El Salvador Healthcare New Technical Regulation for Medical Devices

On February 23, 2023, the new Salvadoran Technical Regulation (STR) entitled Medical Devices: Requirements for the Sanitary Regulation of Medical Devices entered into force. This regulation defines all requirements for the manufacturing, importation, exportation, storage, distribution, and commercialization of medical devices in El Salvador.  For the importation of products, a U.S. company must follow the registration process at the regulatory entity, the National Medicine Directorate (DNM), which also determines the risk of the devices based on different criteria. The product registration will be valid for five years; however, companies must pay an additional annual fee within the first three months of each calendar year to maintain a valid product registration.  

The general requirements to register a medical device include submitting a registration form, the Certificate of Free Sale, a Good Manufacturing Practice Certificate, a Technical Sheet, Labeling and Packaging information, a Safety Report and any Sanitary Alert, a Risk Management Report, etc. The registration of other medical devices, such as in-vitro medical devices, IT systems of medical use, and antiseptics and disinfectants for hospital medical use, require additional documentation described in section 6.3 of the STR.  

The new regulation also states that a Special Permit for Importation will be required to import used or refurbished medical devices.  See section 6.4.2 for a list of all required documentation. Used or refurbished medical devices must be less than 5 years old per the manufacturing date to be imported into El Salvador.  

A full copy of the Salvadoran Technical Regulation is available at the Official Gazette.

For more information, contact the U.S. Commercial Service Office in San Salvador at office.sansalvador@trade.gov.