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Medicines Authority market access

Malta medical device registration resources

Research Medicines Authority registration records, classification, regulations, timelines, fees, and market updates — the stable entrance to every Malta medical device resource.

5 free resources23/25 topics with records11 regulations trackedSep 2026 fees reviewed
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AI medical device classifier

Describe your device and get a preliminary Medicines Authority risk class with an explanation and source links.

Additional certification and licence checker

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

Government registration fees

Review current Medicines Authority application, review, and renewal fees.

Registration timeline

Compare official and realistic approval times by device class and pathway.

Medical device regulations

Browse Malta's official medical-device instruments — the Maltese market regulations, the Medicines Authority's registration and classification guidance, and the applicable EU MDR and IVDR texts — with citeable English passages.

Structured regulatory requirements

Explore all 34 source-linked facts →

23 of 25 research dimensions currently covered · 27 official sources · latest verification 2026-09-16

Market entry

D01

Authority & regime

Verified
Competent authority for medical devices: the Medicines Authority (Malta Medicines Authority)
The national competent authority for medical devices is the Medicines Authority established under article 4 of the Medicines Act (Cap. 458), designated by S.L. 458.59 as the authority in ch…
1 source-linked fact
Checked 2026-09-16
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D02

Legal basis & guidance

Verified
Legal basis: S.L. 458.59 under the Medicines Act, read with the MDR and IVDR
The national legal basis for medical devices is the Medical Devices and In Vitro Diagnostic Medical Devices Provision on the Maltese Market Regulations (S.L. 458.59), made under the Medicin…
1 source-linked fact
Checked 2026-09-16
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D03

Device definition & scope

Verified
Device definition and scope are taken directly from MDR Art. 2(1) and IVDR Art. 2(2)
Maltese law does not define a medical device independently. S.L. 458.59 reg. 2 provides that 'medical device' means any medical device as defined in Article 2(1) of Regulation (EU) 2017/745…
1 source-linked fact
Checked 2026-09-16
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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 · 1 related fact
Checked 2026-09-16
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D05

Registration pathways

Verified
Registration pathway: CE conformity plus national organisation registration and device notification
There is no Maltese pre market approval of a medical device. The pathway has two national steps on top of the CE conformity route: (1) organisation registration of the economic operator wit…
1 source-linked fact
Checked 2026-09-16
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D06

Reliance & recognition

Verified
China NMPA approval: no recognition regime
statement: A China NMPA registration certificate or Class I filing gives no market access route in Malta. Regulation (EU) 2017/745 Art. 52(1) (and Regulation (EU) 2017/746 Art. 48(1) for IV…
EU/EEA CE marking under MDR/IVDR — the domestic route, free movement into Malta
statement: CE marking under Regulation (EU) 2017/745 (MDR) or Regulation (EU) 2017/746 (IVDR) is not a foreign approval in Malta — it is the domestic route. A device that complies with the…
3 source-linked facts
Checked 2026-09-16
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D07

Economic-operator roles

Verified
Non-EU manufacturers must designate a sole EU authorised representative
A manufacturer not established in a Member State may place a device on the Union market — and therefore on the Maltese market — only if it designates a sole authorised representative. The a…
Economic operator roles and the mandatory Medical Device Registered Person (MDRP)
S.L. 458.59 recognises four economic operator roles — manufacturer, authorised representative, importer and distributor — and requires every operator that imports, wholesales, manufactures…
2 source-linked facts
Checked 2026-09-16
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D08

Establishment, import & distribution

Verified
Importation, wholesaling, manufacturing and re-purposing in Malta require authorisation
No person may import, wholesale, manufacture or re purpose in Malta any medical device intended for trade within the European Union or the local market before obtaining all the approvals, a…
1 source-linked fact
Checked 2026-09-16
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D09

Dossier requirements

Verified
National device notification dossier: notification sheet, EU declaration of conformity, proof of payment
The documents submitted with a Maltese medical device notification are the device notification sheet, the Declaration of Conformity (DoC) and proof of payment. The notification sheet must l…
1 source-linked fact
Checked 2026-09-16
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D10

Official forms & portals

Verified
Official forms MT-MDF02/03/05/11/12/13 and the email submission channel
Maltese medical device applications are made on the Authority's own numbered forms: MT MDF02 organisation registration, MT MDF03 revision or withdrawal of a device registration, MT MDF04 us…
1 source-linked fact
Checked 2026-09-16
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Submission & evidence

D11

Label, IFU & language

Verified
Labelling and instructions for use: English, Maltese, or both
Medical devices and all accompanying information placed on the Maltese market must be in one of the national languages of Malta — English and Maltese, or both. The Authority states the requ…
Relabelling or repackaging: 28 days' notice to the manufacturer and the Authority
Any relabelling or repackaging of a medical device within the meaning of Article 16(2) of the MDR must be communicated to the manufacturer and to the Malta Medicines Authority at least 28 d…
2 source-linked facts
Checked 2026-09-16
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D12

QMS, audit & inspection

Verified
Inspection powers and the Good Distribution Practice conditions on operators
The competent authority monitors and reviews operations conducted within premises to ensure the regulations are complied with, and for that purpose it — or any person authorised by it — has…
1 source-linked fact
Checked 2026-09-16
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D13

Standards, testing & ancillary approvals

Unresolved
Medical and radiology electrical equipment outside the Low Voltage Regulations
Electrical safety
Electromagnetic Compatibility Regulations and the MCCAA as market surveillance authority
EMC
Radio Equipment Regulations — MCCAA market surveillance in coordination with the MCA
Wireless / radio
7 maintained overlays · 1 related fact
Checked 2026-09-16
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D14

Fees

Verified
Initial application for organisation registration of distributor/importer
EUR 500
Certificate of Free Sale application
EUR 250
14 maintained fee lines · 1 related fact
Checked 2026-09-16
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D15

Review clocks

Unresolved
Class I · Self-declaration (no notified body)
0 days
Maltese organisation registration, device registration and free-sale certificate — standard service · National registration under S.L. 458.59, processed under the Schedule 5 standard service
30 days
National derogation (MDR Art. 59 and 97, IVDR Art. 54 and 92) — application and renewal · Medicines Authority derogation under S.L. 458.46 Schedule 5
90 working days
4 maintained pathways · 4 related facts
Checked 2026-09-16
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D16

Approval validity & renewal

Verified
CE certificate validity (5 years max) and the MDR transition dates as at 2026-09-15
The substantive term of a device's approval is the CE certificate: a notified body certificate is valid for the period it indicates, which may not exceed five years, and may be extended for…
National registrations and notifications renew annually
The Maltese national registrations do not lapse on a fixed term but renew annually against a fee: the distributor/importer organisation registration, the Medical Device Registered Person re…
2 source-linked facts
Checked 2026-09-16
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Lifecycle & post-market

D17

Change control

Verified
Change control: amendment and withdrawal procedures with fast-track handling
Changes to a Maltese registration are filed as an amendment rather than a new application. The Authority maintains MT MDF03, an application form for revision or withdrawal of a medical devi…
1 source-linked fact
Checked 2026-09-16
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D18

UDI, listing & traceability

Verified
UDI data is carried into the national device notification; EUDAMED registration is the Union layer
Where applicable, the Basic UDI DI and the UDI DI of a device, as written on its EU declaration of conformity, must be entered on the Maltese device notification sheet, along with the MMA r…
1 source-linked fact
Checked 2026-09-16
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D19

Clinical investigation & performance

Verified
Clinical investigations and performance studies: national application, fees and adverse-event reporting
Clinical investigations under the MDR and performance studies under the IVDR are authorised and overseen nationally by the Malta Medicines Authority. The Authority charges EUR 5,000 for an…
1 source-linked fact
Checked 2026-09-16
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D20

Special access & derogation

Verified
National derogation from conformity assessment and related non-CE-device services
By way of derogation from Article 52, the competent authority may authorise, on a duly justified request, the placing on the market or putting into service within Malta of a specific device…
1 source-linked fact
Checked 2026-09-16
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D21

Manufacturer PMS

Verified
Manufacturer post-market surveillance: Union system, with a Maltese complaints register on operators
For each device, the manufacturer must plan, establish, document, implement, maintain and update a post market surveillance system proportionate to the risk class and appropriate to the dev…
1 source-linked fact
Checked 2026-09-16
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D22

Vigilance & incident reporting

Verified
Economic operators must immediately forward incident reports to the competent authority
Any economic operator that receives complaints or reports from healthcare professionals, patients or users about incidents related to a medical device it has made available on the local mar…
Manufacturer reporting deadlines: 15 days, or 2 days for a serious public health threat
Manufacturers of devices made available on the Union market must report to the relevant competent authorities any serious incident involving such a device, and any field safety corrective a…
2 source-linked facts
Checked 2026-09-16
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D23

Recall, FSCA & market surveillance

Verified
Recall and field safety: operator register, FSCA reporting and the Authority's FSN repository
Every economic operator must keep a register containing details of complaints, of non conforming devices and of recalls and withdrawals, and must keep the competent authority informed of th…
1 source-linked fact
Checked 2026-09-16
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D24

Advertising, claims & promotion

Verified
Advertising and claims for medical devices in Malta
Advertising of, and claims for, medical devices in Malta are governed directly by Article 7 of Regulation (EU) 2017/745, which prohibits the use of text, names, trade marks, pictures and fi…
1 source-linked fact
Checked 2026-09-16
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D25

Submission communications & appeal

Verified
Submission channel and appeal route for device decisions in Malta
Submissions to the Maltese competent authority are made on the Medicines Authority's medical device e forms: MT MDF02 for organisation registration, MT MDF05 for notification of medical dev…
1 source-linked fact
Checked 2026-09-16
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Government fees

Full fee schedule (14 lines) →

Medicines Authority registration fees in EUR · reviewed 2026-09-16

Fee lineAmountProvenance
Initial application for organisation registration of distributor/importerEUR 500Verified
Certificate of Free Sale applicationEUR 250Verified
Device Registration — placing a medical device on the European market applicationEUR 100Verified
Derogation application in terms of Article 59 of Regulation (EU) 2017/745 and Article 54 of Regulation (EU) 2017/746EUR 1,000Verified
10 more fee lines on the full schedule · 14 of 14 rows source-verified

Registration timeline

Full registration timeline →

Medicines Authority (Medicines Authority) 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
Maltese organisation registration, device registration and free-sale certificate — standard service(National registration under S.L. 458.59, processed under the Schedule 5 standard service)30 days30-60 daysVerified
National derogation (MDR Art. 59 and 97, IVDR Art. 54 and 92) — application and renewal(Medicines Authority derogation under S.L. 458.46 Schedule 5)90 working days3-6 monthsVerified
Maltese confirmation of risk classification — advisory service(Optional paid Medicines Authority confirmation under S.L. 458.46 Schedule 5)90 days3-4 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)

Key regulations

All 11 Malta regulations →

Official Medicines Authority rules and guidance · 11 of 11 documents linked to official sources

GL-MDF02/05Guidance for Application for Organisation Registration in relation to Medical Devices
RegistrationVerified
GL-MDF05/06Guidance for Application Form for Notification of Medical Devices Made Available on the Local Market
RegistrationVerified
GL-MDF19/02Guidance for Application Forms MT-MDF12 and MT-MDF13 for a Derogation from the Conformity Assessment Procedures of Medical Devices
RegistrationVerified
GL-MDF21/02Guidance for Application for Medical Device / In-Vitro Diagnostic Evaluation of Risk Classification
ClassificationVerified
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