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INFARMED · Europe

Portugal medical device regulatory resources

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

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

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Government registration fees

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Registration timeline

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Structured regulatory requirements

Explore all 48 source-linked facts →

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

Market entry

D01

Authority & regime

Verified
Competent authority (national)
INFARMED — Autoridade Nacional do Medicamento e Produtos de Saúde, I.P. is the national competent authority for Regulation (EU) 2017/745 and the authority responsible for notified bodies in…
National contact point for clinical investigations
INFARMED, IP is the national entity responsible for applying Regulations (EU) 2017/745 and 2017/746 and the national contact point for the purposes of MDR Article 101 and IVDR Article 96.
2 source-linked facts
Checked 2026-08-25
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D02

Legal basis & guidance

Verified
National clinical investigation / performance study law
Lei n.º 71/2025, de 22 de dezembro executes MDR Chapter VII (clinical investigations) and IVDR Chapter VI (performance studies) nationally: INFARMED decides, CEIC gives the binding ethics o…
Revocation of DL 145/2009 with kept-alive provisions
Decreto Lei n.º 145/2009 is repealed by DL 29/2024, except provisions kept in force transitionally by Art. 52: arts 9, 10 and 11(1,2,3,5) and 41(1)(b) (registration duties until EUDAMED), C…
4 source-linked facts
Checked 2026-08-25
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D03

Device definition & scope

Verified
In-house devices: national notification duty
Devices manufactured and used in house by health institutions under MDR Art. 5(5) must be notified to INFARMED electronically, with a declaration of GSPR compliance, exclusive internal use,…
1 source-linked fact
Checked 2026-08-25
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D04

Classification rules

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

Registration pathways

Verified
Custom-made device manufacturers: notification
Any manufacturer domiciled or headquartered in Portugal placing custom made devices on the market in its own name must notify INFARMED electronically.
Transitional national registration until EUDAMED is operational
Until EUDAMED is implemented and operational, manufacturers, authorised representatives, distributors and notified bodies must meet their national notification/registration duties under DL…
2 source-linked facts
Checked 2026-08-25
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D06

Reliance & recognition

Verified
NMPA certificate does not replace EU conformity assessment
statement: For ordinary market placement under MDR/IVDR, a Chinese approval does not replace conformity assessment under MDR Article 52 or IVDR Article 48. The applicable EU class and proce…
EU CE under MDR/IVDR — single market validity
target: geo:prt · sourceApproval: EU CE under MDR/IVDR · edgeType: single market validity · marketAccessStrength: direct · regulatoryLayer: product marketing · sameDeviceRequired: Yes · loc…
2 source-linked facts
Checked 2026-09-15
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D07

Economic-operator roles

Verified
Importers/distributors performing MDR Art. 16(2) activities must communicate to INFARMED
The exercise in Portugal of the activities referred to in MDR Article 16(2)(a) and (b) (activities that make the importer or distributor subject to manufacturer obligations) requires a comm…
1 source-linked fact
Checked 2026-08-25
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D08

Establishment, import & distribution

Verified
Good distribution practices under Portaria 256/2016
Distributors must comply with the good distribution practices of Portaria n.º 256/2016, de 28 de setembro (principles and norms of good distribution practice for medical devices); the same…
IVD wholesale distributors: communication of distributed products
IVD wholesale distributors operating in the national market must communicate to INFARMED the IVDs they distribute, under the still in force Art. 12 of DL 189/2000 (name/address, list of pro…
6 source-linked facts
Checked 2026-08-25
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D09

Dossier requirements

Verified
Submissions to the authority in Portuguese
Documents, elements and information submitted to INFARMED (and to the authority responsible for notified bodies) under DL 29/2024 must be in Portuguese or accompanied by an official transla…
1 source-linked fact
Checked 2026-08-25
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D10

Official forms & portals

Verified
SIDM national registration system (articulated with EUDAMED)
INFARMED operates SIDM (Sistema de Registo de Dispositivos Médicos), the national on line registration system for devices and IVDs, articulated with EUDAMED to avoid duplicate registrations…
1 source-linked fact
Checked 2026-08-25
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Submission & evidence

D11

Label, IFU & language

Verified
IVD labels and IFU in Portuguese
INFARMED requires labels and instructions for use of IVDs to be written in Portuguese, legible and indelible, regardless of whether use is professional, without prejudice to other languages…
Labels, IFU and advertising in Portuguese
Labelling, instructions for use, advertising material, implant card and other manufacturer information (including graphic interfaces) must be in Portuguese, without prejudice to including o…
2 source-linked facts
Checked 2026-08-25
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D12

QMS, audit & inspection

Verified
INFARMED inspection and market supervision powers
INFARMED supervises and inspects compliance with DL 29/2024, MDR and Implementing Regulation (EU) 2020/1207 across all establishments, institutions, units and sites in Portugal where device…
ISO 13485 QMS for sterilisation, maintenance, calibration and technical support providers
Activities not liable to affect device conformity — sterilisation, maintenance, calibration, technical assistance or other services performed per manufacturer instructions — may only be car…
3 source-linked facts
Checked 2026-08-25
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D13

Standards, testing & ancillary approvals

Unresolved
MDR electrical safety in place of the Low Voltage Directive
Electrical safety
MDR electromagnetic compatibility in place of the EMC Directive
EMC
Decreto-Lei 57/2017 radio equipment market access
Wireless / radio
7 maintained overlays
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D14

Fees

Verified
Clinical-study application - non-CE device or CE outside intended purpose
EUR 1,000
Clinical-study application - CE-marked device
EUR 600
5 maintained fee lines · 2 related facts
Checked 2026-08-25
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D15

Review clocks

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

Approval validity & renewal

Verified
Notified body designation revalidated every 5 years; application 1 year ahead
Notified bodies must apply to INFARMED for revaluation of their designation at least one year before the end of each five year period counted from certification or recertification.
Technical documentation retained 10 years (15 for implantables)
Technical documentation must be kept for 10 years after the start of use of the device and remain available for inspection; for implantable devices the period is 15 years.
2 source-linked facts
Checked 2026-08-25
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Lifecycle & post-market

D17

Change control

Verified
Distributors must communicate notification changes
Distributors must transmit electronically to INFARMED changes and updates to the mandatory notification elements, including the date from which they ceased distributing a given device.
1 source-linked fact
Checked 2026-08-25
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D18

UDI, listing & traceability

Verified
Distributors transmit UDI-DI of implantables to INFARMED
Distributors must electronically transmit to INFARMED, for coding and supervision purposes, their device list including the UDI DI of implantable devices supplied (recording UDI DI of other…
Implantable devices: registration of unique identification by user entities
Any public or private entity using implantable devices must record and keep, preferably electronically, the unique identification of the implantable devices used or supplied to them.
3 source-linked facts
Checked 2026-08-25
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D19

Clinical investigation & performance

Verified
INFARMED decides; CEIC gives binding ethics opinion
INFARMED is responsible for decisions on clinical investigation applications and notifications; the CEIC (Comissão de Ética para a Investigação Clínica) is the ethics committee competent fo…
Authorization vs notification routes by CE status
Clinical investigations of devices without CE marking, or CE marked devices used outside the intended purpose, follow the MDR Art. 62 authorization regime; investigations of CE marked devic…
3 source-linked facts
Checked 2026-08-25
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D20

Special access & derogation

Verified
Exceptional authorisation of devices without conformity assessment (MDR Art. 59)
Upon duly justified request, INFARMED may exceptionally authorise the placing on the market or putting into service in Portugal of specific devices that have not undergone the conformity as…
1 source-linked fact
Checked 2026-08-25
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D21

Manufacturer PMS

Verified
Post-market surveillance reporting (Arts. 83-86)
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…
1 source-linked fact
Checked 2026-08-29
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D22

Vigilance & incident reporting

Verified
National reporting channel: EU harmonized forms + dvps@infarmed.pt
Until the EUDAMED vigilance module is implemented, serious incidents and FSCA are reported to INFARMED using the EU harmonized forms published by the European Commission; all communication…
Health professionals and users must report serious incidents
Health professionals (in or outside the SNS), other professional users and other interested parties must equally notify INFARMED of serious incidents they become aware of as soon as possibl…
3 source-linked facts
Checked 2026-08-25
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D23

Recall, FSCA & market surveillance

Verified
FSCA report and safety notice to INFARMED at least 2 days before start
Until the EU implementing act under MDR Art. 91(d) is adopted, manufacturers must submit the field safety corrective action report and the safety notice to INFARMED up to two days before th…
INFARMED protective measures and corrective orders
To protect health, safety or MDR conformity, INFARMED may adopt necessary and transitional measures regarding a device or category of devices (including usage guidance and special monitorin…
2 source-linked facts
Checked 2026-08-25
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D24

Advertising, claims & promotion

Verified
National advertising regime still under DL 145/2009 Chapter XIII
Advertising of medical devices remains governed by DL 145/2009 Chapter XIII (kept in force by DL 29/2024 art. 52(5) until a new advertising law is published), supplemented by the Código da…
Prohibition of advertising to the general public for professional-use devices
Advertising to the general public is prohibited for devices whose use requires the mediation and decision of a health professional, notably implantable devices, long term invasive devices,…
2 source-linked facts
Checked 2026-08-25
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D25

Submission communications & appeal

Verified
Clinical investigation decisions: hierarchical appeal to health minister and courts
Decisions on clinical investigation applications, notifications and substantial modifications may be challenged by administrative impugnation (hierarchical appeal to the member of Governmen…
Reasoned decisions; appeal in general terms
Decisions restricting, conditioning or prohibiting the placing on the market of devices must be reasoned and notified to addressees (to the registered e mail address, per the Administrative…
2 source-linked facts
Checked 2026-08-25
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Government fees

Full fee schedule (5 lines) →

INFARMED registration fees in EUR · reviewed 2026-08-25

Fee lineAmountProvenance
Clinical-study application - non-CE device or CE outside intended purposeEUR 1,000Verified
Clinical-study application - CE-marked deviceEUR 600Verified
Study notification - non-CE deviceEUR 600Verified
Study notification - CE-marked deviceEUR 400Verified
1 more fee lines on the full schedule · 5 of 5 rows source-verified

Registration timeline

Full registration timeline →

National Authority of Medicines and Health Products (INFARMED) review clocks and planning ranges · 4-class (I, IIa, IIb, III) — EU MDR classification

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