NAFDAC Registration Agent

NAFDAC Registration Agent 

In a fast-moving global economy, where NAFDAC-regulated products, including medical devices, drugs, foods, and cosmetics, are imported into Nigeria, strict NAFDAC rules require location compliance. For foreign companies, appointing a NAFDAC Registration Agent in Nigeria is particularly important.

A NAFDAC Agent must be a company organised and having its registered address in Nigeria, and serves as the communication link between the NAFDAC and foreign manufacturers.  The NAFDAC registration agent ensures you will receive urgent notifications, timely inspections, and avoid fines. In a world driven by transactions and emails, missing a regulatory request could jeopardise your product launch, especially given the NAFDAC’s current response windows for regulatory requests, which are as short as 10 business days. 

In this post, we’ll unpack everything from understanding what a NAFDAC registration Agent does to selecting an NAFDAC Agent, and what Ashton can do to help you meet this requirement.

What Is a NAFDAC Registration Agent?

An NAFDAC Registration Agent, also commonly referred to as a NAFDAC Agent, is a local company in Nigeria designated by a foreign company as its Importer of Record to communicate with NAFDAC. Agent during the NAFDAC facility registration. The NAFDAC Agent cannot be a P.O. box or an answering service – it must be a physical address with someone available during normal business hours. 

Their role? It’s simple and important: to ensure all NAFDAC communication gets to the foreign manufacturer, including invites to inspections, holds on import, emergency alerts, etc. Thus, the NAFDAC Agent is responsible for accepting those alerts and routing them as needed. NAFDAC will use the NAFDAC Agent if it cannot reach the manufacturer directly; therefore, the NAFDAC Agent has to respond in a timely fashion. 

Role and Responsibilities of a NAFDAC Agent

A NAFDAC Agent is responsible for: 

• Receiving, routing, and replying to NAFDAC communications (including emergencies).
• Helping facilitate and coordinate NAFDAC inspections at the foreign facility. 
• Answering NAFDAC inquiries regarding imported products. 
• Acting as the NAFDAC’s fallback communication contact if direct communications are impossible. 

Who Needs to Appoint an NAFDAC Registration Agent?

If you are a foreign-based company manufacturing or exporting NAFDAC-regulated products (medical devices, foods, cosmetics, or pharmaceuticals), you must select a NAFDAC Registration Agent. 

This applies to: 

• Foreign manufacturers of devices, contract manufacturers, and sterilisers. 
• Foreign food facility operators.
• Foreign drug companies.
• Foreign cosmetic companies.

Why? Without a U.S. Agent, your FDA establishment registration will not be completed, and your products may be refused entry or seized at the port of entry. As of March 2025, regulatory advisors (e.g., Artixio) point out that all entities, from “primary manufacturers” to specification developers, will require a U.S. Agent.

NAFDAC Agent Requirements

What does NAFDAC look for in a NAFDAC Agent? Legally, they must:

1. Reside or maintain a business in Nigeria—a real office, not just a mailbox.
2. Handle product registration at NAFDAC and submit the dossiers
3. Handle NAFDAC communications and inspection coordination

From a practical standpoint, agents often also:

• Help maintain accurate NAFDAC registration info.
• Prepare and forward emergency or deficiency notices.
• Assist with scheduling NAFDAC inspections, helping manufacturers prep ahead of time.
• Offer intellectual property and brand protection strategy advisory to manufacturers.

Why Having a Reliable NAFDAC Agent Matters

Empowering your NAFDAC Agent isn’t just a checkbox to tick; it keeps your business moving. If you’re exporting life-critical products (like medical devices), nothing is more important than the timeliness of communications with NAFDAC. If the NAFDAC identifies any reason to flag your import, your agent ensures NAFDAC communications reach your business to the appropriate people and as quickly as possible.

Your proactive agent will help provide clarity while wading through the regulatory waters. As outlined, NAFDAC agents can serve as full-service liaisons by providing not only the NAFDAC’s contact information but also helping with inspection preparations, device listings, regulatory questions, and anything else you may need.

Your NAFDAC agent will prove useful as they are vital in emergencies. The NAFDAC guidance on agent roles indicates that your agent must perform “reviewing, routing, responding to all communications, including emergency communications”. That’s not a simple task; one missed call or one email not being forwarded could lead to regulatory compliance actions or issues with product refusals.

• Regulatory Knowledge: The Ashton team is familiar with current NAFDAC guidance and regulations.

• Direct Communication: We help draft practical responses and prepare you for phone conversations, inspections, or urgent notices.

• Inspection Preparation: Ashton can offer mock audits and assist you in preparing your facility for an NAFDAC inspection to meet NAFDAC’s criteria.

To summarise, Ashton offers value, beyond labelling—when you hire them, they assist with a Company’s NAFDAC Agent duties, while aiding you to navigate Nigerian regulatory requirements.

Secure your NAFDAC compliance. Talk to our regulatory affairs specialist to discuss your specific needs and how we can help your business. Email us today at admin@ashtonlp.com.