ANMDMR market access

Romania medical device registration resources

Research ANMDMR registration records, classification, regulations, timelines, fees, and market updates — the stable entrance to every Romania medical device resource.

4 free resourcesAug 2026 fees reviewed

Run the classification agent

Everything we track for Romania

Browse by resource instead →

Additional certification and licence checker

Check whether product features may trigger separate radio, electrical, metrology, radiation, import, or other Romania requirements.

Medical device regulation news

Follow recent National Agency for Medicines and Medical Devices of Romania (ANMDMR) policy, guidance, safety, and compliance updates.

AI medical device classifier

Describe your device and get a preliminary ANMDM risk class with official rule references.

Government registration fees

Review current ANMDMR application, review, and renewal fees.

Government fees

Full fee schedule (17 lines) →

ANMDMR registration fees in RON · reviewed 2026-08-25

Fee line	Amount	Provenance
Customs aviz (import authorisation)	RON 120	Verified
Free-sale certificate	RON 1,240	Verified
National database registration certificate	RON 1,310	Verified
In-house device notification dossier	RON 1,310	Verified

13 more fee lines on the full schedule · 17 of 17 rows source-verified

Latest regulation news

All Romania regulation news →

Newest ANMDMR-related headlines from the daily-refreshed feed — every row links to the publishing source.

Aug 26MGMedEnvoy GlobalWhat Is a Saudi Arabia Authorized Representative for Medical Devices?

Romania Aug 26OSOperon StrategistSFDA Medical Device Establishment License (MDEL): Complete Compliance Guide

Romania Aug 25MGMedEnvoy GlobalHow Does Mexico Classify Single-Use Versus Reusable Medical Devices?

Romania Aug 25FLFDA Law BlogFDA Addresses Device Constituents in New Draft Guidance on Container Closure Systems

Romania Aug 25PBPacific BridgeCan Foreign Clinical Data be Used to Get Your Medical Device Approved in Japan?

Continue with this market

Turn Romania research into practical work

The target market is carried into each tool. Add the product, evidence, or regulatory change you want to assess.

View every AI workpaper →

Build a reusable product master

Structure company, product, model, approval, certificate, and evidence facts before starting Romania work.

Romania market-launch workpaper

Connect the ANMDMR route, evidence, labels, local role, timing, and dependencies to a wider launch plan.

Romania dossier reuse and delta

Compare an existing authorization and evidence set against ANMDMR administrative, testing, labeling, and dossier needs.

Romania change notification workpaper

Map a product or manufacturing change to ANMDMR evidence, notification, timing, and implementation questions.

Romania regulatory change impact

Assess a current ANMDMR update against one product and turn it into an owner-ready action workpaper.

Romania cybersecurity evidence review

Review connected-device architecture, risks, SBOM, testing, lifecycle controls, and market-specific questions for Romania (ANMDMR).

Country hubs in other markets

Other Europe markets

Entering the Romania market?

Local representation, ANMDMR submissions, and lifecycle maintenance — handled with an expert.