Seychelles medical device regulations
Official sources linkedEmployment Department (radiation safety) / Ministry 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 |
|---|---|---|---|---|
| S.I. 113 of 2022 | Customs Management (Tariff and Classification of Goods) Regulations, 2022 Selected definitions needed to interpret S.I. 87 of 2023: citation and commencement, the exclusions in Chapter 30 Note 1 (including IVD reagents of heading 38.22), complete Note 4 and the HS 3006 product descriptions. S.I. 87 specifies only HS 3006.1000–3006.7000; the later 3006.9100–3006.9300 rows are retained as adjacent context. Duty and tax columns and unrelated tariff chapters are omitted. Current duty rates and the currentness of the whole tariff remain unverified. | Classification | 2022-11-01 | Official |
| S.I. 87 of 2023 | Customs Management (Prohibited and Restricted Goods) Regulations, 2023 Selected import provisions require prior written approval from the designated authority for restricted goods. The selected health-authority row specifies HS 3006.1000–3006.7000 by express reference to Chapter 30 Note 4 of SI 113/2022. This does not cover every device or heading 38.22 IVD reagent. Regulation 5 expressly repeals SI 41/2019; that historical original is not patched by this plan. Publication is a selected expression; later amendment/currentness verification remains open. | Registration | — | Official |
| S.I. 88 of 2020 | Customs Management (Tariff and Classification of Goods) (Amendment) (No.3) Regulations, 2020 Historical one-page tariff amendment inserting HS 6307.9020, face masks for medical purposes, into the 2018 tariff after HS 6307.9010. The source shows unit Kg/no. and twelve 0% duty cells. S.I. 113 of 2022 later expressly repealed the 2018 parent; its repeal does not expressly name S.I. 88 of 2020. This original does not establish current duty rates or general medical-device import approval. The 2018 mother instrument and its Chapter 30 Note 4 remain unavailable, and currentness is unverified. | Classification | — | Official |
| Act 17 of 2014 | Radiation Safety and Security Act, 2014 Complete 21-page Gazette Act, including control of radiation practices and equipment, licensing, renewals, licence variations, inspections, licensee responsibilities and enforcement. It is relevant to radiation-emitting medical equipment rather than all device classes. The original Gazette scan is preserved by the Stimson Center’s RadSecLexis archive; the Employment Ministry’s original download now requires login. | General | — | Official |
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