Bolivia medical device regulatory resources

Numeral 3.1.5 fixes 30 working days from entry of the dossier to the Dirección de Medicamentos y Tecnología en Salud for delivery of the original Registro Sanitario certificate, which is valid for five years.

This is a certificate-delivery period, not a substantive review clock: the manual fixes no separate evaluation deadline, and numerals 3.1.4(b) and (c) run before it — an observed dossier gets a written note that must be remedied within 60 calendar days, with one re-entry allowed within 60 days on payment of the second-evaluation tariff.

Numeral 2.6 requires samples only for low-risk devices; for moderate, moderate-high and high-risk devices samples are not part of the dossier, which is why the realistic range is longer for the higher classes.

Circular AGEMED N° 86/2023 numeral 4 states that, once the procedure has entered through the MISA platform, the time established for issuing Certificados de Comercialización for biomedical equipment does not exceed 5 working days.

Numeral 6: observations must be remedied within 5 working days or the file is archived without refund; numeral 12: the certificates have no specific validity until a new norm is issued.

Numeral 4.5 of the annexed directive fixes 2 months for the technical documentary analysis of an inscription once the application and the other pertinent documents are submitted.

TEXT-LAYER DISCLOSURE: the AGEMED-hosted PDF of RA 42/2024 has no digital text layer of its own. Its only extractable text is the publisher's own embedded text layer (Producer 'OmniPageCSDK19', Creator 'HP Smart Document Scan Software 3.80'), which this repository ingests as published; no OCR was run to read it. That layer systematically substitutes 'a' for 'o' — the raw text reads 'Renavacián a Rectificación de Registras Sanitarias' where the instrument says 'Renovación o Rectificación de Registros Sanitarios'. The period is unaffected by the substitution, but anyone re-verifying these figures should read the image directly. The device manual's own 30-working-day clock is a digital text layer and carries no such caveat.

The directive's scope clause (numeral 2) names 'dispositivos médicos' and 'dispositivos de diagnóstico in vitro' among the products it applies to, so a foreign regulatory decision is an admissible input for a Bolivian device registration; the periods themselves are drafted in medicines terms and AGEMED retains sovereignty over the decision.

Eligibility requires a current registration or marketing authorisation from at least one reference authority recognised by law, a PAHO/WHO listed authority being the reference set, and a sworn declaration of equivalence.

Numeral 4.5 fixes 1 month for renewal or rectification under the reliance route, half the inscription period.

Same instrument and same embedded-text-layer disclosure as the reliance-inscription row above: the period was read from the publisher's own embedded text layer, not from a digital text layer and not by OCR.