SAHPRA Medical Device Licence Fees: Costs Explained
Published: 11 April 2023 Last updated: 16 October 2026 The cost of a SAHPRA medical…
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How Foreign Medical Device and IVD Manufacturers Can Enter the South African Market
Published: 22 June 2023 Last updated: 8 October 2026 Entering the South African medical device…
Medical Devices and IVDs in South Africa: The Regulatory Framework Explained
Published: 12 September 2023 Last updated: 30 September 2026 Medical devices and IVDs in South…
SAHPRA Medical Device Reliance Pathway: What Manufacturers Need to Know
Regulatory reliance is becoming increasingly important for manufacturers seeking to place medical devices and in…
How Long Does a SAHPRA Medical Device Licence Take?
For a complete medical device establishment licence application, the South African Health Products Regulatory Authority,…
Medical Device Registration in South Africa: SAHPRA Requirements
Medical device registration in South Africa is often misunderstood because the country’s regulatory framework combines…
ISO 14971 Risk Management for Medical Devices: Practical Requirements
Risk management for a medical device is not a once-off risk assessment completed before product…
Medical Device Tenders in South Africa: What Suppliers Need Before Bidding
Winning a medical device tender in South Africa starts long before the bid submission date.…
Do Class A Medical Devices Need a SAHPRA Licence?
Not every Class A medical device requires the manufacturer, distributor or wholesaler handling it to…
Introducing Verion Medical: A Dedicated Medical Device and IVD Regulatory Operations Company
Verion Medical was created with a specific focus: medical devices and in vitro diagnostic medical…