Overview

Colombia is Latin America’s third-largest medical device market after Brazil and Mexico. The medical device market represents around five percent of Colombia’s health expenditure. It is highly competitive and overwhelmingly relies on imports, which made up about 89 percent of the market in 2022. Domestic production focuses primarily on low-tech consumables. According to Fitch Solutions, the medical device market expects to expand by a compound annual growth rate (CAGR) of 2.1 percent in U.S. dollar terms from 2022 to 2027.

Since implementing the U.S.-Colombia Trade Promotion Agreement (CTPA) in 2012, most U.S. medical equipment enter Colombia without tariffs. Colombia also has Free Trade Agreements (FTAs) with leading medical device producers, such as the European Union and Canada.

The United States was the dominant leading supplier of medical devices to Colombia in 2021. U.S. shipments were valued at USD 284.4 million in 2021, 24.8 percent of total imports. China was the second leading supplier, with USD 246.7 million, 21.5 percent of the total. Colombia’s leading imports from the United States were instruments and appliances used in surgery. Germany supplied imports valued at USD 106.1 million, equal to 9.3 percent. Mexico was the fourth leading supplier, with around USD 50.1 million, equivalent to 4.4 percent of the total. (Fitch Solutions)

Table: Colombia’s Medical Devices Imports and Exports

Units: USD millions

Source: Fitch Solutions

The country’s healthcare infrastructure is adequate in the larger urban areas but generally needs modernization and expansion. The Government of Colombia provides universal medical coverage known as the “General System of Social Security in Health” (SGSSS, or Sistema General de Seguridad Social en Salud) thanks to Law 100 of 1993, which states that all citizens, irrespective of their ability to pay, are entitled to a comprehensive health benefits package.

In February 2023, President Gustavo Petro presented a controversial health reform bill. It aims to improve primary care, expand access to treatment, raise healthcare worker salaries, and eliminate private sector management of payments to fight corruption. This reform could set up primary care centers to guarantee swift patient care, increasing opportunities in the medical devices market.

Leading Sub-Sectors

The general trend for import quantity saw the most significant increase in consumables. Diagnostic imaging and orthopedics & prosthetics encompassed the majority of import shares. Dental product imports increased sharply in 2021 as dental procedures recovered post-COVID 19.

Best prospects for U.S. medical devices manufacturers include:

• Laboratory consumables and equipment
• Diagnostic imaging equipment
• Electro-diagnostic apparatus
• Medical, surgical, and dental instruments
• Orthopedics & prosthetics

Opportunities

The medical device market represented 5.3 percent of health expenditure in Colombia in 2022. The Government of Colombia is the primary buyer, and U.S. companies can find public tender opportunities on the Ministry of Health (MoH) website and on the Colombia Compra Eficiente website (Colombia Compra Eficiente is the government’s Public Procurement System, and it offers participants tools to facilitate the tender process in the Colombian Public Procurement System).

The best approach to enter the Colombian medical device market is through a local partner, such as a distributor. Colombian companies prefer to buy from companies with a local presence that can provide in-country after-sale services; however, some of the country’s largest end-users import equipment and supplies directly.

The medical device industry is concentrated in Bogota and the Department of Antioquia. A few multinationals manufacture within the country. While there is some domestic capacity for manufacturing basic items, the medical device market relies heavily on imports, especially for more high-tech items. U.S. manufacturers should maintain close contact with end-users and provide training and demonstrations to familiarize them with the equipment.

Registration Process

The National Drug and Food Regulatory Agency (Instituto Nacional de Vigilancia de Medicamentos y Alimentos or INVIMA) is in charge of inspecting and supervising the marketing and manufacturing of health products, identifying and evaluating the violation of health standards and procedures, implementing best practices, and providing medical approval for the import and export of products.

U.S. companies should be aware that medical devices require registration with INVIMA. INVIMA continues to work on regulatory cooperation as part of the Pacific Alliance and has implemented ‘Invima a un clic’, a new tool to submit sanitary registrations virtually. It is strongly recommended that U.S. companies process the registration under their name rather than under the local distributor’s name; otherwise, the U.S. company will not be able to change or add distributors until the registration’s expiration, which is ten years.

Colombia’s device classification system is similar to the European Union and other Global Harmonization Task Force (GHTF) systems. The classification of devices in Colombia follows a four-tiered risk model (Class I, Class IIa, Class IIb, and Class III). 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. The market is mature and highly competitive, with many foreign firms selling medical equipment and medical products. Access to this market is challenging for newcomers. It should be noted that the registration procedures can often be challenging and may pose a barrier to entry.

There are many firms in Colombia with expertise in product registration, including the list below. Please be advised that this is not an exhaustive list and does not constitute a recommendation or endorsement of these firms.

Bioaccess – Julio G. Martinez-Clark

SPI Americas - Alvaro Enrique Rincón Mautner

Regulation

The medical device sector is highly regulated and supervised. Decree 4725 of 2005 provides the legal framework for the sector and regulates the health records system, marketing authorizations, and surveillance of medical devices. U.S. exporters should review the following resolutions and decrees when considering market opportunities in Colombia:

Decree No. 582, issued on April 4, 2017, modifies Decree No. 4725, issued in 2005. It concerns the registration of medical devices.

Decree No. 38, issued in 2009, adds a paragraph to Article 24 of Decree No. 4725, issued in 2005.

Decree No. 3275, issued in 2009, modifies Article 1 and adds a paragraph to Article 18 in Decree No. 4725, issued in 2005.

Resolution No. 2020012926, issued in 2020, modifies administrative procedures due to COVID-19.

Resolution No. 1319, issued in 2010, regulates GMPs to manufacture and adapt custom-made prosthetic and external orthopedic devices.

Resolution No. 4816, issued in 2008, regulates the National Tecnovigilance Programme.

External Circular No. 2453, issued in 2015, regulates medical device samples.

External Circular No. 290, issued in 2009, regulates the plans for the gradual implementation of the regulation established by Resolution No. 4396, issued in 2008.

External Circular No. 300-2346, issued in 2008, establishes the expiry date to obtain registrations for aesthetic equipment.

Trade Events

Meditech-Colombia

International Health Fair with Congress of Hospitals and Clinics (every other year)

July 9-12, 2024

Bogotá, Colombia

Web Resources                     

Ministry of Health (Ministerio de Salud y Protección Social)

Colombia Compra Eficiente

National Drug and Food Regulatory Agency (Instituto Nacional de Vigilancia de Medicamentos y Alimentos - INVIMA)

Institute of Health Studies and Technologies (Instituto de Estudios y Tecnologías en Salud – IETS)

For additional information, including market analysis, trade events, and the products and services that the U.S. Commercial Service can provide to help you succeed in the Colombian market, please contact:

U.S. Embassy Bogotá

Rafael Jiménez

Commercial Specialist

Rafael.jimenez@trade.gov

U.S. Commercial Service Bogotá

+57 (601) 275-2764

https://www.trade.gov/colombia