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. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, including El Salvador, to expedite the preparation of your medical device or IVD registration application.

Medical Device Regulations and Classification in El Salvador

REGULATORY AUTHORITY: Medical devices are regulated by the Directorate of Medicines and Health Products (DIRMED).

CLASSIFICATION SYSTEM: Devices are divided according into risk into Classes I, IIa, IIb, and III.

AUTHORIZED REPRESENTATIVE: A local authorized representative is required.

Last updated on March 17 2015.

Other Central America and the Caribbean Countries:

Belize, Costa Rica, Cuba, Dominican Republic, Guatemala, Honduras, Nicaragua, Panama

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