Can I read Medical Device Grouping Guidance Australia on EtoBox?

Medical Device Grouping Guidance Australia by Alaa Al masri is a document available to read on EtoBox.

What is Medical Device Grouping Guidance Australia about?

This document provides guidance on grouping medical devices for product registration. It defines key terms and outlines general principles of grouping. Medical devices can be grouped into categories like family, system, IVD test kit, IVD cluster, group, or single. Applicants must determine the appropriate grouping based on the criteria in this guidance document when preparing medical device registration submissions. The guidance is meant to facilitate including multiple related devices in a single registrat

Author

Alaa Al masri

Language

EN