This is a best prospect industry sector for this country. Includes a market overview and trade data.
Last Published: 8/17/2018
Overview
The Colombian medical devices market relies overwhelmingly on imports, which made up about 93% of the market during 2017, despite strong domestic production focused mainly on consumables. Since the implementation of the U.S.-Colombia Trade Promotion Agreement (TPA) with the United States in 2012, 96% of U.S. medical equipment exports to Colombia receive duty free treatment.

According to BMI Research, 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 31.8% of all medical equipment imports, followed by China (13.3%), Germany (8.4%), Ireland (4.8%) and Switzerland (4.5%), with China quickly increasing market share.

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 and Turkey. Among the top U.S. medical equipment exports to Colombia in 2017 were instruments and apparatus such as electro medical instruments, electrodiagnostic apparatus, diagnostic reagents, and medical supplies, which includes orthopedic and fracture articles and prosthesis.

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% of the population thanks to Law 100 of 1993, whereby all citizens, irrespective of their ability to pay, are entitled to a comprehensive health benefit package.

 
 2015201620172018 estimated
Total Exports676769Not available
Total Imports 1,1109839721,122
Imports from U.S396317263Not Available
Exchange RatesCOP 2,746COP 3,053COP 2,951COP 3,000
Source: BMI Research, millions of USD
 
Leading Sub-Sectors
Best prospects for U.S. medical equipment manufacturers include:
  • Medical, surgical, dental and veterinary instruments
  • Electro-diagnostic apparatus
  • Orthopedic devices, hearing aids
  • Prosthetic devices
  • Diagnostic imaging equipment
  • Laboratory equipment and consumables
  • Ultrasound, mammography, and cardiovascular equipment
  • Dermatological and laser treatment apparatus and apparel (boosted by medical tourism and growing demand for plastic surgery)
  • Intensive care, cardiology, neurology and oncology-related equipment
  • Clinical laboratory equipment for hospitial upgrades
  • Medical, surgical, dental instruments and electro medical equipment
 
Opportunities
Colombia spent 6.8% of its gross domestic product (GDP) on healthcare in 2017. The Government of Colombia is the main buyer and U.S. companies can find public tender opportunities in 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.

There are many high-quality hospitals and clinics located throughout Colombia that provide both general and specialized medical services. There will be upcoming tenders in Bogota for five hospital projects: two new hospitals will be constructed, and three hospitals will have major upgrades and overhauls. Four of these projects will be public private partnerships and one will be done through public works. These projects will add 1,272 beds and nearly 670,000 square feet of infrastructure to Colombia’s health system.

The best approach to enter the Colombian market is through a local partner such as a distributor, as 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 three below. Please be advised that this is not an exhaustive list and this does not constitute a recommendation or endorsement of these firms.

SPI Americas
Alvaro Enrique Rincón Mautner
Email: arincon@spiamericas.com
Address: Calle 105 A N° 14 – 76
Phone: (57 1) 6204920
Bogota D.C, Colombia
 
Aristizabal & Rojas Abogados
Ricardo Aristizabal
Email: ricardo.aristizabal@aristizabal-law.com 
Address: Carrera 11B No. 98-08 Oficina 202
Phone:(57 1) 601-3999
Bogota, D.C. - Colombia
 
Triana Uribe & Michelsen  
Email: tum@tumnet.com 
Address: Calle 93B No. 12-48 P. 4
Phone: (+571) 601 96 60 - (+571) 621 58 10
Bogota D.C. - Colombia
 
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. The following resolutions and decrees are relevant to U.S. exporters:
  • Resolution 004816 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 (registration will take between 1 to 6 months)
  • Decree 1571 of 1993: provides diverse specifications for blood centers
  • Resolution 1319-1310: GMP (good manufacturing practices) for the customized medical devices manufacturing and processing
  • Law 9 of 1979: sets the basic regulations for medical devices and also sets sanctions and prohibitions
Trade Events
Meditech-Colombia
https://feriameditech.com/
July 3-6, 2018
Bogota, Colombia
Meditech is the most important event in Colombia for the health sector. It gathers key stakeholders in the medical industry and is the premier event for generating qualified business contacts. It has positioned itself as one of the most important business events for the health sector in Latin America because it has the most complete commercial showcase of products and services related to the industry. Meditech takes place every two years.
 
Web Resources                                                                                                                                                                                
U.S. Commercial Service Bogota contact: Rafael Jimenez     
Email: Rafael.Jimenez@trade.gov    
Tel: 57 1 275 2814 
               
Key Contacts
Health Ministry (Ministerio de Salud y Protección Social)
National Institute for Food and Medicine Surveillance (Instituto Nacional de Vigilancia de Medicamentos y Alimentos – INVIMA)

Prepared by our U.S. Embassies abroad. With its network of 108 offices across the United States and in more than 75 countries, the U.S. Commercial Service of the U.S. Department of Commerce utilizes its global presence and international marketing expertise to help U.S. companies sell their products and services worldwide. Locate the U.S. Commercial Service trade specialist in the U.S. nearest you by visiting http://export.gov/usoffices.



Colombia Medical Devices Trade Development and Promotion