Frequently Asked Questions
Is home country approval required?
Before beginning your Colombia medical device registration process, you must secure home country approval. Or, if you don’t have approval in your home market, then you can provide a CFS/CFG from one of the following markets: Australia, Canada, Japan, Europe, or the United States.
When am I required to renew my registration in Colombia?
Registrations are valid for 10 years. Application renewals are due to INVIMA three (3) months before the expiration of your registration certificate.
What if we do not have ISO 13485 certification?
The regulation states proof of a QMS (such as ISO 13485) is required; however, if a company doesn’t have it, then they can meet this requirement another way, e.g. providing an ISO 9001 certificate or an FDA Establishment Report. It’s easier and requires less “negotiation” to submit an ISO 13485 certificate, but if a company doesn’t, then it’s still possible to register.