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 ИАОС battery and accumulator producer register in Bulgaria?
Describe your device to check whether ИАОС battery and accumulator producer register 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 ИАОС battery and accumulator producer register check is screening
Identifies RoHS, WEEE/EPR, battery, recycling, and producer obligations without miscalling them safety certificates. Applies when the product, feature, component, or use is in scope.
- Requirement family
- Environmental and battery obligations
- Regulatory object
- battery producer or authorised representative
- Maintained rule status
- mandatory if feature
- Useful product facts
- Battery chemistry/capacity, electrical equipment, importer/producer role, packaging, and market date.
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 and contains no reference to Regulation (EU) 2023/1542, so the national ordinance still rests on the repealed Directive 2006/66/EC and no Article 55 designation has been made in it; the Regulation applies directly in the meantime.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.
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.
Wireless / radio
Наредба за съществените изисквания и оценяване съответствието на радиосъоръженията
Applies when the product, feature, component, or use is in scope.
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
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.
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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