Product approval
A certificate or approval attached to the finished product, component, or radio host.
Free · No signup · Official source linksBulgaria medical device certification and licence checker
Check Bulgaria requirements beyond medical-device classification, including radio, electrical, metrology, radiation, import, environmental, and product-specific routes.
8 maintained routes11 official source links
Preliminary applicability · country-specific scope
What you receive
Not just a yes or no
A route-by-route answer. Separate product certificates, dossier evidence, import documents, and facility licences stay separate.
Trigger reasoning. See which product facts matter and which missing facts prevent a reliable conclusion.
Official starting points. Open the regulator or government sources behind the maintained country matrix.
How to read the answer
Classification is only the first layer
A device may have one medical risk class and still trigger separate radio, electrical, measurement, radiation, environmental, import, or installation requirements. The checker keeps each regulatory object separate.
Dossier or import evidence
Testing can belong inside the medical dossier, while some documents apply to each shipment.
Site or operator licence
Radiation, installation, use, or measurement controls may apply to a facility or operator.
Country-specific scope
Medical device certification routes in Bulgaria
Electrical safety
MDR electrical safety in place of the Low Voltage Directive
Evidence is normally handled inside the medical-device registration route.
Source association awaiting review
EMC
MDR electromagnetic compatibility in place of the EMC Directive
Evidence is normally handled inside the medical-device registration route.
Source association awaiting review
Wireless / radio
Наредба за съществените изисквания и оценяване съответствието на радиосъоръженията
Applies when the product, feature, component, or use is in scope.
No supporting source association
Environmental / battery
Наредба за пускане на пазара на ЕЕО във връзка с ограниченията за употреба на определени опасни вещества
Evidence may be required, but the matrix does not identify a generic separate certificate.
No supporting source association
Environmental / battery
ИАОС register of persons placing electrical and electronic equipment on the market
Applies when the product, feature, component, or use is in scope.
Source association awaiting review
Environmental / battery
ИАОС battery and accumulator producer register
Applies when the product, feature, component, or use is in scope.
Source association awaiting review
Environmental / battery
Продуктова такса, avoidable through individual compliance or a recovery organisation
Applies when the product, feature, component, or use is in scope.
No supporting source association
Product-specific
ЗМИ ISO 15225 nomenclature listing for wholesale permits
Evidence is normally handled inside the medical-device registration route.
Source association awaiting review
Official starting points
Use these authority pages to confirm current scope, technical rules, application routes, and transition dates. A linked source does not turn a preliminary result into an authority decision.
EUR-Lex
Low Voltage Directive 2014/35/EU Annex II — electrical equipment for radiology and medical purposes outside scope
EUR-Lex
EMC Directive 2014/30/EU Article 2(3) — more specific Union legislation displaces the directive
EUR-Lex
RoHS Directive 2011/65/EU Annex I category 8 and Article 4(3) medical-device application dates
EUR-Lex
WEEE Directive 2012/19/EU Article 2(4)(g) medical-device exclusions and Article 16 national producer register
EUR-Lex
Batteries Regulation (EU) 2023/1542 Articles 11 and 55 — medical-device removability derogation and producer register
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
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
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
Министерство на околната среда и водите
Наредба за батерии и акумулатори и за негодни за употреба батерии и акумулатори — чл. 6, чл. 54–55
Министерство на околната среда и водите
Наредба за определяне на реда и размера за заплащане на продуктова такса — чл. 1 and чл. 3
Lex.bg
Закон за медицинските изделия Art. 78 БДС EN ISO 15225 nomenclature and Art. 93(2) accredited-laboratory testing
About this checker
A preliminary tool, not a regulatory determination
Describe the complete product — radio, power, measurement, radiation, battery, materials, accessories, intended use, import route, and existing approvals. The free checker maps those facts to the maintained Bulgaria scheme matrix and links each route to its maintained source associations, with reviewed, candidate and unresolved states shown separately.
Use the result to identify questions and official sources. Final scope can depend on exact models, modules, bands, components, claims, HS codes, import structure, installation site, and current authority interpretation.
- Is this the same as medical device classification in Bulgaria?
- No. Risk classification determines the main medical-device pathway. This checker runs after classification and looks for additional product certificates, dossier evidence, import documents, and facility or operator licences.
- Does “no separate certificate” mean no testing is required?
- No. Safety, EMC, performance, or other evidence can still be required inside the medical-device dossier even when there is no separate national product certificate.
- Is the result an official regulatory determination?
- No. It is a preliminary applicability assessment. Review the linked official source and confirm the final route with the relevant authority, certification body, importer, or regulatory professional.
DJ Fang
MedTech Regulatory Expert
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