Impact of amendments to the application process for inclusion of Class I medical devices in the Australian Register of Therapeutic Goods (ARTG)

Prior to December 2020, lower class medical devices such as Class I non-measuring, non-sterile devices and Class 1 in vitro diagnostic (IVD) devices were included in the Australian Register of Therapeutic Goods (ARTG) based on a computer-generated decision process with applicants self-declaring regulatory compliance. This resulted in some devices being incorrectly included in the ARTG at a lower classification with incorrect or incomplete application forms submitted by applicants. As a result, the TGA amended the Class I medical device inclusion process by revising and simplifying the Class I Declaration of Conformity (DoC) template form and introducing non-mandatory audits for some applications.

The TGA requested feedback on the new Class I device inclusion process through a survey published on TGA Consultation Hub.

Fifty-two (52) responses were received from stakeholders, including sponsors, manufacturers, distributors, regulatory affairs consultants and industry peak bodies.

The majority of the respondents found the amended application process easy and well supported by guidance documentation, with minimal impact on business.  Some respondents reported initial difficulty for the manufacturer in completing the new DoC form, with suggestions for future improvements.  Of the respondents that had undergone an audit of their application, the vast majority found the process straightforward, and an outcome was received in less than five working days.

The feedback we received is summarised in more detail below:

• The majority of respondents found the application process easy.
• The majority of respondents had access to the manufacturer’s DoC prior to submitting their application.
• Where respondents searched the TGA’s website for the DoC form, the majority easily located the form and found it simple to understand.
• Responses were mixed on the difficulty for the manufacturer to fill out the new version of the DoC form. However, the majority of respondents did not face any issues in obtaining the DoC form from the manufacturer.
• A minority of respondents that had submitted an application after 1 October 2020 reported being selected for a non-mandatory audit as part of the application review process. Of those respondents whose applications were selected for audit, the vast majority reported that they understood what information they were required to provide to the TGA.
• Most respondents were satisfied with the time in which they received their application outcome, with 56% receiving the outcome in less than 5 working days, 21% within 10 working days, and 8% in more than 10 working days (not all respondents answered this question). 
• Most respondents reported that these amendments had no impact on their business. A small minority of respondents reported a negative impact due to the mandatory requirement of a DoC while a small minority reported that the revised and simplified version of the DoC had a positive impact.
• Most respondents preferred the option to provide a manufacturer’s DoC with the application for inclusion, rather than separately through the Manufacturer’s Evidence application.

In response to the feedback received, the TGA made the new DoC form more user friendly by using plain language. The TGA will continue to work closely with stakeholders to implement changes to the regulatory process based on the feedback.