General country-specific regulatory information is provided on this page for medical device registration and approval in El Salvador.
We review our Regulatory Information frequently; please check back often for updates
REGULATORY AUTHORITY:
Dirección Nacional de Medicamentos (DNM)
CLASSIFICATION SYSTEM:
Medical Devices/IVDs: I/IIa/IIb/III.
TIMEFRAME:
According to our experience, new product registration in El Salvador will take around 5-6 months (depending on risk classification).
SPECIAL REQUIREMENT:
Local testing and clinical study are not required.
LOCAL FEES (New Application):
New registration (all classes) – USD 75
LOCAL FEES (Manufacturer):
Not applicable
LICENSE VALIDITY:
The registration certificate is valid for 5 years.
LICENSE TRANSFER:
License transfer is possible. The new certificate holder must submit the paperwork.
AUTHORIZED REPRESENTATIVE:
A foreign manufacturer must appoint a local company to become their authorized representative.
ADDITIONAL INFORMATION:
Not applicable.
Other Central America and the Caribbean Countries: Belize, Costa Rica, Cuba, Dominican Republic, Guatemala, Honduras, Nicaragua, Panama
Last Update January 2023
For detailed device-specific compliance information for each market, including El Salvador, to expedite the preparation of your medical device or IVD registration application.
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And, in less than a minute, you can start your device-specific registration application and a complete county-specific registration process in this country or any of the other 140+ countries available for you through the Arazy Group Medtech registration platform.
