Guidance on Medical Device Establishment Licensing (GUI-0016) (French, HTML)

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HTML

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file-only

Publisher-reported update

2020-09-17

This guidance document is intended for any person in the medical device industry and it provides guidance on regulatory requirements in relation to Medical Device Establishment Licences (MDEL), including when and how to apply for an MDEL, and how to maintain an MDEL once issued.

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