International Regulatory Affair Services
Isah Health



In Colombia, Medical devices are divided into four classes (I, IIa, IIb and III) depending on the risk level and are regulated by the National Food and Drug Suveillance Institute (INVIMA).

Colombia has simplified registration requirements for low- and medium-risk devices that are already approved in certain reference countries or areas such as the US, European Union, Japan, Australia and Canada.

The INVIMA - Colombia’s healthcare products regulatory agency is accepting certificates of free sale issued by the referenced countries for Class I, IIa and IIb devices.

The free sale is allowed to be submitted instead of some information companies previously had to supply such as, among others, technical studies or analytical tests. Nevertheless companies must still provide the full description of the device and related safety information.

The free sale certificate must have been issued no more than a year before the Colombian registration submission is made.

To register a medical device with the Colombian Authority (INVIMA), the manufacturer must have an office in Colombia or appoint a local company to submit the registration. ISA HEALTH can offer hosting services for registration in Colombia.