Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi, 

I'm interested in understanding if pain or muscle relief LED devices in Australia MUST be registered as medical devices or if it would be possible to market the devices as normal electronic devices and avoid the medical device registration. 

Please advise.

Hi Anon,

I depends on the claim. If you claim alleviation of an injury (as I can see it), then it is a medical device.

Search the competition and maybe ask a question to the authorities

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Spyros Drivelos
Medical Devices Expert, RAC
Agia Paraskevi, Athens
Greece
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Original Message:
Sent: 30-Sep-2020 10:21
From: Anonymous Member
Subject: Pain Muscle Relief Devices - Australia

This message was posted by a user wishing to remain anonymous

Hi,

I'm interested in understanding if pain or muscle relief LED devices in Australia MUST be registered as medical devices or if it would be possible to market the devices as normal electronic devices and avoid the medical device registration.

Please advise.

Hello,

Agree with Spyros, most medical devices in most regulated regions depends on the claims you are making for the device.  If there are claims for diagnosis, monitoring, or treating a medical condition then would be considered a medical device in most jurisdictions.  As an example, a heating pad provides heat = non-medical device.  A heating pad provides heat for relief of sore muscles and increased blood flow = medical device.

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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 01-Oct-2020 02:21
From: Spyros Drivelos
Subject: Pain Muscle Relief Devices - Australia

Hi Anon,

I depends on the claim. If you claim alleviation of an injury (as I can see it), then it is a medical device.

Search the competition and maybe ask a question to the authorities

------------------------------
Spyros Drivelos
Medical Devices Expert, RAC
Agia Paraskevi, Athens
Greece

Original Message:
Sent: 30-Sep-2020 10:21
From: Anonymous Member
Subject: Pain Muscle Relief Devices - Australia

This message was posted by a user wishing to remain anonymous

Hi,

I'm interested in understanding if pain or muscle relief LED devices in Australia MUST be registered as medical devices or if it would be possible to market the devices as normal electronic devices and avoid the medical device registration.

Please advise.

Hi there,
Have a look at the TGA's website and the definition of medical device here 
https://www.tga.gov.au/what-medical-device

Also, you can use their interactive tool to help you determine if your product is a medical device or not. https://www.tga.gov.au/my-product-medical-device

Good luck and hope this helps!

------------------------------
Laura Castelnoble
Senior RA Business Partner
Putney NSW
Australia
------------------------------

Original Message:
Sent: 30-Sep-2020 10:21
From: Anonymous Member
Subject: Pain Muscle Relief Devices - Australia

This message was posted by a user wishing to remain anonymous

Hi,

I'm interested in understanding if pain or muscle relief LED devices in Australia MUST be registered as medical devices or if it would be possible to market the devices as normal electronic devices and avoid the medical device registration.

Please advise.