Free Bolivia medical device classification tool

What the Bolivia classifier checks

How are medical devices classified in Bolivia?

AGEMED uses a risk-based framework. Possible classes include Clase I — riesgo bajo, controles generales, Clase IIa — riesgo moderado, controles especiales de fabricación, Clase IIb — riesgo alto, controles especiales de diseño, Clase III — riesgo más alto. Bolivia's own four-class axis, set out in numeral 1.7.2 of the Manual para Registro Sanitario de Dispositivos Médicos: Class I low risk under general controls, Class IIa moderate risk with special manufacturing controls, Class IIb high risk with special design controls, and Class III the highest risk. The manual's numeral 1.6 defines the devices in scope, and it is the technical instrument that fixes the requirements and procedure for device registration; AGEMED's later circulars identify it as the operative instrument. There is no Andean Community device mutual recognition: the only automatic homologación route AGEMED operates recognises the sanitary-notification code of another Andean Community member state for cosmetic and household-hygiene products under Decisiones 516 and 706, and no equivalent instrument for medical devices exists — Bolivian registration is what actually happens. The applicable class depends on the product's intended purpose, duration of use, invasiveness, active functions, implantability, sterility, software role, and other market-specific rules.

What information does the Bolivia classifier use?

Current AGEMED requirements and similar registered products for context. Your result includes an explanation and links to the official sources used.

Is the result an official AGEMED classification decision?

No. The result is a preliminary estimate based on the product details you provide and the information available. Confirm the classification with the applicable authority or a qualified regulatory professional before filing.