Medicines Authority market accessResearch Medicines Authority registration records, classification, regulations, timelines, fees, and market updates — the stable entrance to every Malta medical device resource.
Describe your device and get a preliminary Medicines Authority risk class with an explanation and source links.
Check whether product features may trigger separate radio, electrical, metrology, radiation, import, or other Malta requirements.
Review current Medicines Authority application, review, and renewal fees.
Compare official and realistic approval times by device class and pathway.
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.
Common questions about changing a registered medical device in Malta. Each question separates published rules from details still awaiting verification.
23 of 25 research dimensions currently covered · 27 official sources · latest verification 2026-09-16
Medicines Authority registration fees in EUR · reviewed 2026-09-16
| Fee line | Amount | Provenance |
|---|---|---|
| Initial application for organisation registration of distributor/importer | EUR 500 | Verified |
| Certificate of Free Sale application | EUR 250 | Verified |
| Device Registration — placing a medical device on the European market application | EUR 100 | Verified |
| Derogation application in terms of Article 59 of Regulation (EU) 2017/745 and Article 54 of Regulation (EU) 2017/746 | EUR 1,000 | Verified |
Medicines Authority (Medicines Authority) review clocks and planning ranges · 4-class (I, IIa, IIb, III) — EU MDR classification
| Class / pathway | Review clock | Planning total | Provenance |
|---|---|---|---|
| Class I(Self-declaration (no notified body)) 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 the Maltese national registration duties in S.L. 458.59 | 0 days | 6-9 months | Verified |
| 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) This is the national competent-authority clock, not the conformity-assessment clock: Schedule 5 of S.L. 458.46 fixes a standard service of 30 working days from the date of submission of the application and supporting documentation, and the distributor/importer organisation registration, the certificate of free sale and the device registration lines all sit under it Those lines carry the fast-track asterisk, so the applicant may instead buy a 10-working-day service at double the fee The period is interrupted if the Authority requests further information or clarification and recommences on receipt of the applicant's response, which is why the realistic range is wider than the published clock | 30 days | 30-60 days | Verified |
| 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) Schedule 5 places the note 'Timeline for the processing of an application is within a 90 working day timeframe' at the end of the Derogations group, in the same position as the group-level notes under the Notified Body, Clinical Investigation and Request-for-advice groups, so it governs the two EUR 1,000 initial derogation lines and the EUR 750 renewal alike The separate 'Application for use of a Non-CE marked medical device in Malta' line (EUR 500) carries no note and falls under the 30-working-day standard service This is the Maltese national clock for a device that has not completed conformity assessment; it is not the Annex IX notified-body clock | 90 working days | 3-6 months | Verified |
| Maltese confirmation of risk classification — advisory service(Optional paid Medicines Authority confirmation under S.L. 458.46 Schedule 5) Schedule 5 lists the request form for medical device or in-vitro diagnostic confirmation of risk classification at EUR 1,000 under a note fixing the processing time within a 90 working day timeframe from date of submission of the application and supporting documentation The service is optional and confirms the Union class; it is not a prerequisite for placing a device on the Maltese market and it does not replace the manufacturer's own Annex VIII classification | 90 days | 3-4 months | Verified |
Official Medicines Authority rules and guidance · 11 of 11 documents linked to official sources
The target market is carried into each tool. Add the product, evidence, or regulatory change you want to assess.
Structure company, product, model, approval, certificate, and evidence facts before starting Malta work.
Connect the Medicines Authority route, evidence, labels, local role, timing, and dependencies to a wider launch plan.
Compare an existing authorization and evidence set against Medicines Authority administrative, testing, labeling, and dossier needs.
Map a product or manufacturing change to Medicines Authority evidence, notification, timing, and implementation questions.
Assess a current Medicines Authority update against one product and turn it into an owner-ready action workpaper.
Review connected-device architecture, risks, SBOM, testing, lifecycle controls, and market-specific questions for Malta (Medicines Authority).
Albania
Armenia
Austria
Azerbaijan
Belarus
Belgium
Bosnia and Herzegovina
Bulgaria
Croatia
Cyprus
Czech Republic
Denmark
Estonia
European Union
Finland
France
Georgia
Germany
Greece
Hungary
Iceland
Ireland
Italy
Kazakhstan
Latvia
Liechtenstein
Lithuania
Luxembourg
Moldova
Montenegro
Netherlands
North Macedonia
Norway
Poland
Portugal
Romania
Russia
Serbia
Slovakia
Slovenia
Spain
Sweden
Switzerland
Turkey
Ukraine
United KingdomAll 156 markets →
