Liberia medical device regulations

Complete official LMHRA Version 02 policy issued 6 May 2026 and implemented 11 May 2026. Section 3.4 explicitly includes medical devices and applies reliance across regulatory functions throughout the product life cycle; contains principles, reference authority evaluation and implementation arrangements.

Complete official 104-page LMHRA guideline with detailed medical-device GMP provisions covering design controls, quality systems, purchasing, traceability, process control, inspection and corrective measures, plus market surveillance and disposal. The document-control field states DOC-GDL-008, issue 13 April 2026, Version 01; cover and running headers instead show Version 003 and some headers DOC-GDL-018, 2025. Original inconsistencies are preserved.

Complete official 20-page LMHRA guideline issued 13 April 2026 and implemented 16 April. Definitions and assessment provisions explicitly include medical devices; contains submissions, review, amendments, reporting and annexed checklist. The cover says Version 003 while its document-control field says Version 01; both are retained as printed rather than resolved by assumption.

Complete LMHRA regulation covering device registration, classification, manufacturers, dossiers, labelling, variations, imports, vigilance, fees and penalties. The cover records adoption on 30 September 2022, while the operative final page records Board approval on 20 April 2023 and immediate effect upon approval. The fee chapter contains an internal discrepancy between its written amount and numeric amount; the original wording is retained.

Complete official 31-page LMHRA guideline explicitly covering medical devices and diagnostics, including evidence requirements, conditions and annexes. The printed issue date is 13 April 2026 but implementation date is 16 April 2025, and its legal-basis text cites Public Health Act 2012, Act 851. These internal inconsistencies remain visible; no corrected commencement date or independently verified Liberian statutory basis is asserted.

Complete 12-page LMHRA DOC-GDL-017 guideline covers conditional exemption from LMHRA fees for specified products or services. Its health-product definitions expressly include medical devices and medical supplies; its separate orphan-medicinal-product conditions are retained without extending them to all devices. Eligibility evidence, application review, written decisions, non-transferability, monitoring and appeals are included. Ten business days concerns exemption-application review, not device registration or an import-tax waiver. The cover states issue 13 April 2026 and implementation 16 April, while the operative clause states immediate effect on Managing Director approval and the signed approval is dated 13 April; that discrepancy remains unresolved. The printed labelling TOC does not match the fee-exemption body and is preserved.

Complete 19-page official act and enactment/attestation packet supplied by LMHRA, including the operative law through its effective-date clause. Defines health products to include medical devices and medical supplies, and establishes the authority's registration, licensing, inspection, manufacturing, import/export and enforcement powers. This original statutory expression is distinct from the authority's later device regulation and policy documents.

Selected medical-device and IVD provisions from the 43-page LMHRA Regulations on Pharmacovigilance in Liberia: identity and complete definitions, the reporting-duty list and patient/provider/manufacturer roles, the full device-vigilance and falsified-product clauses, and common offences, review and appeal provisions. Fifteen physical pages contain the selected text; this is not the complete regulation or annex inventory. Section 9(1)(c) leaves device reporting requirements and timelines to applicable device-control and vigilance rules; clinical ADR and cosmetic deadlines are not general device deadlines. The cover and citation state 28 May 2025, while the signed final page records submission on 26 September 2024 and Board approval on 3 October 2024 with immediate-effect wording. These dates and medicine-centric definitions remain unresolved; no single effective date or currentness conclusion is asserted.