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: 2020-10-29

Overview

Economic uncertainty due to the COVID-19 pandemic and a depreciated Colombian peso will slow down medical device imports in 2020, according to Business Monitor International (BMI). The market is predicted to recover to pre-COVID-19 levels in 2022. However, the Colombian medical devices market relies overwhelmingly on imports, which made up about 93.7 percent of the market during 2018, despite strong domestic production focused mainly on consumables.

On March 3rd, 2020, President Duque appointed the new Health Minister Fernando Ruiz Gómez, who is carrying out contentious measures to deal with COVID-19 as a key priority.

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

Table 7: Colombia’s Medical Equipment Exports

 

2017

2018

2019 (est.)

2020 (est.)

Total Exports

67

72

77

Not Available

Total Imports

1,030

1,145

1,154

1,141

Imports from U.S.

263

281

Not available

Not Available

Units: USD millions
Source: World Trade Atlas; Industry Associations 

According to BMI, domestic production of medical devices is concentrated at the low technology end of the market. U.S. imports make up the largest share of the Colombian market, accounting for 30.1 percent of all medical equipment imports in 2018, followed by China (14.4 percent), Germany (9.0 percent), Ireland (4.4 percent) and Mexico (4.4 percent), with China quickly increasing market share.

Among the top U.S. medical equipment exports to Colombia in 2018 were orthopedics and prosthetic products, electro-medical instruments, electrodiagnostic apparatus, diagnostic reagents, and medical supplies.

The country’s healthcare infrastructure is adequate in the larger urban areas but is generally in need of modernization and expansion. The Colombian government provides a universal medical system known as the “General System of Social Security in Health” (SGSSS, or Sistema General de Seguridad Social en Salud), which currently covers 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 benefit package.

Leading Sub-Sectors

While there will be an increasing demand for products like personal protection equipment (PPE) and ventilators, most of the other medical devices will experience a demand decrease. This is due to the placement of healthcare resources for COVID-19 as a priority and the deterioration in economic activity caused by the virus.

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

  • Orthopedic devices
  • Prosthetic devices
  • Electro-diagnostic apparatus
  • Medical, surgical, and dental instruments
  • Diagnostic imaging equipment
  • Laboratory equipment and consumables
  • Ultrasound, mammography, and cardiovascular equipment
  • Intensive care, cardiology, neurology and oncology-related equipment
  • Clinical laboratory equipment for hospital upgrades

Opportunities

Colombia spent six percent of its gross domestic product (GDP) on healthcare in 2018, and the medical devices market represents over five percent of health expenditure. The Government of Colombia is the main buyer and U.S. companies can find public tender opportunities at the Ministry of Health (MoH) web site and at the Colombia Compra Eficiente web site (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 market is through a local partner such as a distributor. Colombian companies prefer to buy from companies located in Colombia 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.

While there is some domestic capacity for manufacturing basic items, the medical device market is heavily reliant 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 so end-users can familiarize themselves with the equipment. This strategy has been used effectively in Colombia by European manufacturers.

Registration Process

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). 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.

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.

Access to this market is not easy for newcomers. The market is mature and competitive, with many foreign firms selling medical equipment and medical products. 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 following below, please be advised that this is not an exhaustive list and does not constitute a recommendation or endorsement of these firms.

BioaccessJulio 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
  • Decree 3770 of 2004: regulates sanitary records and sanitary surveillance for diagnostic reactives
  • Resolution 434 of 2001: sets norms for the evaluation and importation of biomedical technologies and provides surveillance and control competencies to national agencies such as INVIMA
  • Resolution 4002 of 2007: regulates the scope of a Certificate of Storage Capacity
  • Resolution 2434 of 2006: remanufactured and repowered biomedical equipment Class II
  • Decree 4957 of 2007: regulates deadlines for obtaining the sanitary registration or the marketing approval of medical devices of human use (registration will take between one to six months)
  • Decree 1571 of 1993: provides diverse specifications for blood centers
  • 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 2019058384, issued on December 27 2019, updated  fees in terms of Tax Value Units (UVT - Unidades de Valor Tributario), effective from January 1, 2020.
  • Law 9 of 1979: sets the basic regulations for medical devices and also sets sanctions and prohibitions

Trade Events

Meditech-Colombia

March 9-12, 2021

Bogotá, Colombia

Web Resources

Ministry of Health (Ministerio de Salud y Protección Social)