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Medical Device Regulatory
Requirements for
Panama

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 Health manages the health care system in Panama. Along with the Social Security System, it is responsible for procuring all of the medical equipment in the public sector. The private hospitals and clinics are the other main buyers of medical equipment in Panama.

Regulations

There are no regulations, technical or safety standards applicable. Both U.S. standards and European standards are accepted in Panama. There is a requirement however, to have labeling in Spanish. The labels may be multi-lingual (e.g., in English and Spanish), but Spanish must be included as one of the languages.

Import Duties and Taxes

In 1998 import duties for medical equipment were lowered to 10%, compared to the previous levels of 35% and 27.5%. Import duties in Panama are assessed over the CIF value. Additionally, a 5% value added tax is charged on the aggregate of the CIF value plus the import duty.

Used Equipment

There are some market opportunities for used/refurbished medical equipment, especially in small hospitals and private hospitals in the interior of the country. The government does not purchase used or refurbished equipment.

Contact Information

Government Agencies

Colon Free Zone Administration

P.O. Box 1118 ZLC, Panama

Phone: (507) 445-1033

Fax: (507) 445-2165

E-mail: zonalibre@zolicol.org

Contact: Jorge Fernandez, Director



Caja de Seguro Social

P.O. Box 1393

Panama 1, Panama

Phone: (507) 261-8002

Fax: (507) 261-2208

Contact: Juan Jovane, Director



Ministerio de Comercio e Industrias

Viceministerio de Comercio Exterior

P.O. Box 61897 El Dorado, Panama

Phone: (507) 236-0511

Fax: (507) 236-0521

E-mail: vicomex@mici.gov.pa

Contact: Meliton Arrocha, Vice-Minister



Ministerio de Economia y Finanzas

Direccion General de Aduanas

P.O. Box 1671 Balboa, Ancon

Phone: (507) 232-5355

Fax: (507) 232-6494

Contact: Mercedes Villalaz, Director



Ministerio de Salud

P.O. Box 2048

Panama 1, Panama

Tel: (507) 225-6080

Fax: (507) 227-5276

Contact: Fernando Gracia, Minister



Trade Associations



American Chamber of Commerce & Industry of Panama (AMCHAM)

P.O. Box 74, Balboa, Panama

Phone: (507) 269-3881

Fax: (507) 223-3508

E-mail: amcham@sinfo.net

Contact: David Hunt, Executive Director



Asociacion de Usuarios de la Zona Libre de Colon

P.O. Box 3118 ZLC, Panama

Phone: (507) 441-4878

Fax: (507) 441-4347

E-mail: au@sinfo.net

Contact: Digna Donado, President



Panamanian Chamber of Commerce, Industry and Agriculture

P.O. Box 74, Panama 1, Panama

Phone: (507) 225-4615

Fax: (507) 225-3653

E-mail: cciap@panama.phoenix.net

Contact: Jose Ramon Varela, Executive Director


Sindicato de Industriales de Panama

P.O. Box 64798, El Dorado, Panama

Phone: (507) 230-0284

Fax: (507) 236-0166

E-mail: sip@sinfo.net

Contact: Daniel Vega, Executive Director


Last updated on 5-2-05 by JF

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