Bolivia AGEMED medical device registration under the Manual para Registro Sanitario (T-N-11-RM-0909). Single registered local entity. All-inclusive annual fee.
Timelines confirmed at proposal stage
Bolivia's AGEMED, under the Ministerio de Salud, issues sanitary registration to a single registered local entity per device under the Manual para Registro Sanitario T-N-11-RM-0909. bioaccess® acts as the Bolivian holder through our own local entity.
Market Access Essentials / LATAM Launch Subscription: USD 7,500 per year per country for the first device family. Includes government submission fees, sworn translations, in-country titular/RH/IOR, and tecnovigilancia as holder. Additional families quoted on request.
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 Bolivia.