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Medical
Device Regulatory
Requirements for
Costa Rica
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Disclaimer: The information contained on this website is derived from public sources and is current to the best of our knowledge. For detailed and definitive information about a country's laws and policies, the government of the country concerned should be consulted.
The Costa Rican Ministry of Health supervises the health care sector for the country. Costa Rica has a socialized health care system identified as the Costa Rican Social Security System (CCSS).
There are no additional regulations applicable. Both U.S. and European registration methods suffice.
All products are expected to meet the highest quality standards. CCSS is presently requesting ISO 9000 certification for the products it purchases. However, the CCSS is also studying the possibility of dropping that requirement in some cases or in preference to another kind of certificate that could demonstrate the quality of individual products.
The Costa Rican Government does not impose any non-tariff barriers on medical equipment. Although all medical equipment pays import duties, these can be reimbursed. Since March 31, 1992, all importers, agents and distributors of medical equipment that are registered with the Costa Rican government are able to request duty-free permits for all imported equipment, instrumentation and medical supplies. The exoneration process, which can take from one week to 30 days, can also be done through a custom broker.
There is a strong preference for new medical equipment. Although some private clinics and independent doctors have purchased used equipment, hospitals and clinics of the public sector, by virtue of a government established norm, only buy new equipment. Used equipment purchased in Costa Rica is usually refurbished by the manufacturer or refurbished by an authorized dealer of the equipment, with a minimum six-month guarantee. Used equipment buyers also require assurances that parts and maintenance can be obtained locally.
Effective local representation and product promotion are key competitive factors in purchasing decisions for medical equipment. It is recommended that U.S. firms work carefully with their local representatives in determining the most effective product promotion strategy for their particular products.
(Costa Rican Social Security Institute) Apartado 10105-1000 San Jose, Costa Rica Phone: (506) 257-9122
(Medical Division Department) Piso 12, Oficinas Centrales Phone: (506) 233-5916 Fax: (506) 233-5682 Contact: Dra. Julieta Rodriguez, Gerente
(Materials Resources Department) Piso 12, Oficinas Centrales Phone: (506) 257-4356 Fax: (506) 233-7383 Contact: Ing. Jose Rafael Gonzalez, Director
(Medical Supplies Programming Department) Piso 12 Oficinas Centrales Phone: (506) 223-8839 Fax: (506) 233-7383 Contact: Lic. Gabriela Arias, Jefe
(Equipment Department) Piso 10 Oficinas Centrales Phone: (506) 233-5984 Fax: (506) 223-6298 Contact: Mario Saavedra, Director
(Adquisitions Department) Piso 11 Oficinas Centrales Phone: (506) 257-4359 Fax: (506) 223-8792 Contact: Manuel Carballo, Jefe
(Costa Rican Ministry of Health) Apartado 10123-1000 San Jose, Costa Rica Phone: (506) 223-0333, or 222-0960 Fax: (506) 255-2594
(Human Resources Department) Phone: (506) 223-0333 Fax: (506) 257-7827 Contact: Lic. Manuel Vargas, Director
(Drugs, Controls and Register Department) Phone: (506) 223-2612, or 221-6058 Fax: (506) 222-1420 Contact: Dra. Marielos Morales, Director
(Costa Rican Association of Physicians & Surgeons) Apartado 548-1000 San Jose, Costa Rica Contact: Dr. Marco Antonio Batalla, Presidente Dr. Manuel Piza, Director Administrativo Phone: (506) 232-3433 Fax: (506) 232-2406
(Costa Rican Association of Optometrists) Apartado 1785-1000 San Jose, Costa Rica Contact: Dr. Alvaro Jimenez,Presidente Phone: (506) 253-6860, or 221-7180 Fax: (506) 225-6440
(Costa Rican Association of Dental Surgeons) Apartado 698-1000 San Jose, Costa Rica Lic. Ricardo Mendez, Director Administrativo Phone: (506) 221-6062 or 223-6383 Fax: (506) 233-9254 Contact: Dr. Octavio Argueta, Presidente
(Costa Rican Chamber of Foreign Firms Representatives) Apartado 3738-1000 San Jose, Costa Rica Phone: (506) 253-0126 or 224-6944 Fax: (506) 234-2557 Contact: Mr. Walter Marin, Executive Director
(Costa Rican Chamber of Commerce) Apartado 1114-1000 San Jose, Costa Rica Phone: (506) 221-0005 or 221-0201 Fax: (506) 233-7901 Contact: Lic. Julio Ugarte, Executive Director
(Costa Rican-American Chamber of Commerce) Apartado 4946-1000 San Jose, Costa Rica Phone: (506) 220-2200 Fax: (506) 220-2300 Contact: Ms. Linda Solar, Executive Director |
Last updated on 5-2-05 by JF
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