The new article highlights aspects related to the application review process and regulatory decisions the authority will make based on its assessment.
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 diagnostics (IVD). The document provides an overview of the applicable regulatory requirements related to mandatory and discretionary audits the authority conducts, as well as additional clarifications and recommendations to be taken into consideration by medical device manufacturers and other parties involved. At the same time, the provisions of the guidance and recommendations contained therein are non-binding in their legal nature, and they are not intended to introduce new rules or impose new obligations. The authority also reserves the right to make changes to the guidance, should such changes be reasonably necessary to reflect corresponding changes to the underlying legislation.
Timeframes
According to the guidance, there are no specific timeframes for audits set forth under the existing legislation, while the actual timeframes would depend on numerous factors, including:
- The time it will take for the applicant to pay the respective audit assessment fee (in case such a fee is payable due to the nature of the audit);
- The time it takes for the applicant to provide additional information requested by the authority in the course of an audit; and
- The quality of the information provided by the applicant to the authority.
Withdrawal
The document also describes the approach to be followed when requesting the application be withdrawn. In accordance with the applicable legislation, the applicant is entitled to submit such a request at any time before the decision on the application has been taken by the authority. For this purpose, the appropriate online submission system should be used. The authority also mentions that in the event of an application fee being withdrawn, any of the fees paid by the applicant would not be refunded. However, in certain circumstances, the applicant will have the right to request a refund.
Once the application has been withdrawn, the applicant will receive the appropriate confirmation via email. The product the application refers to should not be placed on the market since it is not included in the national register. The applicant will have the right to make a new submission referring to the same device at any time later, following the general approach.
Should the applicant fail to provide the information requested by the authority within the timeframes set forth by the latter, the application would lapse, and the appropriate notification letter would be served to the applicant. This also applies in cases where the applicant fails to pay the assessment fee on time. According to the guidance, examples of situations when the application would lapse include, inter alia, failures to:
- Comply with a notice under section 41FH of the Act within 10 working days after the end of the period specified in the notice letter;
- Comply with a requirement to deliver a reasonable number of samples of the kind of medical device to which the application relates;
- Comply with a notice under section 41JA of the Act to give information relating to devices of that kind within a further 10 working days from the day specified in the notice letter;
- Provide information in connection with the application, including information for the purpose of section 41JA of the Act, that is false or misleading in a material particular;
- Pay an audit assessment fee for the application within 28 days after the day that [the applicant] was notified of the amount of the fee.
As in the case of an application being withdrawn, if the application lapses, the fees paid by the applicant would not be refunded, safe for the limited scope of specific circumstances. The authority additionally emphasizes that lapsing is not a regulatory decision; hence, it could not be subject to further review.
Once the application lapses, the applicant will receive the appropriate notification via email and will be prohibited from placing the medical device in question on the market since it is not included in the Australian Register of Therapeutic Goods (ARTG). However, a new application on the same matter could be resubmitted at any time later.
Application Audit Outcome
The document also highlights aspects related to the situation when the application audit has been completed. According to the guidance, upon completion of an audit, the authority makes a regulatory decision and communicates it to the applicant. Depending on the results of the assessment, the authority can come up with one of the following decisions:
- To include the product in question in the register;
- Not to include the product in question in the register.
Should the first decision be taken, the applicant will be able to obtain a certificate confirming inclusion in the ARTG. From this moment on, the applicant, as a registration holder, will be responsible for ensuring compliance with the applicable regulatory requirements and fulfilling the respective obligations as a sponsor.
Should a negative decision be taken, it would also be communicated to the applicant via email, and the applicant would have the right to request a decision review. Moreover, the applicant has the right to submit a new application dedicated to the same medical device at any time later.
In summary, the present TGA guidance highlights certain specific aspects related to the way the audit assessment will be carried out by the authority and also the potential results thereof. The guidance explains the rights and obligations of the applicant depending on the decision made by the authority.
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