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LATAM Regulatory Knowledge Hub

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The LATAM Regulatory Knowledge Hub features expert publications on medical device and IVD regulations across Latin America. Explore insights on market access, registration pathways, digital health and SaMD requirements, evolving national frameworks, and key compliance considerations for regulatory professionals operating in the LATAM markets.

An updated overview of the regulatory requirements for medical devices, including IVDs, in Cuba

Get up to speed on Cuba’s latest regulatory developments, including new provisions covering both medical devices and IVDs, and what they mean for market access and compliance Read More...

Regulatory Monitor – updating you on legislative changes

Get the latest international regulatory updates from the JMDR May 2026 issue – concise, expert-curated updates to keep you ahead in the medical device industry Read More...

Overview of the proposed regulations for medical devices and IVDs in Nicaragua

Prepare for success in Nicaragua by understanding the latest regulatory proposals for medical devices and IVDs, a key resource for market entry Read More...

Registration checklist for Software as a Medical Device in Mexico according to Article 83 of the ‘Health Supplies Regulation’

Simplify the registration process for your Software as a Medical Device in Mexico with this detailed, regulation-compliant tabulated checklist Read More...

An overview of the regulatory requirements for medical devices in Colombia

Navigate the complex regulatory environment for medical devices in Colombia with this comprehensive overview Read More...
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