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ANMDMR · Europe

Romania medical device regulatory resources

Every Romania dataset, comparison, and AI workpaper we maintain — one entry point for the whole market.

5 free resources24/25 requirements coveredAug 2026 fees reviewed
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Medical device regulation news

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

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Government registration fees

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Registration timeline

Compare the statutory notified-body conformity assessment clock under Regulation (EU) 2026/977 with realistic CE marking times by device class.

Structured regulatory requirements

Explore all 58 source-linked facts →

24 of 25 research dimensions currently covered · 25 official sources · latest verification 2026-08-30

Market entry

D01

Authority & regime

Verified
Competent authority for medical devices
ANMDMR (Agenția Națională a Medicamentului și a Dispozitivelor Medicale din România) is designated as the competent authority for medical devices and as the market surveillance authority in…
Competent authority for IVDs
ANMDMR is designated as the competent authority for in vitro diagnostic medical devices and as market surveillance authority in that field.
3 source-linked facts
Checked 2026-08-25
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D02

Legal basis & guidance

Verified
National MDR implementing legislation
authority: ANMDMR (www.anm.ro) · implementingLegislation: OUG 46/2021 of 9 June 2021 (MOf. 588/11.06.2021) — national framework for applying Regulation (EU) 2017/745 · keyDelegatedOrders: O…
National IVDR implementing legislation
OUG 137/2022 of 12 October 2022 establishes the institutional framework and measures for implementing Regulation (EU) 2017/746 in Romania; procedural norms in Ordin 3753/2023.
3 source-linked facts
Checked 2026-08-25
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D03

Device definition & scope

Verified
Any health evaluation or therapy deemed performed for medical purpose
Any form of health state evaluation or therapy, even if the values obtained are informative, including in complementary medicine or bioresonance cabinets, is deemed performed for a medical…
IVD-purpose deeming for in-vitro examination activities
Any diagnostic or treatment activity using equipment for in vitro examination of specimens, including via information society services, is deemed performed for a medical purpose and only IV…
3 source-linked facts
Checked 2026-08-25
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D04

Classification rules

Verified
EU MDR classes I, Is, Im, Ir, IIa, IIb and III
Class I, Class Is, Class Im, Class Ir, Class IIa, Class IIb, Class III
1 maintained scheme
Checked 2026-08-26
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D05

Registration pathways

Verified
National database registration for medical devices
Romanian established manufacturers placing devices on the market under their own name (including systems and procedure packs under MDR art. 21(2)) must register at ANMDMR, giving registered…
National database registration for IVDs
The Romanian established producer or authorised representative placing IVDs on the market under its own name must register at ANMDMR, for IVD classes A, B, C and D, using the notification f…
5 source-linked facts
Checked 2026-08-25
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D06

Reliance & recognition

Verified
EU CE under MDR/IVDR — single market validity
target: geo:rou · sourceApproval: EU CE under MDR/IVDR · edgeType: single market validity · marketAccessStrength: direct · regulatoryLayer: product marketing · sameDeviceRequired: Yes · loc…
1 source-linked fact
Checked 2026-08-30
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D07

Economic-operator roles

Verified
Registration of relabelling/repacking operators
Distributors or importators performing relabelling or repacking under MDR art. 16(2)(a) (b) must inform ANMDMR when making the device available, attaching the Romanian translated label/IFU;…
1 source-linked fact
Checked 2026-08-25
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D08

Establishment, import & distribution

Verified
Operating permit (aviz de funcționare) for import, distribution, installation
Marketing and service activities in the medical device field are subject to ANMDMR operating permit control: (a) import of medical devices; (b) distribution of medical devices; (c) installa…
Online platform for operating permits
The entire permitting process for avize de funcționare is carried out online through the digital platform at https://avizaredm.anmdm.ro/login, where economic operators create user accounts.
3 source-linked facts
Checked 2026-08-25
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D09

Dossier requirements

Verified
Language of documentation submitted to ANMDMR on request
At ANMDMR's request, the manufacturer or authorised representative must transmit all information and documentation demonstrating conformity: drafted in Romanian for manufacturers establishe…
EU declaration of conformity translated
The manufacturer's EU declaration of conformity is translated into Romanian or English (per MDR art. 19(1)); IVD equivalent in Art. 3(9) OUG 137/2022.
2 source-linked facts
Checked 2026-08-25
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D10

Official forms & portals

Verified
EUDAMED actor registration validated by ANMDMR (SRN)
ANMDMR verifies data entered by manufacturers, authorised representatives and importers in EUDAMED, obtains the Single Registration Number from the system and transmits it; per the ANMDMR p…
Clinical investigation application form
The sponsor or authorised representative submits the clinical investigation application to ANMDMR using the application form in Annex 1 to MDCG 2021 8 (Commission document); submissions and…
2 source-linked facts
Checked 2026-08-25
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Submission & evidence

D11

Label, IFU & language

Verified
Romanian language mandatory for information accompanying the device
Information supplied by the manufacturer with the medical device (MDR Annex I Chapter III point 23) must be presented mandatorily in Romanian, without excluding presentation in other offici…
English-language exemption for HCP-only devices
The information may, for justified reasons, be supplied in English for devices intended exclusively for healthcare professionals, only with their written consent and based on an ANMDMR appr…
5 source-linked facts
Checked 2026-08-25
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D12

QMS, audit & inspection

Verified
Manufacturer quality management system (Art. 10(9))
Manufacturers must establish, document, implement, maintain, keep up to date and continually improve a quality management system that ensures compliance with the Regulation in the most effe…
1 source-linked fact
Checked 2026-08-29
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D13

Standards, testing & ancillary approvals

Verified
MDR electrical safety in place of the Low Voltage Directive
Electrical safety
MDR electromagnetic compatibility in place of the EMC Directive
EMC
HG 740/2016 radio equipment market access
Wireless / radio
7 maintained overlays · 2 related facts
Checked 2026-08-29
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D15

Review clocks

Unresolved
Class I · Self-declaration (no notified body)
0 days
1 maintained pathway · 1 related fact
Checked 2026-08-29
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D16

Approval validity & renewal

Verified
Renewed operating permit issued on last day of validity
The renewed aviz de funcționare is issued on the last day of validity of the permit held (or the last working day before it, if that day is not a working day).
Custom-made registration certificates valid 24 months after EUDAMED notice
Custom made registration certificates issued under the old Ordin 1009/2016 regime remain valid for 24 months from publication of the EU notice that EUDAMED has reached full functionality (M…
2 source-linked facts
Checked 2026-08-25
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Lifecycle & post-market

D17

Change control

Verified
Duty to notify changes after national database registration
Persons who registered devices in the national database must communicate to ANMDMR any change occurring after receipt of the registration notice, including interruption/cessation of placing…
1 source-linked fact
Checked 2026-08-25
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D18

UDI, listing & traceability

Verified
Official UDI and listing surfaces
submissionSurface: EUDAMED (actor and device registration, UDI database) validated by ANMDMR, plus the Romanian national device database (baza națională de date) with public search on anm.r…
Health institutions must store UDI of implantables electronically
Public and private health institutions in Romania must store and keep, in electronic format, the UDI of implantable medical devices they supplied or which were supplied to them.
3 source-linked facts
Checked 2026-08-25
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D19

Clinical investigation & performance

Verified
National ethics opinion prerequisite for clinical investigations
ANMDMR approves clinical investigation applications only if accompanied by the ethics opinion of the National Bioethics Commission for Medicines and Medical Devices (CNBMDM), whose composit…
Fee payment precondition for clinical investigation application
The clinical investigation application is registered only if accompanied by proof of payment of the tariff under OMS 3467/2022 (Annex 1 point 3).
2 source-linked facts
Checked 2026-08-25
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D20

Special access & derogation

Verified
National derogation under MDR art. 59(1)
ANMDMR may authorise, on request, placing on the market or putting into service in Romania of devices for which the conformity procedures of MDR art. 59(1) have not been carried out, in wel…
National derogation for IVDs under IVDR art. 54
Under IVDR art. 54, ANMDMR may authorise, on a duly justified request, placing on the market or putting into service in Romania of an IVD for which the relevant procedures have not been car…
2 source-linked facts
Checked 2026-08-25
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D21

Manufacturer PMS

Verified
PMCF/PMPF study plan notification to ANMDMR
Sponsors must notify ANMDMR of PMCF study plans (MDR) and PMPF plans (IVDR); ANMDMR evaluates the notification documentation for a fee of 1,880 lei.
1 source-linked fact
Checked 2026-08-25
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D22

Vigilance & incident reporting

Verified
Centralised national registration of manufacturer vigilance reports
ANMDMR centrally registers at national level every report by manufacturers (other than investigational devices) of serious incidents and field safety corrective actions; manufacturers repor…
15-day national reporting by professionals, patients and users
Healthcare professionals, patients and users must report to ANMDMR any suspected serious incident with devices or IVDs they handle, within maximum 15 days from the date the incident occurre…
6 source-linked facts
Checked 2026-08-25
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D23

Recall, FSCA & market surveillance

Verified
Market surveillance inspections and complaints channel
As competent/market surveillance authority ANMDMR carries out announced and, where necessary, unannounced inspections, including physical controls of products; complaints can be filed at se…
Fine for obstructing market surveillance inspection
Obstruction of market surveillance inspection is sanctioned with a fine from 5,000 to 10,000 lei under art. 935(1)(g) of republished Legea 95/2006.
2 source-linked facts
Checked 2026-08-25
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D24

Advertising, claims & promotion

Verified
ANMDMR competent authority for advertising approval
ANMDMR is the competent authority for evaluating, notifying and approving advertising materials and any other form of advertising for medical devices, except advertising aimed at healthcare…
Prior approval (viză de publicitate) for public advertising
Documentation for advertising of a medical device aimed at the general public must be filed with ANMDMR by the manufacturer, importer or distributor for approval, and the advertising may be…
5 source-linked facts
Checked 2026-08-25
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D25

Submission communications & appeal

Verified
Contestation of ANMDMR clinical investigation decisions
Authorisations, rejection decisions and suspensions for clinical investigations can be contested by the sponsor at ANMDMR within 30 days of receipt; a contestation commission (minimum 3 mem…
Deficiency completion deadlines in clinical investigation validation
If the clinical investigation dossier is incomplete or out of scope, ANMDMR sets a maximum 10 day term for the sponsor to transmit completions, extendable by maximum 20 days for complex inf…
2 source-linked facts
Checked 2026-08-25
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Government fees

Full fee schedule (17 lines) →

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

Fee lineAmountProvenance
Customs aviz (import authorisation)RON 120Verified
Free-sale certificateRON 1,240Verified
National database registration certificateRON 1,310Verified
In-house device notification dossierRON 1,310Verified
13 more fee lines on the full schedule · 17 of 17 rows source-verified

Registration timeline

Full registration timeline →

National Agency for Medicines and Medical Devices (ANMDM) review clocks and planning ranges · 4-class (I, IIa, IIb, III) — EU MDR classification

Class / pathwayReview clockPlanning totalProvenance
Class I(Self-declaration (no notified body))0 days6-9 monthsVerified
  1. 1Pre-Submission Preparation(1-3 months)
  2. 2Application Submission(1-2 weeks)
  3. 3Administrative Review(2-4 weeks)
  4. 4Technical Evaluation(0 days)
  5. 5Registration Approval(1-2 weeks)
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