MEDICAL DEVICES

Romania legal selling pathway

• Import and distribution activities are subject to Romanania-specific control/approval mechanisms under the ANMDMR framework (as applicable to the operator and activity).
• EUDAMED actor registration results in an SRN after competent authority validation (ANMDMR role in verification/validation as applicable).
• National database registration is described as a registration workflow and is not an “approval”—a critical distinction for compliance credibility.
• Small note (optional): We structure the authority-facing documentation and submission workflow; CE conformity remains with the manufacturer and applicable conformity route.

FOOD SUPPLEMENTS

Romania notification dossier, done properly

• Notification dossier and label readiness aligned with Romania’s Ministry of Health notification framework, including CRSP routes where applicable.
• Operational support for the IBA/CRSP workflow expectations (where the relevant route applies).
• Claims discipline + Romanian language compliance to prevent “market-ready” products becoming “stuck at notification”.

GO-TO-MARKET

Compliant channel rollout in Romania

• Pharmacy chains + independents: onboarding support, trade terms alignment, compliant materials pack.
• Marketplaces: compliant listings, claim-safe copy, traceability/returns logic.
• Hospital tenders: SEAP public procurement readiness (documentation pack + bid discipline).

Deliverables

• Route confirmation: MDR / IVDR / Food Supplement (scope + boundaries)
• Claims and labeling gap assessment (EU + Romania)
• Authority workflow checklist (ANMDMR / MoH route as applicable)
• Document pack structure (what’s needed, in what format, who signs)
• Market access readiness pack (channels, listing requirements, compliant content rules)
• Launch execution plan (timeline + responsibilities)
• Scale plan for additional EU markets (market-by-market constraints)