Medical Products Exporter to Peru
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 Peru. Growing public (MINSA/EsSalud) and private hospital procurement sourcing OEM surgical consumables, syringes, IV cannulas, and hospital furniture with DIGEMID registration.
High-Precision Medical Consumables for Peru
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 Peru
Regulator & registration
- Authority
- DIGEMID — Dirección General de Medicamentos, Insumos y Drogas
- Governing instrument
- Decreto Supremo 016-2011-SA y Ley N° 29459 (Ley de los Productos Farmacéuticos y Dispositivos Médicos)
- Classification
- Class I (Bajo Riesgo), Class II (Moderado Riesgo), Class III (Alto Riesgo), Class IV (Crítico)
- Local representative
- Mandatory. A Peruvian Droguería (licensed medical distributor/importer) holding a valid Buenas Prácticas de Almacenamiento (BPA) certificate holds the registration.
- Realistic timeline
- Class I/II: 60 to 90 days; Class III/IV: 6 to 12 months
Registration route, in order
- Partner with a licensed Peruvian Droguería with BPA accreditation
- Obtain Hague Apostille on Certificate of Free Sale (CLV / CFS) and ISO 13485 certificate from India
- Prepare Spanish technical dossier, ISO test reports, clinical risk management file, and packaging artwork
- Submit registration dossier to DIGEMID VUCE (Ventanilla Única de Comercio Exterior)
- Registro Sanitario granted for 5-year renewable terms
Duty & tax by HS heading
| HS | Product | Duty | Tax |
|---|---|---|---|
| 4015.11 | Surgical glovesEssential surgical goods enter under 0% duty | 0% Ad Valorem | 18% IGV (reimbursable) |
| 9018.31 | Hypodermic disposable syringes | 0% | 18% IGV |
| 9021.10 | Orthopedic implants | 0% | 18% IGV |
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 Callao (Lima) is Peru largest maritime container hub receiving direct Pacific sailings from Nhava Sheva/Mundra in 30–35 days. Paita serves northern Peru.
Public procurement
EsSalud (Seguro Social de Salud), MINSA (Ministerio de Salud), and private clinic networks (Clínicas Auna, San Pablo, Internacional).
Failing to provide detailed accelerated and real-time stability testing for tropical climatic Zone IVb.
OEM & private label for Peru
We manufacture private-label medical devices and surgical consumables for brand owners, distributors and pharmacy chains in Peru.
Explore Full Medical Range for Peru
Request Export Pricing for Peru
Share your required product quantities and delivery port in Peru. 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 Callao (Lima), Paita with real-time tracking.
Import-Ready Documentation
Commercial invoice, packing list, COO, CoA, and registration files included.
Exporting Medical Consumables to Peru
Who must hold the medical device registration in Peru?
Mandatory. A Peruvian Droguería (licensed medical distributor/importer) holding a valid Buenas Prácticas de Almacenamiento (BPA) certificate holds the registration.
How do I register a medical device with DIGEMID in Peru?
Partner with a licensed Peruvian Droguería with BPA accreditation. Obtain Hague Apostille on Certificate of Free Sale (CLV / CFS) and ISO 13485 certificate from India. Prepare Spanish technical dossier, ISO test reports, clinical risk management file, and packaging artwork. Submit registration dossier to DIGEMID VUCE (Ventanilla Única de Comercio Exterior). Registro Sanitario granted for 5-year renewable terms. Realistically allow Class I/II: 60 to 90 days; Class III/IV: 6 to 12 months.
What import duty applies to surgical gloves and medical disposables in Peru?
Surgical gloves (HS 4015.11): 0% Ad Valorem, plus 18% IGV (reimbursable). Hypodermic disposable syringes (HS 9018.31): 0%, plus 18% IGV. Orthopedic implants (HS 9021.10): 0%, plus 18% IGV. 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 Peru?
Port of Callao (Lima) is Peru largest maritime container hub receiving direct Pacific sailings from Nhava Sheva/Mundra in 30–35 days. Paita serves northern Peru.
Who buys medical supplies publicly in Peru?
EsSalud (Seguro Social de Salud), MINSA (Ministerio de Salud), and private clinic networks (Clínicas Auna, San Pablo, Internacional).
What most commonly goes wrong importing medical devices into Peru?
Failing to provide detailed accelerated and real-time stability testing for tropical climatic Zone IVb.
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 Callao (Lima), Paita?
FOB (Nhava Sheva JNPT / Mundra), CIF or CFR (Callao (Lima), Paita), 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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