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Medical Device Regulatory
Requirements for
Dominican Republic

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

Within the Dominican government the Secretariat of State for Public Health oversees the health care system. To prioritize the aquisition of medical equipment, the government formed a National Health Commission whose members include: The Secretariat of State for Public Health, the Director of the National Social Security Agency, the President of the Dominican Association of Physicians, Rectors of universities, etc.


Regulations

There are no regulations for the enforcement of quality, technical or safety standards. American standards are currently accepted and respected by the purchasing entities.


Import Duties and Taxes

Import duties on medical devices are 10 percent (with the exception of HS 630790-Surgical Drapes, 35%). The Dominican tariff system is on a CIF basis. The applicable exchange rate for clearing these taxes is dictated by the monetary authorities. The tax assessed on the CIF value is the Industrial Products and Services Tax (ITBIS) at 8 percent.


Distribution

To succeed in the Dominican market an American company must have local distributor. Exporting directly to the end-user is extremely difficult. Importers and distributors usually have sales agents who distribute the products to small retailers throughout the country.


American exporters wishing to find an agent or a distributor for the Dominican market should take in consideration the Dominican Law 173 that regulates the relationship between foreign and local companies. This law is designed to protect Dominican citizens who work as agents or distributors for foreign companies and provides substantial penalties for foreign manufacturers who unilaterally terminate the contracts with local distributors or agents without just cause. One key element of Law 173 is that it is considered as a law of public order whose terms prevail over contradictory terms in any agreement between private parties. The provisions on the distributorship contract establishing the term of an agreement of that give the granting party the unilateral right of rescission are inapplicable under the law. The distributorship contract can only be rescinded by reason of just cause as defined by law or by amicable agreement among the parties. Because the Dominican courts have traditionally been very restrictive in their interpretation of just cause in favor of the Dominican distributor, the Law 173 is potentially very costly to foreign suppliers. In order to obtain the protection of the law, the Dominican Distributors must have registered their license contracts before the Department of Foreign Exchange of the Central Bank within the term established by the law. Therefore, it is advisable not to provide the agent or distributor with any contract or document that indicates an exclusive relationship. Before appointing an agent or distributor in the Dominican Republic, U.S. firms should seek legal counsel. Interested companies may also request a copy of the Law 173 fom the Commercial Section of the U.S. Embassy in Santo Domingo.


Contact Information

Government Agencies


Camara de Comercio y Produccion del Distrito Nacional

Arzobispo Nouel No. 206

Santo Domingo, Dominican Republic

Phone: (809) 682-2688

Fax: (809) 685-2228

Contact: Lic. Milagros Puello, Executive Director

(Dominican Chamber of Commerce)


Camara Americana de Comercio de la Republica Dominicana

(American Chamber of Commerce)

Av. Winston Churchill esq. Luis F. Thomen

Torre BHD, 4th Floor

Santo Domingo, Dom. Rep.

Phone: (809) 544-2222

Fax: (809) 544-0502

Contact: Mr. William Malamoud, Executive Director


Secretaria de Estado de Salud Publica y Asistencia Social

(Secretariat of State for Public Health)

Av. Tiradentes, esq. San Cristobal

Santo Domingo, Dominican Republic

Phone: (809) 541-3121

Fax: (809) 547-2843

Contact: Dra. Altagracia Guzm n, Secretary of State


Instituto Dominicano del Seguro Social (IDSS)

(Social Security Agency)

Calle Pepillo Salcedo No. 22

Santo Domingo, Dominican Republic

Phone: (809) 565-9666

Fax: (809) 544-0555

Contact: Dr. Juan Octavio Ceballos, Director


Last updated on 5-2-05 by JF

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