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ANMDMR · Europe

Romania medical device regulatory resources

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5 free resources23/25 topics with recordsAug 2026 fees reviewed
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Medical device regulation news

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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 59 source-linked facts →

23 of 25 research dimensions currently covered · 27 official sources · latest verification 2026-09-15

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 contravention fines under OUG 46/2021
OUG 46/2021 arts. 28 29 sanction breaches of the MDR and of national rules with fines between 2,000 and 20,000 lei depending on the provision and actor (e.g. placing non compliant devices:…
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
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…
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…
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 registration of custom-made devices
A Romanian established manufacturer placing custom made devices on the market under its own name must register at ANMDMR with registered office address and description of the devices, under…
Filing channel for national database registration
Registration filings are made by email or in person at ANMDMR: the payment form to registratura@anm.ro (or at the headquarters), and the registration request after payment confirmation to d…
5 source-linked facts
Checked 2026-08-25
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D06

Reliance & recognition

Verified
NMPA certificate does not replace EU conformity assessment
statement: For ordinary market placement under MDR/IVDR, a Chinese approval does not replace conformity assessment under MDR Article 52 or IVDR Article 48. The applicable EU class and proce…
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…
2 source-linked facts
Checked 2026-09-15
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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
Permit invoice payment rules and case closure
The fiscal invoice is issued within maximum 90 days of filing the permit application (art. 10(1) Ordin 566/2020); failure to pay the invoice within the stated term leads to closure of the f…
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
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.
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…
2 source-linked facts
Checked 2026-08-25
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D10

Official forms & portals

Verified
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…
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…
2 source-linked facts
Checked 2026-08-25
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Submission & evidence

D11

Label, IFU & language

Verified
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…
Translation exemption is time-limited and exceptional
The exemption from Romanian translation is granted for a determined period only, in exceptional well justified cases when no similar product exists on the market; ANMDMR validates or reject…
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

Unresolved
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 2026-08-25
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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
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…
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).
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
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.
UDI storage obligations for IVDs
Economic operators must electronically store and keep the UDI of IVDs supplied to and by them once the Commission adopts the implementing act (IVDR art. 24(8), (11)(a)); public and private…
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 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…
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…
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
10-day authority disagreement window on trend/rationale reports
For medical devices, within maximum 10 days of receiving the rationale under MDR art. 87(11) third paragraph, ANMDMR informs the manufacturer if it disagrees with the conclusion and may req…
Field safety notice in English and Romanian
The field safety notice under MDR art. 89(8) must be drafted in both English and Romanian and made available without delay to users of the device; for devices used exclusively by healthcare…
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…
ANMDMR enforcement of advertising rules
ANMDMR analyses ex officio or on complaint breaches of the advertising chapter, orders cessation of already published advertising or prohibition of unpublished advertising, and obliges the…
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 (ANMDMR) 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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