Diagnostic Reagents - Chile

In Chile it is required to have the verification of Conformity of the in vitro Diagnostic Reagents; In Chilean territory, diagnostic reagents correspond to medical devices described as chemical, biological, immunological components, solutions or preparations, proposed by the manufacturer to be used as in vitro Diagnostic Medical Devices.

These articles for medical use are used individually or in combination with others, in a non-invasive manner, intended for the in vitro study of clinical samples from the human body, including blood and tissue donations, in order to provide diagnostic information. of the patient related to a physiological or pathological state, predict a response or reaction to a treatment, in addition to having an essential role in the screening of microbiological agents in donors.

Aruna Asesores has an expert regulatory team that will accompany it in the planning and execution of the regulatory processes required in Chile for the implementation of these in the market.