The South African Department of Health has published proposed Regulations regarding fees payable under the Hazardous Substances Act, 15 of 1973, for public comment.

The proposed Regulations introduce a revised fee structure applicable to Group III and Group IV hazardous substances, covering a range of regulatory activities, including applications for licences and authorisations, amendments, renewals, imports and exports, transfers and inspections. The proposed Regulations also prescribe penalties for specified instances of non-compliance.

The proposed framework may have financial and operational implications for stakeholders operating in affected sectors, including healthcare facilities, manufacturers and importers of regulated medical and electronic products, laboratories, research institutions, radiology and imaging facilities, and businesses using regulated radiation equipment or radioactive sources.

Affected stakeholders should consider reviewing the proposed fee structure against their existing and anticipated regulatory activities to assess the potential impact on compliance requirements and associated regulatory costs.

Interested parties are invited to submit substantiated comments or representations to the Director-General of Health within three months of publication of the notice on 7 August 2026.

To view the proposed Regulations in full, please click HERE.

KISCH IP can assist clients in assessing the potential implications of the proposed Regulations and in preparing and submitting comments before the close of the comment period.

For further information or assistance, please contact us at marketing@kisch-ip.com.