Brazil Medical Device Registration

Brazil Medical Device Registration (ANVISA – Agência Nacional de Vigilância Sanitária)

1. Regulatory Authority & Framework

Brazil regulates medical devices under:

• RDC 751/2022 – General medical device regulation (replaces RDC 185/2001)
• RDC 36/2015 – GMP requirements
• RDC 40/2015 – Changes/variations
• RDC 661/2022 – IVD rules
• IN 95/2021 – Classification rules

Authority:
ANVISA – Brazilian Health Regulatory Agency

System platforms:

• Datavisa – registration submission
• SGSCo – GMP inspection
• Solicita – documentation portal

Brazil uses Portuguese as the regulatory language.

2. Device Classification (Class I / II / III / IV)

Categorization aligns with EU/GHTF principles:

Classification based on:
intended purpose, invasiveness, duration, active status, IVD category.

3. Registration Routes

Brazil has two primary pathways:

3.1 Cadastro (Notification) – For Class I & Class II

Simplified pathway for low-risk devices:

• No ANVISA technical review
• Automatic approval upon dossier submission
• No local clinical trials needed
• Validity: Indefinite (as long as GMP is maintained)

Documentation:

• Administrative documents
• Technical dossier summary
• Labeling
• Proof of regulatory approval or safety data

Approval time: 1–3 months

3.2 Registro – For Class III & Class IV

Full ANVISA technical review:

Includes:

• Full technical dossier
• Performance & biocompatibility data
• Clinical evaluation
• Brazilian GMP (ANVISA GMP) mandatory
• Essential principles checklist

Validity: 10 years
Approval time: 9–18+ months

This is the pathway needed for robots, HF devices, blood glucose meters, lenses, many active devices.

4. Mandatory Requirement: ANVISA GMP (Brazil GMP)

ANVISA is strict: GMP certification is mandatory for Class III & IV devices before Registro approval.

GMP Options:

1. ANVISA On-site Inspection (most common; longest timeline)
2. MDSAP certificate (accepted for some devices but not all)
3. Brazil GMP via local manufacturing (if applicable)

Typical GMP timeline: 8–12 months (sometimes longer).

5. Local Authorized Representative (Brazilian Registration Holder – BRH)

Foreign manufacturers cannot register directly and must appoint a:

Brazil Registration Holder (BRH) / Local Company

Responsibilities:

• Owns the registration (CRF)
• Communicates with ANVISA
• Manages vigilance/FSCA
• Handles labeling and import permits

Important:
BRH owns the registration → changing BRH requires re-registration.

6. Dossier Requirements (Brazil Technical File)

Brazil does not use ASEAN CSDT; instead, it uses Brazil-specific structure based on RDC 751/2022.

Administrative Documentation

• Application form (petition)
• BRH authorization letter
• Manufacturer QMS certification
• ANVISA GMP (for Class III/IV)
• FSC / Market Authorization

Technical Documentation

• Device description
• Essential Principles of Safety & Performance
• Risk management (ISO 14971)
• Verification & validation data
• Biocompatibility / sterilization
• Electrical safety & EMC (IEC 60601 series)
• Software documentation (IEC 62304 + cybersecurity)
• Clinical evidence / CER
• Labeling in Portuguese (IFU may be bilingual)

Labeling must be fully compliant with Portuguese language requirements.

7. Fees & Timelines

7.1 Official Fees (Typical)

• Class I/II Cadastro: BRL 500–800
• Class III/IV Registro: BRL 1,000–3,000
• ANVISA GMP inspection: BRL 50,000–70,000 (varies by region)

7.2 Timelines

8. Labeling Requirements

All labeling must be in Portuguese, including:

• Product name, model
• Manufacturer & BRH details
• Country of origin
• ANVISA registration number (post-approval)
• Storage/handling conditions
• Expiry/manufacture date (if applicable)
• IFU in Portuguese (can be electronic where allowed)
• UDI system (gradually implemented)

9. Importation Requirements

Post-registration import steps:

• Use of Licenciamento de Importação (LI) via SISCOMEX
• Pre-shipment instructions
• Inspection at customs
• Compliance with ANVISA, INMETRO (for some electrical devices), and MAPA (for biologics) if applicable
• Batch control for specific device types

10. Post-Market Surveillance

BRH must manage:

• Vigilance & incident reporting
• Corrective and preventive actions (CAPA/FSCA)
• Annual performance monitoring
• Labeling changes
• Variations per RDC 40/2015 rules
• Renewal (Registro valid for 10 years)

11. Consultation Notes for Your Device Portfolio

Brazil is one of the strictest markets globally because of the mandatory GMP for higher-risk devices.

12. Advantages of Brazil Market

• Largest medical device market in Latin America
• Well-defined regulatory framework
• Recognition of EU/US certifications simplifies technical review (not GMP)
• Long validity (10-year Registro)
• Strong private healthcare growth