NAFDAC MEDICAL DEVICES REGULATIONS

What Is This Policy?

Regulations governing the registration, importation, manufacture, distribution, and marketing of medical devices in Nigeria to ensure safety and effectiveness.

Who Does It Target?

Medical device manufacturers, importers, distributors, healthcare facilities, and patients.

What Does It Aim to Achieve?

Ensure the safety, quality, and effectiveness of medical devices used in Nigeria, protect patients, and align with international medical device regulatory standards.

Key Features

Device Classification: Categorizes medical devices by risk level for appropriate regulation. Registration Requirement: All medical devices must be registered with NAFDAC before sale. Post-Market Surveillance: Requires ongoing monitoring of device safety after market entry. Quality Standards: Mandates compliance with ISO and other international quality standards.

Current Status

Rollout Stage: Active and enforceable. Coverage: All medical devices manufactured, imported, or distributed in Nigeria. Funding: NAFDAC regulatory fees.

How to Access

Manufacturers and importers register devices with NAFDAC. Classify the medical device by risk level Submit registration application to NAFDAC Obtain NAFDAC listing/approval Portal: nafdac.gov.ng

Important Terms

Unregistered devices are prohibited from the market; violations result in seizure, fines, or prosecution.

Impact & Metrics

Ensures Nigerians have access to safe and effective medical devices.

Official Resources

Website: https://www.nafdac.gov.ng Contact: NAFDAC Headquarters, 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.