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Tampons and Menstrual Cups

Overview​

Tampons and menstrual cups are regulated as medical devices in Australia. This surprises many people — including some who make and sell them. Because these products are inserted into the body and are intended for a physiological purpose (managing menstruation), they fall within the definition of a medical device under Section 41BD of the Therapeutic Goods Act 1989 and must be included in the ARTG before they can be legally supplied in Australia.

Why They Are Medical Devices​

Under the Therapeutic Goods Act 1989, a medical device includes an article intended to be used for:

  • Investigation, replacement, modification, or support of the anatomy or a physiological process

Tampons and menstrual cups are inserted into the body and interact directly with the vaginal environment and menstrual flow — they support or manage a physiological process. The manufacturer's intended purpose (managing menstruation) brings them within the medical device definition.

Classification​

Tampons — Class IIa​

Tampons are classified as Class IIa medical devices. They are:

  • Surgically invasive (they penetrate the body through a natural orifice — the vagina)
  • Intended for short-term use (continuous use less than 30 days per instance)

Under Schedule 2, Part 1, Rule 2.2 of the MD Regulations, devices that are invasive and intended to be inserted into a natural body orifice for short-term use are generally Class IIa.

Menstrual Cups — Class IIa​

Menstrual cups are also classified as Class IIa medical devices on the same basis — invasive via a natural orifice, short-term use.

Menstrual Discs​

Menstrual discs (worn internally near the cervix) are also classified as Class IIa medical devices for the same reasons as tampons and cups.

Key Regulatory Requirements​

Conformity assessment Class IIa devices require:

  • A certified Quality Management System (ISO 13485 or equivalent) from an accepted certification body
  • A Declaration of Conformity
  • Manufacturer evidence accepted by the TGA before the ARTG application proceeds

Essential Principles Particularly relevant for tampons and menstrual cups:

  • EP 7 (chemical, physical and biological properties) — materials in prolonged contact with vaginal mucosa must be biocompatible. ISO 10993 biocompatibility testing is expected
  • EP 8 (infection) — the risk of Toxic Shock Syndrome (TSS) associated with tampon use must be addressed in the risk management file and labelling
  • EP 13 (labelling) — labelling must include TSS warning information, instructions for use including maximum wear time, and guidance on signs of TSS

Toxic Shock Syndrome (TSS) warnings All tampons supplied in Australia must include a warning about TSS in their labelling and packaging. The TGA has specific expectations for the content and prominence of TSS warnings — these are not optional.

Common Compliance Issues​

Selling without ARTG inclusion Tampons and menstrual cups sold online or in retail stores must have ARTG inclusion. Products sold via international online marketplaces without Australian ARTG entries do not comply with Australian law. The TGA actively monitors this.

Natural and organic product claims The regulatory status of tampons and menstrual cups does not change based on materials. "Organic cotton" tampons, "natural" menstrual cups, or products marketed on environmental grounds are still medical devices and require ARTG inclusion regardless of their materials or marketing positioning.

Labelling in English All labelling must be in English. Products with labelling only in other languages are not compliant for supply in Australia.

Who Needs to Comply​

  • Australian manufacturers of tampons and menstrual cups must hold ARTG entries (as both manufacturer and sponsor)
  • Importers bringing tampons or menstrual cups into Australia for supply are the sponsor and must hold ARTG entries
  • Retailers must ensure the products they stock have valid ARTG entries
  • Online platforms — the sponsor obligation falls on the entity supplying the products in Australia, not the platform itself, but platforms have obligations not to facilitate supply of unapproved medical devices

Official Sources​

Online platforms — the responsibility to verify ARTG inclusion sits with retailers and sellers. Marketplaces that knowingly permit sales of unapproved tampons or menstrual cups may face TGA enforcement action. Products sold via Amazon, eBay, Etsy, or direct-to-consumer websites must have valid ARTG entries.

What Constitutes "Supply"

Under the Therapeutic Goods Act, "supply" includes:

Selling (retail or online) Distribution or delivery Advertising for supply Gifting or providing free samples in a promotional context

If a tampon or menstrual cup product is supplied in any of these ways in Australia without ARTG inclusion, the sponsor and any intermediaries may be in breach of the Act.