Medical Device Registration and Approval in Dominican Republic

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

Medical Device Regulations and Classification in 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.

 

Other Central America and the Caribbean Countries:

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