Medical Products Exporter to Guatemala
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 Guatemala. Supplying hospital procurement teams and distributors with OEM surgical gloves, blades, and medical disposables registered with MSPAS.
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 Guatemala. Shipped from Mundra Port (INMUN1) and Nhava Sheva (INNSA1) to Puerto Quetzal (Pacific), Santo Tomás de Castilla (Atlantic) in 26–32 days. We supply the documentation your MSPAS (Ministerio de Salud Pública y Asistencia Social) 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 Guatemala
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 Guatemala
Verified regulatory authority protocols, mandatory local representations, step-by-step dossier roadmap, and indicative customs tariff lines for Guatemala.
Registration & Clearance Route
- 1Appoint local Guatemalan representative
- 2Submit Apostilled CFS and ISO 13485:2016 certificates
- 3File technical dossier according to RTCA standard
- 4Sanitary registration granted for 5-year renewable term
Entry Ports & In-Land Clearance
Port of Puerto Quetzal (Pacific) and Santo Tomás de Castilla (Atlantic) in 28–32 days from India.
Public Healthcare Procurement
IGSS (Instituto Guatemalteco de Seguridad Social) and MSPAS national hospital tenders.
Non-compliance with RTCA labeling guidelines.
OEM & private label for Guatemala
We arrange private-label production of medical devices and surgical consumables at vetted partner factories for brand owners, distributors and pharmacy chains in Guatemala.
Importación Directa de Dispositivos Médicos y Consumibles desde la India hacia Guatemala
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 Guatemala (MSPAS (Ministerio de Salud Pública y Asistencia Social)), con los certificados del fabricante incluidos en cada cotización.
Dossier completo para registro sanitario ante MSPAS (Ministerio de Salud Pública y Asistencia Social), 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 26–32 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 Guatemala
Request Export Pricing for Guatemala
Share your required product quantities and delivery port in Guatemala. 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 Puerto Quetzal (Pacific), Santo Tomás de Castilla (Atlantic) with real-time tracking.
Import-Ready Documentation
Commercial invoice, packing list, COO, CoA, and registration files included.
Exporting Medical Consumables to Guatemala
Who must hold the medical device registration in Guatemala?
Mandatory local licensed pharmaceutical distributor or regulatory agent.
How do I register a medical device with DRCPFA in Guatemala?
Appoint local Guatemalan representative. Submit Apostilled CFS and ISO 13485:2016 certificates. File technical dossier according to RTCA standard. Sanitary registration granted for 5-year renewable term. Realistically allow 3 to 5 months (valid across RTCA Central American mutual recognition countries).
What import duty applies to surgical gloves and medical disposables in Guatemala?
Surgical gloves (HS 4015.11): 0% – 5% DAI, plus 12% 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 Guatemala?
Port of Puerto Quetzal (Pacific) and Santo Tomás de Castilla (Atlantic) in 28–32 days from India.
Who buys medical supplies publicly in Guatemala?
IGSS (Instituto Guatemalteco de Seguridad Social) and MSPAS national hospital tenders.
What most commonly goes wrong importing medical devices into Guatemala?
Non-compliance with RTCA labeling guidelines.
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 Puerto Quetzal (Pacific), Santo Tomás de Castilla (Atlantic)?
FOB (Nhava Sheva JNPT / Mundra), CIF or CFR (Puerto Quetzal (Pacific), Santo Tomás de Castilla (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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