Panama MINSA medical device registration for FDA-cleared and CE-marked products. Single Authorized Representative must also import. You fund it; you control it.
Timelines confirmed at proposal stage
Panama operates a single-Authorized-Representative model: the named representative is both the regulatory anchor and the importer of record. 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 MINSA 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 Panama: the titleholder must also be the importer, so there is no annual holder fee to quote. DNDM 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 Panama'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 Panama.