Uruguay MSP medical device registration — strict single Local Holder model. The Local Holder is the only entity authorized to import; separate distributors require separate registrations. Scoped case-by-case.
Scoped case-by-case in the proposal
Uruguay's MSP runs a strict single-Local-Holder model — the Local Holder is the only entity authorised to import the registered device. If two Uruguayan distributors want to sell the same product, each must file its own separate registration. bioaccess® can act as a neutral Uruguayan Local Holder on a bespoke fee, or sequence Uruguay after another LATAM market.
Uruguay sits outside the standard bioaccess® flat-fee subscription. Pricing and timeline are scoped case-by-case in the proposal.
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 Uruguay.