Medical Devices And In Vitro Diagnostics Guidelines

Document Number	Title	Categories	Date Updated	Version	Units	File Type	Link	doc_categories_hfilter	doc_tags_hfilter
SAHPGL-MD-07	Guideline on Questions and Answers Licensing of Medical Device Establishments	FAQ, Guideline	17/11/2023	3	Medical Devices	pdf	Download	faq guideline	medical-devices
8.01 (Archived)	General Information Medical Devices And IVDs	Guideline	13/08/2014	1	Medical Devices		Download	guideline	medical-devices
8.06 (Archived)	Guideline For Access To And Control Of Medical Devices And IVDs	Guideline	18/04/2017	1	Medical Devices		Download	guideline	medical-devices
SAHPGL-MD-06	Guideline for a License to Manufacture, Import, Export, or Distribute Medical Devices and IVDs	Guideline	23/03/2023	3	Medical Devices	pdf	Download	guideline	medical-devices
SAHPGL-MD-05	Guideline on Medical Device Quality Manual	Guideline	14/03/2023	4	Medical Devices	pdf	Download	guideline	medical-devices
SAHPGL-MD-04	Guideline for Classification of Medical Devices and IVDs	Guideline	15/03/2024	4	Medical Devices	pdf	Download	guideline	medical-devices
8.04 (Archived)	Recalls Vigilance Medical Devices IVDs	Guideline	14/11/2019	3	Medical Devices		Download	guideline	medical-devices
8.02 (Archived)	Medical Device IVD Essential Principles	Guideline	14/11/2019	2	Medical Devices		Download	guideline	medical-devices