Medical Products Exporter to Chile
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 Chile. High-income healthcare network with stringent ISP quality standards sourcing PPE, sterile gloves, surgical blades, and diagnostic medical devices.
High-Precision Medical Consumables for Chile
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 Chile
Regulator & registration
- Authority
- ISP — Instituto de Salud Pública de Chile
- Governing instrument
- Decreto Supremo N° 825/98 y Ley 20.724 de Dispositivos Médicos
- Classification
- Class I, II, III, IV following GHTF guidelines
- Local representative
- Mandatory. A registered Chilean legal representative or authorized distributor with sanitary storage authorization (Resolución Sanitaria).
- Realistic timeline
- Mandatory registration applies to specific regulated categories (syringes, gloves, condoms); other classes require import verification notice.
Registration route, in order
- Appoint a Chilean commercial importer with SEREMI de Salud storage permit
- Submit ISO 13485:2016 and CE/FDA certificates for Verification of Quality (Control de Calidad de Entrada)
- Prepare Spanish labeling with batch number, sterility date, and importer details
- Customs clearance via Direct Import Clearance (Declaración de Ingreso - DIN)
Duty & tax by HS heading
| HS | Product | Duty | Tax |
|---|---|---|---|
| 4015.12 | Surgical and exam glovesMedical exemptions for public hospital networks | 6% standard (or preferential rate) | 19% IVA |
| 9018.90 | Medical instruments and devices | 6% | 19% 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 Valparaíso and Port of San Antonio handle Pacific container shipments from India in 32–36 days, with immediate highway connectivity to Santiago.
Public procurement
CENABAST (Central de Abastecimiento del Sistema Nacional de Servicios de Salud), Mercado Público tenders, and private RedSalud / Bupa networks.
Overlooking Chilean Cesmec / IDIEM batch certification requirements on specific regulated surgical consumables like exam gloves and hypodermic needles.
OEM & private label for Chile
We manufacture private-label medical devices and surgical consumables for brand owners, distributors and pharmacy chains in Chile.
Explore Full Medical Range for Chile
Request Export Pricing for Chile
Share your required product quantities and delivery port in Chile. 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 San Antonio, Valparaíso, Iquique with real-time tracking.
Import-Ready Documentation
Commercial invoice, packing list, COO, CoA, and registration files included.
Exporting Medical Consumables to Chile
Who must hold the medical device registration in Chile?
Mandatory. A registered Chilean legal representative or authorized distributor with sanitary storage authorization (Resolución Sanitaria).
How do I register a medical device with ISP in Chile?
Appoint a Chilean commercial importer with SEREMI de Salud storage permit. Submit ISO 13485:2016 and CE/FDA certificates for Verification of Quality (Control de Calidad de Entrada). Prepare Spanish labeling with batch number, sterility date, and importer details. Customs clearance via Direct Import Clearance (Declaración de Ingreso - DIN). Realistically allow Mandatory registration applies to specific regulated categories (syringes, gloves, condoms); other classes require import verification notice..
What import duty applies to surgical gloves and medical disposables in Chile?
Surgical and exam gloves (HS 4015.12): 6% standard (or preferential rate), plus 19% IVA. Medical instruments and devices (HS 9018.90): 6%, plus 19% 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 Chile?
Port of Valparaíso and Port of San Antonio handle Pacific container shipments from India in 32–36 days, with immediate highway connectivity to Santiago.
Who buys medical supplies publicly in Chile?
CENABAST (Central de Abastecimiento del Sistema Nacional de Servicios de Salud), Mercado Público tenders, and private RedSalud / Bupa networks.
What most commonly goes wrong importing medical devices into Chile?
Overlooking Chilean Cesmec / IDIEM batch certification requirements on specific regulated surgical consumables like exam gloves and hypodermic needles.
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 San Antonio, Valparaíso, Iquique?
FOB (Nhava Sheva JNPT / Mundra), CIF or CFR (San Antonio, Valparaíso, Iquique), 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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