Fee Revision Background
SAHPRA's previous fee schedule dated from 2020 and had not been revised during the COVID-19 pandemic years. The authority commissioned an independent review in late 2025 that concluded the existing fees covered only 38% of actual regulatory review costs, creating a structural funding gap that contributed to the current backlog of over 4,200 pending medical device registration applications.
New Fee Structure
Under the revised schedule, gazetted in Government Gazette No. 51342, new registration application fees for Class C devices increase from ZAR 18,500 to ZAR 21,800 (18%). Class D device applications increase from ZAR 31,200 to ZAR 36,800 (18%). Annual licence fees for manufacturers and importers increase by 15% across all categories. Class A general devices and Class A IVD self-test devices are exempt from the increase.
Backlog Reduction Plan
SAHPRA has committed to using the additional revenue to fund 18 new evaluator positions in the medical devices and IVD units by Q1 2027. The authority has set a target to reduce its current 4,200-application backlog to fewer than 500 within 24 months and to achieve a 12-month review target for complete new applications by end of 2028.
Industry Response
The South African Medical Technology Association (SAMED) acknowledged the need for fee revision but called for SAHPRA to publish quarterly backlog reduction metrics as a transparency measure. SAHPRA has agreed to publish a quarterly performance dashboard on its website from Q4 2026.