El Salvador DNM / SRS medical device registration for FDA-cleared and CE-marked products. Single local legal representative. 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.
Market Access Essentials / LATAM Launch Subscription: USD 7,500 per year per country for the first device family. Includes government submission fees, sworn translations, in-country titular/RH/IOR, and tecnovigilancia as holder. Additional families quoted on request.
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.
Market Access hub · LATAM registration pricing · LATAM Importer of Record guide
Related: Clinical trials in El Salvador.