This message was posted by a user wishing to remain anonymous
Based on discussion with the TGA in the past, having MDSAP certificate does not place the manufacturer at any significant advantage and esp. for a class IIb implantable medical device inclusion applications, TGA will perform their routine checks anyways regardless if EC is submitted as manufacturer's evidence or MDSAP with 510(K) or PMA with MDSAP.
Original Message:
Sent: 25-Feb-2022 18:04
From: Anonymous Member
Subject: MDSAP in Australia
This message was posted by a user wishing to remain anonymous
I understand that having a MDSAP Certificate is not mandatory for medical device registration but if one does not have that, is the process significantly more arduous for a Class IIb implantable device?