07 Jan Recalls Vigilance Medical Devices IVDs
Posted at 13:18h
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Archive
13 Dec Medical Device Adverse Event Reporting Form
Posted at 11:04h
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This document is intended to assist the holder of a medical device establishment licence (referred to as the “licensee)” and the holder of a certificate of Registration (HCR) in the reporting of an adverse event associated with the use of a medical device (including an...
13 Dec Guideline for Completing Medical Device Adverse Event Form for Licensed Holders (Licensee) / Holders of a Certificate Of Registration of al Medical Device (including an IVD)
Posted at 10:31h
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This guideline provides the information to be supplied to SAHPRA when completing the form to report an adverse event for a medical device (including an IVD), it outlines the format and data requirements for reporting of an adverse event, using the Medical Device Adverse Event...
13 Sep Mpox Diagnostic Tests
Posted at 14:45h
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This communication is intended to provide an update to industry stakeholders concerning Mpox (formerly monkeypox) diagnostic tests in South Africa....
05 Jun Contact details for Guideline SAHPGL-MD-03 Medical Device Vigilance: Adverse Events Reporting for License Holders
Posted at 19:40h
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This document is intended to provide contact details for communicating reportable adverse events, as per Guideline SAHPGL-MD-03, as well as contact details for any Recalls and Market actions for medical devices (including IVDs). Reportable adverse events reports must be emailed to mdvigilance@sahpra.org.za and copy (cc) Puseletso.Mogano@sahpra.org.za...
17 May Expression of Interest for Medical Device Registration Voluntary Feasibility Study
Posted at 09:33h
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SAHPRA intends to conduct a voluntary feasibility study for medical device registration to validate the proposed process for registration of medical devices. The medical device registration feasibility study is only for medical devices intended for human use and aims to provide an approach to benefit stakeholders,...
31 Jan Regulations Relating to Medical Devices and In-Vitro Diagnostic Medical Devices (IVDs)
Posted at 11:26h
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02 Oct SAHPRA position on EU regulatory transition for medical devices from MDD/AIMDD/IVDD to MDR 2017/745 /IVDR 2017/746
Posted at 09:49h
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This communication to industry refers to the Medical Device Unit and Radiation Control Unit publishing SAHPRA’s position on EU regulatory transition for medical devices from MDD/AIMDD/IVDD to MDR 2017/745 /IVDR 2017/746....
28 Feb Guideline on Questions and Answers Licensing of Medical Device Establishments
Posted at 19:16h
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This document is intended to provide clarity on guidelines and applications for the licensing of medical device establishments. It reflects the current situation and will be regularly updated with changes in legislation and experience gained. It is important that applicants adhere to the administrative requirements to...
21 Nov General Information Medical Devices And IVDs
Posted at 12:20h
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