Very nice answer Romit ! Just to add a comment that if you go through a MDSAP audit, sell into Australia, then your Auditing Organisation (AO) will most likely add Australia requirements regardless of class of device. MDSAP is a quality system audit process. So Romit's answer is great, but now you have to try and convince your AO of that fact when they are auditing your entire quality management system (to ISO 13485).
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 04-Feb-2020 17:23
From: Romit Singh, MBA, RAC
Subject: MDSAP Australia exemption
MDSAP is not a mandatory requirement for Australia. If you intend to include your product (Class Im) on the ARTG using FDA 510K, HC or PMDA then you need MDSAP but if you have them covered by CE then MDSAP is not required.
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Romit Singh, MBA, RAC
Pre Market Team Leader
Belrose
Australia
Original Message:
Sent: 03-Feb-2020 19:38
From: Anonymous Member
Subject: MDSAP Australia exemption
This message was posted by a user wishing to remain anonymous
If your devices are class I measuring than are they exempt from MDSAP requirements in Australia?
Thanks in advance