Colombia - Medical EquipmentColombia - Medical Equipment
Overview
The Colombian medical devices market relies overwhelmingly on imports, which made up about 82 percent of the market in 2018, 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 percent of U.S. medical equipment exports to Colombia receive duty free treatment.
Domestic production is concentrated at the low technology end of the market. The National Statistics Department (DANE -Departamento Administrativo Nacional de Estadística) reported production worth USD 238.9 million in 2017 where syringes, needles and catheters, orthopedics and prosthetics, and dental products represent the most important products produced locally.
According to BMI Research, U.S. imports make up the largest share of the Colombian market, accounting for 30.1 percent of all medical equipment imports, followed by China (14.4 percent), Germany (nine percent), Mexico (4.4 percent), and Ireland (4.4 percent), 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, Australia, and New Zealand. Among the top U.S. medical equipment exports to Colombia in 2018 were medical, surgical and dental instruments, as well as electro-diagnostic apparatus.
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 percent of the population due to Law 100 of 1993, whereby all citizens, irrespective of their ability to pay, are entitled to a comprehensive health benefit package
Table 14:
Source: BMI Research, millions of USD
Colombia is seeing an increasing rate of non-communicable diseases, particularly cardiovascular disease, cancer, and diabetes, that will shape the development of Colombia's healthcare market over the coming years. Communicable diseases such as HIV and tuberculosis will remain top public health concerns.
Leading Sub-Sectors
Best prospects for U.S. medical equipment manufacturers include:
Opportunities
INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos, Colombia’s regulatory authority similar to the FDA), 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. 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 Abogados Consultores
Email: ricardo.aristizabal@aristizabal-law.com
Address: Carrera 11B No. 97-56 Oficina 302B
Phone:(57 1) 702-1010
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:
Meditech-Colombia
July 14-17, 2020
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 other year.
Web Resources
Commercial Specialist 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.
The Colombian medical devices market relies overwhelmingly on imports, which made up about 82 percent of the market in 2018, 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 percent of U.S. medical equipment exports to Colombia receive duty free treatment.
Domestic production is concentrated at the low technology end of the market. The National Statistics Department (DANE -Departamento Administrativo Nacional de Estadística) reported production worth USD 238.9 million in 2017 where syringes, needles and catheters, orthopedics and prosthetics, and dental products represent the most important products produced locally.
According to BMI Research, U.S. imports make up the largest share of the Colombian market, accounting for 30.1 percent of all medical equipment imports, followed by China (14.4 percent), Germany (nine percent), Mexico (4.4 percent), and Ireland (4.4 percent), 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, Australia, and New Zealand. Among the top U.S. medical equipment exports to Colombia in 2018 were medical, surgical and dental instruments, as well as electro-diagnostic apparatus.
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 percent of the population due to Law 100 of 1993, whereby all citizens, irrespective of their ability to pay, are entitled to a comprehensive health benefit package
Table 14:
| 2015 | 2016 | 2017 | 2018 | |
| Total Exports | 67 | 67 | 69 | 72 |
| Total Imports | 1,010 | 871 | 830 | 934 |
| Imports from U.S | 396 | 317 | 263 | 281 |
| Exchange Rates | COP 2,746 | COP 3,053 | COP 2,951 | COP 3,000 |
Colombia is seeing an increasing rate of non-communicable diseases, particularly cardiovascular disease, cancer, and diabetes, that will shape the development of Colombia's healthcare market over the coming years. Communicable diseases such as HIV and tuberculosis will remain top public health concerns.
Leading Sub-Sectors
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
Opportunities
INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos, Colombia’s regulatory authority similar to the FDA), 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. 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 Abogados Consultores
Email: ricardo.aristizabal@aristizabal-law.com
Address: Carrera 11B No. 97-56 Oficina 302B
Phone:(57 1) 702-1010
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
Meditech-Colombia
July 14-17, 2020
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 other year.
Web Resources
Commercial Specialist 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.