Classification of Medical Devices in Peru, Bolivia and Chile
In Peru and Chile, medical devices are classified based on the potential or
residual risks associated with their use. This classification considers criteria such as the duration
of body contact, the degree of invasiveness, and both local and systemic effects. Practically,
devices are grouped by the level of risk they present, categorized into:
- Class I: Low risk.
- Class II: Moderate risk.
- Class III: High risk.
- Class IV: Very high risk.
Bolivia: In Bolivia, the classification of medical devices is based on potential risks related to
usage and possible device failures, considering multiple criteria such as duration of body
contact, degree of invasiveness, and local versus systemic effects. In alignment with
international agreements to establish harmonized regulations, this classification system has
been adopted, requiring companies to classify each medical device according to its intended
purpose.
- Class I: Low-risk devices subject to general controls, not intended to protect or sustain life or
for special use in the prevention of human health deterioration, and do not pose an
unreasonable risk of illness or injury. - Class IIa: Moderate-risk devices subject to special controls during the manufacturing phase to
demonstrate safety and effectiveness. - Class IIb: High-risk devices subject to special controls during design and manufacturing to
demonstrate safety and effectiveness. - Class III: Very high-risk devices subject to special controls, intended to protect or sustain life,
for significant use in the prevention of human health deterioration, or if their use poses a
potential risk of illness or injury.