Medical Products Exporter to Ecuador
Manshav Impex is an Indian manufacturer & exporter of surgical gloves, surgical blades, hypodermic syringes, IV cannulas, infection-control PPE, and hospital equipment, supplying healthcare distributors, hospital groups, and government health ministries across Ecuador. Supplying certified medical disposables, sterile surgical blades, hypodermic syringes, and hospital beds directly from Indian factories with ARCSA sanitary registration packs.
Manshav Impex is an Indian manufacturer & exporter of surgical disposables and hospital consumables produced at vetted, ISO 13485-certified partner factories and made to CE marking requirements, supplying Ecuador. Shipped from Mundra Port (INMUN1) and Nhava Sheva (INNSA1) to Guayaquil, Manta, Puerto Bolívar in 28–36 days. We supply the documentation your ARCSA (Agencia Nacional de Regulación, Control y Vigilancia Sanitaria) registration requires, alongside 24-hour paperwork SLAs for Certificate of Origin (COO), Free Sale Certificates (FSC), and commercial invoices.
High-Precision Medical Consumables Exported to Ecuador
Produced at vetted, ISO 13485-certified 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
How Medical Devices & Consumables Clear into Ecuador
Verified regulatory authority protocols, mandatory local representations, step-by-step dossier roadmap, and indicative customs tariff lines for Ecuador.
Registration & Clearance Route
- 1Designate an authorized Ecuadorian regulatory holder
- 2Provide Apostilled Certificate of Free Sale (CFS) and ISO 13485:2016 certificate
- 3Upload technical dossier, Spanish IFU, and labeling through Ventanilla Única Ecuatoriana (VUE)
- 4Pay sanitary fees and obtain Registro Sanitario (valid for 5 years)
Entry Ports & In-Land Clearance
Port of Guayaquil (Contecon / DP World Posorja) receives direct Pacific container lines from India in 30–34 days.
Public Healthcare Procurement
IESS (Instituto Ecuatoriano de Seguridad Social), MSP (Ministerio de Salud Pública), and SERCOP public auctions.
Strict enforcement of Spanish technical data sheets and shelf-life requirements (>80% remaining shelf-life at customs arrival).
OEM & private label for Ecuador
We arrange private-label production of medical devices and surgical consumables at vetted partner factories for brand owners, distributors and pharmacy chains in Ecuador.
Importación Directa de Dispositivos Médicos y Consumibles desde la India hacia Ecuador
Manshav Impex es una casa exportadora india de guantes quirúrgicos estériles, hojas de bisturí, jeringas descartables y suturas, fabricados conforme a CE e ISO 13485 en fábricas asociadas auditadas. Suministramos a redes hospitalarias y licitaciones públicas en Ecuador (ARCSA (Agencia Nacional de Regulación, Control y Vigilancia Sanitaria)), con los certificados del fabricante incluidos en cada cotización.
Dossier completo para registro sanitario ante ARCSA (Agencia Nacional de Regulación, Control y Vigilancia Sanitaria), incluyendo Certificado de Libre Venta (FSC) y validación de esterilidad.
Despachos en contenedores FCL y consolidado LCL desde Puerto Mundra / Nhava Sheva con tiempo de tránsito estimado de 28–36 days. Precios CIF y FOB.
Impresión personalizada de cajas dispensadoras y etiquetas en español con código de barras GS1 y datos del distribuidor local.
Explore Full Medical Range for Ecuador
Request Export Pricing for Ecuador
Share your required product quantities and delivery port in Ecuador. 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 Guayaquil, Manta, Puerto Bolívar with real-time tracking.
Import-Ready Documentation
Commercial invoice, packing list, COO, CoA, and registration files included.
Exporting Medical Consumables to Ecuador
Who must hold the medical device registration in Ecuador?
Mandatory. A local Ecuadorian distributor or regulatory holder with Permiso de Funcionamiento ARCSA.
How do I register a medical device with ARCSA in Ecuador?
Designate an authorized Ecuadorian regulatory holder. Provide Apostilled Certificate of Free Sale (CFS) and ISO 13485:2016 certificate. Upload technical dossier, Spanish IFU, and labeling through Ventanilla Única Ecuatoriana (VUE). Pay sanitary fees and obtain Registro Sanitario (valid for 5 years). Realistically allow Homologation / Simplified Route: 45 to 75 days; Standard Route: 4 to 6 months.
What import duty applies to surgical gloves and medical disposables in Ecuador?
Medical instruments (HS 9018.90): 0% – 5%, plus 15% IVA (0% for basic medical devices). 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 Ecuador?
Port of Guayaquil (Contecon / DP World Posorja) receives direct Pacific container lines from India in 30–34 days.
Who buys medical supplies publicly in Ecuador?
IESS (Instituto Ecuatoriano de Seguridad Social), MSP (Ministerio de Salud Pública), and SERCOP public auctions.
What most commonly goes wrong importing medical devices into Ecuador?
Strict enforcement of Spanish technical data sheets and shelf-life requirements (>80% remaining shelf-life at customs arrival).
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 Guayaquil, Manta, Puerto Bolívar?
FOB (Nhava Sheva JNPT / Mundra), CIF or CFR (Guayaquil, Manta, Puerto Bolívar), 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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