South Africa: SAHPRA Raises the Bar with ISO 13485 Certification and MDSAP Membership, Signals Regulatory Excellence

The South African Health Products Regulatory Authority (SAHPRA) has made significant strides in enhancing its regulatory framework for medical devices and in vitro diagnostics (IVDs). In a landmark move, SAHPRA has:

• Achieved ISO 13485:2016 certification for its own Quality Management System (QMS)

• Joined the Medical Device Single Audit Programme (MDSAP) as an affiliate member

• Rolled out a five-phase compliance plan requiring all medical device license holders to obtain ISO 13485 certification by 2028

  
  

These developments underscore SAHPRA’s commitment to global best practices, regulatory efficiency, and patient safety.

SAHPRA Achieves ISO 13485 Certification: A Benchmark for Quality

ISO 13485 is the international gold standard for QMS in the medical device industry, ensuring rigorous quality control and regulatory compliance. By certifying its own QMS, SAHPRA demonstrates operational excellence and sets a precedent for industry compliance. The achievement reinforces SAHPRA’s authority to enforce stringent standards for manufacturers, distributors, and importers of medical devices and IVDs.

SAHPRA Joins MDSAP: Expanding Global Regulatory Reach

Effective 4 April 2025, SAHPRA has become an affiliate member of the Medical Device Single Audit Programme (MDSAP), a collaborative initiative by leading global regulators to streamline audits of medical device manufacturers.

By joining MDSAP, SAHPRA strengthens its regulatory oversight through international collaboration, gaining the ability to monitor foreign manufacturers via shared audit reports while eliminating redundant inspections, streamlining market access for compliant devices without compromising safety standards. This strategic alignment enhances regulatory efficiency, reduces burdens on industry, and positions South Africa as a trusted participant in global medical device regulation, fostering confidence among manufacturers, healthcare providers, and patients alike.

Phased ISO 13485 Compliance for Industry: Roadmap to 2028

Alongside its certification and MDSAP integration, SAHPRA has implemented a structured five-phase plan to transition the medical device industry to full ISO 13485 compliance:

Conclusion

SAHPRA’s achievement in attaining affiliate member in MDSAP, combined with its ISO 13485 certification and phased compliance roadmap, marks a transformative step in South Africa’s medical device regulation. By aligning with global standards and leveraging international regulatory collaboration, SAHPRA enhances oversight of both domestic and international manufacturers while promoting efficiency and trust in the market. These strategic advancements not only streamline compliance for industry stakeholders but also reinforce patient safety – ensuring access to high quality medical devices that meet rigorous international benchmarks.

As SAHPRA continues to implement these initiatives, South Africa’s regulatory framework is poised to become a model of excellence in the region, driving innovation and safeguarding public health.

Source: South African Health Products Regulatory Authority (SAHPRA)