Our Offering

We offer medical device companies a wide range of regulatory offerings to successfully enable them to access the Colombian market and achieve long-term growth

 

This is what we can do for your medical device:

  • Regulatory registration

  • Trademark registration

  • Regulatory in-country legal representation

  • Distributor search & due diligence


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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.

Source: Export.gov

 

Pricing

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Medical Device Regulatory Registration

RETAIN OWNERSHIP OF YOUR REGISTRATION. MAINTAIN INDEPENDENCE FROM LOCAL DISTRIBUTORS. GET YOUR MEDICAL DEVICE REGISTRATION CERTIFICATE AT INVIMA. QUICKLY START SELLING YOUR DEVICE IN COLOMBIA

Includes: One-hour regulatory and business strategy session, review of your market readiness (i.e., distributor contract, website, marketing material). Search and selection of logistics operator as importer of record. Document review, dossier submission, and payment of INVIMA official fee.

Estimated time: 4-6 months

USD 5,999

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Medical Device Regulatory Legal Representation 

YOU MUST HAVE A LEGAL REPRESENTATIVE IN COLOMBIA. YOU MUST FILE AN ANNUAL REPORT. YOU MUST ENSURE YOUR DISTRIBUTOR COMPLY WITH LOCAL POST-MARKET SURVEILLANCE REGULATIONS

Includes: Our name, mailing address, email address, and phone number on your device submissions and registrations to INVIMA. Changes (e.g., switching importer of record, title holder, storage facility) to your existing registration certificate. Submission of mandated annual report to INVIMA. Ensure distributor compliance of post-market surveillance regulations. 

Duration: 1 year

USD 2,999/year

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Medical Device Distributor Search

CONDUCT DUE DILIGENCE. LEARN ABOUT THE REPUTATION AND FINANCIAL STRENGTH OF YOUR DISTRIBUTOR. FIND THE RIGHT DISTRIBUTOR PARTNER TO SELL YOUR DEVICE IN COLOMBIA. COMPLY WITH COLOMBIA'S CONTRACT LAW

Includes: One-hour session to review your strategy in Colombia. Review of your market readiness (i.e., distributor contract, marketing material), search of logistics operator/importer of record, searching/conducting due diligence/selecting a distributor for your medical device.

Estimated time: 2-3 months

USD 6,999

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Medical Device Trademark Registration

RETAIN CONTROL OF YOUR INTELLECTUAL PROPERTY. MAKE SURE YOUR BRAND IS PROTECTED BEFORE MAKING ANY MOVE INTO LATIN AMERICA. PROTECT YOUR BRAND AGAINST TRADEMARK INFRINGEMENT IN COLOMBIA

Includes: Trademark search in Colombia: Determine the probabilities your trademark has of being successfully registered in Colombia. Trademark application in Colombia: Submission to have your trademark registered at Colombia's patent office and payment of official fee. 

Estimated time: 4 months

USD 999

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Full Market Access Package 

SAVE 20%. We will TAKE CARE OF ALL YOUR MARKET ACCESS NEEDS IN COLOMBIA. IN just a few MONTHS YOU WILL BE ABLE TO FREELY SELL YOUR MEDICAL DEVICE IN COLOMBIA

INCLUDES OUR INVIMAREADY™, MARKREADY™, REPREADY™ (3 years), AND SALESREADY™ OFFERING. ALL FOR ONE SINGLE AFFORDABLE INVESTMENT

usd 15,999