Medical Products Exporter to Brazil
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 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.
High-Precision Medical Consumables for Brazil
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 Brazil
Regulator & registration
- Authority
- ANVISA — Agência Nacional de Vigilância Sanitária
- Governing instrument
- RDC 751/2022, which sets the risk classification and registration framework
- Classification
- Class I and II by notificação; Class III and IV by registro — a materially heavier route
- Local representative
- 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.
- Realistic timeline
- Class I/II notificação can be quick once the holder is set up; Class III/IV registro commonly runs past a year
Registration route, in order
- 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
Duty & tax by HS heading
| HS | Product | Duty | Tax |
|---|---|---|---|
| 4015.12 | Surgical and examination glovesEx-tarifário relief may apply where no local equivalent is produced | Mercosur common external tariff — confirm the current NCM line | ICMS (state-level) plus IPI, PIS and COFINS |
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
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 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 manufacture private-label medical devices and surgical consumables for brand owners, distributors and pharmacy chains in Brazil.
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.
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