The answer is "Probably not"... Beginning in 2021, the Therapeutic Goods Administration (The TGA) began the regulation of Software as a Medical Device (SaMD) – and what drives your intraoral scanner? Software!
The software (including mobile apps) that drive your intraoral scanner are a medical device and fit well within the definition of a medical device in section 41BD of the Therapeutic Goods Act 1989.
Prior to 2021, the correct classification of an Intraoral Scanner was Class Im (Class one measurement device.)
Software is becoming increasingly important in medical devices and digital adoption more broadly. In addition, it is becoming more important as a medical device in its own right.
Rapid innovation in technology, like orthodontic prediction software, has driven significant changes to software function and adoption, giving rise to a larger number of devices able to inform, drive or replace clinical decisions.
Why bring this up?
During the long drawn out registration of our own scanner, it came to light the sheer number of scanners on the market with legacy or incorrect registrations.
How can I look up my scanner's registration?
You can search any device on The Australian Register of Therapeutic Goods (The ARTG) by clicking HERE or by logging into your eBS account. Although, the easiest way is just to ask your rep to send you the registration certificate.
If you've purchased an Aoralscan IOS from Osseo Group (device ID 377218), you can view and print our original Class 2a certificate on the TGA website by clicking HERE.
How can I tell if my scanner is registered correctly?
A quick search of the ARTG will reveal the sheer number of scanners on the market with legacy or incorrect registrations.
Listed as Class I – it's incorrectly registered. X
Listed after Jan 2021 as a Class I or Class Im – it's incorrectly registered. X
Listed before or after Jan 2021 as a Class 2a – it's correctly registered. ✓
What happens if my scanner was registered incorrectly?
Compliance before enforcement is generally the approach of The TGA. If you find that your device is incorrectly registered, you should get in touch with your distributor and ask what is being done to rectify the situation.
Osseo Group will always consider a trade-in for credit towards a new (and correctly registered) AORALSCAN 3 IOS. You can learn more and book a demo HERE.
Book an in-office demo of our AORALSCAN 3 IOS
Let's set aside a time to meet in your office and demonstrate how to use the AORALSCAN IOS. We'll need around 30 minutes of your time and one of your nurses to scan for you to truly see how doctor-friendly the AORALSCAN IOS is.
Learn more about the AORALSCAN 3 IOS by clicking HERE
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