Medical Products Exporter to Dominican Republic
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 Dominican Republic. Leading Caribbean medical hub importing surgical consumables, PPE, examination gloves, and hospital equipment from India with MSP / DIGEMAPS compliance.
High-Precision Medical Consumables for Dominican Republic
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 Dominican Republic
Regulator & registration
- Authority
- DIGEMAPS — Dirección General de Medicamentos, Alimentos y Productos Sanitarios
- Governing instrument
- Ley General de Salud 42-01 y Decreto 246-06
- Classification
- Class I, II, III, IV
- Local representative
- Mandatory Dominican representative with sanitary registration license.
- Realistic timeline
- 3 to 6 months
Registration route, in order
- Appoint a Dominican registration holder
- Legalize Indian CFS and ISO 13485 with Hague Apostille
- Submit technical file in Spanish to DIGEMAPS
- Registro Sanitario issued for 5 years
Duty & tax by HS heading
| HS | Product | Duty | Tax |
|---|---|---|---|
| 4015.12 | Medical gloves | 0% – 5% | 18% ITBIS (exempt on basic medical supplies) |
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 Caucedo and Port of Rio Haina (Santo Domingo) in 26–30 days from India.
Public procurement
PROMESE/CAL (Programa de Medicamentos Esenciales), SNS (Servicio Nacional de Salud), and private health centers (Plaza de la Salud, HOMS).
Delays in apostilled consular legalization.
OEM & private label for Dominican Republic
We manufacture private-label medical devices and surgical consumables for brand owners, distributors and pharmacy chains in Dominican Republic.
Explore Full Medical Range for Dominican Republic
Request Export Pricing for Dominican Republic
Share your required product quantities and delivery port in Dominican Republic. 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 Caucedo, Rio Haina, Puerto Plata with real-time tracking.
Import-Ready Documentation
Commercial invoice, packing list, COO, CoA, and registration files included.
Exporting Medical Consumables to Dominican Republic
Who must hold the medical device registration in Dominican Republic?
Mandatory Dominican representative with sanitary registration license.
How do I register a medical device with DIGEMAPS in Dominican Republic?
Appoint a Dominican registration holder. Legalize Indian CFS and ISO 13485 with Hague Apostille. Submit technical file in Spanish to DIGEMAPS. Registro Sanitario issued for 5 years. Realistically allow 3 to 6 months.
What import duty applies to surgical gloves and medical disposables in Dominican Republic?
Medical gloves (HS 4015.12): 0% – 5%, plus 18% ITBIS (exempt on basic medical supplies). 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 Dominican Republic?
Port of Caucedo and Port of Rio Haina (Santo Domingo) in 26–30 days from India.
Who buys medical supplies publicly in Dominican Republic?
PROMESE/CAL (Programa de Medicamentos Esenciales), SNS (Servicio Nacional de Salud), and private health centers (Plaza de la Salud, HOMS).
What most commonly goes wrong importing medical devices into Dominican Republic?
Delays in apostilled consular legalization.
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 Caucedo, Rio Haina, Puerto Plata?
FOB (Nhava Sheva JNPT / Mundra), CIF or CFR (Caucedo, Rio Haina, Puerto Plata), 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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