El Salvador DNM / SRS medical device registration for FDA-cleared and CE-marked products. Single local legal representative model since the 2024 SRS consolidation. All-inclusive annual fee.
Timelines confirmed at proposal stage
Since 7 August 2024 the SRS — successor to the Dirección Nacional de Medicamentos (DNM) under the Ley de la Superintendencia de Regulación Sanitaria — is the sanitary regulator. Each registration names a single local legal representative. bioaccess® acts as the Salvadoran legal representative through our own local entity.
All-inclusive annual subscription per country; pricing under review — contact us for a quote.
All-inclusive annual subscription includes government submission fees, in-country registered agent, regulatory liaison, and certified/sworn translations where required. Electrical/EMC and RF homologation for wireless devices are handled through the country’s telecom authority at vendor cost plus a 20% G&A handling fee.
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Related: Clinical trials in El Salvador.