18 A & 18 B Exemption Notice for Medtech

Disclaimer: The South African Medical Technology Industry Association (SAMED) provides this content as a complimentary service. The content is not a substitute for appropriate legal advice and is not binding on SAMED. SAMED, its board members, committees, employees and members, will not be responsible for any inaccuracies or omissions, or, liable for any damages or loss of whatsoever nature suffered by any person as a result of relying on or using the content provided.

18A and 18B exemption extension
17 December 2021
SAMED advocated 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 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.

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