Medical Devices Archives - Page 6 of 12

17 May Expression of Interest for Medical Device Registration Voluntary Feasibility Study

Posted at 09:33h in

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 in

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 in

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 in

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 in

This document has been archived....

21 Nov Guideline For Access To And Control Of Medical Devices And IVDs

Posted at 12:08h in

This document has been archived....

30 Aug Withdrawal of Section 21 Authorisation for use of unregistered rapidly developed non-invasive ventilators

Posted at 10:01h in

In response to the anticipated shortage of medical supplies and equipment in the health care system as a result of the outbreak of the Covid-19 pandemic, the South African Health Products Regulatory Authority (the Authority) published minimum requirements for the manufacture, importation, and distribution of...

15 Jul COVID-19 Test Kits Batch Verification

Posted at 12:45h in

The COVID-19 pandemic is caused by SARS-CoV-2, a novel coronavirus that originated in Wuhan, China in late 2019. The virus has since spread around the world, with novel variants of concern causing new waves of infection. Testing is a critical component of COVID-19 control and...

13 Jun Retention Fee Notification – 9 June 2022

Posted at 16:03h in

Payment of Retention Fees for the Year Ending 31 December 2022 in respect of Medicines Registered up and until 31 December 2021 and/or Various Licences...

06 Jun Update on COVID-19 Diagnostic tests

Posted at 13:17h in

2020 May...

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