Imports from the U.S.
***World Trade Atlas (HS Codes 9018-9027)
Colombia benefits from one of the most extensive insurance systems and medical financial protection in Latin America, second only to Chile, due to the 1993 health care reform, also known as Law 100. This reform created the social security system and covers standards governing the general system of pensions, workplace injury insurance and complementary social services. Colombia has universal health insurance as a goal and currently covers approximately 80% of the population.
The country’s healthcare infrastructure is adequate in the larger urban areas, but in need of modernization. The healthcare system is complex, and coverage is not yet universal. Funding is generally very low; as established by Espicom, per capita health spending is estimated at U.S. $516.8 in 2011, while expenditure on medical equipment is only around U.S. $23 per person.
Colombia announced an Emergency Social Plan in 2010, to tackle corruption and find new sources of income for the public healthcare sector. Ten decrees were signed with the purpose of providing health coverage for all. This was followed by Law 1438, which took effect in January 2011.
Large purchases and imports are almost exclusively done by the private sector, which continues to be the most stable sector within the medical industry. The public sector health crisis has affected the ability of the sector to import a larger amount of technological medical equipment. However, the current public healthcare crisis is being addressed and the measures created to mitigate its impact are expected to be implemented in the period 2012/ 2013. Such measures will make the public sector more reliable and attractive to suppliers.
According to a study by America Economia Intelligence, seven of the twenty best hospitals and clinics in Latin America in 2012 are located in Colombia. In fourth place is the Hospital Fundacion Santa Fe in Bogota, in seventh, eighth and ninth place are the Fundacion Valle del Lili in Cali, Fundacion Cardioinfantil in Bogota, and Fundacion Cardiovascular de Colombia in Bucaramanga.
With the FTA in place since May 2012, 96 percent of U.S. Medical equipment exports to Colombia are receiving immediate duty free treatment. Before the FTA, Colombian medical equipment tariffs averaged 7.6 percent, ranging from 0 up to 15 percent. However, Colombia is also implementing other FTAs with Europe, South Korea and Canada which will create strong competition to U.S. manufacturers. U.S. imports enjoy the largest share of the local market, accounting for around a third of all medical equipment imports. Currently the strongest competitors are China, Germany and Japan. China is quickly increasing market share.
Intellectual Property Rights:
The U.S.-Colombia Trade Promotion Agreement 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 Agreement provides enhanced protections for trademarks, copyrights, and patents, such as the implementation a Colombian electronic trademark application system and on-line database, prohibitions on the circumvention of technological protection measures used by copyright holders, as well as ensuring that the parties will provide robust patent and test data protection.
Best prospects for U.S. medical equipment manufacturers include:
Colombia’s health care system improvement aims to upgrade clinical laboratories to guarantee quality of service delivery in the health sector. The market for clinical laboratory medical equipment will benefit from this increase of income and surveillance. Medical, surgical, dental or veterinary instruments and electro medical equipment remain a leading market.
In 2011, Colombia imported medical equipment & supplies valued at U.S. $ 914 million, their highest level ever. The medical device industry is concentrated around the capital Bogotá. Per capita spending on medical devices is average for the region. The medical device market is heavily reliant on imports, especially in the higher tech sectors. There is some domestic capacity for more basic items The medical device industry is concentrated around the capital Bogotá.
On the other hand Colombia is seriously promoting the country as a health destination (Health/Medical Tourism). Colombian medicine 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 regarding medical treatments. This becomes an important market opportunity for the U.S. 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/renewing medical equipment and providing English language training for their staff.
The best approach to enter into this market is through distributors. The U.S. companies must be aware that medical devices require registration at “Instituto Nacional de Vigilancia de Medicamentos y Alimentos” (INVIMA), the country’s medical device regulator. We strongly recommend companies to process the registration under their name and not under the local distributor name.
It’s important that before starting a Colombian medical device registration process, companies acknowledge that classification of devices in Colombia follow a four-tiered risk model (Class I, Class IIa, Class IIb and Class III). Colombia’s device classification scheme is similar to those of the European Union and other 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 process and achieve market entry in less time.
CS Bogotá contact: Paola Lugari, Commercial Specialist
Tel: (571) 275-2796
Health Ministry, Ministerio de la Proteccion Social: www.minproteccionsocial.gov.co
National Industries Association (ANDI) www.andi.com.co
National Institute for Food and Medicine Surveillance (Instituto Nacional de Vigilancia de Medicamentos y Alimentos or INVIMA): www.invima.gov.co
Portafolio Magazine, Editorial El Tiempo, www.portafolio.com.co/
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