Through exempt resolution No. 106, dated January 17, 2023, the Chilean Institute of Public Health through the Department of the National Agency for Medical Devices, Innovation and Development (ANDID) has issued the GMP Guide for Medical Devices (MD) including in vitro diagnostic medical devices (IVDM).
The guide details “the requirements of a quality management system so that a manufacturer can demonstrate the ability to manufacture and make available DM and IVDM that meet its quality specifications.”
Although this guide does not have the force of law and therefore its observation by the addressees is not mandatory, the ANDID department has developed this and other technical guides in order to support the implementation of the regulation of medical devices in the country.
You can check the complete guide in this link.
