LATAM Series: Mexico’s Medical Device Regulatory Pathway

LATAM Series: Mexico’s Medical Device Regulatory Pathway

Our LATAM series continues this week with Mexico’s medical device regulatory pathway. In 2019, Mexico’s import medical device market was estimated to be approximately $5.7 billion USD. In 2020, that number increased to $6.5 billion USD. With demand for medical devices...
UDI Guidance Finalized by FDA

UDI Guidance Finalized by FDA

The U.S. Food and Drug Administration (FDA) has finalized UDI guidance content requirements and form for unique device identifiers (UDIs), after five years from its first drafted release. The guidance covers two types of UDIs, including automatic identification and...