QMS Developments in South Africa: SAHPRA joins MDSAP and starts to require ISO 13485

By Anna Flotilda Desales and Evangeline Loh

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.

SAHPRA ISO 13485 requirements phased-in

After commencing this process in February 2017, SAHPRA issued (April 9, 2025) phased-in requirements for compliance with ISO 13485 for entities seeking a Medical Device Establishment License or renewal or amendment of an establishment license (Medicines Act Section 22C(1)(b)).

From June 1, 2025, a valid ISO 13485:2016 certificate from a SAHPRA-recognized Conformity Assessment Body (CAB) is expected for manufacturers and distributors (importers) seeking to renew their Medical Device Establishment License (Phase 2). There appears to be more flexibility in meeting the same requirement for entities who require an amendment to their establishment license (Phases 3 and 4).

SAHPRA will verify by April 1, 2028

SAHPRA intends to verify that all Medical Device Establishment License holders possess an ISO 13485:2016 certificate from a SAHPRA CAB by April 1, 2028 (Phase 5).

Concluding remarks

These developments signal SAHPRA’s interest in requiring entities to be compliant with ISO 13485 and in global QMS activities.

While SAHPRA requires the QMS to be certified by a SAHPRA-recognized CAB, some of the organizations are also recognized as MDSAP Auditing Organizations and Notified Bodies.