Brazil ANVISA Medical Device Registration
Enter Brazil's USD 12B+ medical device market — Latin America's largest. NexorTest delivers complete ANVISA Notificação and Registro services, Brazil Registration Holder (BRH) representation, INMETRO/ANATEL certification coordination, and phased UDI compliance — all under one expert roof.
Brazil — ANVISA Medical Device Market
215M+ Population | USD 12B+ Medical Device Market | RDC 751/2022 | UDI Phase-In 2025–2028 | INMETRO + ANATEL Required
ANVISA Medical Device Classification System
RDC 751/2022 classifies devices into four risk classes — Notificação (Class I/II, simplified) or Registro (Class III/IV, full ANVISA review)
Notificação Pathway
Lowest-risk devices. Simplified notification to ANVISA, no technical review. GMP certification not required. Complete Portuguese documentation maintained by BRH.
- Bandages
- Surgical Gloves
- Thermometers
Notificação Pathway
Moderate-risk devices. Simplified Notificação with no formal ANVISA review. Technical documentation maintained but not submitted. GMP exempt.
- Infusion Pumps
- Dental Instruments
- Syringes
Registro — Full ANVISA Review
High-risk devices. Complete ANVISA Registro with formal technical review. BGMP (Brazil GMP) certification mandatory. UDI required from January 2026.
- Ventilators
- Dialysis
- Imaging
Registro — Full ANVISA Review
Life-sustaining and active implantable devices. Most rigorous ANMAT review. Complete clinical data, manufacturing audit readiness, and biocompatibility reports required.
- Pacemakers
- Defibrillators
- Heart Valves
Complete ANVISA Registration Services
From Notificação to Registro, BRH representation to INMETRO/ANATEL — NexorTest delivers end-to-end Brazilian regulatory compliance
📋
ANVISA Notificação (Class I/II)
Complete preparation and submission of Class I and II device Notificações. Full Portuguese technical documentation, BRH appointment, and ongoing compliance maintenance included.
- Class I/II
- 30–45 Days
- Portuguese Docs
📄
ANVISA Registro (Class III/IV)
Full technical dossier preparation and Registro management for high-risk devices. Complete Portuguese documentation, BGMP coordination, clinical data compilation, query response management.
- Class III/IV
- Full Dossier
- BGMP
🏛️
Brazil Registration Holder (BRH)
NexorTest acts as your mandatory Brazilian legal entity — the BRH. We manage all ANVISA regulatory obligations, adverse event reporting, labeling compliance, import procedures, and annual compliance.
- BRH Services
- Legal Entity
- Import Mgmt
⚡
INMETRO Certification
Management of INMETRO product safety certification for electro-medical devices under IEC 60601. Required for all powered medical equipment sold in Brazil, separate from ANVISA registration.
- IEC 60601
- Product Safety
- INMETRO
📡
ANATEL Wireless Certification
ANATEL certification management for devices with wireless modules (Bluetooth, Wi-Fi, 4G/5G). Mandatory before commercial sale in Brazil and coordinated in parallel with ANVISA registration.
- Bluetooth/WiFi
- 4G/5G
- ANATEL
🏷️
UDI Implementation (2025–2028)
Complete UDI implementation for Brazil's phased rollout. Label design, GS1/HIBCC/ICCBBA compliance, ANVISA UDI database submission, and ongoing maintenance for all device classes.
- GS1 Compliant
- Label Design
- UDI Database
🏆
BGMP Certification Support
Brazil GMP certification coordination for Class III/IV manufacturers. Pre-inspection gap analysis against ANVISA's manufacturing standards aligned with ISO 13485:2016. Audit preparation and support.
- BGMP Audit
- Gap Analysis
- ISO 13485
🔬
IVD Registration Brazil
Specialized ANVISA registration for In Vitro Diagnostic devices. Classification under RDC 751/2022 IVD provisions, analytical performance data, clinical performance studies, and post-market vigilance.
- IVD Class I–IV
- Performance Data
- Vigilance
🌎
Mercosur Strategy
Leverage Brazil ANVISA documentation to streamline market entry across Mercosur countries (Argentina ANMAT, Uruguay, Paraguay). Maximize your Latin American regulatory investment.
- Argentina ANMAT
- Uruguay
- Paraguay
Brazil UDI Mandatory Dates
ANVISA's UDI requirements roll out by class — is your device ready?
Class IV
July 2025
Class III
July 2025
Class II
July 2025
Class I
July 2025
ANVISA Registration Step-by-Step
Our 5-step process ensures efficient, compliant ANVISA registration for all device classes
Classification & Strategy
Device classification per RDC 751/2022, Notificação vs Registro pathway determination, INMETRO/ANATEL/UDI requirement identification, and project timeline planning.
BRH Appointment
NexorTest appointed as Brazil Registration Holder (BRH). ANVISA company account setup, importer registration, and legal entity documentation prepared.
Portuguese Dossier
Complete technical dossier prepared in Portuguese. BGMP coordination for Class III/IV, clinical data compilation, UDI label design, and INMETRO/ANATEL parallel processing.
ANVISA Submission
Online submission via ANVISA’s digital platform (e-CAF/SOLICITA), fee payment, and proactive query response management to minimize stop-the-clock delays.
Registration & UDI
ANVISA certificate issued, UDI database registration submitted, post-market vigilance system activated, and registration renewal tracking initiated for 5-year validity period.
Ongoing Compliance
Continuous ANVISA regulatory intelligence, adverse event reporting, change notifications, annual reporting, Sicert/UDI database updates, and renewal management.
ANVISA Registration FAQ
What is ANVISA Notificação vs Registro?
Notificação is for Class I/II — simplified notification with no ANVISA technical review, processed in 30–45 days. Registro is for Class III/IV — full ANVISA review taking 4–18 months with BGMP certification required. Both require a Brazil Registration Holder (BRH) for foreign manufacturers.
Do I need a Brazil Registration Holder (BRH)?
Yes — mandatory for all foreign manufacturers without a legal Brazilian presence. The BRH is legally responsible for all ANVISA regulatory obligations. NexorTest provides BRH services, managing your complete Brazilian regulatory presence from registration through renewal.
Is INMETRO certification mandatory?
Yes, for electro-medical devices under IEC 60601. INMETRO certification is a mandatory product safety requirement separate from ANVISA registration. ANATEL certification is additionally required for wireless communication modules. NexorTest coordinates both in parallel with your ANVISA process.
When does UDI apply to my device?
Brazil UDI timeline: Class IV — July 2025 (already mandatory), Class III — January 2026, Class II — January 2027, Class I — January 2028. NexorTest provides complete UDI implementation including GS1/HIBCC label design and ANVISA UDI database submission.
What is BGMP and who needs it?
BGMP (Brazil GMP) is mandatory for Class III/IV manufacturers. It verifies QMS compliance with ANVISA’s manufacturing standards (aligned with ISO 13485). New BGMP standards were issued November 2025, effective November 2026. Class I/II devices are exempt. NexorTest provides pre-audit gap analysis and audit support.
How long does ANVISA Registro take?
ANVISA Registro for Class III/IV devices typically takes 4–12 months for standard review, up to 18 months for complex devices. NexorTest’s thorough Portuguese dossier preparation minimizes ANVISA queries and stop-the-clock delays, targeting the fastest possible approval timeline.
Ready to Enter Brazil's USD 12B+ Medical Device Market?
Get a free ANVISA regulatory assessment. Our expert team will analyze your device, map the correct pathway, and identify all INMETRO, ANATEL, and UDI requirements upfront.