Eswatini medical device regulations
Official sources linkedMinistry of Health rules and guidance for medical device market access, registration, and lifecycle compliance. Each code opens a metadata page with the official source and readable HTML when available.
| Code | Regulation | Category | Effective | Provenance |
|---|---|---|---|---|
| Notice 10/2024 | Guidelines on the Use of Licence Exempt Spectrum Bands in Eswatini, 2024 ESCCOM guidance for radio apparatus using licence-exempt spectrum. Selected clauses cover type approval for import/use, operating limits and interference conditions; selected appendices cover assistive listening systems, active medical implants and non-implantable medical data transmission, including capsule endoscopy and MBANS. Radio-microphone rows are retained within the mixed Appendix 13 for source context. The notice says 10/2024 while its cover also prints October 2023; no effective date is inferred. This source does not establish general medical-device or IVD market approval, and currentness and referenced-parent verification remain open. | General | — | Official |
| Act 9 of 2016 | Medicines and Related Substances Control Act, 2016 Complete 65-page Act supplied through the WHO health-legislation repository. Sections 22–33 regulate medical-device registration, changes, transfers and cancellation; later provisions cover labelling, advertising, licensing, clinical trials and enforcement. The WHO download filename says 1965, but the document itself explicitly identifies Act 9 of 2016. No commencement date is inferred from the filename. | General | — | Official |
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Each row above represents one regulatory instrument. Its code is the authority’s identifier. A regulation page collects the metadata and official source; when readable HTML is available, article links can open and highlight the exact cited passage.
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