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Medicines Authority Factsheet

Factsheet for Importers & Distributors of Medical Devices

Medicines Authority factsheet on importer and distributor obligations under the medical devices regulations
MaltaMedicines AuthorityRegistration
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Factsheet for Importers & Distributors of Medical Devices is the official MMA identifier for “Medicines Authority factsheet on importer and distributor obligations under the medical devices regulations”. Factsheet for Importers & Distributors of Medical Devices is the official identifier MMA uses for this instrument.

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Factsheet
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Factsheet for Importers & Distributors of Medical Devices
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Registration
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12 articles · 1 language version
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About this regulation

Medicines Authority factsheet on importer and distributor obligations under the medical devices regulations

Undated Medicines Authority factsheet for importers and distributors, in nine numbered sections: an introduction to the medical devices regulations; what happened on 26 May 2021 (the date the Union regulations became applicable); what type of economic operator the reader is, with the importer-or-distributor distinction; the obligations that follow; the application forms that apply; timelines; the systems that must be in place, namely good distribution practice and a quality management system; relabelling; and where to get more information. The copy prints no issue date, reference number or revision, so none is asserted; the lastVerifiedOn date records only the calendar day the bytes were checked. The document is written in two columns on its later pages, and the extract preserves the printed reading order — left column to the foot of the page, then right column — rather than pdftotext's row-interleaved output.

Factsheet for Importers & Distributors of Medical Devices is the official identifier MMA uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.