Dirección Nacional de Medicamentos (DNM)
Medical Devices/IVDs: I/IIa/IIb/III.
According to our experience, new product registration in El Salvador will take around 5-6 months (depending on risk classification).
Local testing and clinical study are not required.
LOCAL FEES (New Application):
New registration (all classes) – USD 75
LOCAL FEES (Manufacturer):
The registration certificate is valid for 5 years.
License transfer is possible. The new certificate holder must submit the paperwork.
A foreign manufacturer must appoint a local company to become their authorized representative.
Last Update January 2023