Medical Device Import Requirements by Country (37 Markets)
Who regulates medical devices, who must hold the licence, how long registration really takes, which certificate the container needs before it sails, and the duty and VAT on gloves — for 37 countries, side by side. Each row links to the full country guide.
North Africa
| Country | Regulator | First registration | Before shipment | Duty — gloves (HS 4015) | VAT | Sea transit |
|---|---|---|---|---|---|---|
| 🇪🇬 Egypt | EDA | 6–12 months | GOEIC factory register | Indicative — confirm against the current Egyptian tariff | 14% VAT | 12–16 days |
| 🇩🇿 Algeria | PCH & MSPRH | 3 to 6 months for notification of Class I/IIa consumables | Certificate of Conformity | 5% | 19% TVA | 16–22 days |
| 🇲🇦 Morocco | DMP | 3 to 5 months for Class I/IIa consumables | Port sanitary inspection | 2.5% | 20% TVA | 18–24 days |
West Africa
| Country | Regulator | First registration | Before shipment | Duty — gloves (HS 4015) | VAT | Sea transit |
|---|---|---|---|---|---|---|
| 🇳🇬 Nigeria | NAFDAC | 6–12 months for a first-time listing | SONCAP | ≈ 5–10% (ECOWAS CET) | 7.5% VAT | 22–30 days |
| 🇬🇭 Ghana | FDA Ghana | 3–6 months for Class A/B consumables | GSA conformity assessment | ≈ 5–10% (ECOWAS CET) | 15% VAT plus statutory levies | 25–32 days |
| 🇨🇮 Ivory Coast | AIRP | 3 to 6 months | — | 5% (UEMOA TEC) | 18% TVA | 24–30 days |
| 🇸🇳 Senegal | ARP | 3 to 5 months | — | 5% (TEC CEDEAO) | 18% TVA | 24–30 days |
| 🇨🇲 Cameroon | DPML | 4 to 8 months | — | 10% (CEMAC TEC) | 19.25% TVA | 26–32 days |
East Africa
| Country | Regulator | First registration | Before shipment | Duty — gloves (HS 4015) | VAT | Sea transit |
|---|---|---|---|---|---|---|
| 🇰🇪 Kenya | PPB | 4–8 months typically | PVoC (KEBS) | 0–10% (EAC Common External Tariff) | 16% VAT | 12–18 days |
| 🇹🇿 Tanzania | TMDA | 6–12 months | PVoC (TBS) | 0–10% (EAC CET) | 18% VAT | 14–20 days |
| 🇪🇹 Ethiopia | EFDA | 6–12 months | — | Indicative — confirm against the current Ethiopian tariff | 15% VAT | 16–22 days |
| 🇺🇬 Uganda | NDA | 6–12 months | PVoC (UNBS) | 0–10% (EAC CET) | 18% VAT | 16–22 days |
| 🇷🇼 Rwanda | Rwanda FDA | 2 to 4 months (streamlined online regulatory portal) | — | 0% – 10% (EAC CET) | 18% VAT (exempt on certified medical equipment) | 18–24 days |
Central Africa
| Country | Regulator | First registration | Before shipment | Duty — gloves (HS 4015) | VAT | Sea transit |
|---|---|---|---|---|---|---|
| 🇦🇴 Angola | ARMED | 3 to 6 months | — | 5% – 10% | 14% IVA | 26–34 days |
| 🇨🇩 Democratic Republic of the Congo | DPM | 3 to 6 months | — | 5% – 10% | 16% TVA | 28–36 days |
Southern Africa
| Country | Regulator | First registration | Before shipment | Duty — gloves (HS 4015) | VAT | Sea transit |
|---|---|---|---|---|---|---|
| 🇿🇦 South Africa | SAHPRA | Establishment licensing is the gate and can take many months | — | Indicative — check the SARS tariff, rates vary by line | 15% VAT | 18–24 days |
| 🇲🇿 Mozambique | ANARME | 3 to 6 months | — | 5% – 7.5% | 16% IVA | 16–22 days |
| 🇿🇲 Zambia | ZAMRA | 3 to 6 months for Class A/B consumables | — | 0% (essential health supplies) | 16% VAT (exempt for public health sector tenders) | 20–26 days |
Middle East
| Country | Regulator | First registration | Before shipment | Duty — gloves (HS 4015) | VAT | Sea transit |
|---|---|---|---|---|---|---|
| 🇦🇪 United Arab Emirates | MOHAP | 3–6 months, and among the more predictable regimes in the region | — | 5% GCC common external tariff | 5% VAT | 7–10 days |
| 🇸🇦 Saudi Arabia | SFDA | 6–12 months | SABER / SALEEM | 5% GCC common external tariff | 15% VAT | 10–14 days |
South Asia
| Country | Regulator | First registration | Before shipment | Duty — gloves (HS 4015) | VAT | Sea transit |
|---|---|---|---|---|---|---|
| 🇧🇩 Bangladesh | DGDA | 3–9 months | — | Confirm against the current Bangladeshi tariff | VAT and supplementary duty may apply | 7–10 days |
Southeast Asia
| Country | Regulator | First registration | Before shipment | Duty — gloves (HS 4015) | VAT | Sea transit |
|---|---|---|---|---|---|---|
| 🇵🇭 Philippines | FDA Philippines | 3–6 months for notification-route devices once the LTO is in place | — | Confirm against the current Philippine tariff | 12% VAT | 16–22 days |
| 🇻🇳 Vietnam | Ministry of Health | Class A/B declaration is comparatively quick | — | Confirm against the current Vietnamese tariff | VAT applies; medical equipment may attract a reduced rate | 12–16 days |
Latin America
| Country | Regulator | First registration | Before shipment | Duty — gloves (HS 4015) | VAT | Sea transit |
|---|---|---|---|---|---|---|
| 🇧🇷 Brazil | ANVISA | Class I/II notificação can be quick once the holder is set up | — | Mercosur common external tariff — confirm the current NCM line | ICMS (state-level) plus IPI, PIS and COFINS | 26–34 days |
| 🇲🇽 Mexico | COFEPRIS | Ordinary route is slow | — | Confirm against the current Mexican tariff (TIGIE) | 16% IVA | 28–36 days |
| 🇨🇴 Colombia | INVIMA | Class I and IIa: 60 to 90 business days under expedited review | — | 0% – 5% Arancel | Exempt / 19% IVA with health credit | 25–32 days |
| 🇦🇷 Argentina | ANMAT | Class I/II: 3 to 6 months | — | Mercosur Common External Tariff (AEC 14%) | 21% IVA | 28–35 days |
| 🇨🇱 Chile | ISP | Mandatory registration applies to specific regulated categories (syringes, gloves, condoms) | — | 6% standard (or preferential rate) | 19% IVA | 32–40 days |
| 🇵🇪 Peru | DIGEMID | Class I/II: 60 to 90 days | — | 0% Ad Valorem | 18% IGV (reimbursable) | 30–38 days |
| 🇪🇨 Ecuador | ARCSA | Homologation / Simplified Route: 45 to 75 days | — | — | — | 28–36 days |
| 🇵🇦 Panama | MINSA | 3 to 6 months | — | 0% – 5% | 7% ITBMS | 22–28 days |
| 🇨🇷 Costa Rica | Ministerio de Salud de Costa Rica | Class 1/2: 30 to 60 days via electronic platform Regístrelo | — | 0% – 5% | 13% IVA (1% reduced rate on health products) | 24–30 days |
| 🇩🇴 Dominican Republic | DIGEMAPS | 3 to 6 months | — | 0% – 5% | 18% ITBIS (exempt on basic medical supplies) | 22–28 days |
| 🇬🇹 Guatemala | DRCPFA | 3 to 5 months (valid across RTCA Central American mutual recognition countries) | — | 0% – 5% DAI | 12% IVA | 26–32 days |
| 🇺🇾 Uruguay | MSP | 3 to 6 months | — | Mercosur AEC (14%) | 22% IVA | 28–35 days |
| 🇵🇾 Paraguay | DINAVISA | 3 to 6 months | — | Mercosur AEC (14%) | 10% IVA | 30–38 days |
| 🇧🇴 Bolivia | AGEMED | 3 to 6 months | — | 5% – 10% GA | 14.94% IVA efectivo | 32–40 days |
Duty is the indicative applied rate against the HS heading shown in each country guide; a dash means the dossier gives no single rate. Sea transit is from Nhava Sheva or Mundra. Facts were checked May 2026 — tariffs and guidance change, so confirm against the current schedule and the regulator before you price or file.
Frequently asked questions
Does every country require a local company to hold the medical device registration?
In all 37 markets compared here, yes — the registration is held by a locally incorporated importer, distributor or authorised representative, not by the overseas manufacturer. That makes the choice of local partner the first commercial decision, because moving a registration to a different holder usually means applying again.
Which countries require a certificate before the container sails?
Egypt (GOEIC factory register), Algeria (Certificate of Conformity), Morocco (Port sanitary inspection), Nigeria (SONCAP), Ghana (GSA conformity assessment), Kenya (PVoC (KEBS)), Tanzania (PVoC (TBS)), Uganda (PVoC (UNBS)), Saudi Arabia (SABER / SALEEM). These are separate from the device registration: a registered product can still be refused at the port without them. Kenya, Tanzania and Uganda each run their own PVoC certificate, and one does not transfer to another.
How long does a first medical device registration take?
For low-risk consumables, roughly three to six months in most of Latin America, Ghana and the francophone West African markets, and six to twelve months in Nigeria, Egypt, Saudi Arabia, Tanzania, Uganda and Ethiopia. Higher-risk classes take longer everywhere. The figures in the table are realistic elapsed times, not statutory targets.
How is import duty on medical devices calculated?
On the CIF value — goods, freight and insurance — at the rate for the product's HS heading, with VAT then charged on CIF plus duty in most markets. Customs unions (ECOWAS, EAC, GCC, Mercosur, CEMAC) share a common external tariff, and many countries exempt public-health supply. Our landed cost calculator works it through for any of these countries.
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Source: <a href="https://www.manshavimpex.com/import-requirements">Medical device import requirements by country</a>, Manshav Impex