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.
Update 08/01/2013: The list of products INVIMA now considers medical devices includes the following:
- Hospital beds
- Sterile disposable surgical clothing
- Diagnostic imaging systems
- Device disinfecting equipment
- Centrifuge processors
- Stationary bicycles, treadmills and elliptical steppers
- Electric massagers