Medicines Authority current fee schedule, reviewed for 2026, in EUR.
14 fee lines100% exact amountscurrency EURFX rates 2026-09-17reviewed 2026-09-16
| Fee line | Official amount | USD equivalent | Frequency | Provenance |
|---|---|---|---|---|
| Initial application for organisation registration of distributor/importer Schedule 5, Distributor / Importer group. Carries the fast-track asterisk: fast-track service is offered at double the original fee, i.e. EUR 1,000, for completion within a 10 working day timeframe. | EUR 500 | $575 | Per application | Verified |
| Certificate of Free Sale application Schedule 5, Distributor / Importer group. Fast-track eligible at double the fee. | EUR 250 | $288 | Per declaration of conformity | Verified |
| Device Registration — placing a medical device on the European market application Schedule 5, Device Registration in the European Market group. The amending registration (revised) line is published at the same EUR 100; withdrawal incurs no charge. Fast-track eligible at double the fee. | EUR 100 | $115 | Per declaration of conformity | Verified |
| Derogation application in terms of Article 59 of Regulation (EU) 2017/745 and Article 54 of Regulation (EU) 2017/746 Schedule 5, Derogations group — the public-health derogation route onto the Maltese market for a device that has not completed the applicable conformity assessment. | EUR 1,000 | $1,150 | Per application | Verified |
| Derogation application in terms of Article 97 of Regulation (EU) 2017/745 and Article 92 of Regulation (EU) 2017/746 Schedule 5, Derogations group — the national competent-authority derogation for a device that is not compliant but whose use is in the interest of public health or patient safety in Malta. | EUR 1,000 | $1,150 | Per application | Verified |
| MDR and IVDR derogation renewal Schedule 5 publishes this as a separate line at EUR 750 under a note fixing the processing time within a 90 working day timeframe from date of submission of the application and supporting documentation. This is a lower figure than the EUR 1,000 initial application and is the kind of exact-wording item that is easy to miss. | EUR 750 | $863 | Per renewal | Verified |
| Request form for medical device / in vitro diagnostic confirmation of risk classification Schedule 5, Request for advice group. The note under the group fixes the processing time at 90 working days from submission. The companion request form for advice on making available a device in Malta is EUR 500. | EUR 1,000 | $1,150 | Per request | Verified |
| Pre-submission meeting request application Schedule 5, Clinical Investigation / Performance Study group. | EUR 1,000 | $1,150 | Per request | Verified |
| Application/notification for clinical investigation in accordance with Articles 62 and 74(1) of Regulation (EU) 2017/745 Schedule 5, Clinical Investigation / Performance Study group. The note under the group states the application timeframe is according to EU legislation and guidance document timelines, so the Maltese 30-working-day standard service does not apply to this line. | EUR 5,000 | $5,752 | Per application | Verified |
| Application/notification for clinical investigation in accordance with Article 82 of Regulation (EU) 2017/745 Schedule 5, Clinical Investigation / Performance Study group. Article 82 is the additional national provision for a clinical investigation to be conducted in Malta for a device not covered by the MDR's own investigation chapter. | EUR 1,000 | $1,150 | Per application | Verified |
| Application/notification for performance study in accordance with Regulation (EU) 2017/746 Schedule 5, Clinical Investigation / Performance Study group. Modification to a clinical investigation or performance study application is EUR 500. | EUR 5,000 | $5,752 | Per application | Verified |
| Application for use of a non-CE marked medical device in Malta Schedule 5, Application for use of a Non-CE marked medical device in Malta group. | EUR 500 | $575 | Per application | Verified |
| Inspection letter for distributor/importer Schedule 5. | EUR 300 | $345 | Every 3 years | Verified |
| Notified Body Designation application — initial setup of notified body Schedule 5. Paid by a conformity assessment body seeking designation by the Medicines Authority rather than by a device manufacturer; published here because it is part of the same Maltese device tariff. | EUR 30,000 | $34,511 | Per application | Verified |
Government fees only — service and testing costs are separate- Schedule 5 fixes a standard service of 30 working days for the processing of an application from the date of submission of the application and supporting documentation, unless a line carries a different note; if the Authority requires further information or clarification the period is interrupted and recommences on receipt of the applicant's response.
- Applications marked with an asterisk in Schedule 5 are eligible for fast-track service completed within a 10 working day timeframe, charged at double the original fee.
- All fees under Schedule 5 are non-refundable.
- The low-risk band is the published spread between the EUR 100 device registration line and the EUR 500 distributor/importer organisation registration line; the high-risk band is the spread between the EUR 1,000 derogation lines and the EUR 5,000 clinical investigation and performance study lines. Both bands are per application or per declaration of conformity, not per unit, and the bands are the reporter's grouping of published line items rather than a figure printed by the Medicines Authority.
- The clinical investigation and performance study lines are expressly excluded from the 30-working-day standard service and follow EU legislation and guidance document timelines instead.
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Exact amounts verified against the Medicines Authority fee schedule · full review 2026-09-16 · row IDs are stable — cite as government-fees:malta:distributor-importer-organisation-registration