What does paragraph 1.3 actually block?
A familiar sequence: a Nigerian distributor sees demand for a sterile single-use device line, asks for exclusivity and sends a registration budget. The budget covers a Power of Attorney notarized abroad, a free-sale certificate authenticated by a Nigerian mission, a notarized declaration in Lagos, a factory inspection invitation and an agent's fee. Every line assumes the product can be filed at all. NAFDAC's current device guideline (VBM-R&RA-GDL-001-01, effective 10 April 2025) answers that question before any technical review: 1
“NAFDAC will not entertain new applications for the registration of imported regulated products on the Federal Government Import Prohibition List and NAFDAC Ceiling List.”— NAFDAC Guideline VBM-R&RA-GDL-001-01, paragraph 1.3
Read the scope words carefully. The rule concerns new applications, imported products and two named lists. It does not address locally manufactured products, and it does not decide how an existing registration is renewed; NAFDAC's Ceiling List notice handles renewals separately through the 5+5 pathway. 1 4 Clearing both lists also gives no right to import or sell. Paragraph 1.2 of the guideline says no device may be imported, sold or distributed in Nigeria unless it is registered, and paragraph 11.5 says filing an application or paying a fee does not confer registration status. 1
Treat the check as three separate gates with different owners. If the distributor's plan only covers the third gate, the first two have not been checked. Neighbouring markets split the decision the same way; compare our guide to the Vietnam sterile-device importer file.
| Gate | Owner and instrument | What it decides | Current device relevance |
|---|---|---|---|
| 1. Import Prohibition List (Trade) | Federal Ministry of Finance fiscal policy measures, implemented by the Nigeria Customs Service through the tariff Order 5 6 | Whether goods on listed tariff lines from non-ECOWAS origins may be imported at all 5 | No Chapter 90 instrument category among the 17 items; medicaments, waste pharmaceuticals and soaps/detergents are listed 5 |
| 2. NAFDAC Ceiling List | NAFDAC policy notice under its registration mandate 4 | Whether a listed product can be registered as an import, or only as locally manufactured 3 4 | 36 entries; none is a medical device, but alcohol-based hand sanitizers and several topical preparations are listed 3 |
| 3. Product registration | NAFDAC VBM-R&RA Directorate under the device registration guideline 1 | Whether this product, from this manufacturer, through this Nigerian applicant, may be imported and sold 1 | Always required; gates 1 and 2 only decide whether the application can be entertained 1 |
Source: NAFDAC device registration guideline paragraphs 1.2, 1.3 and 11.5; NAFDAC Ceiling List and notice; Federal Ministry of Finance circular of 1 April 2026 as reported; Customs, Excise Tariff, Etc. (Variation) Order 2026 as reported.
Which version of the trade prohibition list applies in 2026?
The trade list changed this year. A Federal Ministry of Finance circular dated 1 April 2026, signed by Wale Edun as Minister of Finance, introduced the 2026 Fiscal Policy Measures. As quoted by The Guardian, it set an “Import Prohibition List (Trade), applicable only to certain goods originating from non-ECOWAS Member States”, consisting of 17 items. 5 Those items are birds and frozen poultry; pork and beef; bird eggs; refined vegetable oil; flavoured or coloured sugar; cocoa butter, powder and cakes; tomatoes and tomato paste; sweetened or flavoured waters and other non-alcoholic beverages; bagged cement; medicaments under several headings; waste pharmaceuticals; NPK fertilisers; soaps and detergents; corrugated paper and board cartons; hollow glass bottles over 150 ml; certain corrugated flat-rolled steel; and ball-point pens and parts. 5
The legal vehicle is the Customs, Excise Tariff, Etc. (Variation) Order 2026. As quoted by Punch, it was made with effect from 1 May 2026 and states that the Third Schedule “is varied by substituting the existing Import Prohibition List with a new Import Prohibition List”. 7 On 29 July 2026, the Nigeria Customs Service announced that it was implementing the measures, including the “Revised Import Prohibition List (Trade)”, and published the full document on its website. 6 USDA's analysis of the revised list (Annex III) counts 115 HS codes. On the agricultural side, 73 lines remain prohibited and 77 were removed: live poultry, some beef and pork, crude edible oils, pasta, fruit juice and beer lines come off, while poultry meat, offal, refined oils, cocoa butter and tomato paste stay on. 8 USDA also cautions that the final gazetted text may differ from the signed ministerial documents. 8
Older copies of the list are still easy to find online. The FCCPC's resource-library page reproduces a longer, earlier list. It still includes pasta, fruit juice, furniture, footwear and bags, used vehicles and used refrigerators, and it lacks the 2026 tomato, NPK-fertiliser and corrugated-steel entries. 9 The U.S. Commercial Guide page on Nigerian prohibited imports was last published in June 2023. 10 Both are useful history, and they help explain where older broker advice comes from, but neither is the current schedule. We could not obtain the gazetted schedule text directly, so this guide relies on the circular as reported, the Customs announcement, the Order as quoted and USDA's line-by-line analysis. Ask your Nigerian agent for the official Customs document before making a decision that depends on it.
| Source | Status | Use it for | Do not use it for |
|---|---|---|---|
| Customs, Excise Tariff, Etc. (Variation) Order 2026, Third Schedule 6 7 | Operative instrument, made with effect from 1 May 2026 | Exact tariff lines and exclusions for the product's 8–10 digit code | Deciding NAFDAC registration; the Order governs import, not product approval |
| Federal Ministry of Finance circular, 1 April 2026 5 | Policy instrument introducing the 2026 measures; non-ECOWAS origin scope | Category list, origin scope and transition wording | Line-level tariff detail; the reported category labels are broad |
| USDA GAIN NI2026-0010 8 | Foreign-government analysis of Annex III | Cross-checking which agricultural lines were removed or kept | Pharmaceutical or device lines, which it does not analyse |
| FCCPC page; U.S. Commercial Guide (2023) 9 10 | Older reproductions of earlier lists | History and explaining older broker advice | Current verification; both pre-date the 2026 revision |
Source: Sources as cited in each row.
The import paperwork shows the same dependency. The 2026 circular framed its transition around importers who had already opened a Form M, the import declaration lodged through the importer's bank, before 1 April 2026: they received 90 days to clear goods at the prevailing duty rates. 5 Before any registration spend, ask the Nigerian applicant's licensed customs agent to state in writing the full tariff code for each SKU, whether that code appears in the 2026 Third Schedule, and whether the product's origin is ECOWAS or non-ECOWAS.
Where could a device-adjacent product meet a listed heading?
Most single-use surgical devices sit in heading 90.18, which covers instruments and appliances used in medical, surgical, dental or veterinary sciences. 13 No instrument or appliance category appears among the 17 trade items. 5 The questions arise in Chapter 30 and among hygiene products, so it is worth reading the HS legal text rather than relying on assumptions:
- Dressings stay out of the medicament headings. Headings 30.03 and 30.04 cover medicaments “excluding goods of heading 30.02, 30.05 or 30.06”. Heading 30.05 covers wadding, gauze, bandages and dressings “impregnated or coated with pharmaceutical substances or put up in forms or packings for retail sale for medical, surgical, dental or veterinary purposes”. A coated or medicated dressing is therefore not a 30.04 medicament by default. 11
- Sterile tissue adhesives are 3006.10, not waste pharmaceuticals. Subheading 3006.10 names “sterile tissue adhesives for surgical wound closure”. Waste pharmaceuticals are 3006.92, defined in the Chapter notes as pharmaceutical products unfit for their original purpose, for example because their shelf life has expired. 11 Expired, returned or near-dated stock with a pharmaceutical character should not be sent to Nigeria as a workaround.
- Products that are themselves medicaments are exposed. Antiseptic or antibiotic creams, ointments and solutions put up for retail sale are typical 30.04 goods. The older published schedules itemised medicaments such as clotrimazole cream and penicillin/gentamicin ointments, and the 2023 U.S. guide also listed intravenous fluids. 9 10 Check the 2026 schedule line by line rather than relying on those older examples.
- Hand hygiene splits three ways. Disinfectants put up for retail sale fall in heading 38.08 (subheading 3808.94). 12 Soaps and detergents are a 2026 trade-list item. 5 Alcohol-based hand sanitizers are on the NAFDAC Ceiling List. 3 A surgical scrub, a hand rub and a surface disinfectant can therefore face three different answers.
- Laser fibres need a tariff decision. Depending on presentation, a broker may place an endovenous fibre in 90.18 or under optical fibres and cables in 90.01. 13 Neither heading is a 2026 trade item, but the chosen code must be the same on the Form M, the invoice and the registration file.
| Product family | Heading to discuss | 2026 trade-list exposure | Ceiling List exposure | What to ask before spending |
|---|---|---|---|---|
| Circumcision devices and staplers, puncture kits, NPWT pumps | 90.18 13 | No instrument category listed 5 | None 3 | Confirm the full national tariff line per SKU and the country of origin |
| Endovenous laser fibres | 90.18 or 90.01 13 | Neither heading listed 5 | None 3 | Use one agreed code consistently on Form M, invoice and dossier |
| Wound and NPWT dressings, including coated dressings | 30.05 (excluded from 30.03/30.04) 11 | Not the medicament item as defined in earlier lists (30.03/30.04); confirm in the 2026 schedule 9 11 | None 3 | Check how a kit combining dressing, tubing and canister is classified as a set |
| Sterile tissue adhesive | 3006.10 11 | Distinct from waste pharmaceuticals (3006.92) 5 11 | None 3 | Confirm the subheading is not mis-entered as 3006.92 |
| Antiseptic creams, ointments, medicated solutions | 30.04 11 | Medicament item may apply 5 | Topical penicillin, salicylic-acid creams, benzyl benzoate and sulphur ointment are listed 3 | Treat as high risk; check the exact Third Schedule line and NAFDAC route first |
| Hand rubs, scrubs and disinfectants | 38.08 (3808.94), 34.01/34.02 or 30.04 by formulation 9 11 12 | Soaps and detergents listed 5 | Alcohol-based hand sanitizers listed 3 | Confirm formulation, presentation and which NAFDAC directorate regulates the product |
Source: WCO HS 2022 Chapters 30, 38 and 90; Federal Ministry of Finance circular of 1 April 2026 as reported; NAFDAC Ceiling List. The heading to discuss is a starting point for a licensed agent, not a binding classification.
The Ceiling List works differently. NAFDAC first published it on 15 November 2021. The current one-page list names 36 products that “can only be registered as locally manufactured” and sets out the rationale: to prevent importation of pharmaceutical products that domestic manufacturers have the capacity to produce. 3 The accompanying notice states that NAFDAC will no longer accept new applications for imported products on the list. At renewal, existing holders must submit a blueprint or plan for migrating to local manufacture under the 5+5 policy pathway. 4 Most entries are active ingredients in all or oral dosage forms, such as albendazole, amoxicillin, ciprofloxacin, metformin and ibuprofen. The device-adjacent entries are alcohol-based hand sanitizers and four topical preparations. 3 NAFDAC has already updated the list since 2021, so check it again on the day of filing.
What document chain must a China-based manufacturer build?
Once both lists are cleared, the guideline's Step 1 document set applies. Most items are the same for every overseas manufacturer. The declaration template in Appendix I adds one line that names China and India specifically: 1
“Manufacturing license / Certificate for companies from India and China and the authentication thereof by the Nigerian Mission in the country of origin”— NAFDAC Guideline VBM-R&RA-GDL-001-01, Appendix I, paragraph 2(c)
For a Chinese factory, that is the provincial medical-device production licence. The same declaration lists a Certificate of Manufacture and/or Free Sale, and a GMP certificate, each “authenticated by the Nigerian Mission in the country of origin”. 1 The Apostille Convention entered into force for China on 7 November 2023. Nigeria does not appear in the Convention's status table, so a Chinese apostille alone does not meet the guideline's wording. 14 Plan for consular legalization ending at the Nigerian Embassy or the consulate whose district covers the issuing province, and confirm the current sequence and lead time with that mission before booking notaries. For how Chinese export sales certificates are issued and verified, see the certificate of free sale verification guide.
| Document (guideline reference) | Who issues or signs | Authentication | Wording and scope points |
|---|---|---|---|
| Power of Attorney (4.4–4.5) 1 | Manufacturer; signed by its Managing Director, General Manager, Chairman or President | Notarized by a Notary Public in the country of manufacture | Names the products and should indicate “Authority to register product with NAFDAC”; states brand/trademark ownership; valid for at least five years |
| Contract Manufacturing Agreement (4.4, 4.6) 1 | Applicant that owns the brand, and the manufacturer | Notarized in the country of manufacture | Used instead of a PoA where the applicant owns the brand name; signatories, designations and all products named in unambiguous language |
| Certificate of Manufacture and Free Sale (4.7) 1 | Health or regulatory body in the country of manufacture | Nigerian Embassy or High Commission in the country of origin; a Commonwealth or ECOWAS mission where Nigeria has none | Must name the manufacturer and the products; shows the company is licensed and the sale is lawful there |
| Manufacturing licence (Appendix I, 2(c)) 1 | Licensing authority of the manufacturing country; listed for China- and India-based companies | Nigerian Mission in the country of origin | Licence holder, address and scope should match the CFS and the inspection letter |
| GMP inspection invitation (4.12) 1 | Manufacturer | Letter; no authentication stated | Full factory location address, not the administrative office; overseas contact; Nigerian agent's details; products for registration |
| Notarized Declaration (4.3, Appendix I) 1 | Managing Director of the Nigerian applicant | Notary Public in Nigeria | Lists the attached documents; indemnifies NAFDAC and accepts criminal liability for false declarations or forged documents |
| Other Step 1 items (4.8–4.10, 4.13–4.14) 1 | Applicant and manufacturer | As applicable | Certificate of analysis with batch and dates; applicant's CAC incorporation; brand registered with the Nigerian trademark registry in the owner's name; QMS certificate; declaration of conformity; ToC-format product dossier for Classes C and D |
Source: NAFDAC Guideline VBM-R&RA-GDL-001-01, paragraphs 4.3–4.14 and Appendix I; NAFDAC renewal guideline VBM-R&RA-GDL-003-01, paragraph 3.1.
Two drafting choices save rework later. First, decide early who owns the brand in Nigeria. The guideline routes a non-owner applicant to a Power of Attorney and a brand-owning applicant to a Contract Manufacturing Agreement, and it requires the trademark to be registered in Nigeria in the owner's name. 1 Second, think about renewal when you draft the Power of Attorney. NAFDAC's renewal guideline says the initial PoA or agreement may have lapsed by the time the five-year certificate expires. It requires a new one unless the original stated a specific expiry date that is still valid or an indefinite term. 2 A PoA that runs exactly five years is likely to need re-signing, re-notarizing and possibly re-legalizing at renewal. Factory-side evidence for the inspection invitation is covered in our China NMPA GMP factory qualification guide.
Which clocks and conditions can end an application?
Filing runs through the NAFDAC Automated Product Administration and Monitoring System (NAPAMS) at registration.nafdac.gov.ng. 1 Paragraph 3.1 makes Dossier Screening Clearance a prerequisite for moderate- and high-risk devices. Paragraph 3.2 tells applicants to email md.vbmrr@nafdac.gov.ng to request access, after which a unique dossier-submission link is issued. Each device, group, family or system needs its own application, and where a device could fall into more than one class, the higher class applies. 1 After NAPAMS submission of a Class C or D device, the applicant must email the Directorate with the application number so the dossier can progress to full review. 1
After documents are screened, NAFDAC issues an electronic Permit to Import registration samples for laboratory testing. The samples go to the VBM-R&RA Directorate for onward laboratory analysis, accompanied by a certificate of analysis and evidence of fee payment. The overseas factory is inspected under the Drug Evaluation and Research Directorate's procedures. Satisfactory files are then presented to the Food and Drug Registration Committee (FDRC) for approval. 1
| Rule | What the guideline says | Practical consequence |
|---|---|---|
| Processing maxima 1 | Class A: maximum 120 workdays; Classes B, C and D: maximum 240 workdays; overall maximum of 240 workdays from acceptance of submissions to issuance of the registration number | These are ceilings, not promised turnaround times; build the commercial launch plan around the class that applies |
| Clock suspension 1 | The timeline is suspended when there is a Compliance Directive; the clock stops once compliances are issued | Elapsed calendar time can far exceed the workday maximum if responses are slow |
| Query response 1 | Failure to respond within ninety days to NAFDAC queries or enquiries automatically leads to closure of the application | Make the overseas technical owner of each likely query (sterilization, shelf life, biocompatibility) contractually responsive |
| No status from filing 1 | Filing an application and/or paying a fee does not confer registration status | No commercial shipment on the strength of a pending file or a sample permit |
| Validity and advertising 1 | Certificate valid for five years; registration does not confer an advertisement permit, which needs a separate approval | Budget a separate advertising approval if promotion is planned |
| Renewal 2 | A renewal can be initiated six months before expiry; renewal is processed within 60 workdays from acceptance, with the clock stopping on compliances | Start at the six-month mark, together with the refreshed PoA or agreement |
Source: NAFDAC registration guideline VBM-R&RA-GDL-001-01, paragraphs 3.6–3.8 and 11.2–11.8; renewal guideline VBM-R&RA-GDL-003-01, paragraphs 2.1, 3.1 and 9.6–9.7.
The 90-day query rule is the clock most often outside the Nigerian applicant's control. The answer usually has to come from the factory, for example a sterilization validation summary, an accelerated-aging report or a biocompatibility endpoint. The guideline sets the consequence, closure of the application, but does not describe how fees or reapplication are handled after closure. 1 Ask the applicant to confirm that before filing, and agree in the distribution contract on how quickly NAFDAC correspondence is forwarded and answered.
Pre-filing checklist: eight gates before signing a registration budget
- Fix the tariff code. Have the Nigerian applicant's licensed customs agent state the full tariff line and the origin (ECOWAS or non-ECOWAS) for every SKU in writing. Use the HS legal text, not habit: dressings are 30.05 and sterile tissue adhesives 3006.10. 11
- Check the 2026 trade list, not a mirror. Compare each line with the Third Schedule substituted by the Variation Order 2026, and keep a dated copy. 6 7
- Check the Ceiling List on the filing date. Look especially at hand-hygiene products and topical preparations. If a product sits on the borderline between device, drug and disinfectant, get NAFDAC's routing in writing. 3 4
- Settle brand ownership. Decide whether the applicant files under a PoA or a Contract Manufacturing Agreement, and register the brand with the Nigerian trademark registry in the owner's name. 1
- Draft the PoA for the whole lifecycle. Include the products, the ownership statement and “Authority to register product with NAFDAC”. Make it valid for at least five years, and consider a term that survives renewal. 1 2
- Book the legalization route. Plan Nigerian-mission authentication for the CFS, and for China- and India-based factories also the manufacturing licence. An apostille will not substitute. 1 14
- Align factory identities. The factory address on the inspection invitation, the licence, the CFS and the QMS certificate should match, and the invitation must not give an administrative-office address. 1
- Staff the 90-day clock. Name the factory owner for each likely technical query and set a forwarding deadline in the distribution contract that leaves time to prepare a full response. 1
Where VEMERIX fits—and where due diligence still begins
VEMERIX is the international brand of Weihai Medison Medical Equipment Co., Ltd., positioned as a Minimally Invasive Surgery Total Solution Platform serving urology, vascular surgery and perioperative care.
For a Nigerian applicant evaluating Medison-made products, the screening above produces different answers by product family. Instrument-type products such as the Disposable Circumcision Stapler and the NPWT pump fall in the Chapter 90 discussion. NPWT dressing kits raise the 30.05 and set-classification questions. The hypochlorous acid disinfectant needs its own routing: in China it is covered by a disinfectant hygiene licence rather than a medical-device registration, and it is a hand, surface and air disinfectant, not an alcohol-based hand sanitizer. Its Nigerian regulatory route and tariff line should be confirmed before it is added to a device registration plan.
The Chinese records a Nigerian applicant would ask to have authenticated are the Weihai factory's production licence and the product registrations; most Medison device registrations shown on the product pages are Shandong provincial records. Registration documents and ISO 9001 and ISO 13485 files are supplied to qualified buyers and distributors under NDA. Nigerian-mission authentication is a separate step, to be scheduled with the applicant document by document. Distributors can request the document list and the catalogue through VEMERIX Downloads or start a qualification discussion through VEMERIX Contact.
Frequently asked questions
Are medical devices banned from import into Nigeria?
No device category is among the 17 items on the 2026 Import Prohibition List (Trade), and no medical device is among the 36 Ceiling List entries. 3 5 Every device still needs NAFDAC registration before it is imported or sold, and products near the device boundary (medicaments, soaps and detergents, alcohol-based hand sanitizers) need a line-by-line check. 1 3 5
What is the difference between the Import Prohibition List and the NAFDAC Ceiling List?
The trade list is a Finance/Customs tariff instrument covering listed goods of non-ECOWAS origin. 5 7 The Ceiling List is a NAFDAC registration policy: listed products can only be registered as locally manufactured, and existing import registrations move to the 5+5 pathway at renewal. 3 4 Paragraph 1.3 of the device guideline refers to both. 1
Which version of the prohibition list should I check?
Use the list substituted in the Third Schedule by the Customs, Excise Tariff, Etc. (Variation) Order 2026, made with effect from 1 May 2026, following the Finance circular of 1 April 2026. 5 6 7 The FCCPC page and the 2023 U.S. Commercial Guide reproduce earlier lists. 9 10
Is a medicated wound dressing caught by the medicament ban?
Not by default. Headings 30.03 and 30.04 exclude goods of heading 30.05, and 30.05 expressly covers dressings impregnated or coated with pharmaceutical substances. 11 The tariff line is still the customs agent's call, and creams, ointments or solutions sold alongside the dressing are classified on their own merits.
What extra document does NAFDAC require from China-based manufacturers?
The Appendix I declaration lists the manufacturing licence of companies from India and China, authenticated by the Nigerian Mission in the country of origin, alongside the Mission-authenticated CFS and GMP certificate. 1 Because Nigeria is not listed as a party to the Apostille Convention, plan for consular legalization rather than an apostille. 14
What must the Power of Attorney say, and for how long?
Under paragraph 4.5 it is issued by the manufacturer, signed by its Managing Director, General Manager, Chairman or President, names the products, indicates “Authority to register product with NAFDAC”, states brand ownership, is notarized in the country of manufacture and is valid for at least five years. 1 At renewal NAFDAC expects a new PoA unless the original stated a still-valid expiry date or an indefinite term. 2
How long can registration take?
The guideline sets maxima of 120 workdays for Class A and 240 workdays for Classes B to D, with the clock stopped while compliance issues are open. 1 Those are ceilings, not promises; the guideline gives no typical elapsed time.
What happens if a NAFDAC query is not answered within 90 days?
Paragraph 11.6 says failure to respond within ninety days automatically leads to closure of the application. 1 The guideline does not say how fees are treated after closure, so confirm that with the applicant before filing.