Are Menstrual Discs Regulated in Australia? A Plain-English Guide

Date Updated: 22 June 2026
Read Time: 6 minutes

If you're considering trying a menstrual disc, you may be wondering whether these products are regulated in Australia and what standards they need to meet before being sold.

The good news is that menstrual discs are regulated products in Australia. However, many consumers are unsure what this actually means and how it helps protect them.

This guide explains menstrual disc regulation in simple, plain English, including the role of the Therapeutic Goods Administration (TGA), what manufacturers are responsible for, and what you should look for when choosing a menstrual disc.

Yes, menstrual discs are regulated in Australia

Menstrual discs are considered medical devices in Australia.

This means they fall within Australia's regulatory framework for medical products and are subject to specific safety, quality and performance requirements.

Because menstrual discs are designed to be inserted into the body and worn internally for extended periods, they are treated differently from many ordinary consumer products.

Their design, materials and intended use must meet applicable regulatory standards before they can be legally supplied in Australia.

Who regulates menstrual discs in Australia?

The organisation responsible for regulating medical devices in Australia is the Therapeutic Goods Administration (TGA).

The TGA is part of the Australian Government Department of Health and Aged Care.

Its role is to help ensure that medical products supplied to Australians meet appropriate standards for:

• Safety
• Quality
• Performance

The TGA oversees thousands of medical products used every day, including:

• Medical devices
• Medicines
• Diagnostic equipment
• Health products
• Menstrual care devices

What does TGA compliance actually mean?

When a menstrual disc is described as TGA-compliant, it means the product has been supplied in accordance with Australia's medical device regulations.

Manufacturers and sponsors must demonstrate that their products meet relevant requirements relating to:

• Product safety
• Material suitability
• Manufacturing quality
• Performance standards
• Risk management

The exact requirements depend on the type of medical device and its intended use.

The goal is to help ensure consumers receive products that perform as expected and are suitable for their intended purpose.

Why are menstrual discs considered medical devices?

Unlike pads or period underwear, menstrual discs are inserted internally and come into prolonged contact with sensitive body tissue.

Because of this, regulators require a higher level of scrutiny regarding:

• Materials used
• Biocompatibility
• Product design
• Manufacturing processes
• Safety documentation

This helps reduce potential risks and supports safe use by consumers.

What materials should a menstrual disc be made from?

Most high-quality menstrual discs are manufactured from 100% medical-grade silicone.

Medical-grade silicone is commonly used in healthcare products because it is:

• Biocompatible
• Flexible and comfortable
• Durable and long-lasting
• Non-porous
• BPA-free
• Latex-free

Because menstrual discs may be worn for up to 12 hours at a time, material quality is one of the most important safety considerations.

What is biocompatibility?

Biocompatibility refers to how a material interacts with the human body.

For menstrual discs, this means assessing whether the material is suitable for prolonged internal contact without causing harmful reactions when used as intended.

Testing may include assessments for:

• Irritation potential
• Tissue compatibility
• Cytotoxicity
• Sensitisation risk

These evaluations help determine whether a material is appropriate for medical use.

Do all menstrual discs sold online meet Australian standards?

Not necessarily.

Consumers should be cautious when purchasing menstrual discs from unknown overseas sellers or online marketplaces where product information is limited.

Some products may provide little information about:

• Materials used
• Manufacturing standards
• Regulatory compliance
• Testing procedures

Choosing a reputable brand that provides transparent product information can help consumers make more informed purchasing decisions.

What should you look for when buying a menstrual disc?

When comparing menstrual discs, consider the following factors:

• Medical-grade silicone construction
• BPA-free materials
• TGA compliance information
• Clear cleaning instructions
• Transparent product specifications
• Established customer reviews
• Responsive customer support

A trustworthy brand should be able to clearly explain how its products are manufactured, what materials are used and how the product is intended to be used.

Why regulation matters for consumers

Regulation provides an important layer of protection for consumers.

It helps ensure that products supplied in Australia meet recognised standards for safety, quality and performance.

For menstrual discs, this is particularly important because the product is used internally and may be worn for extended periods throughout every menstrual cycle.

Understanding how regulation works can help you choose products with greater confidence.

my mimi and Australian safety standards

The my mimi menstrual disc is designed with safety, comfort and quality in mind.

Every my mimi menstrual disc is:

• Made from 100% medical-grade silicone
• BPA-free
• Latex-free
• TGA-compliant
• FDA-registered
• Designed for up to 12 hours of wear
• Reusable for up to 5 years with proper care

Our goal is to provide Australian consumers with a reusable period care option that combines high-quality materials, thoughtful design and transparent product information.

The bottom line

Yes, menstrual discs are regulated in Australia.

As medical devices, they are subject to requirements relating to safety, quality and performance. Understanding the role of the TGA, the importance of medical-grade silicone and the value of transparent manufacturing standards can help you make a more informed choice when selecting a menstrual disc.

The more you understand about regulation, the easier it becomes to choose a product you can feel confident using every month.

Health Notice: This article is intended for general educational purposes only and should not be considered medical advice. If you experience pain, irritation, unusual symptoms or have concerns about using a menstrual disc, consult your doctor or qualified healthcare professional.