Import Permits and SON Conformity Assessment for Medical Devices in Nigeria

1. Key takeaways

The import stage in Nigeria is often misread as holding a registration certificate is enough to clear customs. The actual situation is three parallel lines:

• Registration line: the product must be registered — Article 47(1) prohibits the manufacture, import, export, distribution, advertisement, sale and use of unregistered devices;
• Permit line: unregistered devices falling under one of the six purposes of Article 47(2) (registration use, repair, performance evaluation studies, research, emergency use, humanitarian donation) require the corresponding permit; the import permit for registration samples is applied for electronically through NAPAMS under R&R-GDL-008-02 §6.0–§6.1;
• Standards line: the conformity assessment procedures of the Standards Organisation of Nigeria (SON) fall under the statutory competence of another agency and run in parallel with NAFDAC registration, not as a substitute for it.

2. Legal basis

3. Expert insights

Insight one: the prohibition list in Article 47(1) covers import and export, not merely sale.

The prohibited acts listed in Article 47(1) are: manufacture, import, export, distribution, advertisement, sale and use. Export is included — which means that transit trade routed through Nigeria is equally constrained; it cannot be assumed that avoiding the Nigerian market is safe. Goods merely passing through the country under a Nigerian bill of lading already engage the provision, and freight forwarders rarely flag this to shippers.

Insight two: the six purposes of Article 47(2) are the only lawful import channel before registration.

The six purposes are: (a) registration, (b) repair of devices, (c) performance evaluation studies, (d) research, (e) use in an emergency, and (f) donation for humanitarian intervention. The purpose must correspond strictly to the actual reason for import, and Article 47(3) requires compliance with the conditions stated on the permit. Importing commercial quantities under a permit issued for purpose (a) registration is use outside scope, and it exposes both the importer and the consignment to seizure and penalties rather than to a routine paperwork correction.

Insight three: the import permit for registration samples goes through the NAPAMS electronic channel.

R&R-GDL-008-02 §6.0–§6.1 provides that the import permit (Permit to Import) is applied for electronically through NAPAMS, for registration samples. This is the same line as the sample delivery process discussed in article 20: first the permit, then the samples may lawfully enter the country, and only then do they reach the laboratory. Sequencing matters because laboratory appointments and dossier screening both hang on the samples being physically available, so any permit delay propagates through the whole registration calendar.

Insight four: SON conformity assessment is another line; do not conflate the two.

The conformity assessment procedures implemented by the Standards Organisation of Nigeria and NAFDAC device registration belong to the statutory competence of different agencies, and the relationship is parallel rather than substitutive: obtaining a NAFDAC registration certificate does not exempt a product from those procedures, and vice versa. The specific scope, product lists and procedures are subject to the current provisions of that agency; this is a practical estimate and must be confirmed case by case. The principle we repeatedly stress in compliance red lines applies here: never treat agency A’s clearance as agency B’s pass.

Insight five: the prohibited and restricted lists are the upstream filter for import.

VBM-R&RA-GDL-001-01 §1.3: for products on the federal government Import Prohibition List or the NAFDAC Ceiling List, new registration applications are not accepted. This is the upstream filter of the import stage — for products on these lists, not even an application can be filed, let alone customs clearance. Checking the lists costs nothing and belongs in the feasibility stage, before any distributor agreement or purchase order is signed.

4. Practical recommendations

1. Before import, confirm whether the product is on the prohibited and restricted lists (§1.3), and place this step at the project initiation stage.
2. Select the Article 47(2) purpose category according to the actual purpose; do not use a permit outside its purpose.
3. Apply for the import permit for registration samples through NAPAMS, and prepare the documents accompanying laboratory analysis in parallel (§7.0–§7.1.4).
4. Transit trade is equally subject to Article 47(1); do not assume that transit equals exemption.
5. Treat SON conformity assessment as a separate workstream, run in parallel and not merged into the NAFDAC registration plan (a practical estimate, confirmed case by case).
6. Retain permits, customs declarations and inspection records for retrieval during renewal self-checks and market surveillance.

5. Verification checklist

• □ It has been confirmed that the product is not on the Import Prohibition List or the NAFDAC Ceiling List (§1.3).
• □ A permit under Article 47(2) corresponding to the import purpose has been obtained (one of the six purposes).
• □ The conditions on the permit are known and implemented in internal SOPs (Article 47(3)).
• □ Registration samples have had an import permit applied for through NAPAMS (§6.0–§6.1).
• □ Transit scenarios have been assessed against the export prohibition in Article 47(1).
• □ SON conformity assessment has been handled separately and confirmed case by case (a practical estimate).
• □ Permit, customs and inspection records are archived.

Regulatory information verified as of 29 October 2026. All citations have been checked against the official NAFDAC Regulations text (S.I. No. 42 of 2024, Articles 11, 15, 47(1)–(3)) and the two guidelines (R&R-GDL-008-02 §6.0–§6.1, §7.0–§7.1.4; VBM-R&RA-GDL-001-01 §1.3, §8.1–§8.2); the conformity assessment procedures of the Standards Organisation of Nigeria are not a NAFDAC text, and their scope and procedures are a practical estimate, subject to the current provisions of that agency and confirmed case by case.

• Local resources in Nigeria: GRZAN can coordinate locally licensed importer and authorised representative resources, covering NAPAMS electronic submission, dossier screening permit coordination, import permits, sample delivery and laboratory analysis support.
• Service capabilities: classification determination, registration pathway selection, technical documentation (IMDRF ToC), CMFS and legalisation, GMP and foreign inspection readiness, advertisement permits, vigilance and PMS reporting, change management and renewal.
• Contact: hito.lin@grzan.cn; website www.grzan.cn; email info@grzanglobal.com.