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: 49,834,000

GDP: USD $307.48 Billion

Currency: Colombian Peso

Language: Spanish

Summary

During 2017, the United States exported US$263.5 million in medical equipment to Colombia. The Colombian medical device market relies on imports, which make up about 93% 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 7.3% in U.S. 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.

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 of social security in health which covers 96% of the population.

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, Ireland and Switzerland, with China quickly increasing market share. Colombia has FTAs with leading medical device producers such as the European Union and Canada, and is in negotiations of an FTA with Israel and France.

Main Competitors

Colombia is a price sensitive market, where prices are a major selling factor for most. Currently the strongest competitors are China, Germany, Ireland and Switzerland, with China quickly increasing its market share.

Current Demand

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

  • Medical, surgical, dental and veterinary instruments
  • Electro-diagnostic apparatus
  • Orthopedics devices, hearing 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 2017 Colombia imported medical equipment and supplies valued at US$830 million. Of this total, US$263.5 million (31.8%) 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.

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.

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:

Aristizabal & Rojas Abogados

Ricardo Aristizabal: ricardo.aristizabal@aristizabal-law.com

https://aristizabal-law.com/

Address: Carrera 11B No. 98-08 Oficina 202

Phone:(57 1) 601-3999

Bogotá, D.C. - Colombia

SPI Americas

arincon@spiamericas.com

http://www.spiamericas.com/

Address: Calle 105 A N° 14 – 76

Phone: (57 1) 6204920

Bogotá D.C, Colombia

Triana Uribe & Michelsen

tum@tumnet.com

http://www.tumnet.com/contact-us.htm

Address: Calle 93B No. 12-48 P. 4

Phone: (+571) 601 96 60 - (+571) 621 58 10

Bogotá D.C. - Colombia

* Inclusion does not constitute an endorsement or recommendation by the U.S. & Foreign Commercial Service. We strongly recommend that you perform your own due diligence investigation and background research on any company. We assume no responsibility for the professional ability or integrity of the providers listed. Order is alphabetical.

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.
  • 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 -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

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.

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, 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.

Procurement & Tenders

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

Colombia Compra Eficiente: https://www.colombiacompra.gov.co/#googtrans/gl/en

Trade Events

Meditech-Colombia

Dates TBC

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 two years.

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

FAQs

1. What's Colombia's Regulatory Agency?

Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA)

2. 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.

3. 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, it can take 6 months on average. For 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.

4. 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.


U.S. Commercial Service Contact Information

Name: Rafael Jimenez

Position: Commercial Specialist

Email: Rafael.Jimenez@trade.gov

Phone: +571- 2752814

Best Prospects

  • Diagnostic Imaging (electrodiagnostic,radiation, imaging)
  • Dental products
  • Orthopaedics & Prosthetics

Market Size

Healthcare spending (including investment)

24.7 (USDbn)

... as percent of GDP

6.8%

Hospitals, Procedures, Healthcare Professionals

Number of hospitals

7,719

…Public

26%

…Private

74%

Number of hospital beds

84,474

Number of surgical procedures

4,575,519

...of which [nose, mouth and pharynx]

2,382,960

...of which [integumentary system]

637,191

Physicians

94,371

Dentists

43,789

Demographics

Population

49,834,000

Life expectancy men/women

76/82

Infant mortality

13.6 rate (2017)

Percent of population older than 65

7.3%

Annual deaths

5.5 rate (2017)


  Notice to Visitors!


  The link you have chosen will take you to a non-U.S. Government website.

  If the page does not appear in 5 seconds, please click this: outside web site

  Export.gov is managed by the International Trade Administration and external links are covered by its website  disclaimer statement.


  Notice to Visitors!


  The link you have chosen will take you to a non-U.S. Government website.

  If the page does not appear in 5 seconds, please click this: outside web site

  BuyUSA.gov is managed by the International Trade Administration and external links are covered by its website disclaimer statement.