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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.
Last updated on November 5th, 2021.
Medical Device Regulations and Classification in Dominican Republic
REGULATORY AUTHORITY: Dirección General de Medicamentos, Alimentos y Productos Sanitarios (DIGEMAPS).
CLASSIFICATION SYSTEM:
Medical Devices: Class I/IIa/IIb/III
IVD Devices: Class I/IIa/IIb/III
TIMEFRAME: Medical Devices/IVDs (Class I/IIa/IIb/III): 180 – 240 working days OR 6 – 12 months
SPECIAL REQUIREMENTS:
SPECIAL REQUIREMENTS (Audit): N/A
SPECIAL REQUIREMENTS (Local Tests/Permit): N/A
SPECIAL REQUIREMENTS (Clinical Evaluation or Studies): N/A
SPECIAL REQUIREMENTS (Other), please specify: certificate of the medical device brand name (local trademark registration) issued by the National Industrial Property Office is required.
LOCAL FEES (New Application): Medical Devices/IVDs (Class I/IIa/IIb/III) – US$ 190
LOCAL FEES (Manufacturer): No manufacturer registration fee is required.
LICENSE VALIDITY: Five years.
LICENSE TRANSFER: License transfer process is possible in Dominican Republic.
AUTHORIZED REPRESENTATIVE: A local Authorized Representative (AR) is required in the Dominican Republic and is responsible for the registration of medical devices.
Other Central America and the Caribbean Countries: Belize, Costa Rica, Cuba, El Salvador, Guatemala, Honduras, Nicaragua, Panama
For detailed device-specific compliance information for each market, including Dominican Republic, to expedite the preparation of your medical device or IVD registration application.
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