Summary
Market Entry
Current Market Trends
Main Competitors
Current Demand
Registration Process Reimbursement
Barriers
Best Prospects
CS Contacts Market Size
Capital: San José
Population: 4.500.000
GDP*: $15,500
Currency: colones
Language: Spanish
Costa Rica has a socialized healthcare system identified as the Costa Rican Social Security System (Costarricense de Seguro Social: CCSS, or “Caja,” as it is popularly known). This system includes 30 hospitals: 10 general hospitals, 7 regional hospitals (1 in each geographic region/province), and 13 peripheral hospitals, which vary in size. In the Central Valley region of the country there are 16 hospitals, where about one-half of the population lives. Additionally, the CCSS is responsible for approximately 500 clinics, and approximately 1,000 small attention units with only basic equipment, known as “Equipos Basicos de Atencion Integral” (EBAIS), which provide basic medical assistance to patients in remote areas of the country.
The CCSS hospitals have approximately 6,000 beds, while there are approximately 223 beds in three private clinics/hospitals. The “Caja” buys approximately 90% of the medical equipment in Costa Rica. The public is very sensitive to the government's programs in public health and forcibly encourages replacement of obsolete medical equipment in the principal hospitals and clinics.
There are several private hospitals and clinics in the country, mainly in the Central Valley. Hospital Clínica Bíblica (HCB) is the largest followed by CIMA Hospital, owned by the International Hospital Corporation (headquartered in Dallas, Texas), and Hospital Hotel La Católica (HCC). These three private hospitals are accredited by the Joint Commission International (JCMI). The HCB is also accredited by the Medical Tourism Associations. Both CIMA Hospital and Hospital Clínica Bíblica are building new facilities in the Guanacaste Province. Hospital Metropolitano in downtown San José, accredited by the Association for Ambulatory Healthcare (AAAHC), is the newest hospital and among their services they aid U.S. veterans, they accept medical insurance under the Foreign Medical Program (FMP) and Tricare.
The number of small, private clinics is growing constantly, as the population is demanding quicker and better health services. The largest private clinics in Costa Rica are Clinica Santa Catalina, Clínica Santa Rita, Clínica Santa Fe, and Hospital Clínica Jerusalem. The influx of foreigners, mainly from North America (U.S. and Canada), is also contributing to this private growth, in what is often known as “medical tourism.”
Costa Rica offers a steady and fast growing market for medical equipment. This is due to a more mature demographic profile compared to the average in the region, a system of universal health quality and a growing number of retirees from industrialized countries that spend part of the year in the country. The level of demand for medical equipment in Costa Rica is expected to rise, as the public system, which represents 90% of the market, will continue replacing obsolete equipment in virtually all categories of products.
To enter the market, U.S. companies will need to register the equipment and supplies at the Ministry of Health before sending it to Costa Rica. As part of the registration requirements a foreign company needs to find a Costa Rican representative or distributor to represent the U.S. in country.
Data in millions of US$ Dollars.
Total Market Size = (Total Local Production + Total Imports) – (Total Exports)
Data Sources:
Total Local Production: Estimated. Importers/distributors of medical devices
Total Exports: Costa Rican Customs Directorate
Total Imports: Costa Rican Customs Directorate
Imports from U.S.: Costa Rican Customs Directorate
Estimated numbers are calculated based on information provided by the Importers/distributors and also taking into consideration the economic growth for Costa Rica and the tendency for the last 3 years.
Statistics are based on the following medical equipment and supplies harmonized codes: 9018.110000 to 9022.90090; 9025.110090; 9402.100000; 9402.901000 to 9402.902090.
The market for imports of medical equipment in Costa Rica consists of 5 main countries representing 31.7% of these imports. The United States is the largest exporter with 44.86% (approximately $71 million) of total imports of medical equipment in Costa Rica. Germany ($18 million), China ($ 11 million), Switzerland ($9 million) and Japan ($6 million). While the United States is the largest exporter to the growing market, Germany has a steady growth in the amount of medical equipment exported to Costa Rica (Source: Ministry of Treasury).
The market size for medical equipment and supplies has increased during 2015 and 2016. In 2015, the market size was US$141 million. In 2016 it grew to US$150 million, an increase of approximately 6.8 percent from 2015. The United States is the largest exporter of medical equipment to Costa Rica, with $71million in 2016 and $66 million in 2015. This volume represents a market share of approximately 44.86 percent during 2016 of total Costa Rican imports. Major competitors to the U.S. in medical equipment are Germany, China, and Switzerland.
The Costa Rican Institute of Social Security (Caja Costarricense de Seguro Social-CCSS) is the government’s second largest entity that requires products and services for their operations (drugs, pharmaceuticals, medical equipment, supplies, etc.) The CCSS also has its own website where they publish their requirements for all the public hospitals (30), clinics (500) and “EBAIS” (Small medical units with basic equipment-1000). U.S. suppliers can access this data base through the following website link: http://www.ccss.sa.cr/licitaciones
Registration Process
The Costa Rican Ministry of Health accepted a petition submitted by U.S. Embassy San Jose to recognize U.S. Food and Drug Administration (FDA) authorizations of medical devices to be sold in the U.S. market as permissible for sale in Costa Rica without additional evaluation on the part of the GOCR. This decision – the result of three years of work - will benefit U.S. exporters of medical devices. Since all medical devices shipped from the U.S. will no longer be required to undergo additional clinical trials or obtain additional documentation (except for a Certificate to Foreign Government, issued by FDA stating that the product is sold freely in the U.S. market and the plant follows good manufacturing practices), U.S. exporters will enjoy lower cost-to-market and significantly faster time-to-market. Costa Rican patients will also benefit from state-of-the-art medical devices and the improved medical care that will result from their use.
The Costa Rican Ministry of Health implemented a digital platform to submit medical device registrations. Medical device manufacturers seeking market authorization in Costa Rica will be able to submit registration applications online once they have chosen a Costa Rican distributor.
To register your medical device to sell in Costa Rica, you must first obtain approval from the Ministry of Health-from Costa Rica. As a prerequisite for registration in Costa Rica, your device should have already received regulatory approval in its home country. You also need to appoint a representative within the country and properly classify your device in accordance with the classification system of four levels of the Ministry of Health to enter the market of Costa Rica.
Reimbursement
In accordance with Article 33 of Law 7494: Administrative Contracting may utilize any method of payment, including electronic. Likewise, Article 44 establishes that the Administration will establish a term to realize the payment, but this term will not exceed 30 calendar days and 45 calendar days for cases of the General Administration. This term will follow the arrival of the commercial product.
The timeframe to register new product is around 4 months once all the documentation is submitted to the Ministry of Health. In the case of Pharmaceutical products, it takes from 12 to 18 months to register the products once the documentation is submitted.
Procurement & Tenders
http://www.ccss.sa.cr/licitaciones
http://www.ccss.sa.cr/portafolio_proyectos/#p=1
http://www.ccss.sa.cr/planes_compra
FAQs
Yes, product regulation of the Ministry of Health and the C.C.S.S. requires that a foreign company has a legal representative in Costa Rica as part of the requisites to register the products.
U.S. Commercial Service Contact Information
Name: Gabriela Lucke
Position: Commercial Specialist
Email: Gabriela.Lucke@gmail.com
Phone: (506) 2519-2271
Market Size
Healthcare spending (including investment)
... as percent of GDP
9.3% (2014)
Hospitals, Procedures, Healthcare Professionals UN:
Number of hospitals
…Public
15 hospitals
…Private
5%
Number of hospital beds
... available beds per capita
12 beds per 10 000 population in 2010
Number of surgical procedures
4214 surgical procedures per 100 000 population in 2012
Physicians
1.15 physicians / 1000 population
Dentists
599 (2013)
Demographics
Population
4 872 543 (2016 est)
Life expectancy men/women
Men: 75.9 / women: 81.4
Infant mortality
8.3 deaths / 1000 live births
Percent of population older than 65
10.15%
Annual deaths
4.6 deaths / 1000 population (2016 est)
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