MEDICAL DEVICES AND IN VITRO DIAGNOSTICS GUIDELINES

Document Number	Title	Categories	Date updated	Version	Units	File Type	Link	doc_categories_hfilter	doc_tags_hfilter
8.02	Medical Device IVD Essential Principles	Guideline	2019 Nov	2	Medical Devices		Download	guideline	medical-devices
5.08	Revised Guideline – DONATION OF MEDICINES MEDICAL DEVICES AND IVDs	Communication to industry, Guideline	2020 Apr	3	Medical Devices		Download	communication-to-industry guideline	medical-devices
8.04	Recalls Vigilance Medical Devices IVDs	Guideline	2019 Nov	3	Medical Devices		Download	guideline	medical-devices
8.05	CLASSIFICATION of MEDICAL DEVICES and IVDs	Guideline	2021 Aug	5	Medical Devices		Download	guideline	medical-devices
8.07	Medical Device Quality Manual	Guideline	2019 Nov	2	Medical Devices		Download	guideline	medical-devices
MD004	Extension – Use of acknowledgement letter in lieu of a licence	Communication to industry, Guideline	2020 Mar	1	Medical Devices	pdf	Download	communication-to-industry guideline	medical-devices
MD010	Guidance Rapidly developed ventilator	Communication to industry, Guideline	2020 May	1	Medical Devices	pdf	Download	communication-to-industry guideline	medical-devices
16.03	Licence Medical Devices IVDs	Guideline	2019 Nov	3	Medical Devices		Download	guideline	medical-devices