Medical Products Exporter to Brazil
Manshav Impex is an Indian manufacturer & exporter of surgical gloves, surgical blades, hypodermic syringes, IV cannulas, infection-control PPE, and hospital equipment, supplying healthcare distributors, hospital groups, and government health ministries across Brazil. Latin America's largest healthcare market — high-volume buyer of sterile latex surgical gloves, surgical blades, DEHP-free IV cannulas, and orthopedic implants requiring ANVISA registration dossier support.
Manshav Impex is an Indian manufacturer & exporter of surgical disposables and hospital consumables produced at vetted, ISO 13485-certified partner factories and made to CE marking requirements, supplying Brazil. Shipped from Mundra Port (INMUN1) and Nhava Sheva (INNSA1) to Santos, Paranaguá, Rio de Janeiro, Itajaí in 26–34 days. We supply the documentation your ANVISA (Agência Nacional de Vigilância Sanitária) registration requires, alongside 24-hour paperwork SLAs for Certificate of Origin (COO), Free Sale Certificates (FSC), and commercial invoices.
High-Precision Medical Consumables Exported to Brazil
Produced at vetted, ISO 13485-certified partner factories in India with 100% lot traceability — certificates and test reports are shared with every quotation.
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, 400 pairs/master carton (OEM private label available)
Surgical Blades & Scalpels
HS 9018.90 · 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 & Consumables Clear into Brazil
Verified regulatory authority protocols, mandatory local representations, step-by-step dossier roadmap, and indicative customs tariff lines for Brazil.
Registration & Clearance Route
- 1Appoint a Brazilian Registration Holder with a valid AFE (Autorização de Funcionamento de Empresa)
- 2Obtain a CBPF — Brazilian GMP certificate — where the class requires it; this can involve an ANVISA audit of the Indian plant
- 3Compile the technical dossier in Portuguese, including instructions for use and labelling
- 4File notificação or registro per the class
- 5Publication in the Diário Oficial; INMETRO certification also applies to certain device categories
Entry Ports & In-Land Clearance
Santos is the principal port, with Paranaguá, Itajaí and Rio de Janeiro serving their regions. Transit from western India is long — routing is usually via transhipment. Brazilian customs clearance is documentation-intensive and Portuguese-language labelling is enforced, not advisory.
Public Healthcare Procurement
Public buying runs through federal, state and municipal tenders under the Brazilian public procurement law; the Ministry of Health also buys centrally.
Underestimating the registration holder decision. Because the detentor owns the registration and a change means starting again, an exporter who appoints a distributor casually can find its Brazilian market access hostage to that relationship.
OEM & private label for Brazil
We arrange private-label production of medical devices and surgical consumables at vetted partner factories for brand owners, distributors and pharmacy chains in Brazil.
Importação Direta de Insumos Médicos e Hospitalares da Índia para Brazil
A Manshav Impex é uma exportadora indiana que fornece luvas cirúrgicas estéreis, lâminas de bisturi, seringas e descartáveis hospitalares, fabricados conforme ISO 13485 e marcação CE em fábricas parceiras auditadas, para distribuidores e compras institucionais em Brazil — os certificados do fabricante acompanham cada cotação.
Documentação técnica para registro e processos licitatórios perante ANVISA (Agência Nacional de Vigilância Sanitária), incluindo Certificado de Análise (CoA).
Consolidação de carga marítima direta da Índia para Santos, Paranaguá, Rio de Janeiro, Itajaí com trânsito de 26–34 days. Condições FOB e CIF com seguro internacional.
Embalagens primárias e secundárias com instruções em português e identificação de lote e validade segundo as normas sanitárias.
Explore Full Medical Range for Brazil
Request Export Pricing for Brazil
Share your required product quantities and delivery port in Brazil. 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 Santos, Paranaguá, Rio de Janeiro, Itajaí with real-time tracking.
Import-Ready Documentation
Commercial invoice, packing list, COO, CoA, and registration files included.
Exporting Medical Consumables to Brazil
Who must hold the medical device registration in Brazil?
Mandatory, and unusually consequential: a Brazilian Registration Holder (detentor) owns the registration outright. Changing holder later is a re-registration, not a transfer, which makes the initial choice of partner close to irreversible.
How do I register a medical device with ANVISA in Brazil?
Appoint a Brazilian Registration Holder with a valid AFE (Autorização de Funcionamento de Empresa). Obtain a CBPF — Brazilian GMP certificate — where the class requires it; this can involve an ANVISA audit of the Indian plant. Compile the technical dossier in Portuguese, including instructions for use and labelling. File notificação or registro per the class. Publication in the Diário Oficial; INMETRO certification also applies to certain device categories. Realistically allow Class I/II notificação can be quick once the holder is set up; Class III/IV registro commonly runs past a year.
What import duty applies to surgical gloves and medical disposables in Brazil?
Surgical and examination gloves (HS 4015.12): Mercosur common external tariff — confirm the current NCM line, plus ICMS (state-level) plus IPI, PIS and COFINS. 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 Brazil?
Santos is the principal port, with Paranaguá, Itajaí and Rio de Janeiro serving their regions. Transit from western India is long — routing is usually via transhipment. Brazilian customs clearance is documentation-intensive and Portuguese-language labelling is enforced, not advisory.
Who buys medical supplies publicly in Brazil?
Public buying runs through federal, state and municipal tenders under the Brazilian public procurement law; the Ministry of Health also buys centrally.
What most commonly goes wrong importing medical devices into Brazil?
Underestimating the registration holder decision. Because the detentor owns the registration and a change means starting again, an exporter who appoints a distributor casually can find its Brazilian market access hostage to that relationship.
Can packaging and documentation be supplied in Portuguese or English?
Yes. Commercial and technical documentation is provided in Portuguese & 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 Santos, Paranaguá, Rio de Janeiro, Itajaí?
FOB (Nhava Sheva JNPT / Mundra), CIF or CFR (Santos, Paranaguá, Rio de Janeiro, Itajaí), 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: