Medical Products Exporter to Kenya
Manshav Impex is a premier Indian OEM manufacturer and global exporter of certified surgical gloves, surgical blades, hypodermic syringes, IV cannulas, infection-control PPE, and hospital equipment to healthcare distributors, hospital groups, and government health ministries across Kenya. East Africa's primary healthcare hub — importing surgical gloves, blades, disposables and medical equipment.
High-Precision Medical Consumables for Kenya
Manufactured in Class 100,000 (ISO Class 8) cleanrooms under strict ISO 13485:2016 and WHO-GMP protocols with 100% lot traceability.
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, 200 pairs/master carton (OEM private label available)
Surgical Blades & Scalpels
HS 8211.91 · 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
How medical devices actually clear into Kenya
Regulator & registration
- Authority
- PPB — Pharmacy and Poisons Board
- Governing instrument
- Pharmacy and Poisons Act (Cap. 244) and the medical device retention framework
- Classification
- Class A, B, C, D by risk
- Local representative
- Mandatory. A Kenyan local technical representative holds the registration; the manufacturer appoints them formally and the appointment is filed with the PPB.
- Realistic timeline
- 4–8 months typically
Registration route, in order
- 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
Pre-shipment conformity
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.
Duty & tax by HS heading
| HS | Product | Duty | Tax |
|---|---|---|---|
| 4015.12 | Surgical and examination glovesMany medical supplies are zero-rated or exempt — the classification decides, so confirm the line before pricing | 0–10% (EAC Common External Tariff) | 16% VAT |
| 9018.31 | Syringes, with or without needles | 0% (EAC CET, medical) | Exempt / zero-rated in most cases |
| 9018.90 | Other instruments and appliances | 0–10% (EAC CET) | 16% VAT unless exempt |
Indicative and tied to the HS heading shown. Tariff lines change and your exact classification governs — confirm against the current schedule before pricing. Checked May 2026.
Ports & 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 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.
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 for brand owners, distributors and pharmacy chains in Kenya.
Explore Full Medical Range for Kenya
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.
Exporting Medical Consumables to Kenya
Who must hold the medical device registration in Kenya?
Mandatory. A Kenyan local technical representative holds the registration; the manufacturer appoints them formally and the appointment is filed with the PPB.
How do I register a medical device with PPB in Kenya?
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.
Is pre-shipment inspection or a conformity certificate required for Kenya?
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.
What import duty applies to surgical gloves and medical disposables in Kenya?
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.
Which port should I use for medical imports into Kenya?
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.
Who buys medical supplies publicly in Kenya?
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.
What most commonly goes wrong importing medical devices into 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.
What Incoterms are available for delivery to Mombasa?
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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