Understanding SAHPRA Medical Device Registration

4 min read Reviewed by the G1 Healthcare Clinical Team

Quick Answer

What SAHPRA Category B registration means for the medical devices you purchase, and why it matters for your safety.

What is SAHPRA?

The South African Health Products Regulatory Authority (SAHPRA) regulates the safety, quality, and efficacy of medicines and medical devices sold in South Africa.

Medical Device Classes

Devices are classified from Class I (lowest risk) to Class III (highest risk) based on the level of risk to the patient. Ostomy bags are typically Class I or II devices requiring documented biocompatibility testing.

Why It Matters to You

Purchasing SAHPRA-registered devices ensures the product has undergone required safety testing (such as ISO 10993 biocompatibility testing) and is legally permitted for sale and clinical use in South Africa.

Verifying Registration

Every G1 Healthcare product page displays its SAHPRA registration status and UDI code — you can always verify these details before purchase.

This article is for general educational purposes and does not replace advice from your stoma care nurse, surgeon, or physician. Always consult a qualified healthcare professional about your specific care needs.

Shop what this guide covers

Browse Ostomy Bags