🇰🇪 Export Market · East Africa

Medical Products Exporter to Kenya

Indian manufacturer & exporter of surgical gloves, blades, syringes, IV cannulas and PPE for distributors, hospitals and health ministries in Kenya.

Trade lane · India → Kenya
Loading ports
🇮🇳 Mundra & Nhava Sheva
Discharge ports
🇰🇪 Mombasa
Sea transit
12–18 days
Regulator
Pharmacy and Poisons Board (PPB)

East Africa's primary healthcare hub — importing surgical gloves, blades, disposables and medical equipment.

In short: sourcing medical consumables for Kenya

Manshav Impex is an Indian manufacturer & exporter of surgical disposables and hospital consumables produced in our own ISO 13485-certified factory and at vetted partner factories and made to CE marking requirements, supplying Kenya. Shipped from Mundra Port (INMUN1) and Nhava Sheva (INNSA1) to Mombasa in 12–18 days. We supply the documentation your Pharmacy and Poisons Board (PPB) registration requires, alongside 24-hour paperwork SLAs for Certificate of Origin (COO), Free Sale Certificates (FSC), and commercial invoices.

Paperwork Language
English
Buyer Local Currency
Kenyan Shilling (KES)
Made to Standards
CE MDR · ISO 13485 · EN 455 · EN 13795
Export Paperwork SLA
24-Hour Complete Dossier Guarantee
Technical Product Portfolio

High-Precision Medical Consumables Exported to Kenya

Produced in our own ISO 13485-certified factory and at vetted partner factories in India with 100% lot traceability — certificates and test reports are shared with every quotation.

Surgical Gloves

HS 4015.11 · AQL 1.0
  • Standards: EN 455 (Parts 1–4), ASTM D3577, ISO 10282, CE 2797
  • Specifications: 280 mm minimum beaded cuff, micro-textured grip, low protein (<50 µg/dm²)
  • Sterilization: Ethylene Oxide (EO) / Gamma Radiation (25 kGy) with sterile peel-pouch
  • Packaging: 50 pairs/dispenser box, 400 pairs/master carton (OEM private label available)

Surgical Blades & Scalpels

HS 9018.90 · ISO 7740
  • Standards: BS 2982, ISO 7740, EN ISO 11607 sterile barrier packaging
  • Material: Grade T10/1095 High-Carbon Steel & AISI 420 Surgical Stainless Steel
  • Sizes: No. 10, 11, 12, 15 (Handle #3) and No. 18, 20, 21, 22, 23, 24 (Handle #4)
  • Sterilization & Packaging: Gamma irradiated 25 kGy in airtight VCI foil packets; 100 pcs/box

Syringes & IV Cannulas

HS 9018.31 / 9018.39
  • Standards: ISO 7886-1, ISO 10555-1/5, ISO 8536-4, Non-pyrogenic & DEHP-free
  • Syringes: 2-part & 3-part Luer Lock / Luer Slip (1ml, 2ml, 3ml, 5ml, 10ml, 20ml, 50ml)
  • IV Cannulas: 14G–26G with injection port & radio-opaque FEP/PTFE catheter wings
  • Needle Quality: Ultra-sharp siliconized triple-facet Japanese stainless steel needle

Surgical Gowns & Infection PPE

HS 6210.10 · AAMI Level 3/4
  • Standards: AAMI PB70 Level 3/4 fluid barrier protection, EN 13795 clinical compliance
  • Fabric: 45–55 GSM medical-grade SMS / SMMS non-woven with ultrasonic welded seams
  • Face Masks: Type IIR EN 14683 3-ply surgical masks (BFE ≥ 98%, fluid resistance 120 mmHg)
  • Drapes & Packs: Sterile laparotomy drapes, ophthalmic packs and universal surgical kits
Import & Regulatory Clearance

How Medical Devices Clear into Kenya

Who registers, the steps in order, and the indicative duty on the main HS lines.

Regulatory Authority
PPB — Pharmacy and Poisons Board
Approval Pathway Timeline
4–8 months typically
Local License Requirement
Mandatory.

Registration & Clearance Route

Sequential legal procedure in Kenya
  1. 1Appoint a Kenyan local technical representative
  2. 2Manufacturer files ISO 13485, CE Declaration of Conformity and a Certificate of Free Sale
  3. 3Product retention/registration application submitted to the PPB with fees
  4. 4Technical evaluation, with samples and batch certificates of analysis as requested
  5. 5Retention certificate issued; annual retention fees keep it live

Indicative Customs Duty & Tax

By Harmonized System (HS) Code for Kenya
HS CodeProductDutyTax
4015.12Surgical and examination glovesMany medical supplies are zero-rated or exempt — the classification decides, so confirm the line before pricing0–10% (EAC Common External Tariff)16% VAT
9018.31Syringes, with or without needles0% (EAC CET, medical)Exempt / zero-rated in most cases
9018.90Other instruments and appliances0–10% (EAC CET)16% VAT unless exempt

Indicative tariffs verified against HS classifications. Actual tariff treatment is governed by local customs declaration schedules. Checked May 2026.

Pre-Shipment Conformity Inspection

PVoC — Pre-Export Verification of Conformity — is compulsory. A Certificate of Conformity must be issued by a KEBS-appointed agent (Intertek, SGS, Bureau Veritas and others) *in India, before the vessel sails*. Destination inspection instead of PVoC attracts a penalty of a substantial percentage of CIF value. This single requirement causes more stranded medical containers into Mombasa than any regulatory issue.

Entry Ports & In-Land Clearance

Mombasa is the gateway for Kenya and for landlocked Uganda, Rwanda, Burundi, South Sudan and eastern DRC. The Standard Gauge Railway to the Nairobi ICD is now the usual inland leg and is faster than road haulage. Clearance runs through KRA's iCMS. Nairobi ICD clearance is often smoother than clearing at the coast.

Public Healthcare Procurement

KEMSA — Kenya Medical Supplies Authority — is the principal public buyer, supplying county health facilities. Counties also procure independently since devolution, and the private hospital groups are significant buyers in their own right.

Crucial Importer Advisory: Costly Mistake to Avoid in Kenya

Shipping before the PVoC Certificate of Conformity is issued. It cannot be obtained retrospectively at Mombasa without a penalty assessed on CIF value, and the goods sit while it is resolved.

OEM & private label for Kenya

We manufacture private-label medical devices and surgical consumables in our own factory and at vetted partner factories for brand owners, distributors and pharmacy chains in Kenya.

Custom packaging
Inner boxes and master cartons in your brand.
Local-language text
Instructions for use printed in English.
Flexible MOQs
Low trial quantities, scaling to full containers.
Lead times
14–25 day production cycles after artwork sign-off.
🌍 Tender Documentation on Request

Ministry Tender Pack & Product Specification Dossier

Our export desk prepares tender documentation for Ministries of Health, Central Medical Stores and hospital supply boards in Kenya. Tell us the tender and we send the matching certificates and product documents.

Export Quote Desk

Request Export Pricing for Kenya

Share your required product quantities and delivery port in Kenya. Our international trade desk will provide formal CIF/FOB pricing, specification sheets, and regulatory support within 24 business hours.

Direct Ocean & Air Shipping

FCL & LCL container routing to Mombasa with real-time tracking.

Import-Ready Documentation

Commercial invoice, packing list, COO, CoA, and registration files included.

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Frequently Asked Questions

Exporting Medical Consumables to Kenya

Mandatory. A Kenyan local technical representative holds the registration; the manufacturer appoints them formally and the appointment is filed with the PPB.
Appoint a Kenyan local technical representative. Manufacturer files ISO 13485, CE Declaration of Conformity and a Certificate of Free Sale. Product retention/registration application submitted to the PPB with fees. Technical evaluation, with samples and batch certificates of analysis as requested. Retention certificate issued; annual retention fees keep it live. Realistically allow 4–8 months typically.
PVoC — Pre-Export Verification of Conformity — is compulsory. A Certificate of Conformity must be issued by a KEBS-appointed agent (Intertek, SGS, Bureau Veritas and others) *in India, before the vessel sails*. Destination inspection instead of PVoC attracts a penalty of a substantial percentage of CIF value. This single requirement causes more stranded medical containers into Mombasa than any regulatory issue.
Surgical and examination gloves (HS 4015.12): 0–10% (EAC Common External Tariff), plus 16% VAT. Syringes, with or without needles (HS 9018.31): 0% (EAC CET, medical), plus Exempt / zero-rated in most cases. Other instruments and appliances (HS 9018.90): 0–10% (EAC CET), plus 16% VAT unless exempt. These are indicative against the HS headings shown and were checked May 2026 — your exact classification governs, so confirm against the current tariff schedule before pricing.
Mombasa is the gateway for Kenya and for landlocked Uganda, Rwanda, Burundi, South Sudan and eastern DRC. The Standard Gauge Railway to the Nairobi ICD is now the usual inland leg and is faster than road haulage. Clearance runs through KRA's iCMS. Nairobi ICD clearance is often smoother than clearing at the coast.
KEMSA — Kenya Medical Supplies Authority — is the principal public buyer, supplying county health facilities. Counties also procure independently since devolution, and the private hospital groups are significant buyers in their own right.
Shipping before the PVoC Certificate of Conformity is issued. It cannot be obtained retrospectively at Mombasa without a penalty assessed on CIF value, and the goods sit while it is resolved.
FOB (Nhava Sheva JNPT / Mundra), CIF or CFR (Mombasa), and DDP. Cargo ships as FCL (20ft / 40ft HC) or LCL consolidation with humidity-protected packaging and marine insurance. Air freight is available for urgent hospital requirements.
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