Columbia ISO 13485 Requirements

J

jennaleeb

#1
#1
Hi all!

I recently saw this on Emergo's website

"ISO 13485 is required in order to register in Colombia. However if you manufacture a low-risk Class I device and have not implemented an ISO 13485 compliant quality system, and you outsource the manufacturing, the ISO certificate from your contract manufacturer would be accepted."

I have not been able to source this information from anywhere else. Does anyone have experience registering devices in Colombia where you didn't have ISO 13485 but your contract manufacturer did? This is exactly the situation we are in and I'd like to validate this info!

Happy holidays,

Jenna
 
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J0anne

J0anne

Joanne
#2
#2
Re: Colombia ISO 13485 Requirements

This was not one of the requirements I had to fulfill for Colombia when I completed my last submission in 2011. Therefore, there should be a reference to this new requirement somewhere and I don't blame you for wanting to verify this information
 
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