Explore the IVD requirements currently available for Romania, organized by topic and linked to official sources.
Source-linked rules for common changes to a registered IVD. Read the scope and conditions with each rule; unverified details are listed separately.
A change to the registered brand name and a change to logo artwork can follow different rules. The legal manufacturer, device design and intended purpose remain the same.
A source-verified answer for this specific scenario is not yet published.
The same legal manufacturer changes its name, potentially alongside the device brand. A transfer to another legal entity is a separate question; permission to combine filings needs its own evidence.
A source-verified answer for this specific scenario is not yet published.
An office address change for the same legal entity, potentially alongside name and brand changes. This does not cover moving a factory or manufacturing site, and a combined filing cannot be assumed.
A source-verified answer for this specific scenario is not yet published.
Check which identifier actually changes. A commercial catalogue, REF or order code is not automatically a device model, registered identifier, GTIN or UDI-DI. Rules for one identifier do not establish the route for another.
A source-verified answer for this specific scenario is not yet published.
A real change of legal manufacturer, registration holder or owner. This differs from renaming the same entity; a change of local representative or importer alone does not establish a registration transfer route. Where other changes occur with the transfer, the exact combination and sequence need separate evidence.
A source-verified answer for this specific scenario is not yet published.
Changes to brand, manufacturer name, office address and reference codes may occur together, including with a real transfer to another legal manufacturer, registration holder or owner. Assess transfer with each single change, and transfer with brand plus reference, manufacturer name plus reference, or office address plus reference changes: seven transfer combinations in total. Evidence must establish the exact combination and the order of filings and approvals. These combinations and their sequence are not all verified by the rules below; a rule for one change does not prove that a single application, fee or review period covers the combination.
A source-verified answer for this specific scenario is not yet published.
Does the event require internal documentation, notice, prior approval, transfer, or a new application?
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 the registered devices on the market; ANMDMR updates the database and informs them within maximum 60 days.
Custom-made equivalent: Art. 6 OMS 2845/2022.
Which clinical or IVD performance evidence or study is required and accepted?
ANMDMR approves clinical investigation applications only if accompanied by the ethics opinion of the National Bioethics Commission for Medicines and Medical Devices (CNBMDM), whose composition and rules are approved by Order of the Minister of Health no. 80/2023.
The clinical investigation application is registered only if accompanied by proof of payment of the tariff under OMS 3467/2022 (Annex 1 point 3).
Is the product a device, IVD, accessory, software, or borderline product locally?
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 IVD medical devices may be used.
Which evidence, local deltas, formats, and signatures are required?
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.
At ANMDMR's request, the manufacturer or authorised representative must transmit all information and documentation demonstrating conformity: drafted in Romanian for manufacturers established in Romania, or in English and translated into Romanian for manufacturers outside Romania.
Which label and IFU elements, languages, symbols, and translation controls apply?
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 approval (aviz).
IVD mirror: Art. 3(2) OUG 137/2022.
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 rejects the exemption request within maximum 30 days of registration, and the distributor/manufacturer must ensure training of the consenting professional receiving English-language information.
The user interface of equipment for healthcare professionals may, for justified reasons, be in English with the user's written consent; for equipment intended for lay users the interface must be in Romanian. For IVD self-tests the interface must be in Romanian.
Which current law, regulation, guidance, and transition provisions apply?
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.
Which PMS plan, report, PMCF or PMPF, trend, and lifecycle-update duties apply?
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.
Which current form, portal, account, and submission package must be used?
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 SAE reporting go to dscdm@anm.ro.
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 page it validates, rejects or requests corrections, and a separate registration with different SRN applies per role.
IVD mirror: Art. 9 OUG 137/2022.
Which recall, FSCA, notice, and authority-coordination duties apply?
As competent/market surveillance authority ANMDMR carries out announced and, where necessary, unannounced inspections, including physical controls of products; complaints can be filed at sesizaridm@anm.ro.
Which registration, notification, listing, reliance, or conformity route applies?
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 drsp@anm.ro; address Strada Aviator Maior Ștefan Sănătescu 48, Sector 1, Bucharest.
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 form of annex 1 to Ordin 3753/2023.
ANMDMR states that registration of devices in the national database does not represent an approval or authorisation from ANMDMR.
Which foreign decisions or evidence can be reused, with what effect and conditions?
Existing records include acceptance, restrictions and evidence reuse. The applicable product scope and conditions are preserved below; a reference does not by itself confer market access.
No linked record is currently maintained. This does not establish that a pathway is unavailable.
Prior approval / evidence record
FDA 510(k)/PMA
No
No substitute for EU MDR conformity assessment; useful as predicate documentation in the technical file
Maintained reference · planning ranges remain estimates · reviewed 2026-08-29
Regulatory reference
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 procedure must be established independently; lower-risk devices may self-declare, while other devices require notified-body assessment. This is a finding about the ordinary conformity route, not a ban on Chinese devices or their technical evidence.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
romania
All NMPA classes (I filing, II, III) -> all EU MDR/IVDR classes
No Reliance Route
none
Product Marketing
null
null
Independent review of current EUR-Lex consolidations supports this bounded ordinary-route conclusion. It does not establish the absence of every special route.
Is an emergency, compassionate, custom, humanitarian, or other exceptional path available?
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 carried out, where use is in the interest of public health or of patient safety or health.
How are deficiencies answered, clocks handled, and decisions escalated or appealed?
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 members not involved in the evaluation) meets within maximum 30 days, and the ANMDMR president's decision is communicated within maximum 7 days of the session; further appeal lies to the competent administrative courts.
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 information; failure to complete in time makes the request caduc (lapsed) without a separate decision; rejection decisions are communicated within maximum 5 days.
Which UDI, device listing, database, and traceability duties apply?
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 health institutions must likewise store the UDI of such IVDs supplied to them.
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.ro
What is reportable, by whom, where, in what format, and by what deadline?
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 require a report under art. 87(1)-(5) and that appropriate actions be taken; equivalent 10-day rule for IVDs under IVDR art. 82(11).
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 professionals, at their request it may be provided in English only.
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 occurred, depending on its consequences, using the national form; reports go to mdevice@anm.ro or by post.
Public and private health institutions in Romania must report to ANMDMR serious incidents involving use of devices manufactured in-house for their own use, and the corrective measures taken.
IVD mirror: Art. 7(5) OUG 137/2022.
ANMDMR centrally registers at national level every report by IVD manufacturers (other than performance-study devices) of serious incidents and field safety corrective actions; manufacturers report serious incidents respecting the IVDR art. 82 deadlines, using the Commission-provided forms.
No maintained record.
These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.
Romania
romania
RO
🇷🇴
National Agency for Medicines and Medical Devices
ANMDMR
europe
3
4-class (I, IIa, IIb, III) — EU MDR
class-i
Class I
low
Self-declaration (no notified body)
0
0
days
official-verified
EUR-Lex Regulation (EU) 2017/745 (MDR)
https://eur-lex.europa.eu/eli/reg/2017/745/oj
2026-08-25
6
9
months
No
No
Yes
FDA 510(k)/PMA
No
No substitute for EU MDR conformity assessment; useful as predicate documentation in the technical file
Yes
EU Authorized Representative
No
ISO 13485 accepted as QMS evidence
5 years (CE certificate)
2026-08-29
partially-verified
Commission Implementing Regulation (EU) 2026/977, Art. 2 — maximum notified-body conformity assessment timelines (30 + 120/90 parallel + 20 days)
https://eur-lex.europa.eu/eli/reg_impl/2026/977/oj
2027-02-25
2026-08-29
EUR-Lex Regulation (EU) 2017/745 (MDR)
https://eur-lex.europa.eu/eli/reg/2017/745/oj
2026-08-25
EUR-Lex MDR consolidated text — Annex IX §5.1 (expert-panel clinical evaluation consultation: 21/60 days) and §5.2(d) (ancillary medicinal-substance opinion: 210 days)
https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:02017R0745-20250110
2026-08-29
2026-08-29
default
planning-template
Maintained planning steps and estimates, not verified regulator deadlines.
1
Pre-Submission Preparation
Gather technical documentation, quality management system (QMS) records, and clinical data required by ANMDMR. Appoint a EU Authorized Representative.
1-3 months
📋
2
Application Submission
Submit complete registration dossier to ANMDMR including device description, risk analysis, and testing reports.
1-2 weeks
📤
3
Administrative Review
ANMDMR reviews application for completeness. May request additional documents or clarifications.
2-4 weeks
🔍
4
Technical Evaluation
In-depth technical assessment of device safety and performance. ANMDMR may issue questions.
0 days
⚙️
5
Registration Approval
Upon successful review, ANMDMR issues Romania market authorization certificate.
1-2 weeks
✅
These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.
romania
Romania
RO
ANMDMR
120
120
RON
No
20450
20450
RON
No
customs-aviz
Customs aviz (import authorisation)
RON
120
RON 120
Per product
exact-current
official-verified
https://www.anm.ro/_/DM/LEGISLATIE/Ordin%203467-2022.pdf
Romania ANM Order 3467/2022: device tariff Annex 1
2022-11-01
2026-08-25
free-sale-certificate
Free-sale certificate
RON
1240
RON 1,240
Per certificate (1–10 articles)
exact-current
official-verified
https://www.anm.ro/_/DM/LEGISLATIE/Ordin%203467-2022.pdf
Romania ANM Order 3467/2022: device tariff Annex 1
2022-11-01
2026-08-25
national-database-registration-certificate
National database registration certificate
RON
1310
RON 1,310
Per certificate (max 5 products)
exact-current
official-verified
https://www.anm.ro/_/DM/LEGISLATIE/Ordin%203467-2022.pdf
Romania ANM Order 3467/2022: device tariff Annex 1
2022-11-01
2026-08-25
in-house-device-notification
In-house device notification dossier
RON
1310
RON 1,310
Per product
exact-current
official-verified
https://www.anm.ro/_/DM/LEGISLATIE/Ordin%203467-2022.pdf
Romania ANM Order 3467/2022: device tariff Annex 1
2022-11-01
2026-08-25
database-modification
Database modification
RON
350
RON 350
Per modification (max 5 products)
exact-current
official-verified
https://www.anm.ro/_/DM/LEGISLATIE/Ordin%203467-2022.pdf
Romania ANM Order 3467/2022: device tariff Annex 1
2022-11-01
2026-08-25
database-search
Database search
RON
220
RON 220
Per search
exact-current
official-verified
https://www.anm.ro/_/DM/LEGISLATIE/Ordin%203467-2022.pdf
Romania ANM Order 3467/2022: device tariff Annex 1
2022-11-01
2026-08-25
eudamed-validation
EUDAMED registration validation
RON
220
RON 220
Per validation
exact-current
official-verified
https://www.anm.ro/_/DM/LEGISLATIE/Ordin%203467-2022.pdf
Romania ANM Order 3467/2022: device tariff Annex 1
2022-11-01
2026-08-25
ci-authorisation-class-iii-iib-invasive
Clinical-investigation authorisation - Class III / IIb invasive / implantable / Annex XVI
RON
20450
RON 20,450
Per authorisation
exact-current
official-verified
https://www.anm.ro/_/DM/LEGISLATIE/Ordin%203467-2022.pdf
Romania ANM Order 3467/2022: device tariff Annex 1
2022-11-01
2026-08-25
ci-validation-iia-iib
Clinical-investigation validation - Class IIa–IIb non-invasive
RON
18030
RON 18,030
Per validation
exact-current
official-verified
https://www.anm.ro/_/DM/LEGISLATIE/Ordin%203467-2022.pdf
Romania ANM Order 3467/2022: device tariff Annex 1
2022-11-01
2026-08-25
ci-validation-i-iia
Clinical-investigation validation - Class I–IIa non-invasive
RON
8770
RON 8,770
Per validation
exact-current
official-verified
https://www.anm.ro/_/DM/LEGISLATIE/Ordin%203467-2022.pdf
Romania ANM Order 3467/2022: device tariff Annex 1
2022-11-01
2026-08-25
ci-substantial-technical-amendment
CI/performance-study substantial or technical amendment
RON
5930
RON 5,930
Per amendment
Administrative amendments: RON 2,620; resubmission after withdrawal/rejection: RON 6,780.
exact-current
official-verified
https://www.anm.ro/_/DM/LEGISLATIE/Ordin%203467-2022.pdf
Romania ANM Order 3467/2022: device tariff Annex 1
2022-11-01
2026-08-25
ivd-performance-authorisation-self-cd
IVD performance-study authorisation - self-test and Class C/D
RON
13710
RON 13,710
Per authorisation
Class A/B: RON 11,200; leftover-specimen studies (IVDR art. 58(2)): RON 6,080.
exact-current
official-verified
https://www.anm.ro/_/DM/LEGISLATIE/Ordin%203467-2022.pdf
Romania ANM Order 3467/2022: device tariff Annex 1
2022-11-01
2026-08-25
pmcf-pmpf-notification
PMCF/PMPF notification evaluation
RON
1880
RON 1,880
Per notification
exact-current
official-verified
https://www.anm.ro/_/DM/LEGISLATIE/Ordin%203467-2022.pdf
Romania ANM Order 3467/2022: device tariff Annex 1
2022-11-01
2026-08-25
advertising-material-approval
Advertising material avizare
RON
2720
RON 2,720
Per material
Educational material: RON 1,730.
exact-current
official-verified
https://www.anm.ro/_/DM/LEGISLATIE/Ordin%203467-2022.pdf
Romania ANM Order 3467/2022: device tariff Annex 1
2022-11-01
2026-08-25
import-distribution-aviz
Import/distribution operating aviz
RON
2620
1480
2620
RON 1,480–2,620
Per aviz
Tiered by number of producers: 1,480 / 1,790 / 2,060 / 2,320 / 2,620 for 1–10 / 11–30 / 31–50 / 51–100 / over 100.
exact-current
official-verified
https://www.anm.ro/_/DM/LEGISLATIE/Ordin%203467-2022.pdf
Romania ANM Order 3467/2022: device tariff Annex 1
2022-11-01
2026-08-25
installation-maintenance-aviz
Installation/maintenance operating aviz
RON
2320
1660
2320
RON 1,660–2,320
Per aviz
Tiered by number of device groups; additional work point: RON 990; name/address change: RON 330; permit/annex issuance: RON 310.
exact-current
official-verified
https://www.anm.ro/_/DM/LEGISLATIE/Ordin%203467-2022.pdf
Romania ANM Order 3467/2022: device tariff Annex 1
2022-11-01
2026-08-25
notified-body-designation
Notified-body designation
RON
40800
RON 40,800
Per designation
Scope extension: RON 24,970; annual surveillance: RON 24,150.
exact-current
official-verified
https://www.anm.ro/_/DM/LEGISLATIE/Ordin%203467-2022.pdf
Romania ANM Order 3467/2022: device tariff Annex 1
2022-11-01
2026-08-25
2026-08-25
official-verified
Romania ANM Order 3467/2022: device tariff Annex 1
https://www.anm.ro/_/DM/LEGISLATIE/Ordin%203467-2022.pdf
2022-11-01
2026-08-25
2026-08-25
exact-current
Yes
These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.
romania
Romania
high
lvd-medical-exclusion-mdr-electrical-safety
MDR electrical safety in place of the Low Voltage Directive
Medical Electrical Safety
Included In Medical Registration
Finished Device
Annex II of Directive 2014/35/EU places electrical equipment for radiology and medical purposes outside the Low Voltage Directive, so there is no separate national electrical-safety certificate for a medical device. Electrical safety is assessed inside the MDR conformity assessment against MDR Annex I, with the harmonised IEC/EN 60601 series carrying the presumption of conformity.
candidate
emc-directive-disapplied-by-mdr
MDR electromagnetic compatibility in place of the EMC Directive
emc
Included In Medical Registration
Finished Device
Article 2(3) of Directive 2014/30/EU switches the EMC Directive off where other Union legislation lays the same essential requirements down more specifically, which MDR Annex I sections 18.5 and 18.6 do for medical devices. EMC is therefore dossier evidence inside the CE route and not a separate national EMC conformity step.
candidate
hg-740-2016-radio-market-access
HG 740/2016 radio equipment market access
Radio Spectrum
Mandatory If Feature
Radio Equipment
Article 6(1) of Hotărârea Guvernului 740 of 5 October 2016 permits making available on the market, putting into service and using only radio equipment that, when correctly installed, maintained and used as intended, meets the requirements of the decree — so compliance with the RED route is the sole condition and there is no Romanian type approval. The only registration duty in the decree is the article 5 Union-level registration for low-compliance categories under RED article 5. Article 23(4) puts market surveillance with ANCOM and ANPC.
candidate
anmdmr-in-use-verification-tests
ANMDMR in-use verification tests
Medical Electrical Safety
Mandatory For Use Site
Electromedical Device In Use
Ordin 3467/2022 Annex 1 items 6.1-6.12 charge in-use verification: electrosecurity tests for electromedical devices 250 lei, performance tests 180 lei, CNCAN acceptability-criteria tests 1,000 lei, CNCAN use authorisation/re-authorisation 30% of base tariff, use-authorisation issuance 20 lei. Periodic in-use verification scope and periodicity are set in Annex 1 to Ordin 2219/2022; health units must keep a designated responsible person and a register of devices in use (Art. 20); devices failing the tests may not be used (Art. 21(1); Legea 95/2006 arts. 931-933).
candidate
hg-322-2013-rohs
HG 322/2013 restricting hazardous substances in electrical equipment
Environmental And Batteries
Evidence Only No Separate Certificate
Electrical Electronic Medical Device
HOTĂRÂRE nr. 322 of 29 May 2013, Monitorul Oficial nr. 348 of 13 June 2013, transposes Directive 2011/65/EU. Article 2(1) applies the decision to the Annex 1 categories, and Annex 1 category 8 is dispozitive medicale. Article 2(4)(h) (as numbered in the published text) keeps active implantable devices out. Article 4(3) is the date that matters for a device manufacturer: the substance restriction applies to medical devices and monitoring and control instruments placed on the market from 22 July 2014, to in vitro diagnostic medical devices from 22 July 2016 and to industrial monitoring and control instruments from 22 July 2017; article 4(4) then leaves devices placed on the market before those dates, and their repair spare parts, outside the restriction. There is no Romanian RoHS certificate sitting next to the CE marking. Directive 2011/65/EU Annex I category 8 covers medical devices, Article 4(3) has bound medical devices since 22 July 2014 and in vitro diagnostic medical devices since 22 July 2016, and Article 2(4)(h) excludes active implantable medical devices.
candidate
oug-5-2015-weee-national-producer-register
OUG 5/2015 national WEEE producer register as a condition of placing on the market
Environmental And Batteries
Mandatory Pre Market
Producer Or Authorised Representative
ORDONANȚĂ DE URGENȚĂ nr. 5 of 2 April 2015, Monitorul Oficial nr. 253 of 16 April 2015. Article 38(1) has the Agenția Națională pentru Protecția Mediului keep a national producer register that includes distance sellers. Article 38(2) is the gate: in order to place EEE on the market, producers must enrol in that register and receive a registration number which they then communicate to every commercial network through which the equipment is sold. Distance sellers into Romania who are not themselves registered enrol through an authorised representative under article 38(4) and article 40(2). Medical devices are inside the open scope: Annex 1 category 8 is dispozitive medicale, with the usual exclusion of implanted and infective products, and article 5(g) repeats the Directive 2012/19/EU exclusion for devices expected to be infective before end of life and for active implantable devices. Directive 2012/19/EU Article 2(4)(g) excludes devices expected to be infective before end of life and active implantable devices; other medical devices are in scope, and Article 16 requires each Member State to keep a producer register.
candidate
hg-1132-2008-battery-producer-register-still-on-2006-66
HG 1.132/2008 battery producer register, not yet adapted to Regulation (EU) 2023/1542
Environmental And Batteries
Mandatory If Feature
Battery Producer Or Authorised Representative
HOTĂRÂRE nr. 1.132 of 18 September 2008, in the form last amended by HG 540/2016. Article 6(3) allows batteries and accumulators to be placed on the market only by producers entered in the Registrul național al producătorilor și importatorilor de baterii și acumulatori, kept by the environment ministry through the Agenția Națională pentru Protecția Mediului, and article 6(4) points the enrolment procedure to Annex 4. A full-text search of that consolidated expression contains no occurrence of '2023/1542', so the national decision still sits on the repealed Directive 2006/66/EC and no Article 55 designation appears in it; the Regulation applies directly in the meantime, which is the same split already recorded for Bulgaria and the Czech Republic and the opposite of Slovenia. Article 11(2)(b) of Regulation (EU) 2023/1542 lets professional medical imaging and radiotherapy devices and in vitro diagnostic medical devices restrict portable-battery replacement to independent professionals, and Article 11(3) lifts the removability duty where continuity of supply is needed for safety or data integrity.
candidate
EUR-Lex
Low Voltage Directive 2014/35/EU Annex II — electrical equipment for radiology and medical purposes outside scope
https://eur-lex.europa.eu/eli/dir/2014/35/oj
EUR-Lex
EMC Directive 2014/30/EU Article 2(3) — more specific Union legislation displaces the directive
https://eur-lex.europa.eu/eli/dir/2014/30/oj
EUR-Lex
RoHS Directive 2011/65/EU Annex I category 8 and Article 4(3) medical-device application dates
https://eur-lex.europa.eu/eli/dir/2011/65/oj
EUR-Lex
WEEE Directive 2012/19/EU Article 2(4)(g) medical-device exclusions and Article 16 national producer register
https://eur-lex.europa.eu/eli/dir/2012/19/oj
EUR-Lex
Batteries Regulation (EU) 2023/1542 Articles 11 and 55 — medical-device removability derogation and producer register
https://eur-lex.europa.eu/eli/reg/2023/1542/oj
Portalul legislativ (Ministerul Justiţiei)
HG 740/2016 arts. 6 and 23 — radio equipment market access and ANCOM/ANPC surveillance
https://legislatie.just.ro/Public/DetaliiDocumentAfis/182813
ANMDMR
Ordin 3467/2022 Annex 1 — in-use device verification test fees including CNCAN
https://www.anm.ro/_/DM/LEGISLATIE/Ordin%203467-2022.pdf
ANMDMR
supraveghere în utilizare — Ordin 2219/2022 periodic verification scope
https://www.anm.ro/dispozitive-medicale/supraveghere-in-utilizare/
Portal Legislativ (legislatie.just.ro)
HG 322/2013 — articles 2 and 4 and Annex 1 category 8
https://legislatie.just.ro/Public/DetaliiDocumentAfis/148892
Portal Legislativ (legislatie.just.ro)
OUG 5/2015 — articles 5(g) and 38 and Annex 1 category 8
https://legislatie.just.ro/Public/DetaliiDocumentAfis/167211
Portal Legislativ (legislatie.just.ro)
HG 1.132/2008 as amended by HG 540/2016 — article 6(3)–(4) battery producer register
https://legislatie.just.ro/Public/DetaliiDocumentAfis/226425
