FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

Brazil’s New Device License Registration Timeframe Will Improve Market Access, Expert Says

Feb. 12, 2018
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Brazil’s National Surveillance Agency’s recent decision to extend the medical device registration period for higher-risk devices to 10 years will substantially improve market access, BMI Research Analyst Karen Simpkins told FDAnews.

“For comparison, medical device registrations are valid for five years in Argentina and Mexico,” Simpkins said. “The extended validity timeframe, along with other recent regulatory developments, will further enhance the attractiveness of the Brazilian market.”

Brazil has made a number of regulatory changes aimed at simplifying market entry for foreign devicemakers, such as getting rid of certain import requirements, including mandatory inspections at entry points.

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