Navigating Nigeria’s Healthcare Regulatory Landscape
Operating a healthcare facility or supplying medical equipment in Nigeria demands strict adherence to a range of statutory and quality standards. At GBioMed, we simplify the complex regulatory environment so you can focus on patient care. Our team stays ahead of evolving directives from the National Agency for Food and Drug Administration and Control (NAFDAC), the Standards Organisation of Nigeria (SON), and other relevant bodies, ensuring that every product we supply and every project we execute meets the highest compliance benchmarks.
We provide end‑to‑end regulatory support — from pre‑import verification and product registration to facility certification and post‑market surveillance. Whether you’re setting up a new dialysis centre, refreshing your laboratory equipment, or planning a turnkey hospital, we guide you through each compliance checkpoint.
Key Regulatory Bodies & Standards
NAFDAC
Registration and regulation of all medical devices, pharmaceuticals, and in‑vitro diagnostics. We handle product registration, import permits, and renewal processes.
SON (Standards Organisation of Nigeria)
Mandatory standards for product quality and safety. We ensure all equipment meets SON‑CAP (Conformity Assessment Program) requirements for imports.
FMOH (Federal Ministry of Health)
Policies, guidelines, and facility accreditation. We align hospital projects with the National Health Act and FMOH infrastructure standards.
International Certifications
ISO 13485, CE marking, FDA approvals. We partner exclusively with manufacturers holding globally recognised quality certifications, ensuring world‑class safety.
How GBioMed Keeps You Compliant
Pre‑Import Verification
We validate product certificates, test reports, and manufacturer credentials before shipment, eliminating the risk of customs rejection.
Product Registration & Listing
Our regulatory team prepares and submits dossiers to NAFDAC for device registration and facility listing, streamlining the approval cycle.
Customs Clearance & SON‑CAP
We manage the entire customs process, including Form M, Pre‑Arrival Assessment Report (PAAR), and SON‑CAP certification, for seamless port clearance.
Facility Inspection & Accreditation Support
We help hospitals prepare for regulatory inspections and meet accreditation criteria (e.g., COHSASA, ISO 15189) through gap analysis and documentation.
Post‑Market Surveillance
Ongoing monitoring of device performance and adverse event reporting, keeping your facility compliant with pharmacovigilance and materivigilance requirements.
Regulatory Training & Updates
We offer workshops and advisory notes to keep your procurement and clinical teams informed of changing regulations, ensuring continuous compliance.
Regulatory & Compliance FAQs
You must comply with NAFDAC’s registration and listing requirements, obtain a SON‑CAP certificate, and secure customs clearance via Form M and PAAR. GBioMed manages this entire process.
Absolutely. We compile technical documentation, liaise with NAFDAC, and follow up until registration is granted. This service is part of our import and procurement support.
All equipment is sourced from manufacturers certified to ISO 13485, and products carry CE, FDA, or equivalent approvals. We verify certificates before procurement.
Our compliance team continuously monitors official gazettes and agency circulars. Clients receive proactive advisories whenever a regulatory change affects their equipment or operations.
Yes. Through our consultancy arm, we provide gap analyses, SOP development, and equipment validation to support COHSASA, ISO 15189, or other accreditation pathways.
Yes. We conduct tailored workshops on import procedures, device handling regulations, and quality management systems to empower your team.