Trial, register, and sell your product in Colombia

 

MARKET ENTRY, MARKET ACCESS, CLINICAL TRIALS, AND INVIMA REGULATORY CONSULTING IN COLOMBIA FOR DRUGS, MEDICAL DEVICES, DIETARY SUPPLEMENTS, FOOD, ALCOHOLIC BEVERAGES, AND PERSONAL HYGIENE PRODUCTS

  • Regulatory registration

  • Trademark registration

  • Legal representation

  • Distributor search & due diligence

  • Clinical trial site selection and approval

  • Market entry research and strategy

  • Market access, health economics and outcomes research (HEOR), health technology assessment (HTA) 

  • New entity set up and incorporation


Bogota-Colombia-Night-Medical Device Regulatory Registration at Invima.jpg

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

INVIMAREADY™_Medical device regulatory registration in Colombia.png

INVIMA Registration

GAIN MARKET AUTHORIZATION AT INVIMA IN COLOMBIA FAST. RETAIN OWNERSHIP OF YOUR REGISTRATION. MAINTAIN INDEPENDENCE FROM LOCAL DISTRIBUTORS. QUICKLY START SELLING YOUR INVIMA-REGULATED PRODUCT IN COLOMBIA NOW.

Includes: 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. Search and selection of logistics operator as importer of record. Document review, dossier submission, and responses to INVIMA requests for additional information. Read more here

Timeline: Varies per product classification. Read more here

Price (USD): Cosmetics, food, personal hygiene, dietary supplements, alcoholic beverages: 2,199. Medical devices: Class I, 2,499; Class IIa, 3,499; Class IIb, 5,499; Class III, 7,799. Drugs: 9,999.

REPREADY™_Regulatory legal representation in Colombia.png

Registered Agent 

HAVE AN AUTHORIZED REGISTERED AGENT IN COLOMBIA. LET US FILE YOUR MANDATED ANNUAL REPORT WITH INVIMA. ENSURE YOUR DISTRIBUTORS COMPLY WITH LOCAL POST-MARKET SURVEILLANCE REGULATIONS.

Includes: Becoming your authorized registered agent in Colombia and placing our name, mailing address, email address, and phone number on your product submission at INVIMA. We will represent your legal and business interest in Colombia. We will facilitate changes (e.g. switching importer of record, title holder, storage facility) to your existing registration certificate. We will facilitate the submission of your mandated annual report to INVIMA to ensure distributor compliance of post-market surveillance regulations. Applies to one (1) registration certificate. Read more here

Duration: 1 year

USD 2,999/year

SALESREADY™_Medical device distributor search and selection in Colombia.png

Distributor Search

FIND THE RIGHT DISTRIBUTOR PARTNER TO SELL YOUR PRODUCT IN COLOMBIA. CONDUCT DUE DILIGENCE, LEARN ABOUT THE FINANCIAL, COMMERCIAL, AND OPERATIONAL STRENGTH OF POTENTIAL DISTRIBUTORS.

Includes: One-hour regulatory and business strategy session to review of your market readiness (i.e. distributor contract, website, marketing material), searching, and conducting due diligence for the selection of a distributor for your product.

Timeline: 2-3 months

USD 6,999

MARKREADY™_Medical device trademark registration in Colombia.png

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 to determine if your trademark was already registered in Colombia, and trademark application in Colombia (assembly of the application and submission to have your trademark registered at Colombia's patent office).

Timeline: 4 months

USD 1,799