Certifications & Regulatory Status

Jos•Hansen is actively pursuing WHO Prequalification (PQ) status for applicable diagnostic and pharmaceutical product lines distributed across Africa. The WHO PQ programme ensures that products meet global standards of quality, safety, and efficacy — a prerequisite for procurement by UN agencies, the Global Fund, PEPFAR, and national governments under international health financing frameworks.

• Alignment with WHO standards for medical devices and diagnostics (IVD PQ)
• Documentation and quality management systems structured to WHO PQ requirements
• Products procured through WHO PQ-approved supply chains where applicable
• Active engagement with WHO PQ assessment timelines for priority product lines

All medical device and diagnostic products distributed by Jos•Hansen are sourced exclusively from manufacturers certified under ISO 13485 — the international standard for quality management systems specific to medical devices. This ensures our supply chain maintains design, production, and distribution controls that meet international regulatory expectations.

• Manufacturer-level ISO 13485 certification required for all medical device suppliers
• Full documentation: Certificates of Conformity, technical files, and CE/FDA clearance records
• Traceability and post-market surveillance obligations met by supply chain partners
• Annual supplier qualification review process

The majority of medical devices, diagnostic systems, and pharmaceutical products supplied by Jos•Hansen carry CE marking under applicable EU directives — including the Medical Devices Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746). CE marking confirms conformity with European safety, performance, and quality standards.

• CE IVD marking required for all diagnostic and laboratory products
• CE MDR compliance for medical devices including imaging and surgical systems
• Technical dossiers and declarations of conformity available upon request
• EU-aligned regulatory documentation maintained for all product lines

Selected medical devices and diagnostic systems in the Jos•Hansen product portfolio carry FDA 510k clearance or Pre-Market Approval (PMA) from the United States Food and Drug Administration. This applies particularly to surgical systems, implantable devices, and oncology equipment sourced from US and internationally registered manufacturers.

• CyberKnife S7 and Radixact — FDA cleared and globally recognised
• MCI CMF titanium plate and screw systems — FDA 510k cleared (K182758)
• Blood gas analyzers and selected IVD products — FDA 510k registered
• Full FDA clearance documentation available for regulated product procurement

Jos•Hansen is aligned with Global Fund procurement requirements for health commodities supplied under malaria, HIV/AIDS, and tuberculosis grant programmes across sub-Saharan Africa. We ensure that relevant product lines — particularly rapid diagnostic tests and pharmaceuticals — meet Global Fund's quality assurance requirements and supply chain standards.

• Rapid diagnostic tests sourced from WHO-prequalified and Global Fund-approved suppliers
• Supply chain documentation aligned to Global Fund quality assurance policy
• Participation in Global Fund-supported procurement frameworks in eligible countries
• Price transparency and documentation standards maintained for donor-funded programmes

Jos•Hansen. is registered and regulated by the Pharmacy and Poisons Board (PPB) of Kenya — the national medicines regulatory authority responsible for licensing, registration, and quality oversight of pharmaceutical and medical device importers and distributors in Kenya.

• Licensed pharmaceutical and medical device importer and distributor
• Products registered and cleared through PPB in accordance with the Pharmacy and Poisons Act (Cap. 244)
• Annual renewal of operating licences and product registrations
• Active cooperation with PPB inspections and regulatory oversight