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Medical Devices And In Vitro Diagnostics Guidelines

Document NumberTitleCategoriesDate UpdatedVersionUnitsLinkdoc_categories_hfilterdoc_tags_hfilter
SAHPGL-MD-18Post Market Surveillance and Post-market Clinical Follow-up Studies09/09/20251Downloadguidelinemedical-devices
SAHPGL-MD-16Guidelines on Clinical Evaluation of Medical Devices09/09/20251Downloadguidelinemedical-devices
SAHPGL-MD-17Guideline on Clinical Investigation of Medical Devices09/09/20251Downloadguidelinemedical-devices
8.04 (Archived)Recalls Vigilance Medical Devices IVDs14/11/20192Downloadguidelinemedical-devices
GLF-MD-11AMedical Device Adverse Event Reporting Form13/12/20241Downloadguidelinemedical-devices
SAHPGL-MD-11Guideline for Completing Medical Device Adverse Event Form for Licensed Holders (Licensee) / Holders of a Certificate Of Registration of al Medical Device (including an IVD)13/12/20241Downloadguidelinemedical-devices
SAHPGL-MD-07Guideline on Questions and Answers Licensing of Medical Device Establishments, 21/05/20254Downloadfaq guidelinemedical-devices
8.01 (Archived)General Information Medical Devices And IVDs13/08/20141Downloadguidelinemedical-devices
8.06 (Archived)Guideline For Access To And Control Of Medical Devices And IVDs18/04/20171Downloadguidelinemedical-devices
SAHPGL-MD-06Guideline for a License to Manufacture, Import, Export, or Distribute Medical Devices and IVDs23/03/20233Downloadguidelinemedical-devices
SAHPGL-MD-05Guideline on Medical Device Quality Manual14/03/20234Downloadguidelinemedical-devices
SAHPGL-MD-04 Guideline for Classification of Medical Devices and IVDs28/02/20255Downloadguidelinemedical-devices
SAHPGL-MD-03 (previously 8.04)Guideline for Medical Device Adverse Event Reporting13/12/20244Downloadguidelinemedical-devices
SAHPGL-INSP-RC-08Guideline for Donation of Medicines, Medical Devices, and IVDs07/11/20254, Downloadguidelinemedical-devices regulatory-compliance
8.02 (Archived)Medical Device IVD Essential Principles14/11/20192Downloadguidelinemedical-devices