Colombian Regulator Lists Additional Products to be Registered as Medical Devices
INVIMA, Colombia’s medical device market oversight agency, has added several “soft line” products to the list of medical devices that require registration in order to be legally sold in the country.
Products affected by the INVIMA decision are indicated for prevention, treatment, relief or compensation for injuries or illnesses. Now considered medical devices, these products include shoulder and elbow supporters, rib and clavicle immobilizers, posture correction products, abdominal girdles and calf and thigh orthotic devices.
Manufacturers of such devices should familiarize themselves with Colombian registration and approval requirements if they have not done so already.