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Guidance for Medical Device Registration in Med Dev Regulations World-Wide



Thanks Steve! I did see that. I haven't found much info beyond what Emergo provides, and I am not fluent in Spanish. We have a dealer in Ecuador that wants to purchase and sell our products. I believe Ecuador has a registration process, but the dealer there is telling me there isn't one. The device they want to sell is Class I in the US, Class II in Canada and Class IIa in Europe.

Any thoughts?


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Hi Marcelo,
Does Chile have a working medical device registration system for implants? I've been to the Chile websites and it looks like they do, but is it actually being used? as we are being told from other sources that there is no requirements for device registration.. can you advise?
Thank you
Yes, for all medical devices in fact. What Chile does not have is a way to verify conformity :-(
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