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Medical Device Regulatory
Requirements for
Costa Rica

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.


Regulatory Agency

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).


Regulations

There are no additional regulations applicable. Both U.S. and European registration methods suffice.


Standards

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.


Import Duties and Taxes

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.


The total import taxes paid on medical products are: a 14 percent ad-valorem tax; a 1 percent Law 6946 tax; and, a 13 percent sales tax applied on the CIF value.


Used Equipment

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.


Distribution

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.


Contact Information


Government Agencies


Caja Costarricense de Seguro Social (CCSS)

(Costa Rican Social Security Institute)

Apartado 10105-1000

San Jose, Costa Rica

Phone: (506) 257-9122


CCSS contacts by Departments:


Division Medica

(Medical Division Department)

Piso 12, Oficinas Centrales

Phone: (506) 233-5916

Fax: (506) 233-5682

Contact: Dra. Julieta Rodriguez, Gerente


Departamento Recursos Materiales

(Materials Resources Department)

Piso 12, Oficinas Centrales

Phone: (506) 257-4356

Fax: (506) 233-7383

Contact: Ing. Jose Rafael Gonzalez, Director


Departamento Programacion de Suministros

(Medical Supplies Programming Department)

Piso 12 Oficinas Centrales

Phone: (506) 223-8839

Fax: (506) 233-7383

Contact: Lic. Gabriela Arias, Jefe


Departamento Equipamento

(Equipment Department)

Piso 10 Oficinas Centrales

Phone: (506) 233-5984

Fax: (506) 223-6298

Contact: Mario Saavedra, Director


Departamento de Adquisiciones

(Adquisitions Department)

Piso 11 Oficinas Centrales

Phone: (506) 257-4359

Fax: (506) 223-8792

Contact: Manuel Carballo, Jefe


Ministerio de Salud

(Costa Rican Ministry of Health)

Apartado 10123-1000

San Jose, Costa Rica

Phone: (506) 223-0333, or 222-0960

Fax: (506) 255-2594


Ministry of Health contacts by Departments:


Sub-Division Recursos Humanos

(Human Resources Department)

Phone: (506) 223-0333

Fax: (506) 257-7827

Contact: Lic. Manuel Vargas, Director


Departamento de Drogas, Estupefacientes, Controles y Registro

(Drugs, Controls and Register Department)

Phone: (506) 223-2612, or 221-6058

Fax: (506) 222-1420

Contact: Dra. Marielos Morales, Director


Trade Associations


Colegio de Medicos y Cirujanos de Costa Rica

(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


Colegio de Optomestristas de Costa Rica

(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


Colegio de Cirujanos Dentistas de Costa Rica

(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


Camara de Representantes de Casas Extranjeras--CRECEX

(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


Camara de Comercio de Costa Rica

(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


Camara Costarricense-Norteamericana de Comercio

(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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