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
