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Executive Summary
During 2018, the United States exported US$281 million in medical equipment to Colombia. The Colombian medical device market relies on imports, which make up about 82% of the market despite strong domestic production focused mainly in consumables. Since the implementation of the U.S.-Colombia Trade Promotion Agreement (TPA) in 2012, 96% of U.S. medical equipment exports to Colombia receive duty free treatment.
According to Business Monitor International, the medical device market will record a Compound Annual Growth Rate (CAGR) of 8.7% in U.S. dollar terms in 2018-2023, up from a CAGR of 7.3% in 2015-2020. The dollar growth rate will reflect the depreciation of the peso; it depreciated substantially in 2015 and is expected to remain depreciated in 2019.
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.
According to the Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA -The Colombia National Food and Drug Surveillance Institute in English), as of 2017 Colombia has 62 certified medical equipment manufacturers, excluding wound care products production.
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. In 1993, Law 100 created the social security system and covers standards governing the general system of social security in health, which covers 96% of the population.
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Market Entry
To successfully penetrate the Colombian market, U.S. firms should offer competitive pricing and financing. Additionally, modern technology coupled with efficient post-sales service and parts support is a winning combination.
New-to-market exporters should develop product or service information in Spanish and check to see whether their competitors already have a presence in the market. U.S. equipment suppliers are generally encouraged to find a local representative/distributor, although this is not a legal requirement for doing business in Colombia. Local companies may operate as a manufacturer’s representative (sales agent), importer/distributor, or dealer, separately or all at the same time. U.S. Companies may find the use of a local sales representative useful given their knowledge of the local market and their understanding of local regulations and import procedures.
Finally, U.S. companies are advised to be on the lookout for relevant trade events to promote their products or to test the market. Trade missions to Colombia have also proven to be an effective means for promoting new U.S. products.
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Current Market Trends
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 Ireland, with China quickly increasing market share. Colombia has FTAs with leading medical device producers such as the European Union and Canada, and is negotiating an FTA with Japan, Australia, and New Zealand.
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Market Size
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Healthcare spending (including investment)
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20.7 (USDbn)
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… as percent of GDP
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6.0%
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Hospitals, Procedures, Healthcare Professionals
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Number of hospitals and Clinics
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1,124
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…Public
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68%
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…Private
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32%
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Number of hospital beds
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53,153
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Number of surgical procedures
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772,320
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Physicians
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102,309
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Dentists
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44,518
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Demographics
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Population
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49,834,000
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Life expectancy men/women
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71/78
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Infant mortality
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15.3 rate (2018)
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Percent of population older than 65
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8.0%
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Annual deaths
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304,300 (2018)
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Main Competitors
Colombia is a price sensitive market, where prices are a major selling factor for most. Currently the strongest competitors are China, Germany, Mexico, and Ireland, with China quickly increasing its market share.
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Current Demand
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, and dental instruments as well as electro-medical equipment.
In 2018 Colombia imported medical equipment and supplies valued at US$1.145 billion. Of this total, US$281 million (30.1%) was from the United States. The medical device industry is concentrated around the capital of Bogota. 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 multinational groups 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 high-tech medical device production.
The best approach to enter this market is through distributors, as companies prefer to buy from someone located in Colombia that can provide after-sales services when needed. 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, is 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.
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Best Prospects
Best prospects for U.S. medical equipment manufacturers include:
- Medical, surgical, and dental instruments
- Electro-diagnostic apparatus
- Diagnostic imaging equipment
- Laboratory equipment and consumables
- Orthopedic devices and hearing aids
- Prosthetic devices
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Registration Process
U.S. companies should be aware that medical devices require registration at the “Instituto Nacional de Vigilancia de Medicamentos y Alimentos” (INVIMA), 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. If it is listed under the local distributor name, the U.S. company will not be able to change or add distributors during the lifetime of the registration, which is between 5 to 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 registration procedures can often be challenging and may pose a barrier to entry into this market.
Here are three firms with expertise in product registration*:
SPI Americas
http://www.spiamericas.com/
arincon@spiamericas.com
Address: Calle 105 A N° 14 – 76
Phone: (57 1) 6204920
Bogotá D.C, Colombia
Ricardo Aristizabal & Rojas Abogados
https://aristizabal-law.com/
ricardo.aristizabal@aristizabal-law.com
Address: Carrera 11B No. 98-08 Oficina 202
Phone:(57 1) 601-3999
Bogotá, D.C. - Colombia
Triana Uribe & Michelsen
http://www.tumnet.com/contact-us.htm
tum@tumnet.com
Address: Calle 93B No. 12-48 P. 4
Phone: (+571) 601 96 60 - (+571) 621 58 10
Bogotá D.C. - Colombia
*Please be advised that this is not an exhaustive list and does not constitute a recommendation on our part to use any of the mentioned firms.
The Medical Devices sector is highly regulated and supervised. Decree 4725 of 2005 is the main guide for the sector. This decree regulates the system of health records, marketing authorizations and surveillance of Medical Devices. Some other relevant sources of regulation include:
- Decree No. 582, issued on April 4, 2017, modifies Decree No. 4725, issued in 2005. It concerns the registration of medical devices.
- Decree No. 581, issued on April 4, 2017, modifies Decree No. 3770, issued in 2004. It concerns the registration of Class III in vitro diagnostics.
- Resolution 004816 of 2008: Techno vigilance criteria and activities.
- Decree 3770 of 2004 regulates sanitary records and sanitary surveillance for the diagnostic reactive.
- Resolution 434 of 2001 sets norms for the evaluation and importation of biomedical technologies. It also 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 under Title VI Drugs, Medicaments, and Cosmetics and related categories, sets the basic regulations for Medical Devices; it also sets sanctions and prohibitions.
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Reimbursement
According to Business Monitor International, Colombia has continued its system of price ceilings and now offers reimbursement in the public sector for drugs included on a positive list known as the Regimen de Libertad Vigilada, or Regulated Freedom Regime. The list covers all active ingredients designated as ‘essential’ under Resolution 1746 of November 1993.
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Barriers
Access to this market is not easy for newcomers. The market is very competitive and there are already many firms (local and foreign) selling medical equipment and medical products. The most common barriers found in Colombia are increased regulatory barriers under the National Development Plan, substandard biologics regulation, and arbitrary and non-transparent market access policies as well price controls, counterfeiting, patentability criteria, weak patent enforcement and issuance of a declaration of public interest to force a price discount.
It should be noted that registration procedures can often be challenging and may pose a barrier to entry into this market.
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Trade Events
Meditech-Colombia
Bogota, Colombia
Meditech is the most important event in Colombia for the health sector. It gathers key stakeholders in the medical industry and stands as the proper platform to generate qualified business contacts. It has positioned as one of the most important business scenarios 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 other year.
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FAQs
What’s Colombia’s Regulatory Agency?
Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA)
What is the medical device classification system in Colombia?
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.
How long does it take to obtain marketing approval for a medical device in Colombia?
Medical devices: Class IIb and III device applications must first be reviewed and approved by INVIMA prior to being placed onto the market, which can take 6 months on average. For a device that 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.
How do I renew a product registration certificate?
Companies can submit the application for renewal 90 days before the expiration date of the registration certificate. Once a product registration certificate expires, then companies will have to re-submit a new application.
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U.S. Commercial Service Contact Information
Name: Rafael Jimenez
Position: Commercial Specialist
Email: Rafael.Jimenez@trade.gov
Phone: +571- 2752814
