Medical Devices Regulatory Updates in North, Central and South America

Medical Devices Regulatory Update – Whitepaper Overview:

The medical devices sector has experienced significant growth in recent years, and the regulatory landscape for medical devices is continuously evolving. 

Countries are implementing an increasing number of regulations and guidelines, leading to significant challenges for medical device manufacturers including intricate regulatory procedures, reimbursement limitations, and the high costs of developing cutting-edge technologies.

This Whitepaper Covers:

This whitepaper gives an overview of medical devices regulatory updates in North, Central and South America, including:

• USA
• Canada
• Mexico
• Brazil
• Colombia
• Chile
• Mercosur
• International Medical Devices Regulators Forum (IMDRF)

*This whitepaper was originally published on 22nd May, 2024. Further regulatory developments may have occurred after publication. To keep up-to-date with the latest compliance news, sign up to our newsletter.

Author

Fernanda Paro, Regulatory Compliance Specialist, Compliance & Risks

Fernanda is a Regulatory Compliance Specialist with the Global Regulatory Compliance team, responsible for the monitoring of regulatory updates in several Latin American countries and specialized in the topic of Medical Devices.

Fernanda holds a Master’s Degree in International Trade Law focused on Medical Devices, Data Protection and Cybersecurity, and is a qualified lawyer, registered in Brazil and Portugal.