Menstrual Disc Safety Standards in Australia: TGA, Materials and Testing Explained

Date Updated: 21 June 2026
Read Time: 6 minutes

If you are considering using a menstrual disc, it is important to understand the safety standards behind the product you are placing inside your body for hours at a time.

Not all menstrual discs are manufactured to the same standards. The quality of materials, regulatory compliance, manufacturing processes and product testing can vary significantly between brands.

This guide explains the key safety standards that apply to menstrual discs in Australia, including the role of the Therapeutic Goods Administration (TGA), the importance of medical-grade silicone, and the testing that reputable brands undertake before products reach consumers.

Are menstrual discs regulated in Australia?

Yes. Menstrual discs are considered medical devices in Australia.

The Therapeutic Goods Administration (TGA) is Australia's regulatory authority responsible for ensuring that medical devices supplied to Australian consumers meet applicable safety, quality and performance requirements.

Manufacturers and suppliers are responsible for demonstrating that their products comply with these requirements before they can be legally supplied in Australia.

Consumers should be cautious when purchasing menstrual discs from unknown overseas sellers that may not meet Australian regulatory expectations or quality standards.

What is the TGA?

The Therapeutic Goods Administration (TGA) is part of the Australian Government Department of Health and Aged Care.

The TGA oversees a wide range of medical products, including:

• Medical devices
• Medicines
• Diagnostic equipment
• Personal health products
• Menstrual care devices

Its role is to help ensure products supplied in Australia are safe, perform as intended and are supported by appropriate evidence.

Why medical-grade silicone matters

The material used in a menstrual disc is one of the most important safety considerations.

High-quality menstrual discs are typically manufactured from 100% medical-grade silicone.

Medical-grade silicone is widely used in healthcare because it is:

• Biocompatible
• Flexible and comfortable
• Durable and long-lasting
• Resistant to bacterial growth when properly cleaned
• Free from latex
• Free from BPA

Because menstrual discs sit internally for extended periods, the material must be suitable for prolonged contact with sensitive tissue.

Low-quality materials may not offer the same level of safety, comfort or durability.

What is biocompatibility testing?

Biocompatibility testing helps determine whether a material is suitable for contact with the human body.

For menstrual discs, testing may assess factors such as:

• Skin irritation potential
• Tissue compatibility
• Cytotoxicity (cell toxicity)
• Sensitisation risks

The goal is to ensure the material does not cause harmful biological reactions during normal use.

Reputable menstrual disc manufacturers work with specialised laboratories and suppliers to verify that their materials meet recognised medical standards.

Why manufacturing standards are important

The safety of a menstrual disc depends on more than just the raw material.

Manufacturing quality can affect:

• Product consistency
• Structural integrity
• Surface finish
• Durability
• Cleanliness

Well-manufactured menstrual discs should have smooth surfaces, consistent dimensions and no sharp edges, rough seams or defects that could cause discomfort.

Quality-controlled manufacturing processes help ensure every product performs as intended.

How are menstrual discs tested?

Responsible manufacturers may undertake multiple forms of testing before products are released.

Testing can include:

• Material verification
• Biocompatibility assessments
• Dimensional checks
• Durability testing
• Packaging validation
• Quality assurance inspections

Testing helps confirm that the product remains safe and functional throughout its intended lifespan.

Are reusable menstrual discs hygienic?

Yes. When used and cleaned according to the manufacturer's instructions, reusable menstrual discs are designed to be a safe and hygienic period care option.

Most menstrual discs can be washed between uses during a cycle and sterilised between cycles.

Following the recommended cleaning instructions is essential for maintaining hygiene and product longevity.

What should consumers look for when choosing a menstrual disc?

When comparing menstrual discs, consider the following:

• Medical-grade silicone construction
• BPA-free materials
• Compliance with Australian requirements
• Clear cleaning instructions
• Transparent product information
• Established customer reviews
• Responsive customer support

A reputable brand should be able to clearly explain the materials used, how the product is manufactured and the standards it has been designed to meet.

my mimi menstrual disc safety standards

The my mimi menstrual disc is manufactured from 100% medical-grade silicone and is designed to provide a reusable, long-term alternative to disposable period products.

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 focus is on providing Australian consumers with a comfortable, reliable and high-quality menstrual disc backed by clear product information and ongoing customer support.

Understanding safety helps you choose with confidence

The safest menstrual discs combine high-quality materials, responsible manufacturing and compliance with recognised regulatory standards.

Understanding concepts such as TGA compliance, medical-grade silicone and product testing can help you make a more informed decision when choosing a reusable period care product.

Whether you are new to menstrual discs or looking to switch brands, prioritising safety standards is one of the best ways to choose a product you can use with confidence.

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.