Medical devices

Documento Guía del trámite "Autorización de Uso Provisional de Dispositivo Médico en Investigación Clínica en Seres Humanos" (Guidance document for the authorization procedure for the temporary use of medical devices in clinical investigations involving human subjects) (42 pages, in Spanish)

The notified technical guidance document establishes the procedural framework and requirements that investigators and sponsors must comply with when applying for authorization for the temporary use of medical devices intended for clinical investigations involving human subjects in Chile. The document, prepared by the National Agency for Medical Devices (ANDIM) of the Public Health Institute (ISP), seeks to standardize the ex ante qualitative assessment process for those medical products that do not yet have a health registration certificate and are not commonly marketed in Chile. This detailed guidance document, covering  basic operational definitions to possible reasons for refusal of an application, sets out the administrative regulations for ensuring that every medical device used in a clinical trial in the national territory meets rigorous safety and quality standards. At its operational core, the text sets out meticulously the single document and technical background information that must be submitted with each application, such as the clinical investigation plan, the investigator's brochure, and evidence of compliance with good clinical practices based on internationally recognized standards (such as ISO 14155 and ICH E6(R3)). It also regulates key aspects such as specific labelling requirements for investigational devices, traceability mechanisms, and managing the reporting of safety issues and adverse events.