Venezuela INHRR medical device registration through SIVERC. Single registrant. U.S. export-control review required before filing. Processing funded by you.
Timelines confirmed at proposal stage
Venezuela's INHRR, an autonomous entity attached to the Ministry of Health, regulates and registers medical equipment and materials. Filings are made through SIVERC and each registration names a single registrant. U.S. sanctions are a material constraint and sponsors should obtain export-control counsel before pursuing Venezuela. Where permitted by applicable export-control regimes, registration ownership is not divisible. Whoever pays for the registration controls it: a distributor that funds the filing will hold it hostage and refuse transfer. bioaccess® processes your INHRR registration funded by you, the manufacturer — dossier, translations, agency liaison — while your distributor is the single registrant on paper only, with tight transfer-upon-demand clauses in your distribution agreement (reviewed by local counsel) forcing transfer to your designee on your demand. See the LATAM Importer of Record guide for the full country breakdown.
bioaccess® sells registration processing — not a holder subscription — in Venezuela: the single registrant must be the importing entity, so there is no annual holder fee to quote. INHRR government submission fees are set by the regulator; certified Spanish translation of IFU, labels, and technical file is typically required; RF homologation for wireless devices runs through Venezuela's separate telecom authority. Registration processing and hostage-proof contracting are quoted as a scoped engagement — dossier preparation, translations, agency liaison, and tecnovigilancia — subject to export-control review.
Market Access hub · LATAM registration pricing · LATAM Importer of Record guide
Related: Clinical trials in Venezuela.