Posts tagged papers regulations
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 Colombia

It 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 the registration, which is 10 years. 

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Market Access, Regulatory, INVIMA, ColombiaJulio G. Martinez-Clarkcolombia medical, device register, colombia timeline, colombian timeline, timeline of colombia, colombian medical device approval, medical device registration colombia, device registration, regulatory process, regulatory representation, regulatory consulting, device regulations, papers regulations, category device, country representation, representation regulatory, legal representativeComment
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 Colombia

Colombia 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. Topics covered include regulations, classes of devices, appointing an independent representative, review times for the controlled and non-controlled products, and registration timelines.

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Market Access, Regulatory, INVIMA, ColombiaJulio G. Martinez-Clarkmedical device registration colombia, colombia medical, device register, colombia timeline, colombian timeline, timeline of colombia, colombian medical device approval, device registration, regulatory process, regulatory representation, regulatory consulting, device regulations, papers regulations, category device, country representation, representation regulatory, legal representativeComment