Description
Expanding into the Brazilian medical device market requires strict compliance with ANVISA regulations, including RDC 751/2022 (Device Classification & Registration), RDC 546/2021 (Regulatory Requirements), and RDC 665/2022 (Good Manufacturing Practices – GMP). Navigating this process can be complex, and non-compliance may lead to delays, rejections, or legal penalties.
SOP-REG-001: Medical Device Marketing Authorization for Brazil provides a step-by-step framework for obtaining ANVISA approval, ensuring your devices meet all regulatory, quality, and post-market compliancerequirements. This SOP is designed for manufacturers, importers, and Brazilian Registration Holders (BRH) looking for a fast, structured, and compliant pathway to market.
This SOP aligns with MDSAP (Medical Device Single Audit Program) requirements, streamlining the ANVISA GMP certification process for manufacturers already certified under ISO 13485 or other MDSAP-recognized audits.
Why You Need This SOP
Obtaining medical device marketing authorization in Brazil can be a complex and time-consuming process due to ANVISA’s strict regulatory requirements. Without a structured approach, companies risk submission delays, application rejections, or compliance penalties. This SOP provides a step-by-step approach to ensure a smooth and efficient regulatory process by:
🔹 Reducing registration time and avoiding costly errors.
🔹 Ensuring full compliance with ANVISA regulations, including GMP and post-market requirements.
🔹 Leveraging MDSAP certification to facilitate ANVISA’s GMP approval process.
🔹 Providing a structured methodology for preparing and submitting Cadastro and Registro applications.
🔹 Meeting ANVISA’s post-market surveillance (PMS) and vigilance reporting obligations.
🔹 Helping manufacturers and BRHs navigate the complex regulatory framework while maintaining compliance with ISO 13485 and MDSAP guidelines.
Who Should Buy This SOP?
This SOP is designed for businesses looking to enter or expand in the Brazilian medical device market and is essential for:
✔ Medical Device Manufacturers seeking ANVISA approval.
✔ Regulatory Affairs Professionals handling ANVISA submissions.
✔ Importers and Distributors acting as Brazilian Registration Holders (BRH).
✔ Consultants and Advisors providing regulatory guidance for Brazil.
✔ Startups and SMEs needing a cost-effective, structured approach to compliance.
