Medical Products Exporter to Colombia
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 Colombia. Fast-growing healthcare sector importing ISO 13485 certified surgical gloves, hypodermic syringes, IV infusion sets, and hospital equipment with INVIMA compliance.
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 Colombia. Shipped from Mundra Port (INMUN1) and Nhava Sheva (INNSA1) to Buenaventura (Pacific), Cartagena & Barranquilla (Atlantic) in 25–32 days. We supply the documentation your INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos) 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 Colombia
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 Colombia
Verified regulatory authority protocols, mandatory local representations, step-by-step dossier roadmap, and indicative customs tariff lines for Colombia.
Registration & Clearance Route
- 1Appoint an authorized Colombian titular or local distributor with INVIMA CCAA storage certification
- 2Legalize Indian manufacturer Free Sale Certificate (CFS) and ISO 13485:2016 certificate with Hague Apostille
- 3Compile the technical dossier (Expediente Técnico) in Spanish, including ISO 10993 biocompatibility and sterilization test reports
- 4Submit electronic application through INVIMA platform with Spanish labeling and IFU
- 5Issuance of Registro Sanitario (valid for 10 years, renewable)
Entry Ports & In-Land Clearance
Port of Buenaventura is the primary Pacific gateway from India (28–33 days transit); Port of Cartagena and Barranquilla serve the Caribbean side. Overland bonded trucking to Bogotá and Medellín runs within 8–12 hours.
Public Healthcare Procurement
EPS (Entidades Promotoras de Salud), IPS hospital networks, and Colombia Compra Eficiente public tenders.
Submitting technical documentation without proper Ministry of External Affairs (MEA) Hague Apostille legalization or non-compliant Spanish labeling.
OEM & private label for Colombia
We arrange private-label production of medical devices and surgical consumables at vetted partner factories for brand owners, distributors and pharmacy chains in Colombia.
Importación Directa de Dispositivos Médicos y Consumibles desde la India hacia Colombia
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 Colombia (INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos)), con los certificados del fabricante incluidos en cada cotización.
Dossier completo para registro sanitario ante INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos), 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 25–32 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 Colombia
Request Export Pricing for Colombia
Share your required product quantities and delivery port in Colombia. 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 Buenaventura (Pacific), Cartagena & Barranquilla (Atlantic) with real-time tracking.
Import-Ready Documentation
Commercial invoice, packing list, COO, CoA, and registration files included.
Exporting Medical Consumables to Colombia
Who must hold the medical device registration in Colombia?
Mandatory. A Colombian legal entity with a valid CCAA (Certificado de Capacidad de Almacenamiento y Acondicionamiento) acts as the titular del registro sanitario or importer.
How do I register a medical device with INVIMA in Colombia?
Appoint an authorized Colombian titular or local distributor with INVIMA CCAA storage certification. Legalize Indian manufacturer Free Sale Certificate (CFS) and ISO 13485:2016 certificate with Hague Apostille. Compile the technical dossier (Expediente Técnico) in Spanish, including ISO 10993 biocompatibility and sterilization test reports. Submit electronic application through INVIMA platform with Spanish labeling and IFU. Issuance of Registro Sanitario (valid for 10 years, renewable). Realistically allow Class I and IIa: 60 to 90 business days under expedited review; Class IIb and III: 6 to 9 months.
What import duty applies to surgical gloves and medical disposables in Colombia?
Sterile surgical gloves (HS 4015.11): 0% – 5% Arancel, plus Exempt / 19% IVA with health credit. Surgical scalpels, blades, needles and instruments (HS 9018.90): 0%, plus Exempt. Orthopedic trauma locking plates and screws (HS 9021.10): 0%, plus Exempt. 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 Colombia?
Port of Buenaventura is the primary Pacific gateway from India (28–33 days transit); Port of Cartagena and Barranquilla serve the Caribbean side. Overland bonded trucking to Bogotá and Medellín runs within 8–12 hours.
Who buys medical supplies publicly in Colombia?
EPS (Entidades Promotoras de Salud), IPS hospital networks, and Colombia Compra Eficiente public tenders.
What most commonly goes wrong importing medical devices into Colombia?
Submitting technical documentation without proper Ministry of External Affairs (MEA) Hague Apostille legalization or non-compliant Spanish labeling.
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 Buenaventura (Pacific), Cartagena & Barranquilla (Atlantic)?
FOB (Nhava Sheva JNPT / Mundra), CIF or CFR (Buenaventura (Pacific), Cartagena & Barranquilla (Atlantic)), 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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