Medical Device Registration in Brazil – Step-by-Step Guide

1. Medical Device Registration in Brazil – Step-by-Step Guide for ANVISA Approval (2025) Operon Strategist

2. Introduction to Medical Device Registration in Brazil • Brazil is one of the largest medical device markets in Latin America and the 10th largest in the world. With more than 210 million people, Brazil offers a high-demand market for healthcare technology and medical devices. However, to legally market medical devices in Brazil, ANVISA registration is mandatory. • If you are planning to export or manufacture medical devices in Brazil, this guide explains everything you need to know about Brazil medical device regulations, ANVISA process, documentation, INMETRO certification, and timelines.

3. What is ANVISA? ANVISA (Agência Nacional de Vigilância Sanitária) is Brazil's National Health Surveillance Agency responsible for regulating: • Medical Devices • Pharmaceuticals • IVDs • Implants • Healthcare products • ANVISA ensures that products imported, distributed, or manufactured in Brazil meet safety, quality, and performance requirements.

4. Do You Need ANVISA Registration? Yes, any foreign or local company wishing to sell medical devices or IVDs in Brazil must obtain ANVISA approval before commercialization. This is applicable to: Manufacturers Importers & Distributors Private label suppliers OEMs

5. Brazil Medical Device Classification (ANVISA) ANVISA follows a risk-based classification systemsimilar to EU MDR: Class Risk Level Examples Class I Low Risk Surgical gloves, dental mirrors Class II Medium Risk Syringes, suction systems Class III High Risk Orthopaedic implants Class IV Highest Risk Pacemakers, life support

6. INMETRO Certification – When is it Required? Electrical and electronic medical devices must obtain INMETRO safety certificationbefore ANVISA submission. Applies to: • ECG Machines • Infusion Pumps • Ultrasound Devices • X-Ray Systems • Patient Monitors

7. Step-by-Step ANVISA Approval Process (2025) Step 1: Appoint a Brazil Registration Holder (BRH) • Foreign manufacturers must appoint a local Brazilian Registration Holder to communicate with ANVISA. Step 2: Device Classification & Regulatory Strategy • Define device risk class, standards, and applicable regulations.

8. Step 3: Prepare Technical Documentation • Documentation includes: • Device description & intended use • Risk management (ISO 14971) – Learn Risk Management • Clinical evaluation data • Design dossier –Design Documentation Support • Label & IFU in Portuguese • Safety & performance testing • Biological evaluation (ISO 10993) • Sterilization validation reports

9. Step 4: ANVISA GMP (For Class III & IV) • Brazil requires ANVISA GMP certificationfor high-risk devices. ISO 13485 alone is not enough. • Need ISO 13485 support? Visit ISO 13485 Certification. Step 5: INMETRO Testing (If Applicable) • Complete electrical safety testing through an accredited Brazilian lab. Step 6: Submit Dossier to ANVISA • Submit registration package via local BRH. Step 7: Approval & Certificate Issuance • ANVISA issues a registration number, valid for 10 years.

10. Required Documentation Checklist Document Required ISO 13485 Certificate Technical File Device Images & Label Risk Analysis (ISO 14971) ANVISA GMP Class III & IV INMETRO Certificate If applicable Clinical Data Device-specific Brazilian Portuguese IFU

11. Why Choose Operon Strategist for ANVISA Approval in Brazil? Operon Strategist provides end-to-end ANVISA regulatory consulting for Class I– IV medical devices in Brazil, ensuring fast and compliant market access. We also support: • Medical Device Technical File Consultation • ISO 13485 Certification Services • CE Marking for Medical Devices • 510(k) FDA Clearance Support • Cleanroom Design for Medical Device Manufacturing