2San Pty Ltd enters into enforceable undertaking after unlawful import and supply of medical devices

The Therapeutic Goods Administration (TGA) has accepted a court enforceable undertaking from 2San Pty Ltd (2San), in relation to breaches of the Therapeutic Goods Act 1989 (the Act) for the unlawful import and supply of unregistered therapeutic goods.

2San imported bacterial vaginosis tests and pregnancy test kits not included in the Australian Register of Therapeutic Goods (the Register). 2San then supplied these medical devices to a national retailer who subsequently sold them to the public. 

Therapeutic goods, including medical devices, must be entered in the Register before they can be lawfully imported and supplied, unless an exemption applies. This is an important safeguard to help ensure the safety, quality, and performance of products. 

The undertaking Enforceable undertaking: 2San Pty Ltd is enforceable for a period of two years and requires 2San to:

• conduct an annual audit and provide the written audit report to the TGA
• pay the costs of its compliance with the enforceable undertaking
• conduct a recall of the unregistered therapeutic goods
• seek to obtain certification under ISO 13485:2916 Medical devices: Quality management systems
• engage an external qualified compliance professional to advise 2San on relevant regulatory procedures
• conduct activities to increase industry awareness of their obligations to comply with the Act and related regulations
• notify the TGA within 48 hours of any instance of suspected non-compliance with the Act and or the regulations.

Nick Henderson, acting Deputy Secretary of the Department of Health and Aged Care said, “This case serves as a warning to businesses that there are financial and reputational consequences for not complying with the requirements of the Act.

“Australian consumers rightly expect that when they are buying medical devices that they have undergone a level of testing to show they are safe for use.

“It’s important that even simple medical devices like at-home test kits are registered, as an unregistered test kit may give an inaccurate reading and influence an individual’s decision to seek further medical advice or not,” Mr Henderson said. 

Breaching any term of the undertaking may result in the Federal Court imposing further orders on the company, including financial penalties or compensation.

Businesses must understand their legal obligations prior to importing and supplying therapeutic goods. Consequences for non-compliance with relevant legislation may include financial penalties, or civil or criminal proceedings.

Further information regarding the product recall, including advice for consumers affected, will be available once the recall notice is published on the Recall actions page on our website.

If you suspect non-compliance in relation to therapeutic goods or their advertising, you can report it to the TGA at any time and it will be actioned in accordance with our regulatory compliance framework.

Contact for members of the media: 

• Email: news@health.gov.au  
• Phone: 02 6289 7400