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Medical Device Registration and Approval in El Salvador
General country-specific regulatory information is provided on this page for medical device registration and approval in El Salvador.
Last updated on January 10th, 2023.
Medical Device Regulations and Classification in El Salvador
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
For detailed device-specific compliance information for each market, including El Salvador, to expedite the preparation of your medical device or IVD registration application.
Any Questions?
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