Medicines Authority S.L.S.L. 458.59
S.L. 458.59 is the official MMA identifier for “Medical Devices and In-Vitro Diagnostic Medical Devices Provision on the Maltese Market Regulations”. S.L. 458.59 is the official identifier MMA uses for this instrument.
- Instrument
- S.L.
- Full name
- S.L. 458.59
- Category
- Registration
- Authority source
- English
- Readable HTML
- 11 articles · 1 language version
- Published
- 4 August 2020
- Effective
- —
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Each version has stable article anchors for direct citations and highlighting. The readable text is generated from an authority source and does not replace the legally controlling publication.
Medical Devices and In-Vitro Diagnostic Medical Devices Provision on the Maltese Market Regulations
Subsidiary legislation of Malta made as Legal Notice 321 of 2020 and published on 4 August 2020, in eleven regulations: citation; interpretation; designation of the competent authority and the accrediting body; administration; importation, wholesaling, manufacturing or re-purposing of medical devices; the obligation of the medical device registered person; issuing of approval; issue of guidelines; monitoring and review of operations; the obligation of economic operators to transmit complaints to the competent authority; and fines and penalties. Regulation 3 is the provision that makes the Medicines Authority the competent authority, which is why the registry regulator label is used for this row. The copy ingested is the instrument as made and shows no amendment history. It is the only Maltese instrument in the corpus that names medical devices, in-vitro diagnostic medical devices and their economic operators in a single text.
S.L. 458.59 is the official identifier MMA uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.