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 ЗМИ ISO 15225 nomenclature listing for wholesale permits in Bulgaria?
Describe your device to check whether ЗМИ ISO 15225 nomenclature listing for wholesale permits may apply, why, what facts are missing, and which official source to review.
1 maintained routes1 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 ЗМИ ISO 15225 nomenclature listing for wholesale permits check is screening
Checks listed products such as syringes, needles, gloves, condoms, implants, IUDs, and blood bags. Evidence is normally handled inside the medical-device registration route.
Source association reviewed. The source association has been reviewed. This does not verify every rule, date or product-specific conclusion; read the cited provisions and their limits.
- Requirement family
- Product-specific compulsory conformity
- Regulatory object
- wholesale permit device list
- Maintained rule status
- included in medical registration
- Useful product facts
- Exact product category, sterile/single-use status, materials, variants, and applicable product standard.
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.
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.
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.
No supporting source association
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
Reviewed source associations
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 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
Need help confirming a classification or planning your registration?
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