Medical Device Regulatory Legal Representation in Colombia
Foreign manufacturers must issue power of attorney to a local third-party in Colombia if they would like to have that third-party represent their interest while doing business in Colombia and communicating with INVIMA on their behalf.
The legal representative acts as a liaison between you, INVIMA, and any other private or government entity. Medical device manufacturers that do not have a physical location within Colombia appoint and maintain that legal representative for as long as they market and sell their products in Colombia.
Your legal representative in Colombia will manage your product registration process, will interact with INVIMA on your behalf, will receive legal notices on your behalf, and will ensure that you comply with local post-marketing surveillance requirements.
Interventional Concepts S.A.S. (ICS), our local entity in Colombia, can act as your legal representative in Colombia, fulfilling all regulatory responsibilities per national health regulations. You will assign power of attorney to ICS to file regulatory submissions to INVIMA on your behalf and to receive notices and appropriately respond to them.
ICS assumes the liability of your company 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.
ICS will assist you while communicating with authorities in Colombia, will submit the required annual report to INVIMA (Article 24, Decree 4725 of 2005), will ensure your importer of record or distributor has a current post-market surveillance program (PMS), and follows Colombian regulations (Ministry of Health, Resolution 4816 of 2008).
This offering includes,
- We will place our name, mailing address, email address, and phone number on your device submissions and registrations to INVIMA.
- Upon request by INVIMA, we will provide information about your device, and names and addresses of distributors established in Colombia. We will have access to your device documentation for inspection by INVIMA if requested. Note that we can only supply this information for inspection by INVIMA upon written permission from you and cannot share it with any other person or entity.
- We will assist you in making changes (e.g., switching importer of record) to your existing registration certificate.
- We will be available to coordinate inquiries, analysis and responses for reportable adverse events as reported by users, distributors, importers of record or INVIMA. We will help you determine the best response.
- We will provide technical assistance for the reporting of adverse events as reported by users, distributors, and importer of record.
- We will make certain your distributor or importer of record follows Colombia's post-market surveillance regulations (Resolution 4816 of 2008).
- We will be available to act as a liaison between INVIMA and you in case of recall or risk for product withdrawal from the market.
We will submit to INVIMA the required annual report (Article 24, Decree 4725 of 2005) stating:
Number of imported devices
Number of sold devices
Location of all sold devices
Serial number of all sold devices
Serious adverse events and the actions taken
*FREE if purchased with our INVIMAREADY™ medical device registration offering. If purchased separately, price is USD $3,999/year (payable one-year in advance). Excludes translation and any applicable INVIMA fees related to making changes to your existing registration certificate.