The medical device regulator in South Africa, the South African Health Products Regulatory Authority (SAHPRA), announced two important Quality Management System (QMS) developments.
SAHPRA joins MDSAP
SAHPRA announced (April 4, 2025) affiliate member status has been bestowed upon the Medical Device Single Audit Program (MDSAP). SAHPRA Chief Executive Officer Dr. Boitumelo Semete-Makokotlela hailed the move as “progress in our strategy to ensure the efficient application of our own resources and those of our peers globally in safeguarding the quality, efficacy and safety of medical devices and in vitro diagnostic (IVD) devices used by the South African public.”
As an affiliate member, SAHPRA is permitted to participate in certain forum sessions and has access to the annual MDSAP Forum and the list of participating MDSAP facilities, which includes information on the manufacturer, manufacturing site, audit dates and responsible Auditing Organizations. SAHPRA may also use audit reports and/or MDSAP Certificates to evaluate a manufacturer's QMS with permission from the manufacturer.
QMS Developments in South Africa: SAHPRA joins MDSAP and starts to require ISO 13485 | Emergo by UL
QMS Developments in South Africa: SAHPRA joins MDSAP and starts to require ISO 13485
The South African Health Products Regulatory Authority (SAHPRA), announced two important Quality Management System developments.
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