REGULATORY AUTHORITY:
Medical devices and IVDs are regulated by the Dirección General de Medicamentos, Alimentos y Productos Sanitarios (DIGEMAPS), under the Ministry of Public Health.
CLASSIFICATION SYSTEM:
Medical devices and IVDs: Class I, IIa, IIb, and III.
TIMEFRAME:
Medical devices and IVDs
All classes: Up to 240 working days
LICENSE VALIDITY:
Medical devices and IVDs: 5 years.
LOCAL FEES (New Application):
Medical devices and IVDs: USD 190.
LICENSE TRANSFER: License transfer is possible in the Dominican Republic and must be processed and approved by DIGEMAPS, after which it is recorded on the registration certificate.
AUTHORIZED REPRESENTATIVE:
A local Authorized Representative (AR) is required and is responsible for the registration of medical devices and IVDs in the Dominican Republic.
ADDITIONAL INFORMATION:
- A local trademark (brand name) certificate issued by the National Industrial Property Office is mandatory as part of the registration dossier.
- Audit/inspection is not required for foreign manufacturers and applies only to local manufacturers.
- All medical devices and IVDs must obtain a registration certificate prior to importation and commercialization, unless authorized under exceptional circumstances (e.g. emergencies, donations).
Other Central America and the Caribbean Countries: Belize, Costa Rica, Cuba, El Salvador, Guatemala, Honduras, Nicaragua, Panama
