Panama MINSA medical device registration for FDA-cleared and CE-marked products. Single Authorized Representative model under the Dirección Nacional de Farmacia y Drogas. All-inclusive annual fee.
Timelines confirmed at proposal stage
Panama's DNFD / Ministerio de Salud operates a single Authorized Representative model — the named representative is the regulatory anchor and importer of record. bioaccess® acts as the Panamanian representative through our own local 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.
Market Access hub · LATAM registration pricing · LATAM Importer of Record guide
Related: Clinical trials in Panama.