Trial, register, and sell your medical device in Colombia
CLINICAL TRIALS, INVIMA REGULATORY CONSULTING, AND MARKET ACCESS PLAN FOR MEDICAL DEVICES.
U.S. Department of Commerce
It is strongly recommended that U.S. companies process the registration under their name and not under the local distributor name
U.S. companies should take care in selecting their Colombian partners and to thoroughly vet theM by conducting a background check
Follow the U.S. Department of Commerce, International Trade Administration's export guidelines to Colombia
It is strongly recommended that U.S. companies process the registration under their name and not under the local distributor's name or else the U.S. company will not be able to change or add distributors during the lifetime of the registration, which is 10 years.
To secure an agent, representative, or distributor the foreign company must execute a contract that meets the provisions of the Colombian Commercial Code. This contract must be registered with the chamber of commerce where the agent/representative is located.
The U.S. Commercial Service recommends that U.S. companies consult a local attorney to execute an agency or distribution contract and to thoroughly vet the prospective partner by conducting a background check.
U.S. suppliers should be aware, however, that their ability to compete in Colombia could be hampered by unfair business practices such as contraband, counterfeiting, intellectual property rights violations, under-invoicing, money laundering, and dumping.
Access to this market is not easy for newcomers. The market is mature and competitive, with many foreign firms selling medical equipment and medical products. It should be noted that the registration procedures can often be challenging and may pose a barrier to entry.