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 Ministry of Public Health and Social Welfare (Ministerio de Salud Publica y Asistencia Social) supervises the health care system in Guatemala. Although regulations are in place they are not fully enforced. The Social Security Institute (Instituto Guatemalteco de Seguridad Social - IGSS), and the Ministry of Defense are the two other governmental agencies that provide health care and purchase medical equipment. Private hospitals, clinics and drugstores also buy medical devices but their needs are much smaller than those of the public sector.

Regulations

Under the Health Registration Law of July 1996 by the Ministry of Health, medical devices should be registered. The following is a list of required documents for medical device registration:

a) Certificate to Foreign Government (or Certificate of Free Sale)

b) Labels/Directions for Use

c) Packaging Materials

d) Quality Control Test Methods/Records

e) Quality Control Certificate

f) Biocompatibility Reports

g) Product Brochure

Standards

Guatemala uses both the metric and English systems of weights and measures. Literature should be written in Spanish.

Used Equipment

Approximately 20 percent of medical equipment imported into Guatemala is used or reconditioned. This equipment consists of, but is not limited to, portable X-ray machines, ultrasound equipment, anesthesia equipment, operating tables, surgical equipment, etc. Clinics and small health care facilities known as osanatorioso usually purchase their equipment from large Guatemalan hospitals or from a small group of firms that refurbish the equipment and offer some sort of short-term guarantee. Sanatorios are usually very small hospitals established by one doctor or a small group of doctors who often do not have the financial resources to purchase new equipment. Used equipment is also purchased by the dozen or so firms that rent home care equipment. The potential for used medical equipment with local representation is very good.

Import Duties and Taxes

All imports are subject to customs duties. In January 1997, the Central American Tariff Reduction Agreement came into effect. This agreement reduced tariffs to 0 percent beginning on January 1, 1998. There is a value added tax of ten percent which must be paid on the sum of ad valorem duty and the C.I.F. value of the import. This ten percent tax can be credited against the local firm's income tax liabilities.

Distribution

Most firms selling into the Guatemalan market do so by means of a Guatemalan agent or distributor. However, used equipment dealers tend to sell directly to Guatemalan buyers. Generally speaking, the more pre-sales marketing and after-sales support and service that a product requires, the more important it is to have a local agent or distributor.

Formal agency or distribution agreements should be reviewed by a Guatemalan attorney hired by the U.S. exporter (independent of the Guatemalan party with which the agreement will be established). The Guatemalan legal system can be slow and the law, under certain conditions, offers local agents and distributors a great deal of protection. Under no circumstances should a U.S. exporter give a local agent or distributor the responsibility of registering any intellectual property (i.e., trademarks, trade names, copyrights, etc.); it should be done directly by the U.S. exporter with the assistance of a Guatemalan attorney.

Contact Information

Government Agencies

Ministerio de Salud Publica y Asistencia Social

(Ministry of Public Health and Social Welfare)

6 Avenida 3-45, Zona 11

01011 Guatemala, C.A.

Phone: [502] 475-2125 through 9

Fax: [502] 475-2168

Contact: Ing. Marco Tulio Sosa, Minister

Instituto Guatemalteco de Seguridad Social

(Guatemalan Social Security Institute)

7 Avenida Zona 1, Centro Civico

01001 Guatemala, C.A.

Phone: [502] 232-8520

Fax: [502] 253-2180

Contact: Victor Suarez, President

Ministerio de la Defensa Nacional

(Ministry of National Defense)

Avenida Reforma 1-45, Zona 10

01011 Guatemala, C.A.

Phone: [502] 360-9907, [502] 360-9917

Fax: [502] 360-9909

Contact: Gen. Hector Mario Barrios, Minister

Trade Associations

Camara de Comercio de Guatemala

(Chamber of Commerce of Guatemala)

10 Calle 3-80, Zona 1

01001 Guatemala, C.A.

Phone: [502] 238-2681/5

Fax: [502] 251-4197

E-mail: info@Guatemala-chamber.org

Contact: Mr. Cesar Estrada, President

Camara de Industria de Guatemala

(Chamber of Industry)

Edificio Camara de Industria

Ruta 6, 9-21, Zona 4, Nivel 12

01004 Guatemala

Phone: [502] 334-0849

Fax: [502] 334-1090

E-mail: cig@ns.comcyt.gob.gt

Contact: Mr. Jaime Botran, President

American Chamber of Commerce of Guatemala (AMCHAM)

6 Avenida 14-77, Zona 10

01010 Guatemala, C.A.

Phone: [502] 337-4489

Fax: [502] 368-3106

E-mail: guamcham@guate.net

Contact: Mr. Frank Galan, President

Camara de Industria de Guatemala

Gremial de Productos Medico Hospitaliarios de la

Camara de Industria

(Chamber of Industry's Medical/Hospital Guild)

c/o EQUIMED LTDA.

8 Avenida 2-08, Zona 10

01010 Guatemala, C.a.

Phone: [502] 361-4141, [502] 361-4107

Fax: [502] 361-4077

Contact: Rafael Perez, President

Asociacion de Azucareros de Guatemala

(Guatemalan Association of Sugar Cane Growers)

6 Avenida 6-38, Zona 9, Nivel 7

01009 Guatemala, C.A.

Phone: [502] 331-3049

Fax: [502] 331-8191

Contact: Mr. Alejandro Botran, President