Regulatory Legal Representation in Colombia
You are required to appoint a local regulatory legal representative as part of your regulatory approval process with INVIMA. Your legal representative in Colombia will manage your product registration process, will interact with INVIMA on your behalf, and will ensure compliance with the local post-marketing surveillance requirements. You must maintain your legal representation relationship for as long as you ship, market, and sell your product in Colombia.
Interventional Concepts will act as your company's regulatory local legal representative in Colombia. You will assign power of attorney to Interventional Concepts to file regulatory submissions to INVIMA on your behalf and to receive request for information notices and appropriately respond to them.
Interventional Concepts S.A.S. (ICS), our local entity in Colombia, will act as your legal representative in Colombia, fulfilling all regulatory responsibilities per national health regulations. ICS covers the legal risk of doing business in Colombia, as, if there ever is a claim in Colombia relating to your product (even if the likelihood of such an occurrence is tiny), the party making the claim would enforce it against ICS. Due to the fact that this legal representative is a Colombian entity, the claimant and the courts would have jurisdiction over it.
Interventional Concepts will also provide assistance related to communications with authorities in Colombia, where applicable.
The role of a Legal Representative in Colombia
Foreign manufacturers must issue power of attorney to a local third-party in Colombia to communicate as legal representative on their behalf with the Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA), specifically in regard to Decree 4725/2005.
The legal representative acts as a liaison between you and INVIMA, and medical device manufacturers that do not have a physical location within Colombia must appoint and maintain that legal representative for as long as they sell in Colombia.
Before selecting Interventional Concepts as their independent legal representative, some clients have considered appointing a distributor to fulfill this role. While it is possible to appoint a distributor located within Colombia, there are valid reasons not to appoint a distributor, including:
- You may need to provide access to your device information and documentation (mandatory for registration purposes) and most companies prefer not to put (confidential) design information in the hands of their distributors.
A conflict of interest may occur in the event of recall and/or incident reporting between you (the manufacturer) and the distributor. If INVIMA questions an incident or a non-compliance that occurred in the distribution system, will your distributor defend his company or yours?
The distributor is focused on sales and marketing, not on regulatory affairs. They may not keep you up-to-date on regulatory changes in the market and provide timely warnings when changes affect your devices.
The legal representative will assign an initial distributor or a logistics operator to act as your importer of record, and may need to assign additional distributors to the approval. If you select Interventional Concepts as your legal representative, Interventional Concepts would fully cooperate with you so that you control the approval of your device on the market.
Interventional Concepts is a professional, independent in-country representative that specializes in medical device regulatory affairs. Your success in Colombia is our goal.