Product approval
A certificate or approval attached to the finished product, component, or radio host.
Free · No signup · Official source linksDoes my medical device need Наредба за съществените изисквания и оценяване съответствието на радиосъоръженията in Bulgaria?
Describe your device to check whether Наредба за съществените изисквания и оценяване съответствието на радиосъоръженията may apply, why, what facts are missing, and which official source to review.
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.
Maintained country rule
What this Наредба за съществените изисквания и оценяване съответствието на радиосъоръженията check is screening
Checks Wi-Fi, Bluetooth, cellular, NFC, RFID, UWB, telemetry, and proprietary radio approval. Applies when the product, feature, component, or use is in scope.
- Requirement family
- Radio and spectrum approval
- Regulatory object
- radio equipment
- Maintained rule status
- mandatory if feature
- Useful product facts
- Radio technologies, bands, power, antenna, module model, approval IDs, and host integration changes.
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.
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
Other Bulgaria routes to check
Electrical safety
MDR electrical safety in place of the Low Voltage Directive
Evidence is normally handled inside the medical-device registration route.
EMC
MDR electromagnetic compatibility in place of the EMC Directive
Evidence is normally handled inside the medical-device registration route.
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.
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.
Environmental / battery
ИАОС battery and accumulator producer register
Applies when the product, feature, component, or use is in scope.
Environmental / battery
Продуктова такса, avoidable through individual compliance or a recovery organisation
Applies when the product, feature, component, or use is in scope.
Product-specific
ЗМИ ISO 15225 nomenclature listing for wholesale permits
Evidence is normally handled inside the medical-device registration route.
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.
The maintained country source registry does not yet map a direct authority page to this exact route. The checker will not substitute an unrelated source. Confirm the current scope with the responsible authority before relying on the result.
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 official source.
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
Need help confirming a classification or planning your registration?
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