DIGEMAPS device registration in the Dominican Republic under Decreto 82-15 and Decreto 246-06. Single holder-importer model. Processing funded by you.
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 by merging the prior Drugs/Pharmacies and Food Risk Control directorates — names a single local Authorized Representative on each registration certificate. The substantive registration, import, distribution and post-market rules are set by Decreto 246-06. Transferring the local Authorized Representative role to a different local entity requires DIGEMAPS approval, which adds friction to commercial reshuffles. 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 DIGEMAPS 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 the Dominican Republic: the Authorized Representative must be 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, agency liaison, and tecnovigilancia.
Market Access hub · LATAM registration pricing · LATAM Importer of Record guide
Related: Clinical trials in Dominican Republic.