NAFDAC Guidelines for Registration of Medical Devices Made in Nigeria
Guideline · Health
Guidelines outline the process for registering medical devices manufactured in Nigeria, including risk-based classification and safety testing requirements. They target local producers and NAFDAC compliance teams. This ensures devices are safe and effective for use.
NAFDAC Guidelines for Registration of Medical Devices Made in Nigeria
What Is This Policy?
Guidelines for registering locally manufactured medical devices with NAFDAC, including classification, safety testing, quality management, and labelling requirements.
Who Does It Target?
Regulated entities as applicable NAFDAC inspection and compliance teams Industry stakeholders
What Does It Aim to Achieve?
Ensure that medical devices produced in Nigeria are safe and effective for their intended use.
Key Features
Device Classification: Risk-based classification determining the level of regulatory scrutiny Technical Documentation: Design specifications, performance data, and biocompatibility testing Quality Management: ISO 13485 or equivalent quality system requirements Labelling: Instructions for use, safety warnings, and device identification
Current Status
Rollout Stage: Active Coverage: All applicable regulated entities Lead Agency: NAFDAC
How to Access
Regulated entities must comply with these guidelines. Classify the device per NAFDAC risk categories Prepare technical documentation Submit registration application
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.