South Sudan medical device regulations
Official sources linkedDrug and Food Control Authority 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 |
|---|---|---|---|---|
| Act 37 of 2012 | Drug and Food Control Authority Act, 2012 Complete 41-page Ministry of Justice publication preserved by WHO. The Act establishes the Drug and Food Control Authority and expressly covers medical devices in manufacture, supply, promotion, marketing, distribution and use, with licensing, registration, inspection and enforcement powers. The source cover is dated 28 February 2012; a separate Gazette publication or commencement date is not inferred. | General | — | Official |
| Financial Act FY 2023/24 — selected device fees | Financial Act, 2023/2024 — selected Schedule 17 medical-device and consumable fees Selected original pages of the Financial Act for FY 2023/24: title/commencement, section 23 fiscal-year link to Schedule 17, the complete Schedule 17 pages, and presidential assent. Schedule 17 rows 27–28 list medical devices registration at USD 1,000 and medical consumable registration fees at USD 500 in the applicable fiscal-year column. No per-model/per-application charging unit is stated in these rows. These are fiscal-year source rates, not verified 2026 rates or general modification fees. Adjacent fiscal and medicine/cosmetics rows are retained only as full-page context; device applicability is not inferred for every generic charge. Later fiscal Acts, DFCA board requirements and current fees remain unverified. | Registration | — | Official |
| Financial Act FY 2024/25 — selected device fees | Financial Act, 2024/2025 — selected Schedule 17 medical-device and consumable fees Selected original pages of the Financial Act for FY 2024/25: title/commencement, section 22 fiscal-year link to Schedule 17, the complete Schedule 17 pages, and presidential assent. Schedule 17 rows 27–28 list medical devices registration at USD 1,000 and medical consumable registration fees at USD 500 in the applicable fiscal-year column. No per-model/per-application charging unit is stated in these rows. These are fiscal-year source rates, not verified 2026 rates or general modification fees. Adjacent fiscal and medicine/cosmetics rows are retained only as full-page context; device applicability is not inferred for every generic charge. Later fiscal Acts, DFCA board requirements and current fees remain unverified. | Registration | — | Official |
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