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Healthcare Resource Guide: Colombia

Colombia Statistics

Summary

Market Entry

Current Market Trends

Main Competitors

Current Demand

Registration Process

Reimbursement

Barriers

Trade Events

CS Contacts

Best Prospects

Market Size

Capital: Bogota

Population: 49,313,000

GDP*: USD 282.46 billion

Currency: Colombian Peso

Language: Spanish

Summary

Colombia is the 25th largest market for U.S. medical equipment exports. During 2016, the United States exported US$318 million in medical equipment to Colombia. The Colombian medical device market relies on imports, which make up about 86.5% of the market. Since the signing of the Free Trade Agreement (FTA), 96% of U.S. medical equipment exports to Colombia receive duty free treatment.

During 2016, the medical device market faced a decrease in imports. A slowing economy and a dramatic devaluation of the Colombian Peso (COP) affected imports and will also constrain market growth during 2017. Imports will be slower in the next few years, while exports will remain low despite the peso plunge. Market competition and consolidation will intensify, keeping prices lower.

According to Business Monitor International, the medical device market will record a Compound Annual Growth Rate (CAGR) of 7.3% in US dollar terms in 2015-2020, up from a CAGR of 4.1% in 2010-2015. The dollar growth rate will reflect the depreciation of the peso -- it depreciated substantially in 2015, and is expected to remain depreciated in 2017.

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 among others.

According to the Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA -The Colombia National Food and Drug Surveillance Institute in English), as of 2015, Colombia has 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 from 1993 created the social security system and covers standards governing the general system. In 2014, there were 45.6M people covered by the system, 95.5% of the population.

According to a study by America Economia Intelligence, 7 of the 20 best hospitals and clinics in Latin America in 2017 are located in Colombia (followed by Brazil with 4). In third place is Fundacion Valle del Lili in Cali, in seventh Fundacion Cardioinfantil in Bogota, in eighth is Fundacion Cardiovascular de Colombia in Bucaramanga, in ninth Hospital Pablo Tobon in Medellin, in thirteenth Centro Medico Imbanaco in Cali, in sixteenth Hospital Universitario de San Vicente in Medellin, and in twentieth Clinica las Americas in Medellin.

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 in order to test the market. Trade missions to Colombia have also proven to be an effective means for promoting new U.S. products.

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 Japan. China has been quickly increasing market share. Since the implementation of the FTA, tariffs on 96% of U.S. medical equipment exports to Colombia went from an average of 7.6% (ranging from zero up to 15%) to zero. Colombia has FTAs with leading medical device producers such as the European Union and Canada, and is in negotiations of an FTA with Japan.

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 Japan. China is quickly increasing market share.

Current Demand

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

  • Medical, surgical, dental and veterinary instruments
  • Electro-diagnostic apparatus
  • Orthopedics devices, hear aids
  • Prosthetic devices
  • Diagnostic imaging equipment
  • Consumables
  • Ultrasound, mammography and cardiovascular equipment
  • Dermatological and laser treatment apparatus and apparel (boosted by medical tourism and expanding plastic surgery demand)
  • 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.

In 2016 Colombia imported medical equipment and supplies valued at US$955 million. Of this total, US$318 million 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 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 high-tech MD production.

In addition, Colombia is seriously promoting the country as a health destination (Health/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 becomes an important market opportunity for the United States because the success of this industry requires high quality standards, technology, and infrastructure. This has led Colombian hospital and clinic management to upgrade existing facilities, adding/updating medical equipment and providing English language training for their staff. In 2014, 41,127 tourists entered the country to have medical treatments. This represents 1.98% of the total number of tourists and USD $28.8M in services exports.

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. 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 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, as 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

arincon@spiamericas.com

Address: Calle 105 A N° 14 – 76

Phone: (57 1) 6204920

Bogotá D.C, Colombia

 

  •   

Ricardo Aristizabal Aristizabal & Rojas Abogados

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

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 this 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.

  • 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.
  • 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 -It 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 it 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.

Reimbursement

Updates to the reimbursement process are ongoing and no details are currently available.

Barriers

Although distribution and sales of imported medical equipment in Colombia is handled principally through importers, distributors, representatives, and agents, a large percentage of materials, supplies, and equipment, are imported directly by end-user firms and/or associations. U.S. manufacturers should maintain close contact with end-users and familiarize themselves with the equipment through training and demonstrations. This strategy is being used effectively in Colombia by European and Japanese manufacturers.

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. It should be noted that registration procedures can often be challenging and may pose a barrier to entry into this market.

It should be noted that registration procedures can often be challenging to U.S. companies and may pose a barrier to entry into this market.

Procurement & Tenders

Healthcare Procurement: https://www.minsalud.gov.co/Avisos%20y%20Licitaciones/Forms/AllItems.aspx

Trade Events

MEDITECH COLOMBIA http://www.feriameditech.com/ (June 2018)

Meditech-Colombia is a specialized trade show in the health sector in Colombia, with national and international participation, that highlights supplies, services and technological advances to foster development of the medical industry in the Andean region, Central America and the Caribbean. Typical attendees include: hospital and clinic managers, Directors General, financial and administrative managers, and purchasing managers; health sector officials; and health sector service providers. Exhibitors include: manufacturers and distributors of medical, surgical, dental, and clinical laboratory equipment; hospital staffing firms; distributors and marketers of direct inputs related to the health sector; entities administering benefit plans; and prepaid medical institutions.

BELLEZA Y SALUD www.feriabellezaysalud.com (September 27- October 1, 2017)

The Beauty and Health Fair has established itself as the leading event where the most recognized companies in the sector and leading professionals in the area of health and beauty will be present to show visitors the latest trends, developments in products, equipment and services integral to beauty for men and women.

Local Associations

  • Health Ministry (Ministerio de Salud y Proteccion Social): www.minsalud.gov.co
  • National Institute for Food and Medicine Surveillance: (Instituto Nacional de Vigilancia de Medicamentos y Alimentos – INVIMA-): www.invima.gov.co

Government Links:

Healthcare Procurement: http://www.minsalud.gov.co/Avisos%20y%20Licitaciones/Forms/AllItems.aspx

Government Health Plans: http://www.minsalud.gov.co/Ministerio/DSector/Paginas/plan-estrategico.aspx


U.S. Commercial Service Contact Information

Name: Paola Lugari

Position: Commercial Specialist

Email: paola.lugari@trade.gov

Phone: +571- 2752796

Best Prospects

  • Consumables (Syringes, needles & catheters formed the largest sector)
  • Diagnostic Imaging (electrodiagnostic,radiation, imaging)
  • Dental products
  • Orthopaedics & Prosthetics

Market Size

Healthcare spending (including investment)

21.1 (USDbn)

... as percent of GDP

7.4 %

Hospitals, Procedures, Healthcare Professionals

Number of hospitals

 

…Public

802 hospitals in 2016, equal to nearly 70%

…Private

352 hospitals in 2016, equal to the remaining 30%

Number of hospital beds

53,143

Number of surgical procedures

759.2-public IPS

Physicians

94,371

Dentists

43,789

Demographics

Population

49,313,000

Life expectancy men/women

76/82

Infant mortality

15.6 rate in 2016

Percent of population older than 65

7.3%

...projection, 2030

 

Annual deaths

3.9 rate in 2016


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