Medical Products Exporter to Mexico
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 Mexico. Strategic healthcare import hub for North & Central America — sourcing CE & ISO 13485 compliant surgical disposables, gloves, blades, and hospital furniture with COFEPRIS documentation.
High-Precision Medical Consumables for Mexico
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 Mexico
Regulator & registration
- Authority
- COFEPRIS — Comisión Federal para la Protección contra Riesgos Sanitarios
- Classification
- Class I, II, III by risk
- Local representative
- Mandatory. A Mexican legal representative holds the sanitary registration (registro sanitario).
- Realistic timeline
- Ordinary route is slow; the equivalence route recognising prior FDA, Health Canada or Japanese approval is substantially faster where the product qualifies
Registration route, in order
- Appoint a Mexican legal representative
- Determine whether the equivalence route (terceros autorizados / prior approval recognition) is available — it materially shortens the timeline
- Compile the dossier with Spanish-language labelling and instructions for use
- File for registro sanitario with COFEPRIS
- Registration granted, renewable on a five-year cycle
Duty & tax by HS heading
| HS | Product | Duty | Tax |
|---|---|---|---|
| 4015.12 | Surgical and examination glovesCertain medical goods attract preferential or zero rates | Confirm against the current Mexican tariff (TIGIE) | 16% 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
Manzanillo on the Pacific is the natural entry from Asia; Veracruz serves the Gulf side. NOM labelling requirements are enforced at clearance, and Spanish-language compliance is checked.
Public procurement
Public health procurement has been restructured repeatedly in recent years; IMSS remains a very large institutional buyer. Confirm the current consolidated purchasing arrangement before planning a tender approach.
OEM & private label for Mexico
We manufacture private-label medical devices and surgical consumables for brand owners, distributors and pharmacy chains in Mexico.
Explore Full Medical Range for Mexico
Request Export Pricing for Mexico
Share your required product quantities and delivery port in Mexico. 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 Manzanillo, Veracruz, Lázaro Cárdenas, Altamira with real-time tracking.
Import-Ready Documentation
Commercial invoice, packing list, COO, CoA, and registration files included.
Exporting Medical Consumables to Mexico
Who must hold the medical device registration in Mexico?
Mandatory. A Mexican legal representative holds the sanitary registration (registro sanitario).
How do I register a medical device with COFEPRIS in Mexico?
Appoint a Mexican legal representative. Determine whether the equivalence route (terceros autorizados / prior approval recognition) is available — it materially shortens the timeline. Compile the dossier with Spanish-language labelling and instructions for use. File for registro sanitario with COFEPRIS. Registration granted, renewable on a five-year cycle. Realistically allow Ordinary route is slow; the equivalence route recognising prior FDA, Health Canada or Japanese approval is substantially faster where the product qualifies.
What import duty applies to surgical gloves and medical disposables in Mexico?
Surgical and examination gloves (HS 4015.12): Confirm against the current Mexican tariff (TIGIE), plus 16% 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 Mexico?
Manzanillo on the Pacific is the natural entry from Asia; Veracruz serves the Gulf side. NOM labelling requirements are enforced at clearance, and Spanish-language compliance is checked.
Who buys medical supplies publicly in Mexico?
Public health procurement has been restructured repeatedly in recent years; IMSS remains a very large institutional buyer. Confirm the current consolidated purchasing arrangement before planning a tender approach.
Can packaging and documentation be supplied in Spanish or English?
Yes. Commercial and technical documentation is provided in Spanish & English, 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 Manzanillo, Veracruz, Lázaro Cárdenas, Altamira?
FOB (Nhava Sheva JNPT / Mundra), CIF or CFR (Manzanillo, Veracruz, Lázaro Cárdenas, Altamira), 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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