Belize Ministry of Health & Wellness medical device registration under the Food and Drugs Act, 1973. Licensed importer with a registered pharmacist in charge. All-inclusive annual fee.
Timelines confirmed at proposal stage
Belize's Drug Inspectorate Unit regulates pharmaceuticals and devices under the Food and Drugs Act, 1973. Importers must hold a licence and a registered pharmacist must be in charge at the importing entity. bioaccess® acts as the Belizean licensed importer through our own local entity.
First device family low-to-mid risk USD 7,500/yr (indicative), 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 Belize.