Medical Products Exporter to South Africa
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 South Africa. Sophisticated market with SAHPRA-aligned documentation for surgical gloves, blades & medical devices.
High-Precision Medical Consumables for South Africa
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 South Africa
Regulator & registration
- Authority
- SAHPRA — South African Health Products Regulatory Authority
- Governing instrument
- Medicines and Related Substances Act 101 of 1965, as amended
- Classification
- Class A, B, C, D by risk
- Local representative
- 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.
- Realistic timeline
- Establishment licensing is the gate and can take many months; device registration is being phased in progressively by class
Registration route, in order
- 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
Duty & tax by HS heading
| HS | Product | Duty | Tax |
|---|---|---|---|
| 4015.12 | Surgical and examination gloves | Indicative — check the SARS tariff, rates vary by line | 15% VAT |
| 9018.90 | Other instruments and appliances | Often free or low under the SACU tariff | 15% VAT |
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
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 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 for brand owners, distributors and pharmacy chains in South Africa.
Explore Full Medical Range for South Africa
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.
Exporting Medical Consumables to South Africa
Who must hold the medical device registration in 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.
How do I register a medical device with SAHPRA in South Africa?
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.
What import duty applies to surgical gloves and medical disposables in South Africa?
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.
Which port should I use for medical imports into South Africa?
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.
Who buys medical supplies publicly in South Africa?
Provincial health departments tender separately under a national framework — there is no single national buyer, and provincial cycles differ.
What Incoterms are available for delivery to Durban, Cape Town?
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: