MEDICAL DEVICES AND IN VITRO DIAGNOSTICS GUIDELINES

Document NumberTitleCategoriesDate updatedVersionUnitsFile TypeLinkdoc_categories_hfilterdoc_tags_hfilter
8.02Medical Device IVD Essential Principles

2019 Nov

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5.08Revised Guideline – DONATION OF MEDICINES MEDICAL DEVICES AND IVDs,

2020 Apr

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8.04Recalls Vigilance Medical Devices IVDs

2019 Nov

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8.05CLASSIFICATION of MEDICAL DEVICES and IVDs

2021 Aug

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8.07Medical Device Quality Manual

2019 Nov

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MD004Extension – Use of acknowledgement letter in lieu of a licence,

2020 Mar

1pdfDownloadcommunication-to-industry guidelinemedical-devices
MD010Guidance Rapidly developed ventilator,

2020 May

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16.03Licence Medical Devices IVDs

2019 Nov

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