DIGEMAPS device registration in the Dominican Republic (Ley 42-01, Decreto 246-06). A licensed local representative files and imports. You fund processing.
Timelines confirmed at proposal stage
DIGEMAPS — the Dominican Republic's General Directorate of Medicines, Food and Health Products, created by Decreto 82-15 on 6 April 2015 — registers medical devices under Ley 42-01, Decreto 246-06 (a medicines regulation that DIGEMAPS lists as the legal basis for productos sanitarios) and its published procedures. A DIGEMAPS-licensed Dominican establishment files the application under a power of attorney from the product owner and imports; it is the importer of record. DIGEMAPS device procedures separate the titular (the product owner) from the local representative, allow co-distributors authorized by the titular's power of attorney, and publish separate procedures to change the representative or the titular. Whoever pays for the registration tends to control it: a distributor that funds the filing and is named titular can hold it hostage. bioaccess® does not act as registration holder, representative or importer of record in the Dominican Republic. bioaccess® processes your DIGEMAPS registration funded by you, the manufacturer — dossier, translations, agency liaison — filed together with your licensed local representative, with change-on-demand clauses in your distribution agreement (reviewed by local counsel). See the LATAM Importer of Record guide for the full country breakdown.
bioaccess® sells registration processing — not a holder subscription — in the Dominican Republic: the licensed local representative is the importing entity, so there is no annual holder fee to quote. DIGEMAPS 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 the Dominican Republic's separate telecom authority. Registration processing and hostage-proof contracting are quoted as a scoped engagement: dossier preparation, translations and agency liaison.
Market Access hub · LATAM registration pricing · LATAM Importer of Record guide
Related: Clinical trials in Dominican Republic.