We help you formulate a regulatory strategy for your medical device
Commercial medical devices in Colombia require registration with INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos), the country’s medical device regulator. 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 will qualify for an automatic certificate upon notification to INVIMA —it will be able to sell its devices immediately.
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 a third-party logistics operator as their importer of record. This logistics operator will be able to import and store your product in its INVIMA-certified warehouse in Colombia.
Upon your instructions, the logistics operator will ship your devices to the local distributor of your choice. By having a logistics operator as your importer of record, you will be able to have several distributors in Colombia —they place an order with you, and the logistics operator will ship your devices 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.
Why choose Interventional Concepts to assist you with your medical device regulatory market access needs in Colombia?
We have extensive experience helping foreign medical device manufacturers register their products in Colombia. We are incorporated both in the US and in Colombia. We have the resources and expertise to serve as your in-country legal representative in order to bring your medical devices to market in Colombia. Acting as your independent legal representative, we can focus fully on Colombian regulatory affairs and how they affect your product registration, as well as to assign Colombian distributors based on your sales and marketing requirements.
Trust us with your regulatory needs in Colombia
- We maintain a local presence to represent your regulatory interests in Colombia
- We have extensive experience in regulatory issues including National Food and Drug Surveillance Institute (INVIMA) compliance
- We have extensive experience registering medical devices at INVIMA
- We have extensive sales, marketing, business development, and distributor management experience in Latin America
- We have a comprehensive knowledge of the Colombian health care market and business culture
- We are a US-based business with local presence in Colombia and with multilingual capabilities
- We stay up to date on the latest Colombian regulatory issues to ensure that you experience a smooth and efficient registration
- We will translate and prepare registration materials for submission, communicate with INVIMA on your behalf, and assist with post-market surveillance regulations and claims against your device
- We can assist you with the search, evaluation and selection of an importer of record so that you have full logistical and market control over your product distribution
- We can assist you with the search, evaluation and selection of a local commercial distributor partner in Colombian based on your sales and marketing requirements
- We will make sure you comply with Colombia's post-marketing surveillance regulations
- We can assist you with registering your trademark in Colombia to protect the trademark from infringement by third parties
- We can assist you with the product registration renewal process