Certification Introduction
To place or import medical devices in the Brazilian market, mandatory access certification from the Brazilian National Health Surveillance Agency (ANVISA) is required, which is the statutory threshold for legal market entry. ANVISA classifies medical devices into four categories based on product risk: Class I (low risk), Class II (low-to-medium risk), Class III (medium-to-high risk), and Class IV (high risk). Different risk levels correspond to different access procedures: Class I adopts the simplified notification procedure, Classes II to IV require a complete registration process, and Classes III and IV additionally require assessment by a Brazilian designated certification body.
Laws and Regulations
Brazilian medical device regulation is led by the Brazilian National Health Surveillance Agency (ANVISA). Current rules are based on medical device registration, classification and post-market supervision regulations issued by ANVISA, and the regulatory system is updated dynamically. The latest rules shall prevail as published on ANVISA's official website. Brazil is an independent regulatory jurisdiction with no unified regional medical device regulation, and all imported/locally manufactured products must comply with ANVISA's domestic regulatory requirements.
Technical Requirements
- Product performance must meet corresponding test requirements, covering electrical safety, biocompatibility, electromagnetic compatibility, etc. Test reports must comply with ANVISA accreditation specifications
- Quality management system requirements: Products of Class II and above must obtain an ISO 13485 system certificate issued by an ANVISA-accredited body, or accept on-site audit by ANVISA
- Technical document requirements: Documents must include product specifications, design description, performance test reports, clinical evaluation data (high-risk products may require local clinical data or equivalence demonstration), and risk management documents; labels and instructions for use must be provided in Portuguese, and non-Portuguese documents require notarized translation
- Certification validity is usually 5 to 10 years, and renewal must be applied for in advance. Major changes to product design, materials, processes, etc. must be approved by ANVISA before implementation, and adverse event reporting obligations must be fulfilled after market entry.
Certification Process
- Conduct product risk classification to confirm the corresponding access procedure type
- Appoint a legally registered entity within Brazil as the legal registration holder, which undertakes official liaison with ANVISA and relevant legal liabilities
- Organize and prepare a full set of qualified technical documents and quality management system certification materials
- Submit registration applications through ANVISA's official electronic system Petro, and pay the corresponding application fees
- Cooperate with ANVISA's review, respond to requests for supplementary materials in a timely manner, and cooperate with the review by the designated body for Class III and IV products
- After obtaining ANVISA registration approval, the product can be legally marketed in Brazil, and must continuously comply with post-market regulatory requirements.
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