IVDs Tag

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12 Apr

Posted at 09:19h in

The South African Health Products Regulatory Authority (SAHPRA) invites industry stakeholders to a targeted stakeholder engagement session focused on training and guidance regarding SAHPRA’s requirements for Adverse Event reporting.   The purpose of this engagement is to enhance industry understanding and effective implementation of Regulation 17 of the...

22 May

Posted at 10:28h in News & Updates, Press Releases

Pretoria, 22 May 2025 –The South African Health Products Regulatory Authority (SAHPRA), having applied Reliance on the World Health Organization (WHO) PQ assessment under Emergency Use Listing, has listed the first mpox (monkeypox) in vitro diagnostic (IVD). This serves as an important step in improving global access to mpox testing by using a reliance process. The emergency use approval of the Alinity m MPX...

04 Apr

Posted at 13:19h in News & Updates, Press Releases

Pretoria, 04 April 2025 –The South African Health Products Regulatory Authority (SAHPRA) has joined the Medical Device Single Audit Programme (MDSAP), an international audit programme of medicines and medical device regulators aimed at improving efficiencies in the regulation of medical device manufacturers by engaging in work...