logoSign upLog in
Buzzes
  1. ProducerJulio G. Martinez-Clark
    How Can Medical Device Companies Avoid Being Taken Advantage of by a Distributor and Have Total Control over their Sales in Colombia
    How Can Medical Device Companies Avoid Being Taken Advantage of by a Distributor and Have Total Control over their Sales in ColombiaIt is strongly recommended that foreign medical device manufacturers process the registration under their name and not under the local distributor name or else the foreign company will not be able to change or add distributors during the lifetime of...
    Relevant
  2. ProducerJulio G. Martinez-Clark
    9 Steps for Medical Device Companies to Register and Sell their Products in Colombia
    9 Steps for Medical Device Companies to Register and Sell their Products in ColombiaColombia has over 48 million residents and is a very strong market for foreign medical device manufacturers. Interested in entering this market? This article explains the process of obtaining regulatory approval from INVIMA, the country's regulator....
    Relevant
  3. ProducerJulio G. Martinez-Clark
    How Can Medical Device Companies Find a Distributor to Increase Sales and Growth in Latin America
    How Can Medical Device Companies Find a Distributor to Increase Sales and Growth in Latin AmericaForeign manufacturers that have been involved in penetrating new overseas markets understand that finding the right distributor is a challenge. Most relationships that initially seemed promising begin to deteriorate when the distributor doesn't meet...
    Relevant
  4. ProducerJulio G. Martinez-Clark
    How Can Medical Device Companies Access the Latin American Market to Increase Sales and Achieve Long-Term Growth
    How Can Medical Device Companies Access the Latin American Market to Increase Sales and Achieve Long-Term GrowthEven if you are used to doing business in your own country or a market that is essentially similar to your own, it is always difficult to enter a new market or region. But when entering another continent or part of one, an additional set of problems...
    Relevant
  5. Julio G. Martinez-Clark
    Colombia's Ministry of Health (MoH) has one of the fastest regulatory approval times in Latin America: 30 days. Colombia's clinical trial regulatory agency —INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos)— is a dependency of Colombia's MoH. The site's Institutional Review Board (IRB)/ethics committee and INVIMA must evaluate and approve all research on human beings in Colombia. Both the IRB and INVIMA will evaluate the study protocol, the investigator's brochure, the patient informed consent form (ICF), the case report form (CRF), all information about the investigational product (e.g., biocompatibility tests, reports of unexpected adverse events), an insurance policy, and all advertising material planned to recruit patients. You must also apply for an import permit at VUCE (Ventanilla Única de Comercio Exterior) —an office within Colombia's Ministry of Commerce, Industry, and Tourism (MinCIT).
    Julio G. Martinez-Clark
    3 Steps for a Medical Device Startup to Run a Foreign Clinical Trial in Colombia and Cost-Effectively Gather Data for FDA/CE Mark Approval
    www.linkedin.com Colombia's Ministry of Health (MoH) has one of the fastest regulatory approval times in Latin America: 30 days. Colombia's clinical trial...
    Relevant