Posts tagged regulatory representation
Frequently Asked Questions About Medical Device INVIMA Regulatory Registration, Legal Representation, and Importer of Record (IOR) in Colombia
Frequently Asked Questions About Medical Device INVIMA Regulatory Registration, Legal Representation, and Importer of Record (IOR) in Colombia

Colombia's medical device market is regulated by the National Food and Drug Surveillance Institute (INVIMA). In order to market your device in Colombia, you must obtain sanitary registration from INVIMA.

INVIMA requires that your medical device is approved in a GHTF-founding member country (i.e., Australia, Canada, European Union, Japan, and the United States of America) or from a country that has an existing regulatory agreement of mutual recognition with Colombia.

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FAQ, RegulatoryJulio G. Martinez-Clarkcolombia medical, device register, colombia timeline, timeline of colombia, colombian medical device approval, medical device registration colombia, device registration, regulatory process, regulatory representation, regulatory consulting, device regulations, category device, country representation, representation regulatory, legal representative, FAQComment
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