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Medical Devices And In Vitro Diagnostics Guidelines

Document NumberTitleCategoriesDate UpdatedVersionUnitsFile TypeLinkdoc_categories_hfilterdoc_tags_hfilter
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)13/12/20241pdfDownloadguidelinemedical-devices
SAHPGL-MD-07Guideline on Questions and Answers Licensing of Medical Device Establishments, 17/11/20233pdfDownloadfaq 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 IVDs23/03/20233pdfDownloadguidelinemedical-devices
SAHPGL-MD-05Guideline on Medical Device Quality Manual14/03/20234pdfDownloadguidelinemedical-devices
SAHPGL-MD-04 Guideline for Classification of Medical Devices and IVDs15/03/20244pdfDownloadguidelinemedical-devices
SAHPGL-MD-03 (previously 8.04)Guideline for Medical Device Adverse Event Reporting13/12/20244pdfDownloadguidelinemedical-devices
8.02 (Archived)Medical Device IVD Essential Principles14/11/20192Downloadguidelinemedical-devices