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Medical Device Edar Permit Guidelines by Amalia Desy Saputri is a document available to read on EtoBox.

What is Medical Device Edar Permit Guidelines about?

This document outlines the requirements for obtaining an EDAR permit for medical devices in Indonesia. It discusses 5 forms (A-E) that are part of the marketing authorization for medical devices and covers administrative and technical requirements. Form A specifically includes administrative data requirements for medical device imports, outlining 9 points of information that must be provided, including documents like certificates of free sale, conformity certifications, and statements of compliance with qua

Author

Amalia Desy Saputri

Language

EN