Overview

Colombia is the third-largest medical device market in Latin America, after Brazil and Mexico. The medical device market represents around 5 percent of Colombia´s health expenditure. It is highly competitive and relies overwhelmingly on imports, which made up about 83 percent of the market in 2021. Domestic production is focused on low-tech consumables. According to Fitch Solutions, the medical device market is expected to expand by a compound annual growth rate (CAGR) of 6.5 percent in U.S. dollar terms from 2021 to 2026.

Since the implementation of the U.S.-Colombia Trade Promotion Agreement (TPA) in 2012, most U.S. medical equipment exports to Colombia have been duty free. Colombia also has Free Trade Agreements (FTA) with leading medical device producers such as the European Union and Canada.

According to Fitch Solutions, China is the dominant leading supplier of medical devices to Colombia. Chinese shipments amounted to around USD 270mn in 2020, 26.5 percent of the total imports. The United States was the second leading supplier, with USD 239.6 million, 23.7 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 87.6 million, equal to 8.7 percent of the total and almost identical to its 2019 value. Mexico was the fourth leading supplier, with around USD 38 million, equivalent to 3.7 percent of the total. Overall, the European Union accounted for USD 206.8 million, equal to just over 20 percent of the total.

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), which in March 2019 covered 95.4 percent of the total population 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.

Leading Sub-Sectors

The general trend for import quantity saw the most significant increase in patient aids, predominantly therapeutic respiratory apparatus, used in critical care units for severe Covid-19 cases. Diagnostic imaging and orthopedics & prosthetics had outstanding import shares.

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 4.6 percent of health expenditure in Colombia in 2021. The Government of Colombia is the primary buyer, and U.S. companies can find public tender opportunities at the Ministry of Health (MoH) website and at 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 after-sales services. However, some of the country’s largest end-users import equipment and supplies directly.

The medical device industry is concentrated around the capital of 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. This strategy has been used effectively in Colombia by European manufacturers.

Registration Process

The National Drug and Food Regulatory Agency INVIMA (Colombia’s regulatory authority) 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 (Instituto Nacional de Vigilancia de Medicamentos y Alimentos). 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 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 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 not easy 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

Regulations

The Medical Devices 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 12-15, 2022 (Next fair is scheduled to take place in 2024 with exact dates TBC).
Bogotá, Colombia

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

Medical Devices Commercial Specialist
Rafael.jimenez@trade.gov

U.S. Commercial Service Bogotá
+57 (601) 275-2764
https://www.trade.gov/colombia