In my prior post, I noted that if a device is an Australian Class I self-declaration device (such as Class I non-measuring or non-sterile), then the manufacturer's Declaration of Conformity, the ARTG application, and the resulting inclusion in the ARTG, are essentially based on an attestation (i.e., a good-faith promise) of conformity with the Essential Principles. That would include any associated quality management system (QMS) solutions implemented toward that goal (remember that, pursuant to Australian medical device law, such conformity assessment is "
mainly about the application of quality management systems"). But because this process (i.e., the Class I self-declaration route) doesn't generally involve submission of actual objective evidence of QMS conformity (like an MDSAP certificate), and because for that matter, MDSAP certificates are just one of various options allowed by the TGA for showing QMS conformity, then that is why a Class I non-sterile or non-measuring device can be included in the ARTG without an MDSAP certificate. Let's not let such scenarios fool us into thinking that Class I non-sterile or non-measuring devices are allowed to be included in the ARTG prior to achieving the necessary QMS conformity.
Also in my prior post, I noted that higher-classed devices (i.e., Class I measuring, Class I sterile, Class IIa, and higher) require assessment (including, but not limited to, QMS assessment and certification) by a recognized auditing organization and/or conformity assessment body. Yet Class I sterile, Class I measuring, or higher classes, can indeed be included in the ARTG
without an MDSAP certificate. While that may seem to be a disparity, it is only because MDSAP certification is just one of various options allowed by the TGA for how a conformity assessment body certifies the manufacturer's conformity with the applicable Australian QMS requirements. The enduring fact remains that, whatever option is selected for showing conformity with applicable Australian QMS requirements (e.g., those related to assuring sterility of a Class I sterile device), it is always true that a certificate (be it an MDSAP certificate; an ISO 13485 certificate; or other QMS certificate) from a conformity assessment body is absolutely required as a prerequisite condition for being included in the ARTG. It would be in unequivocal contravention of Australian medical device law and associated regulations if such a device got included in the ARTG
without certified evidence of conformity with the associated QMS requirements. Consequently, for scenarios where a device, such as a Class I sterile device, is added to the ARTG without an MDSAP certificate, then I'm confident that such inclusion was based on an alternative form of QMS certification given by a conformity assessment body in support of the inclusion. If not, then that would seem to be a scenario quite vulnerable to eventual enforcement action upon discovery.
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Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.
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Original Message:
Sent: 26-Mar-2021 08:26
From: Stacey Benser
Subject: Submitting Devices for Registration in Australia
We obtained TGA approval for our Class I and Is device prior to our MDSAP audit being completed with Australia however we utilized our existing EC Certificate for the device for submission to the TGA.
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Stacey Benser
Senior Quality/Regulatory Manager
York PA
United States
Original Message:
Sent: 22-Mar-2021 10:53
From: Anonymous Member
Subject: Submitting Devices for Registration in Australia
This message was posted by a user wishing to remain anonymous
We are an ISO 13485:2016 certified medical device manufacturer with an MDSAP certificate for the USA, Canada, and Brazil. We are considering adding Australia to the scope of our certificate and pursuing registration with the TGA. My question is in regards to the audit of our QMS to meet the Australian requirements. Does anyone know if the audit will need to happen before the TGA will register our device? Or could we register our device and then have the Australian requirements audited at the time of our annual Notified Body audit? Or does this depend on our Notified Body and I should be asking them?
TIA!