Drugdu.com expert's response:

Medical devices exported to Brazil must obtain ANVISA certification (core market access certification), INMETRO certification (for specific high-risk products), quality management system certification (e.g., ISO 13485), and ensure labeling and instruction compliance. Certain products may also require ANATEL certification (for wireless communication functionality) or MDSAP audit (as an alternative to ANVISA review). Below is a detailed explanation:

I. ANVISA Certification: Core Market Access Threshold

Scope of Application: All medical devices imported or distributed in Brazil, regardless of risk classification, must obtain ANVISA certification.
Key Requirements:

Mandatory Registration: Applications must be submitted online through ANVISA's SGP system, covering all classified medical devices.

Risk-Based Classification: Devices are categorized into four classes (Class I: low risk; Class II: moderate risk; Class III: high risk; Class IV: extremely high risk), with varying documentation requirements:

Class I: Basic information and technical documentation; simpler review process.

Class II: Detailed technical documentation; may require performance test reports.

Class III: Complete clinical data, product performance validation reports, and risk management analysis.

Class IV: Comprehensive clinical trial data and detailed product instructions; strictest review.

Review Process: Includes document completeness checks, technical review (safety, efficacy, quality control), and on-site inspections (for high-risk products).

Certificate Validity: Typically valid for 5 years; renewal required upon expiration.

II. INMETRO Certification: For Specific High-Risk Products

Scope of Application: Certain active medical devices and high-risk non-active medical devices (e.g., hypodermic needles, sterile syringes, infusion sets, breast implants).
Key Requirements:

Mandatory Certification: Products cannot proceed with ANVISA registration without an INMETRO certificate.

Certification Process:

Submit applications to Brazilian local certification bodies (OCPs) or INMETRO-accredited third-party organizations (e.g., SGS, UL, TÜV Rheinland).

Provide technical documentation (test reports, instructions, risk management files) to ensure compliance with Brazilian standards (e.g., IEC 60601 series, ISO 7176 series).

Undergo on-site audits (including factory qualification reviews and production site testing).

Certificate Maintenance: Certificates are permanently valid but require on-site annual audits every 15 months.

III. Quality Management System Certification: ISO 13485

Scope of Application: All medical device manufacturers.
Key Requirements:

International Standard: ISO 13485 is a dedicated quality management system standard for the medical device industry, emphasizing product quality and safety management.

Certification Process: Apply through certification bodies (e.g., TÜV SÜD, BSI, DNV GL), undergo audits, and demonstrate compliance with the standard.

ANVISA Requirement: Manufacturers must hold ISO 13485 certification as a prerequisite for ANVISA certification applications.

IV. Labeling and Instruction Compliance

Scope of Application: All medical devices.
Key Requirements:

Language Requirement: Labels and instructions must be in Portuguese and include mandatory product information (e.g., name, manufacturer details, usage instructions, precautions, batch number, expiration date).

Content Requirements: Labels must include warning statements, manufacturer information, expiration dates, etc., ensuring accuracy and legal compliance.

V. Additional Certifications (Based on product characteristics)

ANATEL Certification:

Scope of Application: Medical devices with wireless communication functionality (e.g., Bluetooth, Wi-Fi).

Key Requirements: Products must be tested at ANATEL-accredited laboratories in Brazil. Companies holding ISO 9001 or ISO 13485 certificates may be exempt from on-site audits.

MDSAP Audit:

Scope of Application: Class III and Class IV high-risk medical devices.

Key Requirements: Manufacturers may use MDSAP audits as an alternative to ANVISA reviews, meeting regulatory requirements for five countries: U.S. (FDA), Australia (TGA), Brazil (ANVISA), Canada (HC), and Japan (MHLW).