SAHPRA Compliance & Our Commitment to Safety

As a company committed to ethical operations and consumer protection, we align fully with the standards and regulations set out by the South African Health Products Regulatory Authority (SAHPRA).

What Is SAHPRA?

The South African Health Products Regulatory Authority (SAHPRA) is the national body responsible for regulating all health products in South Africa.
This includes:

  • Medical devices and related technologies

  • Medicines (human & veterinary)

  • Clinical trials

  • Complementary and alternative health products

  • Licensing and monitoring of health product establishments

SAHPRA’s role is to ensure that every health product sold, distributed, or used in South Africa is safe, effective, of good quality, and ethically marketed.

The Legislative Framework: The Medicines and Related Substances Act

SAHPRA operates under the Medicines and Related Substances Act, 1965 (Act 101 of 1965). This law provides the foundation for:

  • Registration of medicines and medical devices

  • Quality control and testing standards

  • Manufacturing and distribution requirements

  • Import and export regulations

  • Labelling, advertising, and ethical marketing rules

  • Facility licensing and ongoing compliance inspections

The Act ensures that all health products placed on the market protect users rather than exposing them to risk.

Why SAHPRA Compliance Matters

For customers, SAHPRA compliance means:

  • Safety: Products meet strict health and safety standards.

  • Transparency: Clear, honest information about what you’re using.

  • Trust: Products and services have passed regulatory checks.

  • Quality Assurance: Manufacturing, distribution, and storage follow national protocols.

For businesses, compliance ensures:

  • Legal protection

  • Ethical operations

  • Approved and traceable supply chains

  • Long-term credibility in the health sector

How Kuskhona Aligns With SAHPRA Standards

At Kuskhona, we don’t only follow SAHPRA guidelines, we build our entire business model around them. Our compliance approach covers:

1. Verified Products & Approved Suppliers

We only work with manufacturers and suppliers who are SAHPRA-registered or who meet SAHPRA-approved standards. Every product we handle follows strict compliance protocols from production to delivery.

2. Safe Storage & Handling

All products are stored, transported, and handled in line with SAHPRA-approved Good Distribution Practices (GDP). This ensures the integrity, quality, and safety of every item we supply.

3. Ethical Sales & Marketing

Kuskhona follows the Medicines Act requirements for ethical representation, accurate product information, and responsible marketing practices. No claims are exaggerated or misleading — everything we say is backed by regulation and evidence.

4. Continuous Monitoring & Quality Assurance

We maintain ongoing internal checks that comply with SAHPRA standards. This includes product verification, batch tracking where required, and working only through compliant, traceable channels.

5. Staff Training & Knowledge

Our team is trained on compliance, safety standards, ethical practices, and the legal responsibilities outlined in the Medicines Act. This ensures every interaction reflects professionalism and regulatory awareness.

What This Means for You ?

Choosing Kuskhona means choosing safety, compliance, and complete transparency.
You can trust that:

  • Every product meets national health standards

  • Every process is regulated and traceable

  • Every customer is treated with integrity and care

Our commitment to SAHPRA compliance is not a checkbox, it is the foundation of who we are and how we operate.