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. 

Colombia has over 48 million residents and is a very strong market for foreign medical device manufacturers. Interested in entering this market? 

Marketing your medical device in Colombia requires registration with the National Food and Drug Surveillance Institute (INVIMA), the country’s medical device regulator.

INVIMA requires foreign manufacturers to name one importer of record —an entity certified by INVIMA to store medical products— in their registration application. However, if you choose your distributor as your importer of record, you will be limited to having only one distributor in Colombia —as opposed to having several ones that will cover the whole country.

It is advisable that foreign manufacturers choose third-party logistics operators as their importer of record. This third-party will be able to import and store your product in its INVIMA-certified warehouse in Colombia. Upon your instructions, the third-party will ship your products to the local distributor of your choice.

By having a third-party as your importer of record, you will be able to have several distributors in Colombia —they place an order with you, and the third-party will ship the products domestically to your distributor's preferred destination in Colombia.

Commercial medical devices in Colombia require registration with INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos), the country’s medical device regulator. 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

Classification of devices in Colombia follows a four-tiered risk model (Class I, Class IIa, Class IIb and Class III). Colombia’s device classification system is similar to those of the European Union and other Global Harmonization Task Force (GHTF) systems. If the device falls into a lower-risk category in Colombia (Class I or IIa), the company may qualify for an expedited review and achieve market entry in a shorter time.

INVIMA requires foreign manufacturers to name one importer of record —an entity certified by INVIMA to store medical products— in their registration application. However, if you choose your distributor as your importer of record, you will be limited to having only one distributor in Colombia —as opposed to having several ones that will cover the whole country.

It is advisable that foreign manufacturers choose third-party logistics operators as their importer of record. This third-party will be able to import and store your product in its INVIMA-certified warehouse in Colombia. Upon your instructions, the third-party will ship your products to the local distributor of your choice.

By having a third-party as your importer of record, you will be able to have several distributors in Colombia —they place an order with you, and the third-party will ship the products domestically to your distributor's preferred destination in Colombia. Interventional Concepts can help you find an INVIMA-certified third-party logistics operator in Colombia that can act as your importer of record. 

It is important to choose a reputable distributor when entering the Colombian market, as the wrong one can lead to missed sales opportunities, poor relationships with end users and a damaged brand name. Working with local experts ensures that distributors are chosen objectively and evaluated with your specific business needs in mind.

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About Julio G. Martinez-Clark: Julio is CEO of Interventional Concepts, Inc. —a Miami, FL-based market access company for medical device companies looking to expand their market and sell their products in Colombia —and the rest of Latin America. The company offers a wide range of market access options including regulatory product registration, legal representation, distributor search, and trademark registration. Learn more.