Dominican Republic
General country-specific regulatory information is provided on this page. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, free of charge, to expedite the preparation of your medical device or IVD registration application.

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.



Interested in obtaining fast market approval for your medical device or IVD in the Dominican Republic? REQUEST A FREE QUOTE>

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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