Explore the IVD requirements currently available for Bulgaria, organized by topic and linked to official sources.
Source-linked rules for common changes to a registered IVD. Read the scope and conditions with each rule; unverified details are listed separately.
A change to the registered brand name and a change to logo artwork can follow different rules. The legal manufacturer, device design and intended purpose remain the same.
A source-verified answer for this specific scenario is not yet published.
The same legal manufacturer changes its name, potentially alongside the device brand. A transfer to another legal entity is a separate question; permission to combine filings needs its own evidence.
A source-verified answer for this specific scenario is not yet published.
An office address change for the same legal entity, potentially alongside name and brand changes. This does not cover moving a factory or manufacturing site, and a combined filing cannot be assumed.
A source-verified answer for this specific scenario is not yet published.
Check which identifier actually changes. A commercial catalogue, REF or order code is not automatically a device model, registered identifier, GTIN or UDI-DI. Rules for one identifier do not establish the route for another.
A source-verified answer for this specific scenario is not yet published.
A real change of legal manufacturer, registration holder or owner. This differs from renaming the same entity; a change of local representative or importer alone does not establish a registration transfer route. Where other changes occur with the transfer, the exact combination and sequence need separate evidence.
A source-verified answer for this specific scenario is not yet published.
Changes to brand, manufacturer name, office address and reference codes may occur together, including with a real transfer to another legal manufacturer, registration holder or owner. Assess transfer with each single change, and transfer with brand plus reference, manufacturer name plus reference, or office address plus reference changes: seven transfer combinations in total. Evidence must establish the exact combination and the order of filings and approvals. These combinations and their sequence are not all verified by the rules below; a rule for one change does not prove that a single application, fee or review period covers the combination.
A source-verified answer for this specific scenario is not yet published.
What expires, what is retained periodically, and when must renewal start?
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.
Changes trigger a change application under ЗМИ Art. 27(3)/28(7) with a tariff fee.
Does the event require internal documentation, notice, prior approval, transfer, or a new 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) / Art. 28(7) (IVDs); a change fee per the tariff applies, and address changes are notified within 14 days.
Which evidence, local deltas, formats, and signatures are required?
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.
What regulator fee applies to this class, route, event, and date?
Fees for registration and issuance of registration certificates, for permits and certificates under ЗМИ, and for entry of changes therein are charged in amounts set by a tariff approved by the Council of Ministers (Тарифа, adopted by Decree ПМС № 339 of 09.12.2011, amended by Decree № 359 of 29.12.2025, effective 01.01.2026).
Fee amounts are recorded as typedFindings (government-fees).
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.
Effective from 2011-12-16
Which current law, regulation, guidance, and transition provisions apply?
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 remains the national basis for registration, wholesale-trade permits, clinical investigations, vigilance and market surveillance alongside the directly applicable MDR/IVDR.
Effective from 2007-06-12
ЗМИ transposed the legacy device directives and was retained and amended as the national framework; MDR/IVDR apply directly.
Which current form, portal, account, and submission package must be used?
BDA national forms plus EUDAMED shared layer
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.
Which registration, notification, listing, reliance, or conformity route applies?
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.
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)
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.
Which foreign decisions or evidence can be reused, with what effect and conditions?
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.
No linked record is currently maintained. This does not establish that a pathway is unavailable.
Prior approval / evidence record
FDA 510(k)/PMA
No
No substitute for EU MDR conformity assessment; useful as predicate documentation in the technical file
Maintained reference · planning ranges remain estimates · reviewed 2026-08-29
Regulatory reference
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.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
bulgaria
All NMPA classes (I filing, II, III) -> all EU MDR/IVDR classes
No Reliance Route
none
Product Marketing
null
null
Independent review of current EUR-Lex consolidations supports this bounded ordinary-route conclusion. It does not establish the absence of every special route.
Prior approval / evidence record
geo:bgr
EU CE under MDR/IVDR
Single Market Validity
direct
Product Marketing
Yes
No
No
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.
Which UDI, device listing, database, and traceability duties apply?
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.
No maintained record.
These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.
Bulgaria
bulgaria
BG
🇧🇬
Bulgarian Drug Agency
BDA
europe
3
4-class (I, IIa, IIb, III) — EU MDR
class-i
Class I
low
Self-declaration (no notified body)
0
0
days
official-verified
EUR-Lex Regulation (EU) 2017/745 (MDR)
https://eur-lex.europa.eu/eli/reg/2017/745/oj
2026-08-25
6
9
months
No
No
Yes
FDA 510(k)/PMA
No
No substitute for EU MDR conformity assessment; useful as predicate documentation in the technical file
Yes
EU Authorized Representative
No
ISO 13485 accepted as QMS evidence
5 years (CE certificate)
2026-08-29
partially-verified
Commission Implementing Regulation (EU) 2026/977, Art. 2 — maximum notified-body conformity assessment timelines (30 + 120/90 parallel + 20 days)
https://eur-lex.europa.eu/eli/reg_impl/2026/977/oj
2027-02-25
2026-08-29
EUR-Lex Regulation (EU) 2017/745 (MDR)
https://eur-lex.europa.eu/eli/reg/2017/745/oj
2026-08-25
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)
https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:02017R0745-20250110
2026-08-29
2026-08-29
default
planning-template
Maintained planning steps and estimates, not verified regulator deadlines.
1
Pre-Submission Preparation
Gather technical documentation, quality management system (QMS) records, and clinical data required by BDA. Appoint a EU Authorized Representative.
1-3 months
📋
2
Application Submission
Submit complete registration dossier to BDA including device description, risk analysis, and testing reports.
1-2 weeks
📤
3
Administrative Review
BDA reviews application for completeness. May request additional documents or clarifications.
2-4 weeks
🔍
4
Technical Evaluation
In-depth technical assessment of device safety and performance. BDA may issue questions.
0 days
⚙️
5
Registration Approval
Upon successful review, BDA issues Bulgaria market authorization certificate.
1-2 weeks
✅
These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.
bulgaria
Bulgaria
BG
BDA
255.65
255.65
EUR
Yes
255.65
255.65
EUR
Yes
class-i-registration
Class I device registration (single device)
EUR
255.65
EUR 255.65
Per device
exact-current
official-verified
https://www.bda.bg/images/stories/documents/regulations/Тарифа%20медицински%20изделия.pdf
Bulgarian Drug Agency tariff for medical devices (effective 1 January 2026)
2026-01-01
2026-08-25
class-i-group-registration
Class I device registration (group of devices)
EUR
281.21
281.21
1227.1
EUR 281.21–1,227.10
Per group
Rises with the number of devices in the group up to EUR 1,227.10.
exact-current
official-verified
https://www.bda.bg/images/stories/documents/regulations/Тарифа%20медицински%20изделия.pdf
Bulgarian Drug Agency tariff for medical devices (effective 1 January 2026)
2026-01-01
2026-08-25
custom-made-registration
Custom-made device registration (single device)
EUR
25.56
EUR 25.56
Per device
Groups: EUR 102.26 up to EUR 766.94.
exact-current
official-verified
https://www.bda.bg/images/stories/documents/regulations/Тарифа%20медицински%20изделия.pdf
Bulgarian Drug Agency tariff for medical devices (effective 1 January 2026)
2026-01-01
2026-08-25
ivd-list-a-b-registration
IVD List A/B registration (single device)
EUR
204.52
EUR 204.52
Per device
Applies to immunological and molecular-biology IVDs; other IVDs: EUR 51.13 single, groups EUR 255.65–1,124.84.
exact-current
official-verified
https://www.bda.bg/images/stories/documents/regulations/Тарифа%20медицински%20изделия.pdf
Bulgarian Drug Agency tariff for medical devices (effective 1 January 2026)
2026-01-01
2026-08-25
class-i-change
Change to a registered Class I device
EUR
127.82
EUR 127.82
Per change
IVD changes: EUR 102.26.
exact-current
official-verified
https://www.bda.bg/images/stories/documents/regulations/Тарифа%20медицински%20изделия.pdf
Bulgarian Drug Agency tariff for medical devices (effective 1 January 2026)
2026-01-01
2026-08-25
clinical-investigation-permit
Clinical-investigation permit assessment
EUR
1533.88
EUR 1,533.88
Per application
Change to a permit: EUR 76.69.
exact-current
official-verified
https://www.bda.bg/images/stories/documents/regulations/Тарифа%20медицински%20изделия.pdf
Bulgarian Drug Agency tariff for medical devices (effective 1 January 2026)
2026-01-01
2026-08-25
wholesale-certificate
Wholesale-activity certificate
EUR
1533.88
EUR 1,533.88
Per certificate
Change: EUR 76.69.
exact-current
official-verified
https://www.bda.bg/images/stories/documents/regulations/Тарифа%20медицински%20изделия.pdf
Bulgarian Drug Agency tariff for medical devices (effective 1 January 2026)
2026-01-01
2026-08-25
wholesale-permit
Wholesale permit (import/export/distribution)
EUR
2556.46
EUR 2,556.46
Per permit
Change: EUR 127.82.
exact-current
official-verified
https://www.bda.bg/images/stories/documents/regulations/Тарифа%20медицински%20изделия.pdf
Bulgarian Drug Agency tariff for medical devices (effective 1 January 2026)
2026-01-01
2026-08-25
2026-08-25
official-verified
Bulgarian Drug Agency tariff for medical devices (effective 1 January 2026)
https://www.bda.bg/images/stories/documents/regulations/Тарифа%20медицински%20изделия.pdf
2026-01-01
2026-08-25
2026-08-25
exact-current
Yes
These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.
bulgaria
Bulgaria
high
lvd-medical-exclusion-mdr-electrical-safety
MDR electrical safety in place of the Low Voltage Directive
Medical Electrical Safety
Included In Medical Registration
Finished Device
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.
candidate
emc-directive-disapplied-by-mdr
MDR electromagnetic compatibility in place of the EMC Directive
emc
Included In Medical Registration
Finished Device
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.
candidate
naredba-pms-90-2016-radio-conformity
Наредба за съществените изисквания и оценяване съответствието на радиосъоръженията
Radio Spectrum
Mandatory If Feature
Radio Equipment
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.
unresolved
naredba-pms-55-2013-rohs
Наредба за пускане на пазара на ЕЕО във връзка с ограниченията за употреба на определени опасни вещества
Environmental And Batteries
Evidence Only No Separate Certificate
Electrical Electronic Medical Device
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.
unresolved
iaos-eeo-producer-register
ИАОС register of persons placing electrical and electronic equipment on the market
Environmental And Batteries
Mandatory If Feature
Producer Or Authorised Representative
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.
candidate
iaos-battery-producer-register
ИАОС battery and accumulator producer register
Environmental And Batteries
Mandatory If Feature
Battery Producer Or Authorised Representative
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.
unresolved
produktova-taksa-or-recovery-organisation
Продуктова такса, avoidable through individual compliance or a recovery organisation
Environmental And Batteries
Mandatory If Feature
Producer Or Authorised Representative
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.
unresolved
zmi-iso-15225-nomenclature-wholesale-permit
ЗМИ ISO 15225 nomenclature listing for wholesale permits
Product Specific Conformity
Included In Medical Registration
Wholesale Permit Device List
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.
reviewed
EUR-Lex
Low Voltage Directive 2014/35/EU Annex II — electrical equipment for radiology and medical purposes outside scope
https://eur-lex.europa.eu/eli/dir/2014/35/oj
EUR-Lex
EMC Directive 2014/30/EU Article 2(3) — more specific Union legislation displaces the directive
https://eur-lex.europa.eu/eli/dir/2014/30/oj
EUR-Lex
RoHS Directive 2011/65/EU Annex I category 8 and Article 4(3) medical-device application dates
https://eur-lex.europa.eu/eli/dir/2011/65/oj
EUR-Lex
WEEE Directive 2012/19/EU Article 2(4)(g) medical-device exclusions and Article 16 national producer register
https://eur-lex.europa.eu/eli/dir/2012/19/oj
EUR-Lex
Batteries Regulation (EU) 2023/1542 Articles 11 and 55 — medical-device removability derogation and producer register
https://eur-lex.europa.eu/eli/reg/2023/1542/oj
Държавна агенция за метрологичен и технически надзор (ДАМТН)
Наредба за съществените изисквания и оценяване съответствието на радиосъоръженията — consolidated text published by the agency, чл. 2–5 and чл. 10
https://www.damtn.government.bg/wp-content/uploads/2019/02/naredba_za_sysestvenite_iziskvaniq_i_ocenqvane_syotvetstvieto_na_radiosyoryjeniqta_nova.pdf
Държавна агенция за метрологичен и технически надзор (ДАМТН)
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
https://www.damtn.government.bg/wp-content/uploads/2019/02/naredba_za_usloviata_i_reda_za_puskane_na_pazara_na_elektrichesko.pdf
Министерство на околната среда и водите
Наредба за излязлото от употреба електрическо и електронно оборудване — чл. 3, чл. 4, чл. 48–49 and приложение № 3
https://www.moew.government.bg/wp-content/uploads/filebase/Waste/Legislation/Naredbi/waste/NAREDBA_za_izlqzloto_ot_upotreba_elektrichesko_i_elektronno_oborudvane.rtf
Министерство на околната среда и водите
Наредба за батерии и акумулатори и за негодни за употреба батерии и акумулатори — чл. 6, чл. 54–55
https://www.moew.government.bg/wp-content/uploads/filebase/Waste/Legislation/Naredbi/waste/Naredba_za_BA_i_za_NUBA.pdf
Министерство на околната среда и водите
Наредба за определяне на реда и размера за заплащане на продуктова такса — чл. 1 and чл. 3
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
Lex.bg
Закон за медицинските изделия Art. 78 БДС EN ISO 15225 nomenclature and Art. 93(2) accredited-laboratory testing
https://lex.bg/bg/laws/ldoc/2135555444
