Trial, register, and sell your medical device in Colombia
MARKET ENTRY, MARKET ACCESS, CLINICAL TRIALS, AND INVIMA REGULATORY CONSULTING IN COLOMBIA FOR MEDICAL DEVICES.
First-in-man clinical trials
Distributor search & due diligence
Market entry research and strategy
Market access, health economics and outcomes research (HEOR), health technology assessment (HTA)
New entity set up and incorporation
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.