AMERICAS
COLOMBIA
Market Information
Colombia’s healthcare expenditure accounted for around eight percent of the country's Gross Domestic Product (GDP) in 2022, showing a decrease from the nine percent reported in the previous year. This percentage had been on an upward trend since 2013, when healthcare expenditure relative to Colombia's GDP was at seven percent.
Market Trend: The value of accident and health insurance sector in Colombia amounted to approximately 192.75 million U.S. dollars in 2014 and it was projected to grow to approximately 345.8 million U.S. dollars in 2025.
Colombia’s medical equipment market is expected to show an annual growth rate (CAGR 2024-2028) of 6.59%, resulting in a market volume of US$2,859.00m by 2028.
The National Institute of Drug and Food Surveillance (INVIMA) is responsible for the regulation and oversight of foods, drugs, medical devices, pharmaceutical, and biological products.
Medical Device Regulation
National Institute of Drug and Food Surveillance (INVIMA)
Classification, Fees, Timeline
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Product Registration Routes
For Medical Devices and Biomedical Equipment
Class I
Class IIa
Class IIb
Class III
For In Vitro Diagnostic Devices
Category III
Category II
Category I
Useful Information
Validity of License: Class I & II expires after 7 years. All other devices expire after 5 years.
License transfer: Holder of the registration certificate must submit an Ownership Assignment.
Importer and Distributor: Local License Holder, on behalf of the product owner, is responsible to appoint Importers and Distributors.
