El Salvador DNM / SRS medical device registration for FDA-cleared and CE-marked products. Single local representative. Manufacturer-funded processing service.
Timelines confirmed at proposal stage
Until August 2024 El Salvador's medical-device registrations were administered by the Dirección Nacional de Medicamentos (DNM). On 7 August 2024 the Ley de la Superintendencia de Regulación Sanitaria consolidated DNM's competencies into the new Superintendencia de Regulación Sanitaria (SRS). The substantive rule is unchanged for IoR purposes: each registration names a single local legal representative who carries the regulatory obligations. Registration ownership is not divisible. Whoever pays for the registration controls it: a distributor that funds the filing will hold it hostage and refuse transfer. bioaccess® processes your DNM registration funded by you, the manufacturer — dossier, translations, agency liaison — while your distributor is titleholder and importer of record on paper only, with tight transfer-upon-demand clauses in your distribution agreement (reviewed by local counsel) forcing transfer to your designee on your demand. See the LATAM Importer of Record guide for the full country breakdown.
bioaccess® sells registration processing — not a holder subscription — in El Salvador: the local legal representative must be the importing entity, so there is no annual holder fee to quote. Government submission fees are set by the regulator; certified Spanish translation of IFU, labels, and technical file is typically required. RF homologation for wireless devices runs through El Salvador's separate telecom authority. Registration processing and hostage-proof contracting are quoted as a scoped engagement: dossier preparation, translations, agency liaison, and tecnovigilancia.
Market Access hub · LATAM registration pricing · LATAM Importer of Record guide
Related: Clinical trials in El Salvador.