AGEMED current fee schedule, reviewed for 2026, in BOB.
13 fee lines100% exact amountscurrency BOBFX rates 2026-09-17reviewed 2026-09-16
| Fee line | Official amount | USD equivalent | Frequency | Provenance |
|---|---|---|---|---|
| Dispositivo médico importado — Servicio por Registro Sanitario, Inscripción Tariff item 82. | BOB 1,489 | $132 | Per registration | Verified |
| Dispositivo médico importado — Servicio por Registro Sanitario, Reinscripción Tariff item 83. Reinscription is filed within the three months before expiry of the five-year registration. | BOB 1,117 | $98.77 | Per reinscription, every 5 years | Verified |
| Dispositivo médico Nacional — Servicio por Registro Sanitario, Inscripción Tariff item 84. | BOB 993 | $87.81 | Per registration | Verified |
| Dispositivo médico Nacional — Servicio por Registro Sanitario, Reinscripción Tariff item 85. | BOB 745 | $65.88 | Per reinscription, every 5 years | Verified |
| Reactivo para diagnóstico nacional — Servicio por Registro Sanitario, Inscripción Tariff item 90. The national reagent inscription rate is the lowest of the reagent, device and implant inscription rates in section II of the table. | BOB 621 | $54.91 | Per registration | Verified |
| Reactivo para diagnóstico importado — Servicio por Registro Sanitario, Inscripción Tariff item 92. | BOB 1,241 | $110 | Per registration | Verified |
| Prótesis o implante importado — Servicio por Registro Sanitario, Inscripción Tariff item 96, the highest of the device, reagent and implant inscription rates in section II of the table. | BOB 1,737 | $154 | Per registration | Verified |
| Prótesis o implante nacional — Servicio por Registro Sanitario, Inscripción Tariff item 98. | BOB 869 | $76.84 | Per registration | Verified |
| Rectificación de Registro Sanitario, cualquiera sea el producto, nacional o importado, incluido dispositivo médico importado Tariff item 101, whose printed wording runs 'cualquiera sea el producto, nacional o importado, incluido dispositivo médico importado'. | BOB 621 | $54.91 | Per rectification | Verified |
| Segunda evaluación para Registro Sanitario, por falta de uno de los requisitos establecidos Tariff item 102, whose printed wording ties the second evaluation to a dossier re-entered 'por falta de uno de los requisitos establecidos según D.S. N° 25235, cualquiera sea el producto, nacional o importado'. | BOB 621 | $54.91 | Per re-entry of an observed dossier | Verified |
| Evaluación de desempeño para reactivo de diagnóstico cuando corresponda, sea nacional o importado Tariff item 107, under the control-of-quality and performance-evaluation section of the table. | BOB 1,241 | $110 | Per performance evaluation | Verified |
| Firmas Importadoras de Dispositivos Médicos — Evaluación e Inspección por apertura Tariff item 34. Charged to the importing firm, not per product; AGEMED's Form 096 requirements sheet states the same amount for the same item. | BOB 4,964 | $439 | Per establishment opening | Verified |
| Firmas Importadoras de Dispositivos Médicos — Inspección anual Tariff item 35; the GMP or GAP audit of the same firms is item 37 at BOB 1,862. | BOB 1,241 | $110 | Annual | Verified |
Government fees only — service and testing costs are separate- Every published amount is an exact boliviano figure in the tariff table; no formula or base unit is involved, so no amount here is derived.
- Registration tariffs are charged per product registration, not per family and not per model.
- Pricing is by product category and by national or imported origin: a national prosthesis or implant (item 98, BOB 869) costs less than an imported non-implant device (item 82, BOB 1,489), which is why the low-risk and high-risk bands overlap.
- The schedule is the annex to Resolución Ministerial N° 0265 of 25 May 2018: the scanned first page carries 'RESOLUCIÓN MINISTERIAL N° 0265' with a '25 MAY' date stamp, its Article Segundo derogates Resolución Ministerial N° 0493 of 2 August 2004, and the document's own scan metadata records 30 May 2018. AGEMED's Circular N° 86/2023 numeral 3 independently cites the current schedule as Resolución Ministerial N° 0265 de 25 de mayo de 2018 and its item N° 138 as the Certificación de Comercialización — the same item and wording this table carries — so the effective date published here is the resolution's own date.
- Device-specific reinscription and modification charges sit in the same table: item 83 BOB 1,117 and item 85 BOB 745 for reinscription of imported and national devices.
- The AGEMED tariff does not differentiate by device risk class: it prices by product category (dispositivo médico, reactivo para diagnóstico, prótesis o implante) and by national or imported origin. The low-risk band published here is therefore the general device inscription range (item 84 BOB 993 national to item 82 BOB 1,489 imported) and the high-risk band is the prosthesis or implant inscription range (item 98 BOB 869 national to item 96 BOB 1,737 imported), which is why the two bands overlap.
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Exact amounts verified against the AGEMED fee schedule · full review 2026-09-16 · row IDs are stable — cite as government-fees:bolivia:dispositivo-medico-importado-inscripcion