ANVISA defines Mandatory Technical Standards for Medical Equipment 

Important Update! In March 2024, the National Health Surveillance Agency (ANVISA) announced a crucial update: the list of technical standards for the certification of compliance of equipment under Health Surveillance has been revised. This measure is essential to keep pace with technological advancements and regulatory changes, ensuring that products marketed in the Brazilian market meet the latest safety and quality standards. 

This update represents a significant milestone for the healthcare equipment industry and for all professionals involved in the regulation and oversight of Health Surveillance. It demonstrates Anvisa’s ongoing commitment to promoting the safety and efficacy of products available to Brazilian consumers. 

📝 To understand all the changes and their implications, you can access the full text of Regulatory Instruction RDC 283/24: 

It is crucial that companies and professionals in the sector are aware of these updates and adapt to the new requirements. Compliance with technical standards is essential to ensure the approval of registration, notification, revalidation, or equipment change requests. 

Find out more about BPO in RA! 

*Budget for registration ownership transfer, Market Access Strategy, and BPO in RA services for your company: www.brisa.com.br 

Brisa Advisors is a consultancy company for foreign manufacturers of medical devices who wish to enter the Brazilian market.

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