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6.1.aBiological AmendmentsV119-Jun-20171 MB
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
7.06Complementary Medicines - Caffeine and MentholV112-Apr-2017100 KB
16.04Licence to act as a Wholesaler of Medical Devices & IVDsV103-Aug-2017103 KB
2.40Clinical Trial Oversight, Monitoring of Clinical TrialsV110-May-2016162 KB
8.04ADR and Post-Marketing Vigilance Reporting of Medical Devices and IVDs for commentV123-Sep-2015165 KB
2.50Medicines and Human Reproduction for commentV102-May-2018286 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
9.92Proposal to reschedule albendazoleV118-May-201737 KB
8.03Conformity Assessment Procedures - Medical Devices and IVDs for commentV123-Sep-2015407 KB
7.04Complementary Medicines Health Supplements Safety & Efficacy Annexure JV33.130-May-2017408 KB
2.11Safety Reporting during Clinical Trials in South AfricaV220-Aug-2016424 KB
ZACH1.04Application Form: Application for registration of a medical device for commentV123-Aug-2017458 KB
9.65Proposed amendment to scheduling inscription of Codeine and Dihydrocodeine - for commentV125-Aug-201550 KB
2.04Post-importation testing showing changesV220-Jan-2017509 KB
2.04Post-importation TestingV220-Jan-2017526 KB
MDTD01ZA Medical Device Technical Dossier non-IVD for commentV123-Aug-2017535 KB
MDTD02ZA Medical Device Technical Dossier IVD for commentV123-Aug-2017538 KB