How to check a red light device is on the ARTG (and why it matters)

Search for "TGA approved red light therapy" and you'll find plenty of products describing themselves that way. Here's the catch: the Therapeutic Goods Administration (TGA) says advertisers must not use approval wording like that at all. Seeing it doesn't tell you anything about the device itself, but it does suggest the advertising isn't following Australian rules. This guide explains what the Australian Register of Therapeutic Goods (ARTG) actually is, what being "included" means, how medical device classes work, how to look up a device yourself in a couple of minutes, and the red flags worth noticing before you buy.

What is the ARTG?

The ARTG is the TGA's public register of therapeutic goods that can be legally supplied in Australia, from medicines to medical devices. Unless a product is exempt, it has to be entered on the ARTG before it can be supplied here. The TGA's guide to searching the ARTG explains that the register records the details and classification of each product. It isn't intended to give advice or recommendations about those products.

Each entry has its own ARTG number. That number is the simplest way to confirm an entry exists and to see what the product is included for.

What can red light therapy ads say about the TGA?

They can give the product's ARTG number, but they can't suggest the TGA has approved or endorsed the product. That applies to every therapeutic good, from a red light wrap to a blood pressure monitor. The TGA's advertising guidance on ARTG numbers says including a product on the ARTG is not an endorsement by the TGA, and that terms such as "TGA approved" and "TGA registered" must not be used. Advertisers also can't use TGA logos or the Commonwealth Coat of Arms, or describe a product as "Government endorsed".

The ARTG number is there so you can look the product up for yourself. The same guidance goes further: a broad statement that a product is "included in the ARTG" shouldn't be made without the number alongside it.

So the accurate wording is that a device is "included on the Australian Register of Therapeutic Goods", followed by its ARTG number. If a seller leans on approval language instead, take it as a prompt to check more carefully.

What do medical device classes mean?

Medical devices in Australia are sorted into classes based on risk. The TGA's overview of regulating products according to risk gives these examples:

• Class I (low risk): crutches, hospital beds.
• Class IIa (low to medium risk): dental drills, ultrasound machines.
• Class IIb (medium to high risk): surgical lasers, diagnostic X-ray equipment.
• Class III (high risk): absorbable surgical sutures.

A device's class depends on things like what the manufacturer intends it to do, how invasive it is, where it's used on the body and for how long. Higher classes face tougher requirements. The same TGA document explains that lower risk devices, such as bandages, rely on the applicant certifying they meet the regulatory requirements, while for higher risk devices, TGA officers evaluate the evidence directly. The TGA also continues to monitor products once they're on the market.

In plain terms, the class tells you how much risk regulators attach to that type of device. It isn't a quality ranking or a measure of how well a device works.

How do you search the ARTG for a device?

It takes a couple of minutes:

1. Find the ARTG number on the product page, the packaging or the label. If you can't find it, ask the seller.
2. Go to the TGA's ARTG search page and enter the number. You can also search by product name or by sponsor, the company responsible for supplying the product in Australia.
3. Open the entry and check the sponsor and product details match the device you're looking at.
4. Look at the device's class and its intended purpose.

What an ARTG number does and doesn't tell you

A medical device entry lists details such as the sponsor, the manufacturer, the device class, the type of device and its intended purpose. That intended purpose is worth reading, because it sets out what the device is included for. If an ad promises far more than the entry describes, that's worth noticing.

What the entry doesn't tell you is how well a device will work for you, whether it suits your situation, or how it compares with other options. ARTG inclusion means the product can be legally supplied in Australia for its intended purpose. It's not a TGA recommendation.

One more check: make sure the number matches the actual product. An ARTG number belongs to a specific entry, so it's reasonable to confirm the sponsor and device type line up with what you're buying.

Red flags when you're shopping

• No ARTG number anywhere on a product that makes medical claims, such as easing pain.
• "TGA approved", "TGA registered" or "TGA endorsed". The TGA's guidance says terms like these must not be used in advertising.
• "FDA approved" on an Australian site. An overseas approval doesn't replace ARTG inclusion for products supplied here, and the TGA's guidance lists "FDA approved" among the statements advertisers shouldn't use.
• Big medical promises. The TGA's consumer guide to buying medical devices warns to be careful of devices claiming to be "miracle cures" or to diagnose many conditions.
• A number that doesn't match. If the sponsor or device type on the ARTG entry looks nothing like the product, ask the seller about it.

That same TGA guide notes that buying devices online carries extra risks, including products that don't meet Australian requirements, missing instructions or warranty, and copies of known brands.

When to see someone instead

Checking the ARTG helps you choose a device. It doesn't tell you whether a device is right for you. If you're dealing with ongoing pain, a new or worsening symptom, or pelvic or bladder symptoms, see your GP or physio first. You can find a physio through the Australian Physiotherapy Association's Find a physio directory, or call healthdirect on 1800 022 222 for free health advice, 24 hours a day. If a device causes a problem, stop using it and tell your health professional.

Fringe Heals and the ARTG

Here are the ARTG numbers for our devices that are included on the register. They also appear in the disclaimer at the end of this post, and you're welcome to look any of them up yourself.

• Red Light Wrap, Red Light Wrap XL and Red Light Joint Wrap: ARTG 469586
• Red Light Head Wrap: ARTG 469585
• Red Light Panel: ARTG 471109
• Red Light Face Mask: ARTG 464865
• Red Light Pelvic Wand: ARTG 528523

One ARTG entry can cover several devices of the same kind from the same sponsor, which is why our three wraps share a single number.

The Red Light Pelvic Wand is intended to promote blood circulation, support pelvic pain reduction and support muscle relaxation. The Red Light Joint Wrap is designed for the knee, ankle or elbow. The Red Light Joint Wrap is intended for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain or muscle spasm relief, temporary increase in local blood circulation and temporary relaxation of muscles.

With the Pelvic Wand, stop if your symptoms get worse or pain lingers after a session. Don't use it if you've been advised against vaginal insertion for any reason, including pregnancy-related advice. After giving birth, wait until your health professional has cleared you, usually at your six-week check.

If you have questions about any device in our range, our guide to choosing a Fringe device and our FAQ are good places to start.

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The contents of this blog, such as text, content and graphics, are intended for educational purposes only. The content is not intended to substitute for professional medical advice, diagnosis or treatment. Always seek the advice of your healthcare provider. Consult your healthcare provider before use if you are pregnant, are sensitive to light, or are taking medications that may increase light sensitivity. The Red Light Wrap, Red Light Wrap XL and Red Light Joint Wrap are included on the Australian Register of Therapeutic Goods (ARTG 469586). The Red Light Head Wrap is included on the Australian Register of Therapeutic Goods (ARTG 469585). The Red Light Panel is included on the Australian Register of Therapeutic Goods (ARTG 471109). The Red Light Face Mask is included on the Australian Register of Therapeutic Goods (ARTG 464865). The Red Light Pelvic Wand is included on the Australian Register of Therapeutic Goods (ARTG 528523). Always read the label and follow the directions for use.