Chile - Document Guidance for the procedure "Authorization of Provisional Use of Medical Device in Clinical Research in Human Beings"

This technical guide defines the procedures and requirements for investigators and sponsors seeking provisional authorization to use medical devices in human clinical research in Chile. 

Issued by the National Agency for Medical Devices (ANDIM) of the Institute of Public Health (ISP), it standardizes the ex-ante qualitative evaluation process for devices that are not yet registered or commercially available in the country. 

It also specifies the required technical documentation, clinical investigation plans, labeling, traceability, safety reporting, and compliance with Good Clinical Practice standards such as ISO 14155 and ICH E6-R3.