Manshav Impex
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🇿🇦 Export Market · Southern Africa

Medical Products Exporter to South Africa

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

Trade lane · India → South Africa
Loading ports
🇮🇳 Mundra & Nhava Sheva
Discharge ports
🇿🇦 Durban, Cape Town
Sea transit
18–24 days
Regulator
SAHPRA (South African Health Products Regulatory Authority)

Sophisticated market with SAHPRA-aligned documentation for surgical gloves, blades & medical devices.

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In short: sourcing medical consumables for South Africa

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 South Africa. Shipped from Mundra Port (INMUN1) and Nhava Sheva (INNSA1) to Durban, Cape Town in 18–24 days. We supply the documentation your SAHPRA (South African Health Products Regulatory Authority) 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
South African Rand (ZAR)
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 South Africa

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 South Africa

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

Regulatory Authority
SAHPRA — South African Health Products Regulatory Authority
Approval Pathway Timeline
Establishment licensing is the gate and can take many months; device registration is being phased in progressively by class
Local License Requirement
Mandatory in substance: a South African entity must hold the Medical Device Establishment Licence covering import and distribution.

Registration & Clearance Route

Sequential legal procedure in South Africa
  1. 1Local importer/distributor obtains a SAHPRA Medical Device Establishment Licence
  2. 2Manufacturer supplies ISO 13485, CE Declaration of Conformity and technical documentation
  3. 3Product listing/registration per the class and the applicable phase-in
  4. 4SABS conformity evidence where a standard is called up

Indicative Customs Duty & Tax

By Harmonized System (HS) Code for South Africa
HS CodeProductDutyTax
4015.12Surgical and examination glovesIndicative — check the SARS tariff, rates vary by line15% VAT
9018.90Other instruments and appliancesOften free or low under the SACU tariff15% VAT

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

Entry Ports & In-Land Clearance

Durban is the main container port, with Cape Town and Port Elizabeth serving their regions. SARS Customs is comparatively rules-driven and predictable; tariff classification disputes are the common friction point rather than clearance speed.

Public Healthcare Procurement

Provincial health departments tender separately under a national framework — there is no single national buyer, and provincial cycles differ.

OEM & private label for South Africa

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 South Africa.

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 South Africa. Tell us the tender and we send the matching certificates and product documents.

Main products we export to South Africa

Made in India and shipped to Durban, Cape Town. Each page lists sizes, standards, packing and the documents for SAHPRA.

Surgical gloves manufacturer in IndiaLatex examination gloves manufacturer in IndiaNitrile examination gloves manufacturer in IndiaDisposable syringes manufacturer in IndiaBlood collection tubes manufacturer in IndiaIV cannula manufacturer in IndiaIV infusion sets manufacturer in IndiaSurgical sutures manufacturer in IndiaSurgical blades manufacturer in IndiaDisposable scalpels manufacturer in India
Product Catalog

Explore Full Medical Range for South Africa

Surgical Consumables
Sterile · EO
Hypodermic Syringes & Needles
Single-use · ISO 7886
Vascular Access & Infusion
Vascular · ISO 10555
Urology & Fluid Drainage
Closed System · 100% Silicone
Respiratory & Oxygen Delivery
Star Lumen · Medical PVC
Bandages & Wound Management
BP Grade · 100% Cotton
Personal Protective Equipment
EN 455 · AQL 1.5
Diagnostic & Lab Consumables
CE · ISO 6710
Orthopedic Trauma Implants
Titanium · SS 316L
Hospital Furniture & Beds
ICU Grade · IEC 60601
Electromedical Devices
CE · IEC 60601
Rehabilitation & Mobility
Mobility · 120 kg Load
Buyer Guides

Guides for Buyers in South Africa

Export Guide
Medical Consumables Exporter to South Africa: SAHPRA Licensing, Durban Port Logistics & Hospital Procurement from India
3 min read
Manufacturing
Orthopedic Implants & Hospital Supplies in South Africa: SAHPRA Compliance, German vs. Indian Quality & Tender Economics
3 min read
Documentation
Medical Device Registration Dossiers: Step-by-Step Regulatory Clearance for NAFDAC, PPB, EDA, SFDA & SAHPRA
4 min read
Logistics
Port-to-Hospital Supply Chain: How to Clear & Transport Indian Medical Devices via Mombasa, Lagos, Durban & Alexandria
3 min read
Export Guide
Supplying Surgical Consumables & Hospital Equipment to African Markets: Registration, Logistics & Port Clearance
2 min read
Export Guide
Importing Medical Consumables to Botswana: BoMRA Import Permits, CMS Central Tenders & Gaborone Distribution
4 min read
Landed cost calculator for South AfricaCompare import rules across 37 countries
Export Quote Desk

Request Export Pricing for South Africa

Share your required product quantities and delivery port in South Africa. 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 Durban, Cape Town with real-time tracking.

Import-Ready Documentation

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

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We respond to quote requests within one business day. Your details are kept strictly confidential.
Frequently Asked Questions

Exporting Medical Consumables to South Africa

Mandatory in substance: a South African entity must hold the Medical Device Establishment Licence covering import and distribution. The licence attaches to the establishment, not the product — a distinction that catches exporters used to product-only registration regimes.
Local importer/distributor obtains a SAHPRA Medical Device Establishment Licence. Manufacturer supplies ISO 13485, CE Declaration of Conformity and technical documentation. Product listing/registration per the class and the applicable phase-in. SABS conformity evidence where a standard is called up. Realistically allow Establishment licensing is the gate and can take many months; device registration is being phased in progressively by class.
Surgical and examination gloves (HS 4015.12): Indicative — check the SARS tariff, rates vary by line, plus 15% VAT. Other instruments and appliances (HS 9018.90): Often free or low under the SACU tariff, plus 15% VAT. 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.
Durban is the main container port, with Cape Town and Port Elizabeth serving their regions. SARS Customs is comparatively rules-driven and predictable; tariff classification disputes are the common friction point rather than clearance speed.
Provincial health departments tender separately under a national framework — there is no single national buyer, and provincial cycles differ.
FOB (Nhava Sheva JNPT / Mundra), CIF or CFR (Durban, Cape Town), 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.

Explore other destination markets in Southern Africa:

🇲🇿 Mozambique🇿🇲 Zambia🇿🇼 Zimbabwe🇳🇦 Namibia🇧🇼 Botswana🇸🇿 Eswatini
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