Sierra Leone medical device regulations

Complete 120-page PBSL clinical-trial guideline, including its application requirements, oversight provisions and annexes. Its scope expressly includes medical devices alongside medicines, vaccines and food supplements. The authority lists the file in its 2025 collection; the document itself states the 2024 issue and effective dates.

Complete seventy-page PBSL guideline covering medical-device registration, manufacturers, applications, classification, labelling and annexed technical requirements. The authority lists this file under its 2025 guidelines collection, while the document-control block identifies issue on 15 May 2024 and effect on 17 May 2024. The internal dates are preserved.

Complete authority import and clearance guideline, cover version 03/revision 02, issued 15 May 2024 and effective 17 May 2024. Expressly includes medical devices and IVDs, special importation of unregistered products, personal use and investigational devices. Retrieved from the live PBSL guideline index, which labels the upload 2025; document dates are taken from its printed cover.

Complete licensing guideline, version 01, expressly covering medical-device shops as well as other regulated outlets. The document cover identifies PBSL/GL/043, despite the website index labelling this download PBSL-GL-013. Includes establishment approvals, application requirements, renewals and responsibilities.

Complete version 03 guideline for listing specialised or orphan products. Its definitions expressly include medical devices, diagnostic reagents and test kits for rare conditions, with administrative, renewal and technical requirements and application material. Preserves the source's printed May 2024 dates separately from the index's 2025 label.

Official PBSL clinical-trial submission checklist, retained as a supporting template under PBSL/GL/002 version03 whose title expressly includes medical devices. Preserves blank applicant/PBSL check columns, dossier/declaration/insurance/ethics items and the conditional footnotes, including the printed incomplete final Annex reference. The body contains medicine-oriented IMP/GMP/analysis fields: their device-specific applicability and adaptation remain unresolved and must not be promoted as new universal MD/IVD obligations. Complete three-page source and derived rendering read; form date/currentness not established.

Official ten-page medical-device registration application form with a seven-item checklist, applicant, manufacturer and local-agent details, certification, and three appendices covering manufacturing controls, administrative status and attached materials. The printed form retains generic-name, dosage-unit and formulation fields; their device-specific application is not resolved here. No issue date, fee amount or processing deadline is printed, and later versions and current applicability remain unverified.

Official premises-licensing application form with selectable business activities and categories that expressly include medical devices, business and proprietor details, proposed opening hours, responsible-pharmacist or pharmacy-technician details, and declarations. The complete two-page expression is retained; a three-page expression has the same operative wording and an additional header-and-footer-only page. This is a premises form, with no proven publication date, fee amount, processing deadline or version succession; current applicability remains unverified.