Medical Technology Industry Code of Practice Compliance Statement (MTAA)

1. Our commitment

Innovia Group (ABN 56 688 008 380) (we, us, our) is an Australian-owned medical device manufacturer and distributor based in Sydney, New South Wales. We are committed to conducting our business in accordance with the highest ethical and professional standards expected of the Australian medical technology industry.

While Innovia Group is not currently a member of the Medical Technology Association of Australia (MTAA), we have voluntarily adopted the standards set out in the Medical Technology Industry Code of Practice (Edition 14) (Code) published by MTAA, and we conduct our business in alignment with Australian Standard AS 5182:2018 — Vendor Credentialling for Healthcare Facilities (AS 5182).

We have made this commitment because we believe that adherence to these standards is fundamental to ethical engagement with healthcare professionals, healthcare facilities, patients and consumers in Australia.

2. About the Code

The MTAA Code of Practice sets out the ethical framework within which medical technology companies operate in their relationships with healthcare professionals, healthcare facilities, patients and consumers in Australia. The Code forms part of a wider regulatory framework that also includes the Therapeutic Goods Act 1989 (Cth), the Therapeutic Goods Advertising Code and the Competition and Consumer Act 2010 (Cth).

The Code addresses areas including:

• Interactions between medical technology companies and healthcare professionals.
• Advertising and promotion of medical technologies.
• Educational and training activities, including company-sponsored and third-party educational conferences.
• Consulting arrangements with healthcare professionals.
• Hospitality, meals, gifts and other transfers of value.
• Support for clinical research and grants.
• Sample provision and product evaluations.
• Relationships with patient organisations and consumers.

The current edition of the Code is available from the MTAA website at www.mtaa.org.au.

3. Our compliance approach

We have adopted internal policies, procedures and training designed to ensure that our directors, employees, contractors, agents and any other party who represents, acts for or advances our interests conducts themselves in a manner consistent with the Code and AS 5182.

In particular, we are committed to:

• Conducting all interactions with healthcare professionals on the basis of legitimate need, ethical conduct and the best interests of patients.
• Ensuring that hospitality provided in connection with our business activities is modest, appropriate and incidental to a legitimate business purpose, and does not aim to impress or influence clinical decision-making.
• Ensuring that any consulting arrangements with healthcare professionals are based on a genuine need for services, are documented in a written agreement and provide fair market value remuneration.
• Providing educational support, sponsorships and grants only where they meet a legitimate educational or scientific purpose and align with the Code.
• Ensuring that all advertising directed at healthcare professionals is accurate, balanced, supported by appropriate evidence and consistent with the Therapeutic Goods Advertising Code.
• Not advertising medical devices to the general public in a manner inconsistent with the Therapeutic Goods Act 1989 (Cth) or the Therapeutic Goods Advertising Code.
• Ensuring that our company representatives who enter healthcare facilities are credentialled in accordance with AS 5182:2018 and the requirements of the individual healthcare facility.
• Providing training to relevant personnel on the requirements of the Code, AS 5182 and our internal compliance policies.

4. Vendor credentialling

We require all Innovia Group representatives who attend healthcare facilities (including hospitals, clinics and operating theatres) to be appropriately credentialled in accordance with AS 5182:2018 and the credentialling requirements of the individual healthcare facility.

This includes, where applicable, the provision of evidence of identity, qualifications, training, immunisation status, police checks and other documentation required by the relevant healthcare facility or its credentialling provider.

5. Membership status

Innovia Group is not currently a member of the MTAA. References in this statement to the Code and to AS 5182 reflect a voluntary commitment by Innovia Group to align its conduct with these standards. This commitment is genuine and is supported by our internal policies and training. However, Innovia Group is not subject to the MTAA Code Authority's complaints and disciplinary processes that apply to MTAA member companies.

We will update this statement if our membership status changes.

6. Reporting concerns

We take any concerns regarding our conduct or compliance with the standards set out in this statement seriously.

If you are a healthcare professional, healthcare facility, patient, consumer or other party and you believe that Innovia Group, or any person acting on our behalf, has engaged in conduct inconsistent with the Code or AS 5182, please contact us using the details in section 8. We will investigate your concern and respond promptly.

7. Review

We review our compliance arrangements and this statement periodically, and we update them to reflect changes to the Code, AS 5182, applicable laws or our business practices. The current version of this statement will always be available on our website.

8. How to contact us

For questions about this statement, our compliance arrangements, or to report a concern, 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

9. Governing law

This statement is governed by the laws of New South Wales, Australia.