Medical Products Exporter to Costa Rica
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 Costa Rica. Sourcing ISO 13485 certified medical devices, sterile gloves, and surgical consumables for CCSS public health and private hospital networks.
High-Precision Medical Consumables for Costa Rica
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 Costa Rica
Regulator & registration
- Authority
- Ministerio de Salud de Costa Rica — Dirección de Regulación de Productos de Interés Sanitario
- Governing instrument
- Decreto Ejecutivo N° 32780-S (Reglamento de Inscripción y Control de Material Biomédico)
- Classification
- Class 1, 2, 3, 4
- Local representative
- Mandatory local representative with legal registration authority.
- Realistic timeline
- Class 1/2: 30 to 60 days via electronic platform Regístrelo; Class 3/4: 3 to 5 months
Registration route, in order
- Create profile on Regístrelo digital platform
- Upload Apostilled Free Sale Certificate (CFS) and ISO 13485:2016
- Submit Spanish instructions for use and primary packaging artwork
- Digital sanitary registration approval granted for 5 years
Duty & tax by HS heading
| HS | Product | Duty | Tax |
|---|---|---|---|
| 4015.11 | Surgical glovesHealth sector tax concessions apply | 0% – 5% | 13% IVA (1% reduced rate on health products) |
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 Caldera (Pacific) and Port of Moín (Caribbean) in 26–30 days from India.
Public procurement
CCSS (Caja Costarricense de Seguro Social) central purchasing tenders and private Clinica Biblica / CIMA networks.
Missing digital token authorization on Regístrelo platform.
OEM & private label for Costa Rica
We manufacture private-label medical devices and surgical consumables for brand owners, distributors and pharmacy chains in Costa Rica.
Explore Full Medical Range for Costa Rica
Request Export Pricing for Costa Rica
Share your required product quantities and delivery port in Costa Rica. 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 Limón, Caldera with real-time tracking.
Import-Ready Documentation
Commercial invoice, packing list, COO, CoA, and registration files included.
Exporting Medical Consumables to Costa Rica
Who must hold the medical device registration in Costa Rica?
Mandatory local representative with legal registration authority.
How do I register a medical device with Ministerio de Salud de Costa Rica in Costa Rica?
Create profile on Regístrelo digital platform. Upload Apostilled Free Sale Certificate (CFS) and ISO 13485:2016. Submit Spanish instructions for use and primary packaging artwork. Digital sanitary registration approval granted for 5 years. Realistically allow Class 1/2: 30 to 60 days via electronic platform Regístrelo; Class 3/4: 3 to 5 months.
What import duty applies to surgical gloves and medical disposables in Costa Rica?
Surgical gloves (HS 4015.11): 0% – 5%, plus 13% IVA (1% reduced rate on health products). 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 Costa Rica?
Port of Caldera (Pacific) and Port of Moín (Caribbean) in 26–30 days from India.
Who buys medical supplies publicly in Costa Rica?
CCSS (Caja Costarricense de Seguro Social) central purchasing tenders and private Clinica Biblica / CIMA networks.
What most commonly goes wrong importing medical devices into Costa Rica?
Missing digital token authorization on Regístrelo platform.
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 Limón, Caldera?
FOB (Nhava Sheva JNPT / Mundra), CIF or CFR (Puerto Limón, Caldera), 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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