Guinea-Bissau medical device regulations
Official sources linkedMinistério da Saúde Pública / UEMOA 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 |
|---|---|---|---|---|
| Despacho n.º 14/GMSP/2024, de 26 de setembro de 2024 | Aprovação da 5.ª edição da Lista de Medicamentos e Produtos Essenciais de Saúde, incluindo produtos prioritários de tecnologia assistiva Complete 67-page ministry publication held by WHO, including the signed two-page Despacho 14/GMSP/2024 of 26 September 2024, the entire fifth-edition list, foreword, explanatory material, tables, index and bibliography. Article 2 provides immediate commencement. Article 1 adopts the annex and restricts National Health Service procurement to listed products, with its stated case-by-case exception for specialist medicines; it is not a general device marketing-authorisation rule. Chapter II contains 36 priority assistive-technology products, including hearing aids, orthoses, prostheses, wheelchairs and accessibility software. The earlier edition approved under Despacho 043/GMSP/2020 is identified in the publication; the 2024 order repeals contrary provisions without an identified wholesale repeal of every earlier instrument. Current amendments, parent pharmacy legislation and ARFAME registration/import/variation procedures remain under review. | General | 2024-09-26 | Official |
| Décision n° 03/2022/CM/UEMOA du 24 juin 2022, annexes | Lignes directrices relatives à l’harmonisation de la réglementation des dispositifs médicaux dans les États membres de l’UEMOA Regional original-text entry for Guinea-Bissau, one of the eight UEMOA member states addressed by this instrument. The complete French guidelines cover classification, essential requirements, operator responsibilities, market access, dossiers and surveillance. This country view reuses the single existing corpus expression filed under Senegal; it is not a second copy or a Guinea-Bissau national act. National transposition and any domestic implementing instrument have not been verified and remain a separate source gap. | General | — | Official |
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