration should be paired with either a contract with a recovery organisation or an approved individual programme.

    Source Binding

    unresolved

  • Id

    zmi-iso-15225-nomenclature-wholesale-permit

    Name

    ЗМИ ISO 15225 nomenclature listing for wholesale permits

    Category

    Product Specific Conformity

    Status

    Included In Medical Registration

    Object

    Wholesale Permit Device List

    Note

    Art. 78 ЗМИ requires wholesale-permit applicants to list device categories according to the БДС EN ISO 15225 nomenclature system; market-surveillance testing under Art. 93(2) ЗМИ must be carried out in a laboratory accredited by the Bulgarian Accreditation Service (Изпълнителна агенция «Българска служба за акредитация») or by an authority of another EU/EEA member state.

    Source Urls
    • https://lex.bg/bg/laws/ldoc/2135555444
    Source Binding

    reviewed

Official Sources
  • Authority

    EUR-Lex

    Topic

    Low Voltage Directive 2014/35/EU Annex II — electrical equipment for radiology and medical purposes outside scope

    Url

    https://eur-lex.europa.eu/eli/dir/2014/35/oj

  • Authority

    EUR-Lex

    Topic

    EMC Directive 2014/30/EU Article 2(3) — more specific Union legislation displaces the directive

    Url

    https://eur-lex.europa.eu/eli/dir/2014/30/oj

  • Authority

    EUR-Lex

    Topic

    RoHS Directive 2011/65/EU Annex I category 8 and Article 4(3) medical-device application dates

    Url

    https://eur-lex.europa.eu/eli/dir/2011/65/oj

  • Authority

    EUR-Lex

    Topic

    WEEE Directive 2012/19/EU Article 2(4)(g) medical-device exclusions and Article 16 national producer register

    Url

    https://eur-lex.europa.eu/eli/dir/2012/19/oj

  • Authority

    EUR-Lex

    Topic

    Batteries Regulation (EU) 2023/1542 Articles 11 and 55 — medical-device removability derogation and producer register

    Url

    https://eur-lex.europa.eu/eli/reg/2023/1542/oj

  • Authority

    Държавна агенция за метрологичен и технически надзор (ДАМТН)

    Topic

    Наредба за съществените изисквания и оценяване съответствието на радиосъоръженията — consolidated text published by the agency, чл. 2–5 and чл. 10

    Url

    https://www.damtn.government.bg/wp-content/uploads/2019/02/naredba_za_sysestvenite_iziskvaniq_i_ocenqvane_syotvetstvieto_na_radiosyoryjeniqta_nova.pdf

  • Authority

    Държавна агенция за метрологичен и технически надзор (ДАМТН)

    Topic

    Наредба за пускане на пазара на ЕЕО във връзка с ограниченията за употреба на определени опасни вещества — чл. 1–3 and §3 of the transitional provisions

    Url

    https://www.damtn.government.bg/wp-content/uploads/2019/02/naredba_za_usloviata_i_reda_za_puskane_na_pazara_na_elektrichesko.pdf

  • Authority

    Министерство на околната среда и водите

    Topic

    Наредба за излязлото от употреба електрическо и електронно оборудване — чл. 3, чл. 4, чл. 48–49 and приложение № 3

    Url

    https://www.moew.government.bg/wp-content/uploads/filebase/Waste/Legislation/Naredbi/waste/NAREDBA_za_izlqzloto_ot_upotreba_elektrichesko_i_elektronno_oborudvane.rtf

  • Authority

    Министерство на околната среда и водите

    Topic

    Наредба за батерии и акумулатори и за негодни за употреба батерии и акумулатори — чл. 6, чл. 54–55

    Url

    https://www.moew.government.bg/wp-content/uploads/filebase/Waste/Legislation/Naredbi/waste/Naredba_za_BA_i_za_NUBA.pdf

  • Authority

    Министерство на околната среда и водите

    Topic

    Наредба за определяне на реда и размера за заплащане на продуктова такса — чл. 1 and чл. 3

    Url

    https://www.moew.government.bg/wp-content/uploads/filebase/Waste/Legislation/Naredbi/waste/NAREDBA_za_opredelqne_na_reda_i_razmera_za_zaplasane_na_produktova_taksa.pdf

  • Authority

    Lex.bg

    Topic

    Закон за медицинските изделия Art. 78 БДС EN ISO 15225 nomenclature and Art. 93(2) accredited-laboratory testing

    Url

    https://lex.bg/bg/laws/ldoc/2135555444

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