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16.04Licence to act as a Wholesaler of Medical Devices & IVDsV103-Aug-2017103 KB
2.04Post-importation TestingV220-Jan-2017526 KB
2.04Post-importation testing showing changesV220-Jan-2017509 KB
2.11Safety Reporting during Clinical Trials in South AfricaV220-Aug-2016424 KB
2.40Clinical Trial Oversight, Monitoring of Clinical TrialsV110-May-2016162 KB
2.42Post Clinical Trial Drug AccessV110-May-201698 KB
2.45Borderline ProductsV130-Mar-2017795 KB
2.46Co-packaging of MedicinesV105-May-201793 KB
5.07Guideline for recall / withdrawal of Medicines, Medical devices and IVDs - for commentV421-Sep-2015314 KB
5.07 Guideline for recall / withdrawal of Medicines, Medical devices and IVDs - showing changesV421-Sep-2015316 KB
6.1.aBiological AmendmentsV119-Jun-20171 MB
7.04Complementary Medicines - Health Supplements Safety & EfficacyV312-Apr-2017680 KB
7.04Complementary Medicines Health Supplements Safety & Efficacy Annexure JV3.130-May-2017408 KB
7.06Complementary Medicines - Caffeine and MentholV112-Apr-2017100 KB
8.01General Information - Medical Devices and IVDs for commentV223-Sep-2015807 KB
8.03Conformity Assessment Procedures - Medical Devices and IVDs for commentV123-Sep-2015407 KB
8.04ADR and Post-Marketing Vigilance Reporting of Medical Devices and IVDs for commentV123-Sep-2015165 KB
8.06Access to & Control of Medical Devices & IVDs for commentV101-Aug-2017692 KB
8.08Registration of an IVD medical device technical dossier for commentV123-Aug-20171 MB
8.09Registration of a Medical Device non-IVD Technical Dossier for commentV123-Aug-20171 MB