The Medical Device Single Audit Program (MDSAP) offers a way to streamline the pre- and post-market audit process required by medical device regulatory authorities in...
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Colombia has over 48 million residents and is a very strong market for foreign medical device manufacturers. Interested in entering this market? This...
Registration Process | Process Charts
To market a medical device or IVD, manufacturers must register with the National Food and Drug Surveillance Institute (INVIMA), the country’s medical device regulator....
Regulatory Compliance | Device Regulations
All Colombia medical device regulations listed below are in PDF format. Please help us maintain this list by reporting outdated or missing documents. If you...
