ANVISA Quality System Management Implementation and Maintenance  

If you export medical devices to Brazil, getting ANVISA registration is the first step to making them viable in the market. 

ANVISA requires you to ensure that all your manufacturing locations meet Brazilian Good Manufacturing Practices (GMP) requirements, the local equivalent of the  ISO 13485 Medical Devices Standard. 

ANVISA uses a risk-based categorization system to categorize medical devices into one of four risk groups ranging from Class 1 (low risk) to Class IV (high risk). 

International manufacturers need the services of a local Brazilian Registration Holder (BRH) to facilitate the process of submitting technical files to ANVISA. 

At Passarini, We help you with the implementation and maintenance of ANVISA’s Good Manufacturing Practices in line with the global ISO 14971 medical devices risk management requirements. 

Based on the set schedule, and understanding of your company culture we assist you through; 

  • Working with relevant collaborators to facilitate the  ANVISA registration process
  • Carrying out normative interpretation and implementation based on past experience and focus on the values that will be aggregated. 
  • Brainstorming with your implementation team to ensure our process is consistent with your company’s work process
  • Standardizing procedures consistent with your company’s unique needs
  • Offering advanced Quality Management System maintenance training to your team 
  • Help you establish an internal team of auditors and offering them continuous training   

For more information, feel free to contact us.