TGA Time Frames – How Long Should You Wait?

Are you waiting to hear from the TGA about your new medical device or IVD application? Maybe it’s an application audit response…. read on for more information about TGA time frames…

There are two categories of time frames used within the Australian medical devices regulatory framework. These are as follows:

1.        Legislated time frames: these are times that are specified within the Therapeutic Goods Act 1989 (the Act) and the Therapeutic Goods (Medical Devices) Regulations 2002.

2.        Target time frames: these are anticipated time frames that have been developed over time in consultation with industry. These targets are based on the average periods required to undertake the relevant assessment work. The TGA says it endeavours to complete ARTG inclusion applications and conformity assessment applications within these target time frames. The TGA advise it is difficult to provide an estimate of the time required to complete any particular assessment as this will depend on a variety of factors including the nature of the devices and complexity of issues identified for that application, the volume and quality of data to be reviewed, the need to seek additional information from the applicant, and the number of applications to be assessed waiting in a queue.

Time Frames for ARTG Inclusion Applications

Legislated Time Frames: An ARTG medical device inclusion application (Sections 41FG and 41FH of the Act): The Secretary (or delegate) has 20 working days after receiving an effective medical device ARTG inclusion application (after the application fees have been received by the TGA) to inform the applicant that the application has been selected for audit, or to inform the applicant that a decision has been made to include the medical device in the ARTG.

Target Time Frames: Target times are a guide only.  Failure to complete an application within the target time frame does not require the TGA to make a decision, and does not result in automatic approval of an application. It is important to highlight that in the interest of fairness to all applicants, the TGA assesses applications in the order that they are received.

Application Type	Time	Notes	Further Information
Medical Device Manufacturer’s Evidence Lodgement	15 TGA working days	Time taken to consider and, where appropriate, accept lodged Manufacturer’s Evidence.	Australian Regulatory Guidelines for Medical Devices, Section 7
Level 1 Audit: ARTG Inclusion Application selected for audit under Section 41FH of The Act	30 TGA working days	Time frame commences from the date on which the TGA receives a response to a notice under section 41FH of the Act (this notice informs the applicant that the application has been selected for audit and requests information to undertake this audit).	Australian Regulatory Guidelines for Medical Devices, Section 11
Level 2 Audit: ARTG Inclusion Application selected for audit under Section 41FH of The Act	60 TGA working days	Time frame commences from the date on which the TGA receives a response to a notice under section 41FH of the Act (this notice informs the applicant that the application has been selected for audit and requests information to undertake this audit).	Australian Regulatory Guidelines for Medical Devices, Section 11

The TGA advise that a working day is any day other than a weekend or a public holiday in the Australian Capital Territory. A TGA working day does not include any period during which the TGA is waiting for information from the applicant or payment of fees.

Importantly – an application is not considered effective until the relevant fees have been received by the TGA so make sure payment is made as soon as possible for a quicker turnaround time.
We hope this answers your questions and gives you an idea of how long to wait before checking in on your application or submission.

Need help with a product registration or application audit, visit our product registration page, or contact KD&A to discuss your query.