Over the last several months, SAMED has been advocating for the extension of the exemption for medical devices from sections 18A and 18 B within the Medicines and Related Substances Act. These sections pertain to the supply of medical devices and IVDs according to a bonus system, rebate system and other incentive schemes and sampling of medical devices and IVDs.
We have been acutely aware of the risk the expiry posed to the sustainability of our members and the need for certainty to remain compliant with the law. We took these concerns very seriously and SAMED has extensively campaigned on behalf of members for exemption extension beyond the 31 December 2021 expiry. Through our Code Committee, SAMED approached the Pricing Committee, then the National Department of Health and finally the South African Health Products Regulatory Authority (SAHPRA) on why the medtech sector should be exempt from the 18A & B provisions, including the impact that a failure to do so would have on the sustainability of medical technology suppliers and providers.
As your association, it was vital for us to work to resolve this matter on your behalf and we are pleased to announce that the exemption has been issued for another three year period ending 17 December 2024. Members are still bound to all clauses of the Medical Device Code of Ethical Marketing and Business Practice.
As always, SAMED will keep a watching brief on this and will take up any further calls to action should the need arise.