09/22/2021 | News release | Distributed by Public on 09/21/2021 23:11
The purpose of this guidance is to assist sponsors and manufacturers of spinal implantable medical devices to understand and comply with new regulatory requirements.
From 25 November 2021, some spinal implantable medical devices will be required to be reclassified. The new regulatory requirements will also include:
The classification of your spinal implantable medical device will determine the safety and performance requirements to be demonstrated to meet regulatory requirements.