Uruguay MSP medical device registration — strict single Local Holder. Only the holder may import; one registration per partner. Manufacturer-funded processing.
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 a manufacturer wants two Uruguayan distributors to market the same product, each distributor must file its own separate registration — there is no multi-importer shortcut. This is the most restrictive of the major Southern Cone regimes. 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 MSP 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 Uruguay: the Local Holder must also be the importer, so there is no annual holder fee to quote. MSP government submission fees are set by the regulator; certified Spanish translation of IFU, labels, and technical file is typically required. 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 Uruguay.