DIGEMAPS medical device registration in the Dominican Republic under Decreto 82-15 and Decreto 246-06. Single Authorized Representative model. All-inclusive annual fee, neutral local holder.
Timelines confirmed at proposal stage
DIGEMAPS names a single local Authorized Representative on each registration certificate. Transferring the representative role requires DIGEMAPS approval. bioaccess® acts as the Authorized Representative through our own Dominican entity.
First device family low-to-mid risk USD 7,500/yr, all-inclusive. Additional families +USD 3,500/yr.
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 Dominican Republic.