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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 November 22nd, 2021.
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.
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.
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