Regulatory Offering

We offer foreign companies a wide range of regulatory offerings to successfully enable them to conduct trials and access the Colombian market

INVIMA REGULATORY REGISTRATION IN COLOMBIA FOR DRUGS, MEDICAL DEVICES, DIETARY SUPPLEMENTS, FOOD, AND PERSONAL HYGIENE PRODUCTS

  • Regulatory registration

  • Trademark registration

  • Regulatory in-country legal representation

  • Distributor search & due diligence

  • Clinical trials

  • New entity set up and incorporation


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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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INVIMA Regulatory Registration

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

Includes: FREE & unlimited regulatory and business strategy sessions to review of your market readiness (i.e. gap analysis, distributor contract, website, marketing material, choice of distributor and/or importer of record) and to answer all your pre and post-submission questions. FREE search and selection of logistics operator as importer of record. Document review, dossier submission, and responses to INVIMA requests for additional information (if applicable).

Timeline: Varies per product clasification

ASK FOR QUOTE

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Regulatory Legal Representation 

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

Includes: Becoming your registered agent in Colombia and placing our name, mailing address, email address, and phone number on your product submissions and registrations at INVIMA. Representation of your legal and business interest in Colombia. Unlimited changes (e.g. switching importer of record, title holder, storage facility) to your existing registration certificate. Facilitation of the submission of your mandated annual report to INVIMA to ensure distributor compliance of post-market surveillance regulations. 

Duration: 1 year

Price: 2,999/year*

*Payable one-year in advance. Fee is for one (1) registration certificate regardless of the type of product. Excludes translations to Spanish or English and any applicable INVIMA fees. 

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Medical Product Distributor Search

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

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

Timeline: 2-3 months

USD 6,999

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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: Assembly of the application and submission to have your trademark registered at Colombia's patent office and payment of official fee. 

Timeline: 4 months

USD 999

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Full Market Access Package 

SAVE 22%. 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

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