NAFDAC Guidelines for Renewal of Certificate of Registration for Medical Devices Made in Nigeria
Guideline · Health
Guidelines provide the framework for renewing registration of medical devices made in Nigeria, including updated technical documentation and quality system certification. They target regulated entities, NAFDAC teams, and industry stakeholders, requiring post-market data on incidents. This ensures compliance with safety and quality standards.
NAFDAC Guidelines for Renewal of Certificate of Registration for Medical Devices Made in Nigeria
What Is This Policy?
Guidelines for renewing the registration of locally manufactured medical devices.
Who Does It Target?
Nigerian manufacturers of medical devices including surgical instruments, diagnostic equipment, and consumables; NAFDAC's medical devices registration and inspection teams; quality management personnel in device manufacturing companies
NAFDAC teams Industry stakeholders
What Does It Aim to Achieve?
Ensure continued compliance of Nigerian-made medical devices with safety and quality standards.
Key Features
Device Review: Updated technical documentation reflecting any design or manufacturing changes Quality System: Current quality management system certification Post-Market Data: Incident reports and corrective actions during the registration period
Current Status
Rollout Stage: Active Coverage: All applicable entities Lead Agency: NAFDAC
How to Access
Regulated entities must comply. Submit renewal application with updated technical file Provide quality system certification Report any device incidents
Official Resources
Website: nafdac.gov.ng Contact: NAFDAC, Abuja
Legal Framework
Issued under the National Agency for Food and Drug Administration and Control Act 1993 (as amended). Operates alongside the Food and Drugs Act Cap F32 LFN 2004, the Standards Organisation of Nigeria Act 2015, WHO/GHTF (Global Harmonization Task Force) guidelines on medical device regulation, and the International Medical Device Regulators Forum (IMDRF) standards.