Pure Global AI
Norwegian Medical Products Agency · structured requirements

🇳🇴 Norway medical device regulatory data

Explore the medical device requirements currently available for Norway, organized by topic and linked to official sources.

43 facts23 dimensions16 official sourceslatest verification 2026-09-15

Advertising, claims & promotion

Which claims, audiences, channels, approvals, and restrictions apply?

Compare countries

Misleading claims prohibition (Art. 7)

advertising.misleading-claims-art-7
Fact-level verified

In the labelling, instructions for use, making available, putting into service and advertising of devices it is prohibited to use text, names, trade marks, pictures and figurative or other signs that may mislead the user or the patient with regard to the device's intended purpose, safety and performance by: ascribing functions and properties to the device which the device does not have; creating a false impression regarding treatment or diagnosis; failing to inform the user or patient of a likely risk associated with the use of the device in line with its intended purpose; or suggesting uses for the device other than those stated to form part of the intended purpose for which the conformity assessment was carried out.

Conditions
  • EEA rule incorporated into Norwegian law; Regulation (EU) 2017/745 applies with EEA adaptations. National implementing or administrative details are not covered by this fact.

Effective from 2021-05-26

Lov om medisinsk utstyr (LOV-2020-05-07-37)

Approval validity & renewal

What expires, what is retained periodically, and when must renewal start?

Compare countries

Certificate validity and renewal (Art. 56(2))

validity.certificate-validity-art-56-2
Fact-level verified

EU certificates issued by notified bodies are valid for the period they indicate, which may not exceed five years. On application by the manufacturer the validity of the certificate may be extended for further periods, each not exceeding five years, based on a re-assessment in accordance with the applicable conformity assessment procedures; any supplement follows the same rules.

Conditions
  • EEA rule incorporated into Norwegian law; Regulation (EU) 2017/745 applies with EEA adaptations. National implementing or administrative details are not covered by this fact.

Effective from 2021-05-26

Lov om medisinsk utstyr (LOV-2020-05-07-37)

Authority & regime

Which authority and binding regime govern this product, task, and date?

Compare countries

Competent authority

authority.competent-authority
Fact-level verified

Direktoratet for medisinske produkter (English: Norwegian Medical Products Agency, NoMA/DMP; website dmp.no; formerly Statens legemiddelverk) is the competent authority for medical devices and IVDs in Norway and supervises economic operators and notified bodies.

Conditions
  • Applies to all device classes and IVDs.

Agency renamed from Statens legemiddelverk to Direktoratet for medisinske produkter; English name Norwegian Medical Products Agency. CA website also states: 'The Norwegian Medical Products Agency is the competent authority for medical devices in Norway'.

National handling regulation for the health service

regime.handling-regulation-user-side
Fact-level verified

A separate national regulation on handling of medical devices (Forskrift om håndtering av medisinsk utstyr, FOR-2013-11-29-1373) binds the health and care service (and other entities handling electromedical equipment) to keep devices safe, correctly maintained and properly used.

Conditions
  • Applies to user establishments (health and care service, electromedical equipment handlers), not to market authorisation.

User-side national regime on top of MDR; breach by institutions can trigger sanctions for improper reprocessing/handling.

National penalties for breaches

regime.penalties
Fact-level verified

Wilful or negligent breach of the national regulation's provisions (including listed MDR/IVDR articles) is punishable by fines or imprisonment; aggravated violations carry up to 2 years' imprisonment. The Directorate may also impose infringement fines (overtredelsesgebyr).

Conditions
  • Aggravation weighed against death or serious health harm caused or threatened.

Ordinary violations: fines or imprisonment up to 3 months per § 19 first paragraph.

Reprocessing of single-use devices prohibited

regime.reprocessing-single-use-prohibited
Fact-level verified

Reprocessing of single-use medical devices is not permitted in Norway: Norway did not open the MDR Article 17 option in national law, following a 2021 public consultation assessment by DMP.

Conditions
  • Applies to devices defined as single-use devices (MDR Article 2(8)).

CA news item of the same agency states the prohibition applies from 1 January 2022 ('Forbud mot reprosessering av medisinsk engangsutstyr fra 1. januar 2022'). Reprocessing of reusable devices per IFU remains allowed.

Change control

Does the event require internal documentation, notice, prior approval, transfer, or a new application?

Compare countries

Notified-body certificate reporting to CA

change.certificate-reporting
Fact-level verified

Notified bodies must inform Direktoratet for medisinske produkter about all certificates issued, amended, extended, suspended, withdrawn or refused (and inform other notified bodies about suspended/withdrawn/refused certificates).

Conditions
  • Duty on notified bodies designated under the device directives/regulations.

Clinical investigation & performance

Which clinical or IVD performance evidence or study is required and accepted?

Compare countries

Clinical investigations requiring application to DMP

clinical.application-scope
Fact-level verified

An application to DMP is required for clinical investigations of devices that are not CE-marked, or CE-marked devices investigated outside the manufacturer's stated intended purpose; this covers both conformity-assessment purposes (MDR Article 62(1)) and other purposes (MDR Article 82).

Conditions
  • Non-CE device, or CE device used outside intended purpose.

Art. 74(1) investigations (CE device within intended purpose) are notification- rather than application-required.

MDR Article 62 requirements extended to all investigations

clinical.art62-applies-to-other-purpose-investigations
Fact-level verified

National special requirement: clinical investigations conducted for purposes other than future conformity assessment and CE marking (MDR Article 82) must fulfil all requirements of MDR Article 62; investigations of CE-marked devices used within their intended purpose are exempt.

Conditions
  • Applies to non-CE devices or use outside intended purpose investigated for non-CE purposes.
  • Exemption: CE-marked device used within intended purpose.

Forskrift § 16: 'Kliniske utprøvinger skal oppfylle kravene i forordning (EU) 2017/745 (MDR) artikkel 62.'

IVD performance study application/notification route

clinical.ivd-performance-study-route
Fact-level verified

Performance studies of IVDs covered by IVDR Article 58 or 70 require an application or notification to the Norwegian Medical Products Agency (NOMA); performance studies may also require an application to the Norwegian ethics committees (REK KULMU).

Conditions
  • Applies generally to studies involving risks to subjects.
  • Companion-diagnostic studies with left-over samples only are notified, not applied for.

Safety reporting in performance studies: form by email to kki@noma.no per the CA safety-reporting page.

Same-day ethics committee application

clinical.rek-kulmu-same-day
Fact-level verified

The same day the application is emailed to DMP, it must also be submitted to the ethics committee REK KULMU via the REK portal; documents sent to both bodies must be identical, and a negative REK KULMU opinion prevents the investigation from starting.

Conditions
  • Applies to clinical investigations of medical devices.

Sponsor must ensure DMP and REK KULMU always hold updated, identical documents.

CI summary in Norwegian and English

clinical.summary-norwegian-and-english
Fact-level verified

The general summary of a clinical investigation (MDR Annex XV No. 3.1.5) must be provided in both Norwegian and English (the two versions must be identical per CA guidance).

Conditions
  • Applies to clinical investigations of medical devices.

CA application page: 'Sammendragene på norsk og engelsk skal være identiske.'

Device definition & scope

Is the product a device, IVD, accessory, software, or borderline product locally?

Compare countries

Borderline qualification decision

device-definition.borderline-authority
Fact-level verified

In cases of doubt, Direktoratet for medisinske produkter decides whether a product is to be regarded as a medical device (national rule; device definition itself follows MDR/IVDR Article 2 via the EEA Agreement).

Conditions
  • Applies where qualification as a device is doubtful.

Dossier requirements

Which evidence, local deltas, formats, and signatures are required?

Compare countries

Documentation language on authority request

dossier.documentation-language-ca-request
Fact-level verified

On request from Direktoratet for medisinske produkter, the manufacturer and the authorised representative must present all information and documentation necessary to demonstrate the device's conformity, in Norwegian or English.

Conditions
  • Applies on CA request under market surveillance/supervision powers.

Economic-operator roles

Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?

Compare countries

Authorised representative for non-EEA manufacturers

roles.authorised-representative-eea
Fact-level verified

A manufacturer without a business address in the EEA that markets devices in its own name in the EEA must, before marketing, appoint an authorised representative established in the EEA; an authorised representative with a Norwegian business address must register its company and device data in the public device register like a Norwegian manufacturer.

Conditions
  • Applies to non-EEA manufacturers marketing in the EEA/Norway.

EUDAMED actor registration and SRN

roles.eudamed-actor-registration
Fact-level verified

Manufacturers, authorised representatives, importers and system/procedure-pack assemblers must register in the EUDAMED actor registration module and receive a Single Registration Number (SRN); distributors are not required to register in EUDAMED.

Conditions
  • Applies to those economic operator roles; distributor registration is voluntary in Norway.

No fee is mentioned on the CA actor-registration page.

Establishment, import & distribution

Which establishment licences, importer permissions, and distribution controls apply?

Compare countries

Economic operator registration (EUDAMED)

establishment.registration-mdr-art-31
Fact-level verified

Manufacturers, authorised representatives and importers must register through the electronic system (EUDAMED) and provide the Annex VI Part A Section 1 information before placing devices, other than custom-made devices, on the market, obtaining a Single Registration Number; where the conformity assessment procedure requires a notified body, the information must be supplied before applying to it. Importers additionally bear the general obligations of Art. 13 (verify CE marking and EU declaration of conformity, ensure storage and transport conditions, register complaints).

Conditions
  • EEA rule incorporated into Norwegian law; Regulation (EU) 2017/745 applies with EEA adaptations. National implementing or administrative details are not covered by this fact.

Effective from 2021-05-26

Lov om medisinsk utstyr (LOV-2020-05-07-37)

Fees

What regulator fee applies to this class, route, event, and date?

Compare countries

No fee for clinical investigation applications

fees.no-fee-clinical-investigation
Fact-level verified

There are no fees for processing applications and notifications of clinical investigations of medical devices at DMP.

Conditions
  • Applies to application-required and notification-required clinical investigations.

No fee for IVD performance study applications

fees.no-fee-performance-studies
Fact-level verified

There are no fees for applications and notifications of performance studies of IVD medical devices at the Norwegian Medical Products Agency.

Conditions
  • Applies to IVDR Article 58/70 applications and notifications.

Statutory fee/cost authority

fees.statutory-authority
Fact-level verified

The Medical Devices Act allows market actors and technical control bodies to be ordered to cover costs of supervision and control, and empowers the ministry to prescribe fees for processing clinical investigation and performance-evaluation applications; no such application fees are currently charged.

Conditions
  • Enabling provision; current CA practice charges no CI/performance-study fees.

Late payment interest per the Interest on Late Payments Act; fees are enforceable attachment grounds.

Label, IFU & language

Which label and IFU elements, languages, symbols, and translation controls apply?

Compare countries

Implant card information in Norwegian

label-ifu.implant-card-norwegian
Fact-level verified

Information given to patients with implantable devices that is to accompany an implant card must be provided in Norwegian.

Conditions
  • Applies to patient information accompanying an implant card under MDR Article 18.

Exemption from Norwegian language requirement

label-ifu.language-exemption
Fact-level verified

Direktoratet for medisinske produkter may exempt a device from the Norwegian-language requirement for labels/IFU where safe and correct use is ensured; exemptions are not granted on a general basis or for an unlimited period.

Conditions
  • Case-by-case application to the Directorate; safe and correct use must be secured.

CA guidance: 'It is possible to apply for an exemption from the language requirement, cf. regulation on medical devices § 15' and 'Exemptions are not granted on a general basis, nor for an unlimited period of time.'

Norwegian language for labels and IFU

label-ifu.norwegian-required
Fact-level verified

Information on the label and in the instructions for use of a device must be given in Norwegian; the CA confirms the requirement applies both to devices for professional use and for general use.

Conditions
  • Applies to devices made available on the Norwegian market.
  • No general carve-out for professional-only devices.

CA guidance page: 'There are requirements for the Norwegian language for medical devices in Norway, both for professional use and for general use'.

Manufacturer PMS

Which PMS plan, report, PMCF or PMPF, trend, and lifecycle-update duties apply?

Compare countries

Post-market surveillance reporting (Arts. 83-86)

pms.reporting-duties-arts-83-86
Fact-level verified

Manufacturers must implement a post-market surveillance system (Art. 83) and a documented post-market surveillance plan proportionate to the risk class and appropriate to the type of device (Art. 84). Class I devices require a post-market surveillance report summarising results and conclusions (Art. 85); class IIa, IIb and III devices require a periodic safety update report (PSUR) per device or category, updated at least annually for class IIb and III devices and at least every two years for class IIa devices, forming part of the technical documentation (Art. 86).

Conditions
  • EEA rule incorporated into Norwegian law; Regulation (EU) 2017/745 applies with EEA adaptations. National implementing or administrative details are not covered by this fact.

Effective from 2021-05-26

Lov om medisinsk utstyr (LOV-2020-05-07-37)

Official forms & portals

Which current form, portal, account, and submission package must be used?

Compare countries

Clinical investigation submission channel and forms

submission.ci-application-channel
Fact-level verified

Until EUDAMED is available, clinical investigation applications are submitted by email to kki@dmp.no with the subject 'Søknad om klinisk utprøving av medisinsk utstyr' plus sponsor and device names; DMP provides national forms/templates (Application-Notification form, cover letter, MDR Annex XV checklist, GSPR/standards checklist, statement of conformity).

Conditions
  • Applies to application-required clinical investigations of medical devices.
  • Interim channel until the EUDAMED clinical investigation module is available.

Notifications (Art. 74(1) investigations) go to the same mailbox, subject 'Melding om klinisk utprøving av medisinsk utstyr'.

Official form or portal surface

submission.official-form-or-portal-surface
Fact-level verified
Submission Surface

EUDAMED

Details

Actor and device registration in Norway takes place in EUDAMED; the CA (dmp.no) publishes the registration pages. Clinical investigation submissions use a separate national channel (email kki@dmp.no) until EUDAMED is available.

Conditions
  • Applies to device/actor registration.

QMS, audit & inspection

Which QMS, audit, inspection, and certificate scope is accepted or required?

Compare countries

Norwegian notified body

qms.norwegian-notified-body
Fact-level verified

DNV Product Assurance AS has been designated by the Norwegian Medical Products Agency as a notified body under the MDR and, as the first Norwegian notified body for IVDs, under the IVDR.

Conditions
  • Certification capacity fact; manufacturers may use any EEA-designated notified body.

Notified-body designation and oversight authority

qms.notified-body-authority
Fact-level verified

Direktoratet for medisinske produkter designates and supervises notified bodies in Norway (per MDR Article 35 and IVDR Article 31, read with the Act on technical control bodies).

Conditions
  • Applies to conformity assessment bodies seeking/holding Norwegian notification.

Recall, FSCA & market surveillance

Which recall, FSCA, notice, and authority-coordination duties apply?

Compare countries

FSCA reporting channel

recall.fsca-channel
Fact-level verified

Reports on field safety corrective actions and the field safety notice for devices on the Norwegian market or from Norwegian manufacturers shall be sent to the Norwegian Medical Products Agency (NOMA) by email to MSOD@dmp.no; NOMA responds with a case number that must be stated in all subsequent communications.

Conditions
  • Applies to FSCAs concerning devices on the Norwegian market or from Norwegian manufacturers.
  • Reports must also go to authorities of all affected EU/EEA countries (EU-level rule).

Report content must include e.g. UDI/identification, SRN, manufacturer's reference number, risk profile, reason and user instructions.

Field safety notice language

recall.fsnotice-language
Fact-level verified

Safety communications from manufacturers to users of devices must be given in Norwegian; in special cases they may be given in English until a Norwegian translation is available, and the Norwegian translation must follow without undue delay.

Conditions
  • English only accepted temporarily, in special cases.
  • Applies to safety communications under MDR Art. 89(8)/IVDR Art. 84(8).

CA FSCA page: 'In Norway, field safety notices must be in Norwegian, but an English version may be accepted' temporarily pending translation.

Registration pathways

Which registration, notification, listing, reliance, or conformity route applies?

Compare countries

Market-access registration route

registration.market-access-route
Fact-level verified
Submission Surface

EUDAMED

Obligation

Manufacturers must register their devices in EUDAMED prior to placing the devices on the market in Norway/EU-EEA.

Transition Deadline

Devices placed on the market before 28 May 2026 fall under a six-month transition and must be registered by 28 November 2026.

Conditions
  • Applies to all devices requiring registration under MDR/IVDR.
  • Conformity (CE) route itself is EU-level.

No national pre-market approval: CE-marked devices circulate EEA-wide; national registration duty is discharged in EUDAMED.

Public device register duty

registration.public-device-register
Fact-level verified

Anyone with a business address in Norway who produces and markets medical devices in their own name (including as systems or procedure packs) must enter company name, organisation number, business address and data enabling unambiguous identification of the devices in a public device register (offentlig utstyrsregister).

Conditions
  • Applies to producers/marketers with Norwegian business address, including own-name marketers of systems and procedure packs.

In practice discharged through EUDAMED registration per the CA's registration pages.

Reliance & recognition

Which foreign decisions or evidence can be reused, with what effect and conditions?

Compare countries

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.

Norway approvals and evidence in other markets (11 records)

BotswanaEU conformity assessment · US FDA · Japan MHLW / PMDA · Swissmedic · Health Canada · Australia TGA · Iceland · Norway

Prior approval / evidence record

Stringent Regulatory Authority approval — ICH members (European Commission, US FDA, Japan MHLW/PMDA), ICH observers (Swissmedic, Health Canada) or an authority associated with an ICH member through a legally binding mutual recognition agreement (including Australia, Iceland, Liechtenstein and Norway)

Authority

Stringent Regulatory Authority approval — ICH members (European Commission, US FDA, Japan MHLW/PMDA), ICH observers (Swissmedic, Health Canada) or an authority associated with an ICH member through a legally binding mutual recognition agreement (including Australia, Iceland, Liechtenstein and Norway)

Accepted

No

Benefit

The SRA definition in G01 s.3.1.26 is used for dossier and reference purposes rather than as an automatic grant: an SRA approval does not by itself confer a Botswana registration, and it benefits the applicant only through the abridged pathway's proof-of-reference-agency requirement, which is defined by the separate Reference Regulatory Authority concept.

Maintained reference · planning ranges remain estimates · reviewed 2026-09-16

BotswanaEU conformity assessment · US FDA · Japan MHLW / PMDA · Swissmedic · Health Canada · Australia TGA · Iceland · Norway · WHO

Prior approval / evidence record

A prior approval from an SRA, an RRA, or WHO (with ISO 13485) opens the abridged assessment pathway

reliance.abridged-assessment-on-sra-rra-or-who-approval
Fact-level verified
Statement

For a Class B, C or D general medical device, an existing approval from a Stringent Regulatory Authority, a BoMRA-recognised Reference Regulatory Authority, or WHO prequalification, together with a valid ISO 13485 certificate, qualifies the application for the abridged assessment pathway instead of full evaluation. Class B accepts one approval from an RRA, an SRA or WHO. Class C requires at least one SRA or WHO approval, plus at least three years on the market in an SRA jurisdiction and no safety issues in the previous three years. Class D requires approvals from at least two RRAs including one SRA, plus the same three-year marketing and safety conditions. The local application and the final BoMRA decision are retained in all cases.

Source Approval

Any Stringent Regulatory Authority (ICH member: European Commission, US FDA, Japan MHLW/PMDA; ICH observers: EFTA/Swissmedic, Health Canada; ICH-associated via MRA: Australia, Iceland, Liechtenstein, Norway) or a BoMRA-recognised Reference Regulatory Authority, or WHO (with valid ISO 13485 certification or equivalent)

Edge Type

Abridged Or Recognition Route

Market Access Strength

facilitated

Regulatory Layer

Premarket Review

Local Application Required

Yes

Target Decision Retained

Yes

Conditions
  • Each class has its own threshold: Class B - one RRA, SRA or WHO approval; Class C - one SRA or WHO approval plus 3 years marketed in an SRA jurisdiction; Class D - two RRAs including one SRA plus 3 years marketed.
  • The three-year safety test is defined as no reported deaths, no reported serious deterioration in the state of health of any person, and no open field safety corrective actions including recalls at the point of submission.
  • A prior rejection or withdrawal by a foreign jurisdiction for quality, performance/efficacy or safety reasons disqualifies the abridged route.
  • The RRA list itself is not published in the guideline; it lives in BOMRA-ER-MED-Policy No.1, which BoMRA's site did not serve.
  • Regulatory layer is premarket_review: the abridged route shortens the assessment, it does not dispense with BoMRA's registration.

Effective from 2024-12-09

SRA is defined in the same guideline at s. 3.1.26 as an ICH member (European Commission, US FDA, MHLW/PMDA), an ICH observer (EFTA as represented by Swissmedic, and Health Canada), or an authority associated with an ICH member through a legally binding mutual recognition agreement (Australia, Iceland, Liechtenstein, Norway). China NMPA is NOT an SRA on that definition. RRA is defined at s. 3.1.25 by cross-reference to BoMRA policy 'Recognition and-or Reliance on Information on Medical Devices including IVDs from Regional and International Regulatory Agencies BOMRA-ER-MED-Policy No.1', which was not found published on the BoMRA site.

Dominican RepublicUS FDA · Health Canada · Japan MHLW / PMDA · Australia TGA · EU conformity assessment · Iceland · Norway

Prior approval / evidence record

WHO Strict Authorities — US FDA, Health Canada, Japan NIHS, Australia TGA, EMA, Icelandic Medicines Agency, Norwegian Medicines Agency, Liechtenstein AML

Authority

WHO Strict Authorities — US FDA, Health Canada, Japan NIHS, Australia TGA, EMA, Icelandic Medicines Agency, Norwegian Medicines Agency, Liechtenstein AML

Accepted

Yes

Benefit

Eligibility for the simplified registration procedure under Resolución No. 000004 on a Certificate of Free Sale plus a good-manufacturing-practices certificate from that authority, for new registrations and renewals of imported products; the remaining legal requirements still apply and DIGEMAPS retains the decision.

Timeline Savings

No published period: the MSP service listing shows 'Inmediatamente' rather than a number of days.

DIGEMAPS — Registro sanitario de productos sanitarios: tiempo de respuesta (90 días laborables)DIGEMAPS — Renovación de registro sanitario de productos sanitarios: tiempo de respuestaMSP — Procedimiento simplificado: costo del servicio y tiempo de respuesta (Inmediatamente / según los requisitos)Decreto núm. 45-23 que modifica el Decreto núm. 117-18 — renovación automática de registros sanitarios, Artículos 2, 3 y 4Resolución No. 000004 del 27 de enero de 2016 — criterios para la aplicación del registro sanitario, venta libre y buenas prácticas de establecimientos

Maintained reference · planning ranges remain estimates · reviewed 2026-09-16

Dominican RepublicUS FDA · Health Canada · Japan MHLW / PMDA · Australia TGA · EU conformity assessment · Iceland · Norway · Brazil ANVISA

Prior approval / evidence record

Simplified registration for imported products previously authorised by a WHO Strict Authority or a PAHO/PARF regional reference authority

reliance.strict-authority-prior-authorisation-simplified-procedure
Fact-level verified
Statement

An imported product that has previously been authorised by a WHO Strict Authority or by a regional reference regulatory authority (ARNr) of the PAHO/PARF network may be registered through the simplified procedure, evidenced by a Certificate of Free Sale and a Certificate of Good Manufacturing Practices issued by that authority, in addition to the other requirements of current legislation. Products that any of those authorities has refused to authorise are excluded from the simplified procedure.

Source Approval

WHO Strict Authorities: US FDA; Health Canada; Japan NIHS (National Institute of Health Science); Australia TGA; EMA; Icelandic Medicines Agency; Norwegian Medicines Agency; Liechtenstein (Amt für Lebensmittelkontrolle und Veterinärwesen). PAHO/PARF regional reference authorities (ARNr): ANMAT (Argentina), ANVISA (Brazil), CECMED (Cuba), INVIMA (Colombia), COFEPRIS (Mexico)

Edge Type

Abridged Or Recognition Route

Market Access Strength

facilitated

Regulatory Layer

Premarket Review

Local Application Required

Yes

Target Decision Retained

Yes

Conditions
  • Eligibility runs to 'nuevos registros sanitarios y renovaciones' (new registrations and renewals of existing registrations) of imported products.
  • The prior authorisation is evidenced by a Certificate of Free Sale plus a Certificate of Good Manufacturing Practices issued by the listed authority; the rest of the legally established requirements still apply.
  • A product that one of the listed authorities has refused to authorise may not use the simplified procedure (CUARTO).
  • Products identified as having quality failures in post-market monitoring or serious safety reports are excluded (PÁRRAFO of SEGUNDO).
  • Resolution in force from 1 April 2016 (SEXTO).
  • The resolution is drafted around the medicines framework; the MSP service listing for the simplified procedure expressly covers 'Productos Sanitarios' with its own fee, but the MSP listing shows Productos Sanitarios under the renewal modality only, while the fee table lists them under both new and renewal — the scoping for new device registrations is therefore stated by the MSP rather than by the resolution text itself.

Effective from 2016-04-01

Spanish. Source PDF is an image-only scan (Adobe 'Image Conversion Plug-in'); the passage below was read from the scan by OCR and OCR spacing artefacts were normalised. Original: "Productos importados que previamente hayan sido autorizados por Autoridades Estrictas (OMS) y/o de Autoridades Reguladoras de Referencia Regional (ARNr) de la Red Panamericana para la Armonización de la Reglamentación Farmacéutica (RED PARF/OPS), lo cual debe ser avalado mediante la presentación del 1. Certificado de Libre Venta y Certificado de Buenas Prácticas de Manufactura emitido por las referidas autoridades en adición a los demás requisitos establecidos en la legislación vigente." English: imported products previously authorised by WHO Strict Authorities and/or PAHO/PARF regional reference authorities, evidenced by the free-sale and GMP certificates issued by those authorities, in addition to the other requirements of current legislation. The recognised-authority list (TERCERO) names FDA, Health Canada, NIHS, TGA, EMA, the Icelandic and Norwegian medicines agencies and Liechtenstein as Strict Authorities, and ANMAT, ANVISA, CECMED, INVIMA and COFEPRIS as ARNr.

EgyptUS FDA · EU conformity assessment · Australia TGA · Health Canada · Japan MHLW / PMDA · UK MHRA · Swissmedic · Norway · New Zealand · Ireland · Iceland

Regulatory reference

List of reference countries

reliance.reference-countries
Fact-level verified

EDA recognizes reference countries: EU member states plus Australia, Canada, Iceland, Ireland, Japan, New Zealand, Norway, Switzerland, United Kingdom and United States of America; devices from these countries get reduced documentation, while devices from non-reference countries need extra evidence.

Variation guideline v03 (res-eg-variations) lists the same set plus Croatia and Liechtenstein.

IsraelUS FDA · UK MHRA · Germany · France · Italy · Spain · Netherlands · Belgium · Ireland · Denmark · Sweden · Finland · Norway · Iceland · Greece · Portugal · Austria · Swissmedic · Australia TGA · Health Canada · New Zealand

Regulatory reference

Recognized-state registration route

reliance.recognized-country-route
Fact-level verified

A device registered, or approved for marketing and actually marketed, in a 'recognized state' (מדינה מוכרת) is registered in the Israeli register for a period not exceeding the period it may be marketed in that state, capped at 5 years from Israeli registration. Recognized states are listed in the First Addendum to the law — 21 states including the US, UK, Germany, France, Italy, Spain, the Netherlands, Belgium, Ireland, Denmark, Sweden, Finland, Norway, Iceland, Greece, Portugal, Austria, Switzerland, Australia, Canada and New Zealand (no single 'EU' entry: member states are listed individually).

Conditions
  • Device must be registered or permitted for marketing and actually marketed in the recognized state.

First Addendum list per the official Sefer HaChukim text of the law held from gov.il.

PakistanAustralia TGA · Health Canada · Japan MHLW / PMDA · UK MHRA · Swissmedic · US FDA · Austria · Belgium · Denmark · France · Germany · Ireland · Italy · Netherlands · Norway · Spain · Sweden · WHO · EU conformity assessment

Regulatory reference

Rule 67 lists reliance reference countries plus WHO prequalification and CE marking

reliance-reference-countries
Fact-level verified

Rule 67 names the reference countries and schemes whose market authorisations DRAP relies on: USA, Japan, Australia, Canada, Austria, Belgium, Denmark, France, Germany, Ireland, Italy, Netherlands, Norway, Spain, Sweden, Switzerland and United Kingdom, or devices pre-qualified by the World Health Organization, or CE marked by conformity assessment bodies (CABs) notified in the NANDO database under the relevant European directive for medical devices, subject to evidence and supporting documents.

Conditions
  • Reliance subject to evidence and supporting documents

Effective from 2018-01-16

ParaguayBrazil ANVISA · US FDA · Health Canada · Austria · Belgium · Denmark · Finland · France · Germany · Hungary · Ireland · Italy · Netherlands · New Zealand · Norway · Spain · Sweden · Japan MHLW / PMDA · UK MHRA · Swissmedic · Australia TGA · WHO

Prior approval / evidence record

IVD Annex I reference-country list drives the 30/45/120-business-day clocks

reliance.ivd-anexo-i-reference-country-list
Fact-level verified
Statement

For IVDs, DINAVISA decides within 30 business days for products manufactured nationally or in a country of Annex I, within 45 business days for products manufactured outside Annex I but registered and commercialised in an Annex I country (which must additionally file the foreign registration certificate and free-sale certificate), and within 120 business days for other imports. Annex I names high-surveillance and adequate-surveillance authorities and the full MERCOSUR members; the United States and Japan are on it and Korea is not.

Source Approval

Sanitary registration and free-sale certificate in force in an Annex I country — high-surveillance authorities (Germany, Austria, Belgium, Canada, Denmark, Spain, United States, France, Israel, Italy, Japan, Netherlands, United Kingdom, Sweden, Switzerland) or adequate-surveillance authorities (Australia, Chile, Cuba, Finland, Hungary, Ireland, Luxembourg, Mexico, Norway, New Zealand); Annex I also lists full MERCOSUR members (Argentina, Brazil, Paraguay, Uruguay) and PAHO/WHO reference authorities

Edge Type

Abridged Or Recognition Route

Market Access Strength

facilitated

Regulatory Layer

Premarket Review

Local Application Required

Yes

Target Decision Retained

Yes

Conditions
  • The Annex I list derives from Ley N° 3283/2007 Art. 11 (high and adequate sanitary surveillance).
  • A product made outside Annex I is admitted on a 45-day clock only if it is registered and commercialised in an Annex I country.
  • Korea (MFDS) does not appear in Annex I, so a Korean-only IVD authorisation does not by itself reach the 30/45-day clocks.
  • A Paraguayan sanitary registration is still required in every case.

Source language: Spanish. Translation of the quoted Annex I heading and entries: 'Countries with High and Adequate Sanitary Surveillance Authorities (Law 3283/07 Article 11)' / 'Countries with high sanitary surveillance regulatory authorities: Germany, Austria, Belgium, Canada, Denmark, Spain, United States, France, Israel, Italy, Japan, Netherlands, United Kingdom, Sweden and Switzerland.' / 'Full MERCOSUR members: Argentina, Brazil, Paraguay and Uruguay.' The excerpt is taken from the resolution's own Annex I; Art. 6 supplies the 30- and 45-business-day clocks.

PeruAustralia TGA · Health Canada · Japan MHLW / PMDA · Swissmedic · US FDA · UK MHRA · France · Netherlands · Germany · Spain · Denmark · Italy · Norway · Belgium · Sweden

Regulatory reference

High-vigilance countries list for evidence

reliance.free-sale-high-vigilance-countries
Fact-level verified

For free-sale certificate and related evidence purposes, the high-vigilance countries are France, Netherlands, UK, USA, Canada, Japan, Switzerland, Germany, Spain, Australia, Denmark, Italy, Norway, Belgium and Sweden.

Conditions
  • List per Art. 9 D.S. 016-2011-SA.

D.S. 018-2019-SA subsequently added Austria to this list (as shown on DIGEMID's normas-legales repository).

PeruUS FDA · UK MHRA · Health Canada · Japan MHLW / PMDA · Australia TGA · Swissmedic · South Korea MFDS · Germany · France · Netherlands · Spain · Italy · Belgium · Portugal · Ireland · Austria · Hungary · Denmark · Norway · Sweden

Prior approval / evidence record

País de Alta Vigilancia Sanitaria (art. 9 D.S. 016-2011-SA): United States, Canada, Japan, Australia, Switzerland, South Korea, United Kingdom, Germany, France, Netherlands, Spain, Italy, Belgium, Portugal, Ireland, Austria, Hungary, Denmark, Norway, Sweden

Authority

País de Alta Vigilancia Sanitaria (art. 9 D.S. 016-2011-SA): United States, Canada, Japan, Australia, Switzerland, South Korea, United Kingdom, Germany, France, Netherlands, Spain, Italy, Belgium, Portugal, Ireland, Austria, Hungary, Denmark, Norway, Sweden

Accepted

Yes

Benefit

The Peruvian route to relying on a foreign approval is documentary, not procedural. A certificate of free sale or a GMP certificate issued by a high-surveillance authority is accepted directly, and if the issuing authority appears on the Resolución Directoral 169-2014-DIGEMID list the document does not need an apostille. Everything else still goes through DIGEMID certification.

Timeline Savings

None published — the TUPA period is set by class, not by origin

DIGEMID TUPA (D.S. 011-2026-SA) — device procedure attention periodsPeru D.S. 016-2011-SA — Reglamento para el Registro, Control y Vigilancia Sanitaria de Productos Farmacéuticos, Dispositivos Médicos y Productos Sanitarios (arts. 7 and 9, as amended)

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

Sri LankaEU conformity assessment · Australia TGA · Health Canada · Japan MHLW / PMDA · Swissmedic · Singapore HSA · US FDA · UK MHRA · Norway

Regulatory reference

Reliance pathway reference countries

reliance.reference-countries
Fact-level verified

For general medical devices, registrations from USA, UK, Australia, Canada, Japan, Norway, Switzerland and all EU member countries are considered under the reliance pathway; for IVD medical devices the same list applies plus Singapore.

Conditions
  • IVD list: 'USA, UK, Australia, Canada, Japan, Norway, Switzerland, Singapore & All European Union (EU) member countries'.
  • Reference NRA evidence: product registration certificate or free sale certificate issued by the reference authority.

Prior approvals and evidence for Norway (3 records)

NorwayEU conformity assessment

Prior approval / evidence record

EU CE under MDR/IVDR — single market validity

reliance.reliance-edge-eu-ce-to-eea30-approval-eu-ce-mdr-ivdr-norway
Fact-level verified
Target

geo:nor

Source Approval

EU CE under MDR/IVDR

Edge Type

Single Market Validity

Market Access Strength

direct

Regulatory Layer

Product Marketing

Same Device Required

Yes

Local Application Required

No

Target Decision Retained

No

Conditions
  • medical devices and IVDs subject to route-specific scope
  • valid CE conformity route for the device
  • country language, economic-operator, EUDAMED, and national vigilance obligations still apply

CA treats Norway as part of the single EU/EEA market: registration (not approval) is the national act; MDR/IVDR are Norwegian law via the EEA Agreement (Lov om medisinsk utstyr § 1).

NorwayNMPA

Regulatory reference

NMPA certificate does not replace EU conformity assessment

reliance.china-nmpa-no-recognition-route
Fact-level verified
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 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.

Source Jurisdiction Id

china

Source Authority Id

nmpa

Source Approval

China NMPA medical device registration certificate (Class II/III) or Class I filing record

Target Jurisdiction Id

norway

China Classes In Scope

All NMPA classes (I filing, II, III) -> all EU MDR/IVDR classes

Edge Type

No Reliance Route

Market Access Strength

none

Regulatory Layer

Product Marketing

Local Application Required

null

Target Decision Retained

null

Conditions
  • Determine the local class independently; NMPA Class III is not an automatic EU class assignment.
  • A local regulatory application/decision is not universal: MDR Article 52(7) and IVDR Article 48(10) permit specified self-declaration routes.
  • Clinical, performance and technical evidence must meet the applicable EU requirements; the certificate alone does not replace them.
  • Special-purpose, investigational, custom-made and derogation regimes require separate assessment.
Lov om medisinsk utstyr (LOV-2020-05-07-37)MDR consolidated text, 19 July 2026IVDR consolidated text, 10 January 2025

Independent review of current EUR-Lex consolidations supports this bounded ordinary-route conclusion. It does not establish the absence of every special route.

NorwayUS FDA

Prior approval / evidence record

FDA 510(k)/PMA

Authority

FDA 510(k)/PMA

Accepted

No

Benefit

No substitute for EU MDR conformity assessment; useful as predicate documentation in the technical file

Commission Implementing Regulation (EU) 2026/977, Art. 2 — maximum notified-body conformity assessment timelines (30 + 120/90 parallel + 20 days)EUR-Lex Regulation (EU) 2017/745 (MDR)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)

Maintained reference · planning ranges remain estimates · reviewed 2026-08-29

Review clocks

What review, validation, and applicant stop-clock rules apply?

Compare countries

Clinical investigation stop-clock rule

review-clocks.ci-stop-clock
Fact-level verified

For clinical investigation applications requiring assessment (invasive class IIa/IIb and class III devices), the 45-day assessment period is frozen for the time DMP awaits requested additional information from the sponsor; expert consultation may add 20 days.

Conditions
  • Applies to assessment-route applications (invasive IIa/IIb, III).

CA page: 'DMP må etterspørre mer informasjon fra sponsor. Saksbehandlingstiden vil da fryses den tiden vi venter på svar.'

Special access & derogation

Is an emergency, compassionate, custom, humanitarian, or other exceptional path available?

Compare countries

National exemption (dispensation) power

derogation.dispensation-power
Fact-level verified

Direktoratet for medisinske produkter may, in special cases, grant exemptions from provisions laid down in or under the Medical Devices Act, provided this does not conflict with Norway's international obligations, including the EEA Agreement.

Conditions
  • Special cases only; cannot conflict with EEA/international obligations.

Submission communications & appeal

How are deficiencies answered, clocks handled, and decisions escalated or appealed?

Compare countries

Appeal against authority decisions

appeal.administrative-appeal
Fact-level verified

Individual decisions (enkeltvedtak) of Direktoratet for medisinske produkter may be appealed under the Public Administration Act § 28 to the immediately superior administrative organ (for a directorate, the ministry); the CA's clinical-investigation pages expressly state that sponsors may appeal rejections of applications.

Conditions
  • Appeal by a party or others with legal appeal interest.

CA CI page: 'Ved avslag på søknaden kan sponsor klage på avgjørelsen.' forskrift § 17 ties supervision and decisions to the Medical Devices Act.

UDI, listing & traceability

Which UDI, device listing, database, and traceability duties apply?

Compare countries

Official UDI/listing surface

udi.official-listing-surface
Fact-level verified
Submission Surface

EUDAMED

Details

Device registration (with UDI data) takes place in EUDAMED; devices placed on the market before 28 May 2026 must be registered by 28 November 2026.

Conditions
  • Applies to devices subject to EUDAMED registration under MDR/IVDR.

Vigilance & incident reporting

What is reportable, by whom, where, in what format, and by what deadline?

Compare countries

Serious incident reporting deadlines

vigilance.deadlines
Fact-level verified
Serious Public Health Threat

2 days

Death

10 days

Unexpected Serious Deterioration

10 days

Other Serious Incidents

15 days

Clock

From the date the manufacturer became aware of the incident until the report is sent to the authorities

Conditions
  • Manufacturers (or their authorised representatives) must report immediately once a causal relationship is established or reasonably assumed.

Deadlines as published by the Norwegian CA (mirroring MDR Article 87 timelines); the channel is the national MIR-form email route.

Healthcare facility reporting duty

vigilance.healthcare-facility-duty
Fact-level verified

Healthcare facilities in Norway have a national obligation to report serious incidents that have or may have a connection with the use of a medical device; they report via the national reporting portal melde.no.

Conditions
  • Applies to healthcare facilities (national duty beyond economic operators).

Statutory basis: Lov om medisinsk utstyr § 8 empowers regulation of a reporting duty for owners and users of medical devices.

Serious incident reporting channel (MIR form)

vigilance.reporting-channel-mir
Fact-level verified

Serious incidents occurring in Norway are reported to the Norwegian Medical Products Agency using the common European Manufacturer Incident Report (MIR, version 7.3.1), sent by email with both PDF and XML versions attached; NoMA responds with a case number to be quoted in subsequent correspondence.

Conditions
  • Incidents are reported only in the country where they occurred; in Norway to NoMA.
  • Channel applies until reporting through EUDAMED is taken into use.

Address stated on this page: MSOD@noma.no; the FSCA reporting page of the same CA states MSOD@dmp.no for corrective-action reports.

Transitional national malfunction/withdrawal reporting

vigilance.transitional-national-reporting
Fact-level verified

Transitional national duty: anyone producing devices in their business must without undue delay report to Direktoratet for medisinske produkter any malfunction, performance deterioration or label/IFU deficiency that led or could have led to death or serious worsening of health, and any technical or medical reason prompting systematic withdrawal or device modification.

Conditions
  • Transitional provision (forskrift kapittel VI) applicable until EUDAMED is fully functional.
  • Duty on producers.

Related structured datasets

Classification systems · 1 record
Open EU MDR classes I, Is, Im, Ir, IIa, IIb and III →
Id

norway:medical-device

Jurisdiction Id

norway

Domains
  • medical-device
Name

EU MDR classes I, Is, Im, Ir, IIa, IIb and III

Description

National projection of the directly applicable EU MDR classification. The canonical class axis and rules are maintained in eu:medical-device; national references describe only administration or local deltas.

Classes
  • Id

    i

    Label

    Class I

    Normalized Risk Level

    low

  • Id

    is

    Label

    Class Is

    Normalized Risk Level

    low

  • Id

    im

    Label

    Class Im

    Normalized Risk Level

    low

  • Id

    ir

    Label

    Class Ir

    Normalized Risk Level

    low

  • Id

    iia

    Label

    Class IIa

    Normalized Risk Level

    medium

  • Id

    iib

    Label

    Class IIb

    Normalized Risk Level

    high

  • Id

    iii

    Label

    Class III

    Normalized Risk Level

    highest

Regulator

DMP

Official Domains
  • legemiddelverket.no
  • eur-lex.europa.eu
  • europa.eu
Source Status

official-source-verified

Reference Sources
  • Title

    Page section on classification rules

    Url

    https://www.dmp.no/en/medical-devices/development-and-manufacturing/qualification-and-classification

    Reviewed On

    2026-08-25

    Supports

    No national classification scheme: classification of medical devices in Norway follows MDR Annex VIII and IVDs follow IVDR Annex VIII, applicable via the EEA Agreement; no Norwegian classification rules on top.

  • Title

    § 3 Myndighet til å avgjøre om et produkt er medisinsk utstyr

    Url

    https://lovdata.no/dokument/SF/forskrift/2021-05-09-1476

    Reviewed On

    2026-08-25

    Supports

    Borderline/qualification: in cases of doubt the national authority (Direktoratet for medisinske produkter) decides whether a product is a medical device (forskrift § 3), and also handles classification enquiries per its qualification-and-classification guidance.

Inherited From Scheme Id

eu:medical-device

Source Title

Regulation (EU) 2017/745, Art. 51 and Annex VIII

Source Url

https://eur-lex.europa.eu/eli/reg/2017/745/oj

Verified On

2026-08-26

Source Supports
  • class-axis
  • classification-rules
Registration pathways, prior approvals and planning · 1 record
Open Norway registration →
Country

Norway

Jurisdiction Id

norway

Country Code

NO

Flag

🇳🇴

Regulator

Norwegian Medical Products Agency

Regulator Abbrev

Norwegian Medical Products Agency

Region

europe

Tier

3

Risk Classification

4-class (I, IIa, IIb, III) — EU MDR

Classes
  • Id

    class-i

    Class Name

    Class I

    Risk Level

    low

    Pathway

    Self-declaration (no notified body)

    Official Timeline
    Min

    0

    Max

    0

    Unit

    days

    Verification Status

    official-verified

    Official Source
    Title

    EUR-Lex Regulation (EU) 2017/745 (MDR)

    Url

    https://eur-lex.europa.eu/eli/reg/2017/745/oj

    Accessed Date

    2026-08-25

    Realistic Timeline
    Min

    6

    Max

    9

    Unit

    months

    Notes
    • MDR Art. 52(7): non-sterile, non-measuring, non-reusable-surgical Class I devices are self-declared, so no authority or notified body reviews the file and there is no review clock
    • Elapsed time is Eudamed actor and device registration, which has no guaranteed processing time, plus any national registration duty
    Clinical Trial Required

    No

    Local Testing Required

    No

    Gmp Required

    Yes

Key Requirements
  • EU/EEA Authorized Representative (for non-EEA manufacturers)
  • Clinical investigation validation: feedback within 15 days of receipt; if invalid, 10 days to comment (+20); final validity within 10 days after resubmission
  • Assessment: decision within 45 days of validation, clock frozen awaiting sponsor information, +20 with experts
  • Transitional MDD rules until EUDAMED is mandatory: notification at least 60 days before start; class III/implantable/long-term invasive IIa/IIb start 60 days after notification unless objected
  • End-of-investigation notification within 15 days; final report within 1 year
Prior Approvals
  • Authority

    FDA 510(k)/PMA

    Accepted

    No

    Benefit

    No substitute for EU MDR conformity assessment; useful as predicate documentation in the technical file

Local Rep Required

Yes

Local Rep Name

EU Authorized Representative

Mdsap Accepted

No

Mdsap Benefit

ISO 13485 accepted as QMS evidence

Registration Validity

5 years (CE certificate)

Last Updated

2026-08-29

Verification Status

partially-verified

Official Sources
  • Title

    Commission Implementing Regulation (EU) 2026/977, Art. 2 — maximum notified-body conformity assessment timelines (30 + 120/90 parallel + 20 days)

    Url

    https://eur-lex.europa.eu/eli/reg_impl/2026/977/oj

    Effective Date

    2027-02-25

    Accessed Date

    2026-08-29

  • Title

    EUR-Lex Regulation (EU) 2017/745 (MDR)

    Url

    https://eur-lex.europa.eu/eli/reg/2017/745/oj

    Accessed Date

    2026-08-25

  • Title

    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)

    Url

    https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:02017R0745-20250110

    Accessed Date

    2026-08-29

Reviewed On

2026-08-29

Process
Template Id

default

Status

planning-template

Usage Rule

Maintained planning steps and estimates, not verified regulator deadlines.

Steps
  • Step

    1

    Title

    Pre-Submission Preparation

    Description

    Gather technical documentation, quality management system (QMS) records, and clinical data required by Norwegian Medical Products Agency. Appoint a EU Authorized Representative.

    Duration

    1-3 months

    Icon

    📋

  • Step

    2

    Title

    Application Submission

    Description

    Submit complete registration dossier to Norwegian Medical Products Agency including device description, risk analysis, and testing reports.

    Duration

    1-2 weeks

    Icon

    📤

  • Step

    3

    Title

    Administrative Review

    Description

    Norwegian Medical Products Agency reviews application for completeness. May request additional documents or clarifications.

    Duration

    2-4 weeks

    Icon

    🔍

  • Step

    4

    Title

    Technical Evaluation

    Description

    In-depth technical assessment of device safety and performance. Norwegian Medical Products Agency may issue questions.

    Duration

    0 days

    Icon

    ⚙️

  • Step

    5

    Title

    Registration Approval

    Description

    Upon successful review, Norwegian Medical Products Agency issues Norway market authorization certificate.

    Duration

    1-2 weeks

    Icon

    ✅

Government fee schedules · 1 record
Open Norway fees →
Jurisdiction Id

norway

Country

Norway

Country Code

NO

Authority

Norwegian Medical Products Agency

Low Risk Local
Min

0

Max

0

Currency

NOK

Per Product

Yes

High Risk Local
Min

0

Max

0

Currency

NOK

Per Product

Yes

Details
  • Id

    clinical-investigation-processing

    Item

    Processing of clinical-investigation applications and notifications

    Currency

    NOK

    Amount Local

    0

    Amount Local Formatted

    NOK 0

    Frequency

    Per application

    Notes

    DMP charges no fee for processing applications and notifications of clinical investigations of medical devices.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.dmp.no/medisinsk-utstyr/klinisk-utproving-av-medisinsk-utstyr/introduksjon-til-klinisk-utprøving-av-medisinsk-utstyr

    Source Title

    Norway DMP: no fee for clinical-investigation applications and notifications

    Verified On

    2026-08-25

Notes
  • DMP and NOMA expressly state that they charge no fee for the cited clinical-investigation and IVD performance-study applications and notifications.
Last Updated

2026-08-25

Verification Status

official-verified

Official Sources
  • Title

    Norway DMP: no fee for clinical-investigation applications and notifications

    Url

    https://www.dmp.no/medisinsk-utstyr/klinisk-utproving-av-medisinsk-utstyr/introduksjon-til-klinisk-utprøving-av-medisinsk-utstyr

    Accessed Date

    2026-08-25

  • Title

    Norway NOMA: no fees for IVD performance-study applications and notifications

    Url

    https://www.dmp.no/en/medical-devices/performance-studies-of-in-vitro-diagnostic-medical-devices/introduction-to-performance-studies-of-ivd-medical-devices

    Accessed Date

    2026-08-25

Reviewed On

2026-08-25

Amount Status

exact-current

Range Available

Yes

Additional certifications and licences · 1 record
Open Norway certifications →
Slug

norway

Market

Norway

Confidence

high

Schemes
  • Id

    lvd-medical-exclusion-mdr-electrical-safety

    Name

    MDR electrical safety in place of the Low Voltage Directive

    Category

    Medical Electrical Safety

    Status

    Included In Medical Registration

    Object

    Finished Device

    Note

    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.

    Source Urls
    • https://eur-lex.europa.eu/eli/dir/2014/35/oj
    Source Binding

    candidate

  • Id

    emc-directive-disapplied-by-mdr

    Name

    MDR electromagnetic compatibility in place of the EMC Directive

    Category

    emc

    Status

    Included In Medical Registration

    Object

    Finished Device

    Note

    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.

    Source Urls
    • https://eur-lex.europa.eu/eli/dir/2014/30/oj
    Source Binding

    candidate

  • Id

    forskrift-377-2016-radio-market-access

    Name

    EEA radio equipment forskrift market access

    Category

    Radio Spectrum

    Status

    Mandatory If Feature

    Object

    Radio Equipment

    Note

    Norway implements Directive 2014/53/EU through the EEA Agreement in forskrift 15 April 2016 nr. 377, laid down by Nkom itself. §4 allows radio equipment to be made available on the market when it satisfies the §6 essential requirements and is correctly marked under §28, and to be put into service when it also is correctly installed, maintained and used as intended, with a frequency licence under the ekomlov chapter 11 where one is needed. §33 gives Nasjonal kommunikasjonsmyndighet supervision. The only extra Norwegian element is that spectrum licence, which is a use authorisation rather than a product approval.

    Source Binding

    unresolved

  • Id

    produktforskriften-kap-2a-rohs

    Name

    Produktforskriften chapter 2a substance restriction (RoHS)

    Category

    Environmental And Batteries

    Status

    Evidence Only No Separate Certificate

    Object

    Electrical Electronic Medical Device

    Note

    §2a-3 of the produktforskriften (FOR-2004-06-01-922) prohibits placing on the market and exporting electrical and electronic products where lead, mercury, hexavalent chromium, PBB, PBDE, DEHP, BBP, DBP or DIBP exceed 0.1 % by weight in homogeneous materials, or cadmium exceeds 0.01 %; §7-2 gives Miljødirektoratet supervision. Chapter 2a's vedlegg 2 carries exemptions specific to medisinsk utstyr and to monitoring and control instruments. 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.

    Source Urls
    • https://lovdata.no/dokument/SF/forskrift/2004-06-01-922/KAPITTEL_3
    Source Binding

    candidate

  • Id

    avfallsforskriften-kap-1-returselskap-membership

    Name

    Returselskap membership and the EE register

    Category

    Environmental And Batteries

    Status

    Mandatory If Feature

    Object

    Producer Or Authorised Representative

    Note

    Norway's structure differs from the EU member states and the difference is load-bearing. §1-10 of the avfallsforskriften requires producers to finance collection, sorting and treatment of WEEE through membership of a collectively or individually financed returselskap approved by Miljødirektoratet, and §1-25 has Miljødirektoratet own a register covering all producers of EE products, which the returselskap populate under §1-19. The binding duty is therefore membership rather than direct registration, and chapter 1 contains no prohibition on placing equipment on the market for non-registration. 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.

    Source Urls
    • https://lovdata.no/dokument/SF/forskrift/2004-06-01-930/KAPITTEL_1
    Source Binding

    candidate

  • Id

    batteries-regulation-not-yet-in-norwegian-law

    Name

    Batteries Regulation not yet carried into Norwegian law

    Category

    Environmental And Batteries

    Status

    Transition Not Yet Mandatory

    Object

    Battery Producer Or Authorised Representative

    Note

    No Norwegian instrument implementing Regulation (EU) 2023/1542 is in force and no Article 55 register has been designated. Miljødirektoratet's battery guidance states that the batteriforskrift will implement the Regulation but that the rules do not apply in Norway until the forskrift is adopted, which depends on incorporation of the Regulation into the EEA Agreement. The operative national rules remain avfallsforskriften chapter 3, whose §3-7 requires battery producers to discharge producer responsibility through membership of an approved returselskap, and produktforskriften chapter 2, both implementing the repealed Directive 2006/66/EC — which independently confirms the Regulation has not yet landed. Currency caveat: the guidance page still expects incorporation in spring 2025, so the EEA Joint Committee decisions should be re-checked before relying on the timing.

    Source Urls
    • https://www.miljodirektoratet.no/ansvarsomrader/avfall/for-naringsliv/batteriveilederen/
    Source Binding

    candidate

  • Id

    dsa-godkjenning-for-supply-and-medical-use

    Name

    DSA godkjenning for radiation source supply and medical use

    Category

    Ionizing Radiation

    Status

    Mandatory If Feature

    Object

    Radiation Source Sale Rental Or Medical Use

    Note

    Strålevernforskriften (FOR-2016-12-16-1659) § 9 letter r requires approval from the Direktoratet for strålevern og atomsikkerhet for selling and renting out radiation sources, which reaches the supplier rather than only the clinical user. The same section requires approval for acquiring and using radiotherapy equipment (f), healthcare X-ray apparatus including plain radiography, fluoroscopy, angiography and intervention, CT and mammography (g, with simple low-dose apparatus exempt), acquiring and administering radiopharmaceuticals (e), and manufacturing or importing radiopharmaceuticals (i). § 8 requires a written application giving the information DSA needs to set conditions.

    Source Urls
    • https://lovdata.no/dokument/SF/forskrift/2016-12-16-1659
    Source Binding

    reviewed

  • Id

    dsa-mri-approval-and-source-notification

    Name

    DSA MRI approval and source notification

    Category

    Non Ionizing Radiation

    Status

    Mandatory If Feature

    Object

    Mri Or Notified Optical Radiation Source

    Note

    Strålevernforskriften § 9 letter s extends the approval duty to acquiring and using magnetic resonance imaging for medical purposes, a non-ionising requirement that has no EU equivalent. § 13 requires notification to DSA by undertakings that acquire, rent out, use or handle X-ray apparatus, accelerators and radioactive sources above the annex exemption limits when they are not approval-liable under § 9 or § 10, and by undertakings that rent out, acquire, use or handle class 4 lasers and intense pulsed light. The sources may not be taken into use until DSA confirms it has received the electronic notification.

    Source Urls
    • https://lovdata.no/dokument/SF/forskrift/2016-12-16-1659
    Source Binding

    candidate

Official Sources
  • Authority

    EUR-Lex

    Topic

    Low Voltage Directive 2014/35/EU Annex II — electrical equipment for radiology and medical purposes outside scope

    Url

    https://eur-lex.europa.eu/eli/dir/2014/35/oj

  • Authority

    EUR-Lex

    Topic

    EMC Directive 2014/30/EU Article 2(3) — more specific Union legislation displaces the directive

    Url

    https://eur-lex.europa.eu/eli/dir/2014/30/oj

  • Authority

    EUR-Lex

    Topic

    RoHS Directive 2011/65/EU Annex I category 8 and Article 4(3) medical-device application dates

    Url

    https://eur-lex.europa.eu/eli/dir/2011/65/oj

  • Authority

    EUR-Lex

    Topic

    WEEE Directive 2012/19/EU Article 2(4)(g) medical-device exclusions and Article 16 national producer register

    Url

    https://eur-lex.europa.eu/eli/dir/2012/19/oj

  • Authority

    EUR-Lex

    Topic

    Batteries Regulation (EU) 2023/1542 Articles 11 and 55 — medical-device removability derogation and producer register

    Url

    https://eur-lex.europa.eu/eli/reg/2023/1542/oj

  • Authority

    Lovdata

    Topic

    Forskrift 2016-04-15-377 om EØS-krav til radioutstyr §§ 4 and 33

    Url

    https://lovdata.no/dokument/SF/forskrift/2016-04-15-377

  • Authority

    Lovdata

    Topic

    Produktforskriften kapittel 2a § 2a-3 — RoHS substance prohibition for EE products

    Url

    https://lovdata.no/dokument/SF/forskrift/2004-06-01-922/KAPITTEL_3

  • Authority

    Lovdata

    Topic

    Avfallsforskriften kapittel 1 §§ 1-10, 1-19 and 1-25 — returselskap membership and the EE register

    Url

    https://lovdata.no/dokument/SF/forskrift/2004-06-01-930/KAPITTEL_1

  • Authority

    Miljødirektoratet

    Topic

    batteriveilederen — the Batteries Regulation does not apply in Norway until the forskrift is adopted

    Url

    https://www.miljodirektoratet.no/ansvarsomrader/avfall/for-naringsliv/batteriveilederen/

  • Authority

    Lovdata

    Topic

    strålevernforskriften — approval and notification duties for radiation sources and MRI

    Url

    https://lovdata.no/dokument/SF/forskrift/2016-12-16-1659

Keep researching this market

More Norway medical device resources

View the Norway resource hub →
Continue with this market
DJ Fang
Need to apply Norway's requirements to a product?
Confirm the current Norwegian Medical Products Agency pathway, evidence, and local-role details for the actual device before filing.
Pricing