Colombia - Country Commercial Guide
Medical Equipment

This is a best prospect industry sector for this country. Includes a market overview and trade data.

Last published date: 2021-11-08

Overview

Colombia is the third-largest medical device market in Latin America, after Brazil and Mexico. The medical device market represents around five percent of Colombia´s health expenditure. It relies overwhelmingly on imports, which made up about 80 percent of the market during 2019, despite solid domestic production focused mainly on consumables concentrated at the low technology end of the market. It is expected to expand by a compound annual growth rate (CAGR) of 7.1 percent in U.S. dollar terms from 2020-2025 according to Fitch Solutions.

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

According to the National Business Association of Colombia (ANDI), the U.S. was the leading supplier in 2020, with almost 25 percent of the total. China and Germany were second and third suppliers, China with around 15 percent and Germany with nine percent.  Fitch Solutions forecasts Colombia´s medical device market growth is unlikely to return to pre-pandemic levels until 2022. In the long term, the market will be supported by epidemiological changes and healthcare sustainability.

Colombia’s Medical Devices Imports and Exports

 

2018

2019

2020 (est.)

2021 (est.)

Total Exports

72

74

77

Not Available

Total Imports

1,145

1,134

1,160

1,176

Imports from the U.S.

281

274

Not available

Not Available

Units: USD millions
Source: Fitch Solutions

Among the top U.S. medical equipment exports to Colombia in 2020 were personal protection equipment (PPE), ventilators, diagnostic reagents, surgical instruments, and orthopedics and prosthetic products.

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 currently covers around 96 percent of the population thanks to Law 100 of 1993. All citizens, irrespective of their ability to pay, are entitled to a comprehensive health benefits package.

Leading Sub-Sectors

While there was an increased demand for products like personal protection equipment (PPE) and ventilators due to COVID-19 and the deterioration in economic activity caused by the pandemic, the medical devices market is recovering and will continue to grow.

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

  • Laboratory consumables and equipment
  • Medical, surgical, and dental instruments
  • Orthopedic devices
  • Prosthetic devices
  • Electro-diagnostic apparatus
  • Diagnostic imaging equipment
  • Intensive care, cardiology, neurology, and oncology-related equipment

Opportunities

Colombia spent nine percent of its gross domestic product (GDP) on healthcare in 2020, and the medical devices market represents almost five percent of health expenditure. 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 do import equipment and supplies directly.

The medical device industry is concentrated around the capital of Bogota and the department of Antioquia. The National Statistics Department (DANE) reported that consumables were the most significant product area representing 45.6 percent in 2017, with syringes, needles & catheters representing more than half of consumables; orthopedics & prosthetics (17 percent) and dental products (ten percent).

While there is some domestic capacity for manufacturing basic items, the medical device market relies heavily on imports, especially for more high-tech items. A few multinationals manufacture within the country. 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 must be aware that medical devices require registration with INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos). INVIMA continues to work on regulatory co-operation 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 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.

Colombia’s device classification system is similar to the European Union and other Global Harmonization Task Force (GHTF) systems. 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 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 Devices sector is highly regulated and supervised. Decree 4725 of 2005 provides the legal framework for the sector and regulates the system of health records, marketing authorizations, and surveillance of medical devices. U.S. exporters should review the following resolutions and decrees when considering market opportunities in Colombia:

  • Resolution 4816 of 2008: regulates techno vigilance criteria and activities
  • Resolution No. 529, issued in 2004, partially modifies Resolution No. 434, published in 2001, regarding the acquisition of controlled biomedical technology
  • Resolution 4002 of 2007: regulates the scope of a Certificate of Storage Capacity
  • Decree 4957 of 2007: regulates deadlines for obtaining the sanitary registration or the marketing approval of medical devices of human use
  • External Circular No. 3052, issued in 2016, establishes the documentation needed for medical device kits.
  • Resolution 1319 of 2010: regulates GMPs (good manufacturing practices) for the customized medical devices manufacturing and processing
  • Resolution No. 2020012926, issued in 2020, modifies administrative procedures due to Covid-19. It includes changes to the medical devices doctorate and the biological medicines and medicines doctorate
  • Law 9 of 1979: sets the basic regulations for medical devices and also sets sanctions and prohibitions

Trade Events

Meditech-Colombia

July 12-15, 2022
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.Fimenez@trade.gov

U.S. Commercial Service Bogotá

+57 (313) 275-2764
https://www.trade.gov/colombia