Venezuela INHRR medical device registration through SIVERC. Single registrant per registration. U.S. export-control review required before pursuing Venezuela. All-inclusive annual fee (indicative).
Timelines confirmed at proposal stage
Venezuela's INHRR registers medical equipment and materials through SIVERC (Sistema Venezolano de Registro y Control de Medicamentos y Evaluación de Productos Sanitarios); single registrant per registration. U.S. sanctions are a material constraint — sponsors must obtain export-control counsel before pursuing Venezuela. bioaccess® acts as the Venezuelan registrant through our own local entity where permitted.
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.
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Related: Clinical trials in Venezuela.