The new article provides an overview of the applicable regulatory procedures and requirements.

The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of healthcare products, has published a guidance document dedicated to auditing medical device applications. The scope of the guidance also covers aspects related to in vitro diagnostic medical device applications. The document is intended to provide additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be considered by the parties responsible for medical devices in order to ensure compliance. In particular, the recommendations provided in the guidance are addressed to the ones applying for the inclusion of their products in the Australian Register of Therapeutic Goods (ARTG) which is a prerequisite for placing medical devices on the country’s market. 

The guidance describes the application audits to be conducted by the authority in order to verify that devices submitted for inclusion in the ARTG meet the relevant legislative requirements. It is important to mention that, depending on certain factors related to the application and underlying product, an audit could be either mandatory or voluntary. In the case of a mandatory audit, there will be an audit assessment fee payable by the applicant in addition to the initial application fee.

Mandatory Audit: Scope

First of all, the authority outlines the scope of applications that are subject to mandatory audits and also provides a list of exclusions to be considered when determining whether an audit is required. According to the guidance, a mandatory application audit will not be required with respect to medical devices that:

  • Have a TGA conformity assessment certificate, or
  • Have EU MDR 2017/745 or EU IVDR 2017/746 certification that has not been suspended or revoked, or
  • Are included in the ARTG as export-only medical devices, including export-only IVD medical devices. 

Apart from this, the document provides a few examples of medical devices that are subject to mandatory audits based on  existing legislation. According to the guidance, such devices include, inter alia, the following ones: 

  • A medical device (other than a condom) that is a barrier indicated for contraception or prevention of the transmission of disease in the course of penile penetration during sexual intercourse;
  • A medical device that is an implantable contraceptive device;
  • A medical device that is a spinal infusion implantable device;
  • A medical device that is specifically intended by the manufacturer to be used for disinfecting another medical device;
  • A medical device that is an implantable intraocular lens;
  • A medical device that is an intraviscoelastic fluid.

The list of examples provided by the TGA also includes certain in vitro diagnostic medical devices, such as those intended for self-testing or point-of-care testing. The parties intending to place their products on the market should consider the list of products subject to mandatory application audit as set forth by the applicable legislation in order to determine whether the respective requirement will apply. 

With respect to systems and procedure packs, the authority mentions that they would be subject to mandatory application audits if they met the criteria outlined in the aforementioned regulation.

Audit at the Discretion

The document also describes the situation when the mandatory audit requirements shall not apply, but the application could still be selected for an audit at the discretion of the delegate in order to determine the following:

  • The product in question is a medical device and, consequently, should be subject to regulation as a medical device.
  • The clinical benefits associated with the product in question outweigh the respective risks;
  • The application for inclusion refers to the intended purpose initially determined by the original product manufacturer;
  • The information contained in the application is false or misleading;
  • The way classification rules are applied is correct;
  • There is sufficient information in place to demonstrate that the product subject to review complies with any and all applicable essential principles;
  • The product does not contain prohibited substances;
  • The information provided by the applicant when requesting inclusion in the ARTG is complete and correct.

Additional Audit: Notification and Response

The guidance further describes specific steps to be taken in the course of an application audit. 

According to the guidance, should an application be selected for the audit, the applicant will be notified in writing within 20 days from the date the respective fee has been paid. In particular, the authority will issue a notification letter addressing the following aspects:

  • Information to be provided by the applicant;
  • Timeframes within which the authority expects the information to be provided;
  • Additional fees are payable by the applicant (when necessary). 

Should the applicant fail to pay the additional fee or provide the additional information requested within the timeframes set by the authority, the application will be rejected. 

Under the general rule, the applicant will have between 10 and 20 business days to provide additional information requested by the authority with respect to the product in question’s compliance with the essential principles it is subject to. Moreover, the authority is entitled to request additional information be provided by the applicant on top of the above. 

In summary, the present TGA guidance provides an overview of the regulatory framework for application audits it may conduct in order to ensure compliance with the relevant essential principles. The document outlines the applicable procedures and provides recommendations to be followed by the parties involved.

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