The Emergo Group Blog provides short updates on quality and regulatory topics that may be of interest to QA/RA professionals in the medical device and IVD industry. No fluff, just straight to the point. We hope you'll enjoy the content.
By Stewart Eisenhart, Emergo Group
INVIMA, Colombia's medical device market regulator, has published an updated list of products that qualify as medical devices, expanding the pool of medical products that require market authorization to be legally sold in the country.
According to Communication No. 500-22385 (links to document in Spanish), products on the new list must obtain INVIMA medical device registration by December 10, 2013; any affected devices remaining unregistered may no longer be legally imported or sold in Colombia. (Manufacturers and importers originally faced a June 18 deadline for registration, but that deadline was extended.)
Manufacturers and importers active in the Colombian market should verify whether their products now fall under INVIMA oversight as medical devices, and if so, familiarize themselves with the requirements necessary for medical device registration in Colombia.
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.