The Therapeutic Goods Administration (TGA), the Australian authority responsible for regulations in the sphere of healthcare products, has published guidance dedicated to auditing medical device applications. The scope of the document covers not only general medical devices but also in vitro diagnostic devices. The document is intended to provide medical device manufacturers and other parties (e.g., authorized representatives) applying for inclusion of their products in the Australian Register of Therapeutic Goods with additional clarifications on the application audit and the way it should be performed.
Regulatory Background
Under the general rule, any and all medical devices should be included in the Australian Register of Therapeutic Goods (ARTG) in order to be approved for marketing and use in the country. Hence, an entity interested in placing its medical device on the Australian market shall submit the appropriate application for inclusion in the ARTG. In order to ensure the medical device subject to review complies with the applicable regulatory requirement, the authority is entitled to carry out an application audit.
According to the present guidance, such an audit could take place in the following cases:
- The application must be selected for auditing under the legislation;
- The application is selected for auditing at the discretion of the delegate.
The authority also mentions that the applicant shall also pay the appropriate fee in the case of a mandatory audit.
An application audit should not be performed if there is a valid TGA conformity assessment certificate for the medical device already in place or if the device is intended to be exported outside Australia and will not be available on the internal market.
Mandatory Application Audit
According to the Therapeutic Goods (Medical Devices) Regulations 2002, there are certain types of medical devices for which application audits are mandatory. Such devices include active implantable medical devices, disinfecting equipment, and certain in vitro diagnostic medical devices. However, the authority states that the list of medical devices subject to mandatory application audit provided in the guidance is not exhaustive, so the applicant shall additionally check the aforementioned regulation itself to determine whether the medical device in question falls within the scope of this rule.
Discretional Audit Rules
In addition to the situations when an application audit is mandatory, such an audit could take place on a discretionary basis in order to determine whether:
- The product is a medical device, including an IVD medical device,
- The clinical benefit of the device outweighs any risk associated with its use,
- The device is being included for the purpose intended by the manufacturer,
- The application contains information that is false or misleading,
- The device is correctly classified,
- The applicant has sufficient information available to substantiate (i) compliance with the Essential Principles or procedures in place, (ii) the application of those conformity assessment procedures,
- The device does not contain substances that are prohibited imports for the purpose of the Customs Act 1901,
- The information included in or with the application is complete and correct.
Application Audit Process in Detail
The present TGA guidance also provides a detailed step-by-step description of the audit process. According to the document, the authority will notify the responsible entity about a planned audit within 20 days of the date the initial application fee has been paid. In particular, the TGA will provide a notification letter indicating the information to be provided, the time during which the authority expects to receive a response, and also the fee payable for the audit. Should the responsible entity fail to pay the aforementioned fee or provide the information requested in time, the initial application will lapse. Thus, the interested party will have to submit a new application, pay the application fee and start the whole process from the very beginning.
Usually, the authority requires the applicant to provide the information requested within 10-20 business days. As mentioned, the final date the authority expects to receive a response will be explicitly indicated in the notification letter served by the TGA to the applicant. The information should be provided not later than 10 business days of the date specified therein.
The language used to provide the information should be English, so if the original documents were initially issued in any other language, a translation in English should be submitted accordingly. If the information contains some visual elements, all such elements should have the appropriate notes and labels.
The authority mentions that any advertising materials submitted for review should comply with the following regulations:
- The Therapeutic Goods Act 1989,
- The Therapeutic Goods Regulations 1990, and
- The Therapeutic Goods Advertising Code.
The TGA also prescribes the particular form the information should be provided in, namely:
- Short submissions (up to fifteen pages) could be submitted via email containing the name of the applicant and the application ID,
- Long submission (more than fifteen pages) should be submitted on a hardware media carrier delivered via postal services.
Supporting Documentation
In order to assist medical device manufacturers and other parties in achieving and ensuring compliance with the regulatory requirements for application audits, the TGA provides some examples of documentation the applicant will likely have to submit. However, the actual list of documents requested will depend on the application, the medical device in question, and the level of assessment to be determined by the authority based on the factors above. It is important to mention that there are two levels of assessment for general medical devices and only one for in vitro diagnostic ones.
For the first level of assessment, the applicant shall provide:
- A Declaration of Conformity issued by the medical device manufacturer,
- Separate evidence of compliance for a system or procedure pack,
- Supplementary information and document accompanying the device (e.g., labeling, instructions for use, or advertising materials used to promote the product).
- For the second level of assessment, apart from the documentation required for the first level, the applicant shall provide:
- Clinical evidence,
- Risk management report,
- Efficacy and performance data (in case of products intended for disinfecting purposes).
The information to be provided in the course of an application audit related to in vitro diagnostic device is described in a separate guidance document to which the authority refers.
Audit Assessment Fees
As mentioned, in certain cases the applicant will also have to pay the fee associated with an application audit. However, the authority mentions that such a fee should not be applied in the case of an application audit performed on a discretional basis. The audit assessment fee should be paid only if such an audit is mandatory for the type of medical device in question. The amount payable will also depend on the level of assessment (for general medical devices) and remains unchanged for all in vitro diagnostic medical devices irrespectively of their classification.
In summary, the present TGA guidance provides an overview of the application audit process and highlights the most important aspects associated thereto. In particular, the guidance describes the documents to be submitted and fees to be paid.
Sources:
https://www.tga.gov.au/auditing-medical-device-including-ivd-medical-device-applications
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