Pure Global AI
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 resources24/25 requirements coveredAug 2026 fees reviewed
Run the classification agent

Everything we track for Portugal

Medical device regulation news

Follow recent INFARMED, I.P. policy, guidance, safety, and compliance updates.

AI medical device classifier

Describe your device and get a preliminary INFARMED risk class with official rule references.

Government registration fees

Review current INFARMED application, review, and renewal fees.

Additional certification and licence checker

Check whether product features may trigger separate radio, electrical, metrology, radiation, import, or other Portugal requirements.

Registration timeline

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

Structured regulatory requirements

Explore all 47 source-linked facts →

24 of 25 research dimensions currently covered · 23 official sources · latest verification 2026-08-30

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
Open details →
D02

Legal basis & guidance

Verified
National MDR execution law
Decreto Lei n.º 29/2024, de 5 de abril (as amended by Decreto Lei n.º 118/2025) ensures the execution of Regulation (EU) 2017/745 in the national legal order; it regulates economic operator…
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Decreto Lei n.º 145/2009 is repealed by DL 29/2024, except provisions kept in force transitionally by Art. 52: arts 9, 10 and 11(1,2,3,5) and 41(1)(b) (registration duties until EUDAMED), C…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
Open details →
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
Open details →
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
Open details →
D05

Registration pathways

Verified
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…
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.
2 source-linked facts
Checked 2026-08-25
Open details →
D06

Reliance & recognition

Verified
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…
1 source-linked fact
Checked 2026-08-30
Open details →
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
Open details →
D08

Establishment, import & distribution

Verified
Distribution activities subject to notification
Wholesale type distribution activities in Portugal — supply, possession, storage or delivery of devices for resale or use in medical services, health units, pharmacies and other retail outl…
Distribution requirements: responsible technical person and facilities
Distribution activity is only permitted if the operator has a responsible technical person (responsável técnico) ensuring compliance and adequate facilities/equipment for storage, conservat…
6 source-linked facts
Checked 2026-08-25
Open details →
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
Open details →
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
Open details →

Submission & evidence

D11

Label, IFU & language

Verified
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…
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…
2 source-linked facts
Checked 2026-08-25
Open details →
D12

QMS, audit & inspection

Verified
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…
ISO 13485 QMS for loan/consignment providers
Entities making devices available under loan or consignment must have an implemented QMS, notably per EN ISO 13485, proportionate to device risk class and type, plus qualified staff and a w…
3 source-linked facts
Checked 2026-08-25
Open details →
D13

Standards, testing & ancillary approvals

Verified
MDR electrical safety in place of the Low Voltage Directive
Electrical safety
MDR electromagnetic compatibility in place of the EMC Directive
EMC
Decreto-Lei 57/2017 radio equipment market access
Wireless / radio
7 maintained overlays
Checked 2026-08-29
Open details →
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
Open details →
D15

Review clocks

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

Approval validity & renewal

Verified
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.
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.
2 source-linked facts
Checked 2026-08-25
Open details →

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
Open details →
D18

UDI, listing & traceability

Verified
National listing: SIDM records with UDI-DI/EUDAMED ID; CDM code; InfoDM portal
Devices already registered in EUDAMED are recorded in SIDM using the EUDAMED data with the UDI DI/EUDAMED ID; after upload of labelling, IFU and declaration the CDM device code is automatic…
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
Open details →
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…
Submissions via EU electronic system or INFARMED national electronic system
Clinical investigation applications/notifications are submitted through the EU electronic system of MDR Art. 73 or, for the national routes of Lei 71/2025 Art. 5, through INFARMED's nationa…
3 source-linked facts
Checked 2026-08-25
Open details →
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
Open details →
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
Open details →
D22

Vigilance & incident reporting

Verified
Serious incident suspicions reported to INFARMED
The persons referred to in MDR Art. 22 must additionally communicate to INFARMED all information on suspicions of serious incidents occurring in Portugal after devices are placed on the mar…
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
Open details →
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
Open details →
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
Open details →
D25

Submission communications & appeal

Verified
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…
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…
2 source-linked facts
Checked 2026-08-25
Open details →

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)
Continue with this market

Turn Portugal research into practical work

The target market is carried into each tool. Add the product, evidence, or regulatory change you want to assess.

View every AI workpaper →

Build a reusable product master

Structure company, product, model, approval, certificate, and evidence facts before starting Portugal work.

Portugal market-launch workpaper

Connect the INFARMED route, evidence, labels, local role, timing, and dependencies to a wider launch plan.

Portugal dossier reuse and delta

Compare an existing authorization and evidence set against INFARMED administrative, testing, labeling, and dossier needs.

Portugal change notification workpaper

Map a product or manufacturing change to INFARMED evidence, notification, timing, and implementation questions.

Portugal regulatory change impact

Assess a current INFARMED update against one product and turn it into an owner-ready action workpaper.

Portugal cybersecurity evidence review

Review connected-device architecture, risks, SBOM, testing, lifecycle controls, and market-specific questions for Portugal (INFARMED).

Country hubs in other markets

Other Europe markets

AlbaniaAustriaBelarusBelgiumBulgariaCzech RepublicDenmarkEuropean UnionFinlandFranceGermanyGreeceHungaryIrelandItalyKazakhstanLiechtensteinLithuaniaLuxembourgNetherlandsNorwayPolandRomaniaRussiaSerbiaSlovakiaSloveniaSpainSwedenSwitzerlandTurkeyUkraineUnited KingdomAll 82 markets →
DJ Fang
Entering the Portugal market?
Local representation, INFARMED submissions, and lifecycle maintenance — handled with an expert.
Pricing