Meeting regulatory requirements for menstrual cups in Australia

Menstrual cups are therapeutic products which are exempt from inclusion on the Australian Register of Therapeutic Goods (ARTG). 

Prior to 1 July 2018, menstrual cups were required to be listed on the ARTG.

Menstrual cups are required to comply with Therapeutic Goods (Standard for Menstrual Cups) (TGO 99) Order 2018 before they can be supplied in Australia. 

To comply with regulatory requirements, you may need to do the following: 

Existing ARTG entries

Sponsors with existing ARTG entries for tampons and/or menstrual cups can contact us and request cancellation of their listed ARTG entries for these products. We will notify you when your ARTG entry is cancelled.

If you decide to maintain ARTG listing for these products, you will continue be responsible for paying all respective future annual charges.

Current applications

You do not require ARTG listing for menstrual cups, and therefore you may decide to withdraw your application. If you choose to do so, you will be free from paying any future fees or charges. You should know, however, that there is no provision for us to refund the fees you have already paid. 

If you decide to continue with your application, the TGA will follow the normal assessment process, and you will be obliged to pay all respective fees and charges (as applicable).

Related guidance and legislation

Menstrual cups must adhere to the requirements as set out in the:

• Therapeutic Goods Act 1989
• Therapeutic Goods Regulations 1990
• Therapeutic Goods Advertising Code 2015
• Therapeutic Goods (Standard for Menstrual Cups) (TGO 99) Order 2018.

Each section below gives a brief outline of the regulatory requirements stated in TGO 99.

Permissible raw materials

Menstrual cups should be manufactured from material suitable for their intended purpose. None of the ingredients contained in the menstrual cup should appear in a sufficient concentration to cause an irritant or toxic reaction when the product is used as directed.

The manufacturer/supplier should hold sufficient evidence to demonstrate that materials used for this purpose are in compliance with pharmacopoeia or other relevant standards.

Design requirements

Your menstrual cup should be smooth and designed to minimise trauma to the end consumer.

Packaging

Packaging materials and processes such as assembly and sealing should be validated under the requirements of relevant standards.

Labelling requirements

Menstrual cups must include the following labelling on the packaging of the product:

• the name of your product
• the name and address of the manufacturer or the sponsor
• the batch number or serial number for the product contained within the pack
• if the package contains two or more menstrual cups, the name of all the goods within the package and the quantity of each of the goods
• if your product comes in multiple sizes, the size of the unit contained in the pack
• the following warning in letters having a height of not less than 1 mm:

IMPORTANT: Menstrual cups have been associated with Toxic Shock Syndrome (TSS). TSS is a rare but serious disease that may cause death. Read and keep the enclosed information.

Information to be provided with the menstrual cup

The following information must be supplied with your product:

• information to identify the manufacturer or supplier of the product. The name or trademark should be permanently and legibly included on the packaging or material enclosed inside the pack
• an information leaflet that contains:
  • detailed instructions for use, including warnings emphasising the need for hygiene and care during insertion, as well as how the product should be cleaned prior to, and in between, uses
  • a limit to the duration of use, not exceeding 12 hours
  • information about Toxic Shock Syndrome (TSS), noting that while TSS is rarely associated with the use of menstrual cups, still occurs
  • notification that your menstrual cup is not supplied sterile:
    • Although the Australian Standard AS 2869-2008 Menstrual Tampons is written for tampons, it contains an example of wording that can be used in the information leaflet for the menstrual cup. Generally, the leaflet should be written in plain English and a simple style that will be easy for younger women, and women for whom English is a second language, to understand. Other factors you might like to consider in the preparation of your information leaflet are:

An example of the information you might include is contained in Appendix E of AS 2869-2008 Menstrual Tampons.

Your menstrual cup must continue to meet all regulatory, safety and performance requirements and standards while it continues to be supplied within Australia. Reporting adverse events associated with your product is a mandatory requirement.

Adverse events relating to your product can be reported at: Report a medical device adverse event (sponsor/manufacturer).