In brief

In December 2021, the existing exemption that excludes medical devices and in-vitro diagnostics from the application of sections 18A and 18B of the Medicines and Related Substances Act was extended. This extention means that suppliers of medical devices and in-vitro diagnostics are permitted to supply their products according to bonus, rebate and incentive systems for another three years. 

Key takeaways

On 10 December 2021, the South African Minister of Health, Dr Joseph Phaahla, on the recommendation of the South African Health Products Regulatory Authority, extended the existing exemption that excludes medical devices and in-vitro diagnostics (IVDs) from the application of sections 18A and 18B of the Medicines and Related Substances Act, 1965 (MRSA).

Section 18A of the MRSA prohibits suppliers of medicines, medical devices and IVDs from providing their products according to a bonus, rebate and incentive system. Further, section 18B of the MRSA prohibits those suppliers from providing free products to healthcare practitioners or any person authorized to use the device. 

This extension was issued before the end of the initial exemption period on 18 December 2021, and will remain in effect until 17 December 2024.

The extension provides much awaited certainty to medical industry participants who have, in accordance with industry practice, provided these products subject to various rebates or schemes in a manner that is cost effective, competitive and allows practitioners to become familiar with their products.

If you require any further assistance with this matter, please contact us.