Understanding SAHPRA Medical Device Registration
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.