What Is the ARTG & the TGA

Confused woman regarding TGA and the ARTG

When choosing postpartum recovery products, comfort and quality are usually top of mind. One important factor that’s often overlooked, however, is how those products are regulated in Australia.

You may have seen the term ARTG-listed on some Ninja Mama product pages and wondered what it means — or why it matters. Understanding this can help you make more informed choices during postpartum recovery, when your body is healing and care decisions feel especially important.

 

TGA Listed

 

 


What is the ARTG?

The Australian Register of Therapeutic Goods (ARTG) is the official register of therapeutic goods that are legally supplied in Australia. It is overseen by the Therapeutic Goods Administration (TGA), Australia’s health regulator.

The ARTG includes medicines and certain medical devices that are regulated under Australia’s therapeutic goods framework. Some postpartum recovery products fall into this category, depending on how they are supplied and their intended use.


What does “ARTG-Included” mean?

When a product is ARTG-included, it means it has been included on the Australian Register of Therapeutic Goods and is regulated for:

  • Safety

  • Intended use

  • Performance

For products supplied as medical devices, ARTG listing is required in order for them to be legally supplied in Australia in that category.

Being ARTG-included does not mean a product is endorsed or approved by the TGA. Rather, it means the product is regulated in line with Australian therapeutic goods requirements for its classification and intended use.


How Ninja Mama products are regulated

Some Ninja Mama postpartum recovery products are supplied in Australia as medical devices, which is why they are ARTG-included.

The following Ninja Mama products are supplied as Class I medical devices and are listed on the ARTG:

Our Instant Perineal Ice Packs are supplied as a Class IIa medical device, which is a higher classification reflecting their intended use and additional regulatory requirements.

All medical devices supplied in Australia — regardless of class — are required to be listed on the ARTG.


Why not all postpartum products are ARTG-listed

Not all postpartum products are supplied as medical devices.

Many items are supplied as:

  • Lifestyle products

  • Personal care items

  • General consumer goods

These products are regulated differently and are not required to be listed on the ARTG.

Supplying products as medical devices involves specialist regulatory knowledge, detailed documentation, ongoing compliance obligations and — depending on the device classification — significant cost. For these reasons, not all brands choose to supply their postpartum products as medical devices.

ARTG listing  provides transparency about how a product is supplied and regulated for its intended use.


Why this matters during postpartum recovery

Postpartum recovery often involves caring for sensitive, healing areas of the body. For many parents, understanding whether a product is supplied as a medical device — and regulated accordingly — offers added reassurance during the recovery period.

ARTG listing helps clarify:

  • How a product is classified

  • What it is intended to be used for

  • How it is regulated under Australian therapeutic goods requirements

It’s one more piece of information to support confident decision-making during the fourth trimester.


How to check an ARTG listing

Anyone can check whether a product supplied as a medical device is listed on the ARTG.

You can search the public ARTG database here:
👉 https://www.tga.gov.au/resources/artg

You can search by:

  • ARTG number

  • Product name

  • Sponsor or manufacturer name

For transparency, the ARTG numbers for Ninja Mama medical devices are included on each individual product detail page, so customers can easily check them if they wish.


Frequently Asked Questions

Are all Ninja Mama products medical devices?

No. Only products that are supplied to support healing are regulated as medical devices.

Some Ninja Mama products are designed purely for comfort or self-care and are supplied as general consumer or personal care products. Others are designed to be used on healing areas of the body after birth and are supplied as medical devices.


What makes a product a medical device?

It comes down to what the product is intended to do.

If a product is supplied to support healing, or a physiological change in the body — such as perineal recovery, scar support, or breast recovery/breast pumps — it may be regulated as a medical device.

If a product is supplied purely for comfort or relaxation, (like a foot soak)  it is generally not a medical device.


What is the difference between Class I and Class IIa medical devices?

Class I medical devices are considered lower-risk devices. Class IIa medical devices are subject to additional regulatory requirements due to their intended use. Both classes must be listed on the ARTG when supplied as medical devices in Australia.


Does ARTG-listed mean TGA approved?

No. ARTG listing does not mean a product is approved, endorsed, or recommended by the TGA. It means the product is regulated under Australia’s therapeutic goods framework for its classification and intended purpose.


Why aren’t all postpartum brands ARTG-listed?

Not all postpartum products are supplied as medical devices. Supplying products as medical devices involves regulatory expertise, documentation, ongoing compliance obligations and cost. Some brands choose to supply products as lifestyle or personal care items, which do not require ARTG listing.


Can I check an ARTG number myself?

Yes. ARTG listings are publicly searchable via the TGA website. If an ARTG number is provided, you can use it to view a product’s regulatory details at any time.

👉 https://www.tga.gov.au/resources/artg

 


A considered approach to postpartum care

ARTG listing isn’t about marketing claims — it’s about understanding how a product is supplied and regulated in Australia.

At Ninja Mama, we aim to be transparent about how our products are regulated, so parents can make informed choices that feel right for their recovery.

Because when it comes to postpartum healing, clear information matters.

 

Pregnant woman reading about the TGA

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