Colombian Medical Device Regulation Updates Under Decree 582/17

Published April 25, 2017/Colombia

Key Changes to Colombian Medical Device Regulations

Key changes to Colombian medical device regulations under Decree 582/17 include review timeframes and automatic modification acceptance by INVIMA.

Improved Review Timeframes

For Class IIb and III moderate to high-risk devices, INVIMA will review registration applications within 90 working days following submission. Although official review timelines are already 90 working days, actual timelines can last as long as six months. Decree 582/17 now obligates INVIMA to conduct more efficient application reviews within 90-day timeframes.

Colombia Quick Facts

Regulatory Agency	Comisión de Regulación de Comunicaciones (CRC)
Certification Type	Mandatory
License Validity	Indefinite
Application Language	Spanish
Legal License Holder	Not required
In-country Testing Requirement	No testing required

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