Medical Products Exporter to Argentina
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 Argentina. Major Southern Cone medical importer sourcing sterile surgical blades, examination gloves, diagnostic consumables, and orthopedics with ANMAT registration files.
High-Precision Medical Consumables for Argentina
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 Argentina
Regulator & registration
- Authority
- ANMAT — Administración Nacional de Medicamentos, Alimentos y Tecnología Médica
- Governing instrument
- Disposición ANMAT 2318/02 (Reglamento Técnico MERCOSUR de Registro de Productos Médicos)
- Classification
- Class I, II, III, IV by risk matrix
- Local representative
- Mandatory. An Argentine company holding a Buenas Prácticas de Fabricación y Control (BPF) import license and designated Technical Director (Director Técnico Farmacéutico / Bioingeniero).
- Realistic timeline
- Class I/II: 3 to 6 months; Class III/IV: 8 to 14 months
Registration route, in order
- Appoint an ANMAT-authorized Argentine importing enterprise
- Obtain Hague Apostille on CFS, ISO 13485:2016, and legal authorization letters from India
- Prepare technical dossier in Spanish according to MERCOSUR technical standard
- File online registration via ANMAT HELENA platform
- Product PM (Producto Médico) certificate issued upon review
Duty & tax by HS heading
| HS | Product | Duty | Tax |
|---|---|---|---|
| 4015.12 | Surgical glovesCertain medical products qualify for reduced IVA of 10.5% | Mercosur Common External Tariff (AEC 14%) | 21% IVA |
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
Port of Buenos Aires (Puerto Nuevo / Dock Sud) is the primary Atlantic maritime destination (30–35 days transit from India).
Public procurement
PAMI (Programa de Atención Médica Integral), national ministry tenders, provincial public hospitals, and private Obras Sociales.
Complex foreign currency import license procedures (SEDI / SIRA); working with experienced importers who have pre-approved foreign exchange access is vital.
OEM & private label for Argentina
We manufacture private-label medical devices and surgical consumables for brand owners, distributors and pharmacy chains in Argentina.
Explore Full Medical Range for Argentina
Request Export Pricing for Argentina
Share your required product quantities and delivery port in Argentina. 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 Buenos Aires, Zárate, Campana with real-time tracking.
Import-Ready Documentation
Commercial invoice, packing list, COO, CoA, and registration files included.
Exporting Medical Consumables to Argentina
Who must hold the medical device registration in Argentina?
Mandatory. An Argentine company holding a Buenas Prácticas de Fabricación y Control (BPF) import license and designated Technical Director (Director Técnico Farmacéutico / Bioingeniero).
How do I register a medical device with ANMAT in Argentina?
Appoint an ANMAT-authorized Argentine importing enterprise. Obtain Hague Apostille on CFS, ISO 13485:2016, and legal authorization letters from India. Prepare technical dossier in Spanish according to MERCOSUR technical standard. File online registration via ANMAT HELENA platform. Product PM (Producto Médico) certificate issued upon review. Realistically allow Class I/II: 3 to 6 months; Class III/IV: 8 to 14 months.
What import duty applies to surgical gloves and medical disposables in Argentina?
Surgical gloves (HS 4015.12): Mercosur Common External Tariff (AEC 14%), plus 21% IVA. 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 Argentina?
Port of Buenos Aires (Puerto Nuevo / Dock Sud) is the primary Atlantic maritime destination (30–35 days transit from India).
Who buys medical supplies publicly in Argentina?
PAMI (Programa de Atención Médica Integral), national ministry tenders, provincial public hospitals, and private Obras Sociales.
What most commonly goes wrong importing medical devices into Argentina?
Complex foreign currency import license procedures (SEDI / SIRA); working with experienced importers who have pre-approved foreign exchange access is vital.
Can packaging and documentation be supplied in Spanish?
Yes. Commercial and technical documentation is provided in Spanish, and artwork for inner dispenser boxes, sterile peel-pouches and master carton markings is prepared with local regulatory text, batch numbers, manufacturing and expiry dates, and GS1 EAN-13 barcodes.
What Incoterms are available for delivery to Buenos Aires, Zárate, Campana?
FOB (Nhava Sheva JNPT / Mundra), CIF or CFR (Buenos Aires, Zárate, Campana), 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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