MEDICAL DEVICE REGISTRATION AND APPROVAL IN El Salvador

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 update: December 2022

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: BelizeCosta RicaCubaDominican RepublicGuatemalaHondurasNicaraguaPanama

Last Update January 2023

JUST SAY WHEN!

Did you know you can onboard your medical device or IVD compliance information to our system in less than 15 minutes?

And, in less than a minute, you can start your device-specific registration application and a complete country-specific registration process in this country or any of the other 140+ countries available for you through the Arazy Group Medtech registration platform. You can start your product registration right now!

Ready to Get Started?