Already on April 4, 2025, the South African Health Products Regulatory Authority (SAHPRA) announced its affiliation with the Medical Device Single Audit Programme (MDSAP). As an Affiliate Member, SAHPRA receives access to a list of participating MDSAP facilities but does not participate in decision-making or have access to the MDSAP IT Portal. Affiliate Members can request MDSAP audit reports and certificates directly from participating manufacturers.
From 1 June 2025, medical device manufacturers wishing to renew their Medical Device Establishment License will be required to have a valid ISO 13485:2016 certificate from a SAHPRA-recognized Conformity Assessment Body (CAB). The MDSAP membership expands SAHPRA's ability to monitor manufacturing of medical devices beyond South Africa's borders and leverages resources of other regulators. While MDSAP certification isn't mandatory for South African market entry, it demonstrates compliance with internationally recognized quality standards.
Manufacturers with MDSAP certification can now more easily demonstrate compliance across multiple markets. The current affiliate members (Argentina, Israel, Kenya, South Korea, Mexico, Taiwan, and now South Africa) represent market opportunities where MDSAP recognition can streamline regulatory processes.
NSF supports medical device manufacturers to maintain their regulatory compliance. Our services include:
- Preparing your organization for successful MDSAP audits.
- Auditing your quality management systems against MDSAP criteria.
Contact us today to learn more about how we can support your MDSAP certification.
Image from Jacques Nel
