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Brazil Medical Device Registration

Agência Nacional de Vigilância Sanitária (ANVISA) approval timelines and requirements

2-3 months

Typical Timeline

Device Classes

Yes

MDSAP Accepted

Required

Brazil Registration Holder (BRH)

Brazil Medical Device Registration Overview

Brazil medical device registration through ANVISA typically takes 2-3 months for Class I devices. The official ANVISA target is 1-2 months, but realistic timelines include preparation, documentation review, and potential questions from regulators.Brazil uses a 4-class (I, II, III, IV) risk-based classification system. Foreign manufacturers must appoint a Brazil Registration Holder (BRH) to register devices in Brazil. ANVISA accepts MDSAP certification, which waives anvisa on-site inspection, extends b-gmp validity to 4 years. Registration is valid for Unlimited (Class I-II), 10 years (Class III-IV).

Registration Timeline by Device Class

Brazil uses a 4-class (I, II, III, IV) risk-based classification system.

Class I

Notification

Low Risk

Official

1-2 months

Realistic

2-3 months

• No ANVISA review required

• Unlimited validity

Class II

Notification

Medium Risk

Official

1-2 months

Realistic

2-15 months

• Unlimited validity

• INMETRO certification adds 3-12 months if required

Class III

Registration

High Risk

Official

4-12 months

Realistic

1.5-2 years

With Prior Approval

8-12 months

Accelerated with: FDA 510(k)/PMA (via IN 290/2024), MDSAP for B-GMP

• B-GMP certificate mandatory

• 10 year validity

GMP/QMS Required

Class IV

Registration

Highest Risk

Official

8-15 months

Realistic

2-3 years

With Prior Approval

10-14 months

Accelerated with: FDA 510(k)/PMA (via IN 290/2024), MDSAP for B-GMP

• Clinical evidence mandatory

• 10 year validity

Clinical Trial RequiredGMP/QMS Required

Expedited Pathways

Reliance Pathway (IN 290/2024)

Leverages FDA, TGA, Health Canada, or MHLW approvals

30% faster ANVISA review

Eligibility: Class III & IV only, Device approved by TGA, Health Canada, FDA, or MHLW

MDSAP B-GMP Extension

Extended GMP certificate validity with MDSAP

4 years validity (vs 2 years standard)

Eligibility: MDSAP certified manufacturer

Prior Approval Recognition

Existing approvals from other regulatory authorities can accelerate your Brazil registration.

FDA 510(k)/PMA

30% faster via IN 290/2024

3-5 months

EU CE Mark

Not recognized (use Australia TGA as bridge)

Indirect

MDSAP

Waives ANVISA inspection, extends B-GMP to 4 years

4-6 months

TGA (Australia)

30% faster via IN 290/2024

3-5 months

Health Canada

30% faster via IN 290/2024

3-5 months

Key Requirements

Brazil Registration Holder (BRH) - mandatory for foreign manufacturers
B-GMP certificate (Class III & IV)
Portuguese labeling and IFU
Clinical evidence (Class III & IV)
UDI (phased: Class IV Jul 2025, Class III Jan 2026)

Registration Validity:

Unlimited (Class I-II), 10 years (Class III-IV)

MDSAP Benefit:

Waives ANVISA on-site inspection, extends B-GMP validity to 4 years

Registration Process Flowchart

Brazil Medical Device Registration Process

Step-by-step ANVISA registration process. Total estimated timeline: 2-3 months.

Step 1: Device Classification

2-4 weeks

Classify device under ANVISA RDC 751/2022 (Class I, II, III, or IV).

Step 2: Appoint BRH

4-8 weeks

Foreign manufacturers must appoint a Brazil Registration Holder (BRH) for registration.

Step 3: GMP Certificate

6-12 months

Obtain ANVISA B-GMP certificate or MDSAP certificate covering Brazil. Facility audit required.

Step 4: Technical Documentation

2-4 months

Prepare ANVISA-compliant technical dossier. Portuguese translation required.

Step 5: ANVISA Submission

1-2 weeks

BRH submits registration application to ANVISA via electronic system.

Step 6: ANVISA Review

6-18 months

ANVISA conducts technical review. IN 290/2024 offers faster pathway with FDA/EU/TGA approval.

Step 7: Registration

2-4 weeks

ANVISA issues registration. Valid 10 years (or 5 years without MDSAP).

Summary: The Brazil medical device registration process through Agência Nacional de Vigilância Sanitária (ANVISA) consists of 7 main steps: Device Classification → Appoint BRH → GMP Certificate → Technical Documentation → ANVISA Submission → ANVISA Review → Registration.

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Related Resources

Brazil Classification (RDC 751)Brazil GMP Requirements Choose a Brazil Registration Holder ANVISA Regulation News Government Registration Fees

Compare With

🇺🇸 United StatesFDA 🇪🇺 European UnionEU MDR 🇨🇳 ChinaNMPA 🇯🇵 JapanPMDA 🇨🇦 CanadaHealth Canada 🇦🇺 AustraliaTGA

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Timelines are estimates based on 2024-2025 data. Last updated: 2025-12-01.