This is a best prospect industry sector for this country. Includes a market overview and trade data.
Last Published: 8/1/2017
Overview
Colombia Medical Equipment Production Data
Year201420152016
Imports from the U.S.USD 432,230,027USD 396,751,527USD 317,925,695
ImportsUSD 1,205,118,962USD 1,118,949,272USD 954,647,280
ExportsUSD 49,219,900USD 48,977,384USD 47,652,285
Total Market SizeUSD 1,390,000,000 (est)USD 1,193,300,000 (est)USD 1,197,100,000 (est)
Exchange Rate1 USD = COP 1,997.831 USD = COP 2,748.781 USD = COP 3,050.15
Sources: World Trade Atlas (HS Codes 9018-9027- Direccion de Impuestos y Aduanas Nacionales de Colombia – DIAN); BMI

Colombia was the 25th largest market for U.S. medical equipment exports in 2016, with annual exports valued at USD 318 million. The Colombian medical device market relies on imports, which make up about 86.5 percent of the market. Since the implementation of the U.S.-Colombia Trade Promotion Agreement (TPA) with the United States in 2012, 96 percent of U.S. medical equipment exports to Colombia receive duty free treatment.

A slowing economy and devaluation of the Colombian Peso over the past several years has had a negative effect on imports of medical devices and will constrain market growth during 2017. According to Business Monitor International, Colombia’s medical device market will record an annual growth rate of 7.3 percent in US dollar terms in 2015-2020, up from 4.1 percent in 2010-2015. The dollar growth rate will reflect the depreciation of the peso.

U.S. imports make up the largest share of the Colombian market, accounting for around one-third of all medical equipment imports. Currently, the strongest competitors are China, Germany, Mexico and Japan, with China quickly increasing market share. Since the implementation of the TPA, tariffs on 96 percent of U.S. medical equipment exports to Colombia went from an average of 7.6 percent to zero. 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.

The top U.S. medical equipment exports to Colombia include instrument and apparatus such as electro medical instruments, electro-diagnostic apparatus, diagnostic reagents, and medical supplies. It also includes syringes and needles, orthopedic and fracture articles and prosthesis.

According to INVIMA (Colombia’s equivalent to the US FDA), as of 2015 Colombia had 254 certified medical equipment manufacturers and 1,445 certified importers of medical equipment between national and international companies.
The country’s healthcare infrastructure is adequate in the larger urban areas but is in need of modernization. Colombia has the most extensive health insurance system and medical financial protection in Latin America. Law 100 of 1993 created the social security system and covers standards governing healthcare in the country. In 2014, there were 45.6 million people covered by the system, or 95.5 percent of the population.

According to a study by America Economia Intelligence, seven of the 20 best hospitals and clinics in Latin America in 2017 are located in Colombia (followed by Brazil with four). In third place is Fundacion Valle del Lili in Cali, in seventh is Fundacion Cardioinfantil in Bogotá, in eighth is Fundacion Cardiovascular de Colombia in Bucaramanga, in ninth is Hospital Pablo Tobon in Medellin, in thirteenth is Centro Medico Imbanaco in Cali, in sixteenth is Hospital Universitario de San Vicente in Medellin, and in twentieth is Clinica las Americas in Medellin.

Regarding procurement and transparency practices, the launch in February 2017 of an inter-American coalition on ethical business practices for medical device manufacturers, distributors and healthcare professionals, will strengthen regional transparency and integration and fight corruption. Inter-American harmonization of ethical business practices will follow the steps undertaken by Asia Pacific economies in the medical device sector, and will support efforts to advance global harmonization.

Intellectual Property Rights
The TPA requires high levels of intellectual property protection and enforcement consistent with U.S. and international standards and will support the growth of trade in valuable digital and other intellectual property-based products. The TPA also provides enhanced protections for trademarks, copyrights, and patents, such as the implementation of a Colombian electronic trademark application system and online database, prohibition on the circumvention of technological protection measures used by copyright holders, and requirements for the parties to provide robust patent and test data protection.

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;
  • It is expected that a number of Colombia’s clinical laboratories will be upgraded in the near future, which will provide an opportunity for exporters of clinical laboratory equipment. Opportunities also exist in medical, surgical, dental and veterinary instruments and electro medical equipment.
Opportunities
In 2016 Colombia imported medical equipment and supplies valued at USD 955 million. Of this total, USD 318 million was from the United States. The medical device industry is concentrated around the capital of Bogotá. Per capita spending on medical devices is average for the region. 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. Colombia has a domestic production capacity for basic items such as surgical and dental instruments, orthopedic appliances, bandages, x-ray equipment, thermometers, syringes and catheters, but there is no production of sophisticated medical devices.

In addition, the Colombian government is promoting the country as a destination for medical tourism. Colombia is well known in Latin America and the rest of the world as a pioneer and leader in health services, positioning the country as one of the most attractive destinations to receive medical treatments. This trend is an important market opportunity for the United States because the success of this industry requires high quality standards, technology, and infrastructure. As a result, Colombian hospitals and clinics are upgrading existing facilities, adding/updating medical equipment and providing English language training for their staff. Over 41,000 tourists entered the country in 2014 to have medical treatments. This figure represents 1.98 percent of the total number of tourists and USD 28.8 million in service exports.

The best approach to enter this market is through distributors, as companies prefer to buy from someone located in Colombia who can provide after-sales services. Although distribution and sales of imported medical equipment in Colombia is handled principally through importers, distributors, representatives, and agents, an increasing percentage of materials, supplies, and equipment are imported directly by end-users. 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 is being used effectively in Colombia by European and Japanese manufacturers.

Registration Process
U.S. companies should be aware that medical devices require registration with INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos), the country’s medical device regulator. 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:

SPI Americas
Calle 105 A N° 14 – 76
Bogotá D.C, Colombia
Phone: 571-620-4920
Email: arincon@spiamericas.com
 
Ricardo Aristizabal Aristizabal & Rojas Abogados
Carrera 11B No. 98-08 Oficina 202
Bogotá, D.C. - Colombia  
Phone: 571-060-13999
Email: ricardo.aristizabal@aristizabal-law.com

Triana Uribe & Michelsen  
Calle 93B No. 12-48 P. 4
Bogotá D.C. – Colombia
Phone: 571-601-9660 | 571-621-5810
Email: tum@tumnet.com
 
Please be advised that this is not an exhaustive list and this does not constitute a recommendation of the mentioned firms.
 
The Medical Devices sector is highly regulated and supervised. Decree 4725 of 2005 is the main guide 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:
  • Decree 1571 of 1993 it provides diverse specifications for blood centers;
  • Decree 3770 of 2004 regulates sanitary records and sanitary surveillance for the diagnostic reactive;
  • 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);
  • Law 9 of 1979 under Title VI Drugs, Medicaments, and Cosmetics and related categories, sets the basic regulations for medical devices; it also sets sanctions and prohibitions.
  • Resolution 004816 of 2008, techno vigilance criteria and activities;
  • Resolution 1319-1310- GMP (good manufacturing practices) for the customized medical devices manufacturing and processing;
  • Resolution 2434 of 2006: remanufactured and repowered biomedical equipment Class II;
  • Resolution 4002 of 2007 regulates the scope of a Certificate of Storage Capacity;
  • 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;
 
Trade Events
Beauty and Health Fair
September 27- October 1, 2017
Bogotá, Colombia

Meditech Colombia (Healthcare and Medical Care Trade Show)
June 2018
Bogotá, Colombia

Web Resources
Paola Lugari
U.S. Commercial Service Bogotá
Phone: 571-275-2796 
Email: Paola.Lugari@trade.gov
 
Key Contacts
Ministry of Health and Social Protection (MinSalud)
National Institute for Food and Medicine Vigilance (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