EU Market Entry & Romania Distribution for Medical Devices and Evidence-Based Food Supplements
Romania-based partner managing regulatory pathway, local authorisations, and commercial rollout—pharmacies, e-commerce, and hospital tenders.
What we do
Regulatory execution and market access for medical devices and food supplements—Romania-first, EU-ready.
MEDICAL DEVICES
EU MDR/IVDR Readiness
EU market entry support for medical devices, covering importer/distributor obligations and Romania execution.
FOOD SUPPLEMENTS
EU + Romania Compliance
EU-aligned formula and labeling readiness, plus Romania notification dossier preparation for compliant market entry
ROMANIA MARKET ACCESS
Romania Market Access
Commercial rollout in Romania via pharmacy channels, compliant marketplaces, and hospital tender readiness.
Why Europe, why now
The EU single market combines scale with a harmonised regulatory framework—making it one of the most attractive regions for compliant, evidence-based healthcare products.
- Access to the EU single market through an EU-based commercial and regulatory setup
- A large consumer market with strong demand for compliant healthcare products
- A mature medtech ecosystem with established procurement and distribution channels
- Strong B2B infrastructure supporting partnerships and scale
27
EU Member States in the single market
~450M
Consumers in the EU single market
€170B
European medical technology market
~23M
Companies in the EU single market
Sources: European Commission; Council of the EU; MedTech Europe.
Why Romania
Romania is an EU Member State and can serve as a practical base for EU economic-operator setup and first-market execution—combining regulatory discipline with hands-on commercial rollout.
- EU-based economic-operator setup: structured onboarding for importer/distributor responsibilities under EU rules (MDR/IVDR where applicable)
- Romania authority pathway management: support for ANMDMR steps related to import activity approval and national database registration workflows for medical devices.
- Food supplement notification support: guidance aligned with Romania’s official notification framework published by the Ministry of Health (CRSP routes as applicable).
- Commercial execution: Romania go-to-market across regulated channels (pharmacies, e-commerce, and hospital tenders), built on local operational experience.
Romania-first, EU-ready expansion
Any EU Member State can be an entry base. We focus on Romania because we can execute end-to-end locally—regulatory setup, authority workflows, and commercial rollout—then support structured expansion into additional EU markets.
References: European Union; ANMDMR (Romania); Ministry of Health (Romania).
EU BASE
EU Economic-Operator Setup
Importer/distributor readiness for non-EU manufacturers entering the EU, with audit-friendly documentation workflows.
FOOD SUPPLEMENTS
Romania Notification Support
Dossier and label readiness aligned with Romania’s food supplement notification framework (Ministry of Health / CRSP route as applicable).
MEDICAL DEVICES
ANMDMR Pathway Support
Romania-specific operational guidance for medical device import/distribution requirements with the competent authority (ANMDMR).
ROMANIA EXECUTION
Romania Go-To-Market
Pharmacy channel rollout, compliant marketplaces, and hospital tender readiness based on local execution capability.
How it works
01 → 02 → 03 → 04 → 05
STEP 01
Regulatory screening
- Confirm product route: Medical Device (MDR) / IVD (IVDR) / Food Supplement
- Review intended purpose + claims and identify compliance gaps
- Define the economic-operator setup needed for EU market entry (importer/distributor model)
Output: Regulatory screening memo + gap checklist
STEP 02
Documentation & labelling readiness
- Align technical/commercial documentation to the applicable route (MDR/IVDR or food rules)
- Prepare label/IFU readiness including Romanian language where required for the local launch
- Ensure information supplied with devices follows Member State language rules (as applicable)
Output: Label/IFU pack + claims alignment notes
STEP 03
Romania authorisations & notifications
Medical devices
- Support for ANMDMR/NAMMDR operating approvals for import/distribution activity in Romania
- EUDAMED economic operator registration workflow: submission → authority validation → SRN issued
Food supplements
- Dossier support aligned to Romania’s official notification pathway (MoH / CRSP / IBA, as applicable)
Output: Romania approval/notification dossier pack
STEP 04
Commercial launch in Romania
- Channel rollout: pharmacy chains + independents + compliant e-commerce
- Marketplace readiness (correct listings, compliant claims, traceability)
- Hospital/tender readiness where relevant (documentation discipline + procurement execution)
Output: Launch plan + compliant listings pack
STEP 05
Scale into other EU markets
- Medical devices: EU scaling is driven by MDR/IVDR compliance plus Member State requirements (notably language requirements for IFU/labeling).
- Supplements: expansion is assessed country-by-country (composition limits, claims, and notification rules may differ).
- Mutual recognition (Reg. (EU) 2019/515): relevant mainly for non-harmonised/partly harmonised goods; we assess applicability case-by-case and document the rationale.
Output: EU expansion plan (markets, requirements, sequencing)
Romania Market Access
The practical difference between “EU-ready” and “Romania-ready”: authority pathways, notification realities, and compliant channel execution.
MEDICAL
DEVICES
Romania legal selling pathway
- Import/distribution activities: controlled via an approval/permit mechanism (“avizare”) under the ANMDMR framework.
- EUDAMED actor registration: SRN is issued after competent-authority validation/verification (ANMDMR role).
- National database registration: ANMDMR states this is not an approval/authorization and not a confirmation of compliance.
We support documentation discipline and authority-facing workflows; CE/technical conformity remains with the manufacturer and the applicable conformity assessment route.
FOOD SUPPLEMENTS
Romania notification dossier
- Notification dossier and label readiness aligned with Romania’s Ministry of Health notification framework (including the regional CRSP routes where applicable).
- Operational support for the IBA notification workflow and documentation package expectations (where the IBA route applies).
- Claims discipline + Romanian language compliance: we prevent “market-ready” products from becoming “stuck at notification.”
We align dossiers to the applicable notification route and prevent claim-related rework
GO
TO MARKET
Compliant channel rollout in Romania
- Pharmacy chains + independents: onboarding support, trade terms alignment, compliant materials pack.
- Marketplaces: compliant listings, claim-safe content, traceability/returns logic.
- Hospital tenders: SEAP public procurement readiness (documentation pack + bid discipline)
We execute channel rollout with compliance-safe assets and documentation discipline.
Sources: ANMDMR guidance (operation permits / EUDAMED actor registration / national database note); Ministry of Health notification framework; IBA notification portal; SEAP (e-licitatie.ro).
Why AlaQPharma (Romania-based)
Practical execution for EU entry—combining Romania authority handling, compliant launch delivery, and a structured approach for scaling across additional EU markets.
REGULATORY
Regulatory handling (Romania)
- Medical devices: ANMDMR “avizare” pathway support—documentation structure and authority-facing workflow.
- EUDAMED actors: SRN workflow support—issued after competent-authority validation.
- Food supplements: notification dossier support aligned to the Ministry of Health framework (CRSP/IBA routes as applicable).
EXECUTION
Launch execution (Romania)
- Pharmacy channel: onboarding support for chains + independents, trade terms alignment, compliant materials pack.
- E-commerce & marketplaces: compliant listings, claim-safe copy, traceability/returns logic, localization.
- Hospital tenders: SEAP readiness—documentation pack structure, bid discipline, and procurement execution support.
EU SCALING
EU scaling framework
- Medical devices: scaling built on MDR/IVDR compliance and importer/distributor obligations, plus country-specific “information supplied” .
- Supplements: expansion is assessed market-by-market (composition limits, botanicals acceptance, labeling and claims practice can differ by Member State).
- Local stakeholder access: compliant materials and onboarding support aligned to Romanian channel realities.
Sources: ANMDMR guidance; Ministry of Health notifications; EUR-Lex (Reg. (EU) 2019/515); SEAP (e-licitatie.ro).