Dominican Republic
REGULATORY AUTHORITY: The Directorate General of Drugs & Pharmaceuticals, under the Ministry of Public Health and Social Assistance, oversees the registration of medical devices in the Dominican Republic.

CLASSIFICATION SYSTEM: No classification system is currently in place. Some medical devices are excluded from registration. It is mandatory for disposable devices, as well as any devices which are invasive or in direct contact with the body.

TIMEFRAME: The registration process takes 9-12 months.

LICENSE VALIDITY:  Licenses issued in the Dominican Republic expire after five years.

AUTHORIZED REPRESENTATIVE:  An authorized representative is required.

Last updated on February 26 2015.



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For​ more information on registration in the Dominican Republic, check out the following articles on our blog:
5 Questions & Answers: The Dominican Republic
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