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
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.
Other Central America and the Caribbean Countries: Belize, Costa Rica, Cuba, Dominican Republic, Guatemala, Honduras, Nicaragua, Panama
Please fill out your contact information so we can better assist you.
* Note: If you use your general ISP e-mail address, such as gmail, yahoo etc. your LinkedIn profile address is required to process your request.