Download Code Edition 14

 

Download: Medical Technology Industry Code of Practice - Edition 14

 

Medical Technology Industry Code of Practice - Edition 14: What's New?

Changes to Layout

  • The desktop version now appears in single column format, making it easier to read on other types of devices as well, including cell phones and tablets.
  • The sections “Administration of the Code” and “Interpretation” are numbered as 8 and 9, respectively, and have been shifted to appear before the Glossary.
  • Explanatory Notes and Frequently Asked Questions now appear as footnotes in the main document, improving accessibility.

Changes to Defined Terms

  • Charitable Donation – new definition
  • Sample – new definition
  • Restricted Medical Technology – definition removed
  • Monitoring – change to the definition
  • Vendor Credentialling Standard – change to the definition

Amendments for the Purpose of Providing Clarity

  • The term “Vendor Credentialling Standard”, wherever it occurs in the Code, has been replaced by “Australian Standard 5182:2018 – Vendor Credentialling for Healthcare Facilities”.
  • A new Explanatory Note has been inserted alongside section 2.1(b) to clarify that members can apply to be certified as complying with AS 5812:2018.
  • The section “Objectives and Scope of the Code” has been amended to clarify that compliance with the Code requires that MTAA member companies ensure that any person or entity that represents, acts for or advances the interest of a member company must conduct itself in a manner which complies with the Code. A corresponding Explanatory Note has been amended and a second one added to assist mem-bers.
  • A new Explanatory Note has been added alongside Section 2.3.1 to clarify that the presentation of information not directly relate to a medical technology or else to the treatment of a medical condition is permissible at both company-sponsored and during company-led sessions at third-party conferences and events, provided certain conditions are met. 

Substantial Amendments

  • It is understood that the Therapeutic Goods Administration (TGA) currently does not, outright, prohibit the advertising of unregistered medical technologies exclusively to Healhcare Professionals. Section 1.5 and 2.3.5, as well as associated Explanatory Notes, have been updated to reflect this.
  • Sections 1.7 and 1.8, as well as the associated Explanatory Notes, have been updated to ensure consistency with the TGA’s latest guidance on the use of social media (or other web-based) platforms to advertise medical technologies to Healthcare Professionals.

Download: Medical Technology Industry Code of Practice - Edition 13 [Superseded - available for reference only]