The new article addresses aspects related to the documentation to be provided by the interested party responsible for the medical device in question and also describes the way the fees associated with the application audit should be calculated.
Table of Contents
The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of healthcare products, has published a guidance document dedicated to auditing applications related to medical devices (including in vitro diagnostic (IVD) ones). The document describes in detail the situations when medical device applications could be subject to mandatory or discretionary audits and highlights the most important aspects associated with them. In particular, the guidance provides additional clarifications regarding the existing regulatory framework and applicable regulatory requirements, as well as recommendations to be followed by medical device manufacturers and other parties involved in order to ensure compliance. It is also important to emphasize the non-binding nature of the said recommendations, as they are not intended to introduce new rules or impose new obligations. The authority also reserves the right to make changes to the guidance and recommendations provided therein, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation.
The scope of the guidance covers, inter alia, the particular steps of the application review process.
Presentation of Documentation Requested
In accordance with the guidance, additional information and documentation requested by the authority in the context of an application audit should be provided as a separate submission. The authority explicitly states that all the information should be presented in English, while for all the documents initially issued in other languages, a translation will be required. All the visual materials provided to illustrate the aspects related to the device in question should be properly labeled in order to ensure clarity.
The authority further explains that relatively short applications (less than 15 pages) should be submitted via email with the name of the interested party and application ID indicated in the subject line to ensure proper identification. At the same time, longer submissions should be provided on hardware media (e.g., CD or DVD) delivered via mail.
Supporting Documentation
The authority further outlines the list of supporting documentation it expects to receive in the context of the medical device application audit. It is also important to mention that the examples of documentation provided in the guidance and the appropriate lists are not exhaustive and are provided for merely illustrative purposes – to describe the general approach to be followed by applicants – while the authority reserves the right to request additional information and documentation beyond the scope outlined herein, should it be reasonably necessary due to the nature of the device in question and specific risks associated.
As further explained by the TGA, there are two levels of audit assessment, Level 1 and Level 2 respectively, determining the level of regulatory scrutiny the application in question will be subject to. The authority has the right to decide on the applicable level and request documentation based on it. It is important to mention that for applications related to in vitro diagnostic medical devices, only one type of assessment applies – a technical file review.
According to the guidance, the documentation to be provided by the applicant in line with the Level 1 audit would include:
- Manufacturers Declaration of Conformity (DOC);
- For a system or procedure pack – evidence of compliance of the kind of medical device with the requirements under regulation 3.10 of the Regulations and clause 7.5 of Schedule 3 of the Regulations;
- Documentation containing additional information, namely:
- Labelling,
- Pictorial images of the device,
- Packaging – inner and outer packaging for the device,
- Instructions for use,
- Product manual,
- Other brochures related to the device,
- Advertising material for the medical device, including brochures, extracts from web pages, and advertisements,
- Medical device patient cards and leaflets.
For the Level 2 application audit, the scope of information to be provided by the applicant will include:
- All the documentation listed for a Level 1 audit;
- Clinical evidence;
- Risk management report;
- Efficacy and performance data (for medical devices that are intended to be used for disinfecting other medical devices).
Applicable Fees
The document also highlights aspects related to the fees payable by the applicants responsible for the applications subject to the audit. Under the general rule, should an application be selected for a discretionary audit, no additional fee would apply. However, an additional fee would apply in the case of an application being subject to a mandatory audit in accordance with the respective criteria. In such cases, the applicant will receive the appropriate invoice, with the amount payable to be determined based on the applicable level of audit assessment. In the case of an in vitro diagnostic medical device, the audit assessment fee would be determined based on the classification of the device subject to review. Should the applicant fail to pay the said fee within the respective timeframes, the application will lapse. It is also important to mention that in certain cases, the audit assessment fees could be reduced – in particular, this applies when the audit assessment could be abridged.
In summary, the present TGA guidance describes the scope of additional information the authority expects the applicant to submit with respect to the application subject to a mandatory or discretionary audit. The document also provides additional clarifications regarding the fees payable for the audit assessment and explains how they should be calculated.
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