Key considerations regarding regulatory and intellectual property requirements applicable to medical devices in Colombia.

To manufacture, import, distribute, or commercialize a medical device in Colombia, it is mandatory to obtain the corresponding sanitary registration or authorization from INVIMA. This requirement is part of the Colombian health regulatory framework and aims to ensure that medical devices meet applicable standards of quality, safety, and performance. Without this authorization, the product cannot be lawfully marketed in the country and may be subject to administrative sanctions or even market withdrawal. Regarding trademarks, registration of the brand is not a legal requirement to obtain the sanitary registration of a medical device or to commercialize it in Colombia. A medical device may be placed on the market even if the trademark has not been registered. However, we strongly recommend registering the trademark under which the medical device is marketed. Trademark registration grants exclusive rights over the brand and is an important legal tool to prevent counterfeiting, unauthorized use by third parties, and unfair competition, which are relevant risks in the Colombian market. Additionally, trademark protection strengthens market positioning and facilitates enforcement actions in case of infringement.In summary, while medical device registration before INVIMA is mandatory, trademark registration is optional but highly advisable as part of a comprehensive legal and commercial protection strategy.Please let us know if you would like us to provide further guidance or assistance on either the regulatory or trademark registration process.