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Innovia

TGA Disclaimer

Innovia Group · ABN 56 688 008 380 · Effective date: 8 May 2026

1. About this Disclaimer

This TGA Disclaimer applies to all content on the website operated by Innovia Group (ABN 56 688 008 380) (we, us, our) at innoviagroup.com.au (Website), including all product pages, news articles, resources, technical specifications, images and any other material relating to medical devices.

This Disclaimer should be read together with our Terms of Use, Privacy Policy and Cookie Notice. By accessing or using the Website, you acknowledge that you have read, understood and agree to be bound by this Disclaimer.

2. Regulatory context

Innovia Group is an Australian-owned medical device manufacturer and distributor based in Sydney, New South Wales. We manufacture and distribute medical devices within Australia and New Zealand.

In Australia, therapeutic goods (including medical devices) are regulated by the Therapeutic Goods Administration (TGA) under the Therapeutic Goods Act 1989 (Cth), the Therapeutic Goods Regulations 1990 (Cth), the Therapeutic Goods (Medical Devices) Regulations 2002 (Cth) and the Therapeutic Goods Advertising Code (TGA Advertising Code).

In New Zealand, medical devices are regulated by Medsafe under the Medicines Act 1981 (NZ) and the WAND (Web Assisted Notification of Devices) database.

Content on the Website is prepared and published in accordance with these regulatory frameworks.

3. Intended audience

The Website, and in particular all product-related content, is intended for use by qualified healthcare professionals only. This includes:

  • Registered medical practitioners, including surgeons and specialists.
  • Registered nurses and allied health professionals.
  • Hospital procurement personnel.
  • Biomedical engineers and clinical technical staff.
  • Authorised representatives of medical device manufacturers, distributors and regulatory bodies.

The Website is not directed at members of the general public, patients or consumers seeking medical advice or information about treatment options.

If you are a member of the general public and have a medical question, please consult a qualified healthcare professional. Do not rely on information contained on the Website to make decisions about your health or treatment.

4. Not medical advice

Information on the Website is provided for general informational and educational purposes only and is intended to support qualified healthcare professionals in the exercise of their independent clinical judgment.

Nothing on the Website constitutes:

  • Medical advice, diagnosis, treatment or recommendation.
  • A substitute for consultation with a qualified healthcare professional.
  • A recommendation that any patient should or should not use a particular medical device, undergo a particular procedure, or receive any particular treatment.
  • An offer, promotion or advertisement of any therapeutic good to the general public in contravention of the Therapeutic Goods Act 1989 (Cth) or the TGA Advertising Code.

Clinical decisions, including the selection and use of medical devices, must be made by a qualified healthcare professional based on the individual circumstances of each patient, the clinical context, the relevant Instructions for Use (IFU), product labelling, and applicable clinical guidelines.

5. Product information and Instructions for Use

Product descriptions, specifications, indications, contraindications, warnings, precautions and other information on the Website are summarised for general informational purposes only and are not a complete statement of the information necessary for safe and effective use of any medical device.

Before using any medical device described on the Website, you must:

  • Read the full Instructions for Use (IFU) supplied with the device.
  • Review the product labelling, technical documentation and any applicable user manual.
  • Ensure you have received appropriate training in the use of the device.
  • Confirm the device is appropriate for the intended patient and clinical application.
  • Comply with all applicable laws, regulations, professional standards and institutional policies.

If you require an IFU, technical documentation or training resources for any product, please contact us using the details in section 14.

6. Australian Register of Therapeutic Goods (ARTG)

Medical devices supplied in Australia must generally be included in the Australian Register of Therapeutic Goods (ARTG), unless an exemption, approval or authority applies.

Where a product on the Website is included in the ARTG, the relevant ARTG number is available on request. Inclusion of a product in the ARTG does not imply endorsement by the TGA, nor does it constitute a representation about the comparative quality, safety or efficacy of the product.

Not all products described on the Website may be available, registered or approved for supply in every jurisdiction. Product availability, indications, claims and specifications may vary by country and are subject to local regulatory approval. Some products may be available in Australia but not in New Zealand, or vice versa.

7. Indications, claims and off-label use

Indications, intended uses and claims for medical devices described on the Website are those approved by the relevant regulatory authority for the jurisdiction in which the product is supplied.

Healthcare professionals must:

  • Use medical devices in accordance with the approved indications and intended use.
  • Not rely on the Website as authority for any off-label use of a medical device.
  • Refer to the current IFU and product labelling for the definitive statement of approved indications, contraindications, warnings and precautions.

Any clinical or technical claims made on the Website are supported by appropriate evidence and comply with the TGA Advertising Code requirements applicable to communications directed at healthcare professionals.

8. Advertising of therapeutic goods to consumers

Under the Therapeutic Goods Act 1989 (Cth) and the TGA Advertising Code, certain therapeutic goods, including most medical devices supplied to healthcare facilities, must not be advertised directly to the general public.

Content on the Website concerning specific medical devices is directed at healthcare professionals and is not intended as advertising to consumers. If you are not a healthcare professional and have accessed product-related content on the Website, please be aware that:

  • The information is not intended to encourage or recommend the use of any therapeutic good to you as a consumer.
  • You should not interpret any product information as a representation that the product is suitable for your personal use.
  • You should consult a qualified healthcare professional for any medical advice or treatment recommendations.

9. Adverse events and complaints

If you are a healthcare professional, patient or member of the public and you wish to report:

  • An adverse event, malfunction or quality issue involving an Innovia Group product;
  • A suspected counterfeit or tampered product; or
  • Any other product safety concern;

please contact us as soon as practicable using the details in section 14.

You may also report adverse events and product issues directly to the TGA through the TGA website (www.tga.gov.au), or in New Zealand through Medsafe (www.medsafe.govt.nz).

Innovia Group is committed to fulfilling its post market surveillance, vigilance and reporting obligations under applicable therapeutic goods legislation.

10. Product recalls and safety notices

Where a product recall, hazard alert, safety notice or other corrective action is required, Innovia Group will issue communications in accordance with the Uniform Recall Procedure for Therapeutic Goods (URPTG) and applicable regulatory requirements.

Current safety notices and recall information, where applicable, will be published on the Website and communicated to affected customers. If you believe you have an affected product, please contact us immediately using the details in section 14.

11. Third-party manufacturers and distributed products

Innovia Group distributes medical devices manufactured by third-party global manufacturers. Where the Website includes information about products manufactured by third parties:

  • The product remains the intellectual property of the original manufacturer.
  • Product specifications, indications and claims are based on information provided by the manufacturer and are subject to the manufacturer's own regulatory approvals and documentation.
  • Manufacturer names, logos, brands and trademarks are the property of their respective owners and are used on the Website with permission or as permitted by law.

Innovia Group acts as the sponsor (within the meaning of the Therapeutic Goods Act 1989 (Cth)) for products it imports into Australia, and assumes the regulatory responsibilities of a sponsor under Australian law for those products.

12. No warranty regarding completeness or currency

While we take reasonable care to ensure that information on the Website is accurate, current and consistent with applicable regulatory approvals at the time of publication, we do not warrant that:

  • All information on the Website is complete, accurate or current at all times.
  • Product information reflects the most recent version of the relevant IFU, labelling or regulatory approval.
  • The Website reflects all recent changes to therapeutic goods legislation, the TGA Advertising Code or related regulatory guidance.

Regulatory information, product specifications and clinical evidence may change over time. Always refer to the current IFU, product labelling and TGA or Medsafe regulatory information for the most up-to-date and authoritative information.

13. Limitation of liability

To the maximum extent permitted by law, Innovia Group, its directors, officers, employees, contractors, agents and affiliates will not be liable for any loss, damage, injury, claim or expense arising out of or in connection with:

  • Any reliance placed by you on information contained on the Website.
  • Any clinical decision made by a healthcare professional in connection with information on the Website.
  • Any use or misuse of a medical device described on the Website.
  • Any inaccuracy, omission or out-of-date information on the Website.

Nothing in this Disclaimer excludes, restricts or modifies any guarantee, right or remedy that you may have under the Australian Consumer Law (Schedule 2 of the Competition and Consumer Act 2010 (Cth)) or any other applicable law, where to do so would be unlawful.

This section is in addition to, and does not limit, the disclaimers and limitations of liability set out in our Terms of Use.

14. How to contact us

For product enquiries, IFU requests, adverse event reports, recall information or any questions about this Disclaimer, please contact us using the details below:

Innovia Group
36/2 Chaplin Drive, Lane Cove NSW 2066, Australia
Email: info@innoviagroup.com.au
Phone: +61 2 8313 5478

15. Changes to this Disclaimer

We may update this Disclaimer from time to time to reflect changes in our product portfolio, regulatory approvals, applicable laws or our practices. The current version will always be available on the Website, and the effective date at the top of this Disclaimer will be updated accordingly. We encourage you to review this Disclaimer periodically.

16. Governing law

This Disclaimer is governed by the laws of New South Wales, Australia. Any dispute arising in connection with this Disclaimer or your use of the Website will be subject to the exclusive jurisdiction of the courts of New South Wales and the courts competent to hear appeals from those courts.