Medical Products Exporter to Guatemala
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 Guatemala. Supplying hospital procurement teams and distributors with OEM surgical gloves, blades, and medical disposables registered with MSPAS.
High-Precision Medical Consumables for Guatemala
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 Guatemala
Regulator & registration
- Authority
- DRCPFA — Departamento de Regulación y Control de Productos Farmacéuticos y Afines (MSPAS)
- Governing instrument
- Reglamento Técnico Centroamericano (RTCA 11.04.41:06 Dispositivos Médicos)
- Classification
- Class I, II, III, IV (harmonized across Central America)
- Local representative
- Mandatory local licensed pharmaceutical distributor or regulatory agent.
- Realistic timeline
- 3 to 5 months (valid across RTCA Central American mutual recognition countries)
Registration route, in order
- 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
Duty & tax by HS heading
| HS | Product | Duty | Tax |
|---|---|---|---|
| 4015.11 | Surgical gloves | 0% – 5% DAI | 12% 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 Puerto Quetzal (Pacific) and Santo Tomás de Castilla (Atlantic) in 28–32 days from India.
Public procurement
IGSS (Instituto Guatemalteco de Seguridad Social) and MSPAS national hospital tenders.
Non-compliance with RTCA labeling guidelines.
OEM & private label for Guatemala
We manufacture private-label medical devices and surgical consumables for brand owners, distributors and pharmacy chains in Guatemala.
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.
Explore other destination markets in Latin America: