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.
All-inclusive annual subscription per country; pricing under review — contact us for a quote.
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.
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Related: Clinical trials in Belize.