National Agency for Food and Drug Administration and Control (NAFDAC) (Nigeria)
No Medical Device shall be manufactured, imported, exported, advertised, sold, distributed, or used in Nigeria unless it has been registered in accordance with the provisions of NAFDAC Act CAP N1(LFN)2004, other related Legislation and the accompanying Guidelines.
1. Classification of medical Device
NAFDAC classifies medical devices into four risk classes (A to D), aligned with international guidelines such as those from the IMDRF and GHTF. The classification is based on the intended use, duration of contact with the body, and the potential risk to the patient or user.
Here is a breakdown of the risk classification system:
Class A (Low Risk)
- Minimal risk to patient or user
- Generally non-invasive
Examples:
- Surgical retractors
- Tongue depressors
- Examination gloves
- Thermometers (non-electronic)
Class B (Low to Moderate Risk)
- Moderate risk
- May be invasive (short-term)
- May require some level of performance testing or clinical evaluation
Examples:
- Hypodermic needles
- Suction equipment
- Electronic thermometers
- Infusion sets
Class C (Moderate to High Risk)
- Higher risk, typically invasive and/or used in critical care situations
- Often used to sustain or support life
Examples:
- Ventilators
- Infusion pumps
- Diagnostic X-ray machines
- Blood glucose monitors
Class D (High Risk)
- Highest risk, used in life-supporting systems or where failure could cause death or serious injury
2. Product Registration with NAFDAC
Before importation, all medical devices must be registered with NAFDAC.
Documents typically required:
- Duly completed application form
- Certificate of Incorporation of the Nigerian importing company
- Power of Attorney or Contract Manufacturing Agreement (if the manufacturer is not the applicant)
- Certificate of Free Sale or equivalent from the country of origin
- Device Master File (DMF) or Product Dossier, including:
- Device description and intended use
- Manufacturing process
- Labelling and packaging information
- Instructions for use
- Clinical data (if required)
- ISO 13485 or other relevant Quality System Certificates
- Evidence of payment of prescribed fees.
3. Appoint a Local Representative
- The foreign manufacturer must appoint a local Nigerian agent or importer, registered in Nigeria and authorized to act on their behalf for registration and importation purposes.
4. Product Testing (if applicable)
- NAFDAC may require product samples for laboratory analysis.
- Not all devices are tested, but high-risk ones may be subject to evaluation.
5. Labelling Requirements
- Labels must be in English and include:
- Product name
- Manufacturer details
- Expiry date (if applicable)
- Storage conditions
- Instructions for use
6. Obtain NAFDAC Registration Number
- Once all requirements are met, NAFDAC issues a registration certificate and NAFDAC number, which is required for customs clearance and marketing in Nigeria.
7. Customs and Importation Requirements
- Submit the NAFDAC registration number during import.
- Comply with Nigerian Customs documentation including:
- Form M
- Proforma Invoice
- Bill of Lading
- Packing List