Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

We are submitting an application to TGA for a IIa device, and have MDSAP Cert and FDA 510k clearance.  We have a Business Services acct and are in Australia, so no Sponsor needed.   Need some benchmarking information. 

2 questions:

1) What are people experiencing re: application audits.  Do you agree it is likely (what probability do you think for IIa)?

2) Once submitted, what time frame if TGA decides an audit is not required are people currently experiencing to receive a TGA decision ? 
     If you have had a request for Level 1 audit of the application for this class of device - what time frames are you currently experiencing?
     Same question if you have had a Level 2 for a IIa  (personally we think this is unlikely, but would love all feedback)

Thanks!

I was looking into similar for TGA just over a year ago, and I was told the audit was mandatory, even with ISO 13485 certification, and was quoted an 18 month timeframe.

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Beth Gordon
Systems Manager
Christchurch
New Zealand
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Original Message:
Sent: 24-Feb-2022 21:57
From: Anonymous Member
Subject: TGA Timing for application

This message was posted by a user wishing to remain anonymous

We are submitting an application to TGA for a IIa device, and have MDSAP Cert and FDA 510k clearance.  We have a Business Services acct and are in Australia, so no Sponsor needed.   Need some benchmarking information.

2 questions:

1) What are people experiencing re: application audits.  Do you agree it is likely (what probability do you think for IIa)?

2) Once submitted, what time frame if TGA decides an audit is not required are people currently experiencing to receive a TGA decision ?
     If you have had a request for Level 1 audit of the application for this class of device - what time frames are you currently experiencing?
     Same question if you have had a Level 2 for a IIa  (personally we think this is unlikely, but would love all feedback)

Thanks!

This message was posted by a user wishing to remain anonymous

Firstly, make sure that your MDSAP cert covers AU TGA MD Regulations since some manufacturers are choosing the scope of the certification based on revenue projections.
Regarding chances of a level 1 audit, it depends on the complexity of the device and whether the submitted information has some deficiencies or gaps requiring clarifications. If you believe the submitted documentation is accurate and complete then chances of an audit are minimal.
Due to Covid, applications are taking much longer to be approved by the TGA but on an average, a class IIa inclusion application should not take more than 2-3 months, of course depending upon if the application is selected for an audit or not.
The overall timeframe from submission to approval of the application (assuming application is audited) will depend upon how soon the response to "request for further information' is submitted.
Original Message:
Sent: 24-Feb-2022 21:57
From: Anonymous Member
Subject: TGA Timing for application

This message was posted by a user wishing to remain anonymous

We are submitting an application to TGA for a IIa device, and have MDSAP Cert and FDA 510k clearance.  We have a Business Services acct and are in Australia, so no Sponsor needed.   Need some benchmarking information.

2 questions:

1) What are people experiencing re: application audits.  Do you agree it is likely (what probability do you think for IIa)?

2) Once submitted, what time frame if TGA decides an audit is not required are people currently experiencing to receive a TGA decision ?
     If you have had a request for Level 1 audit of the application for this class of device - what time frames are you currently experiencing?
     Same question if you have had a Level 2 for a IIa  (personally we think this is unlikely, but would love all feedback)

Thanks!

This message was posted by a user wishing to remain anonymous

Thanks for the response.

Yes, the MDSAP has Australian requirements in it.  Australia, Canada and US at the moment.  Brazil and Japan are not yet in the mix.
Original Message:
Sent: 26-Feb-2022 04:10
From: Anonymous Member
Subject: TGA Timing for application

This message was posted by a user wishing to remain anonymous

Firstly, make sure that your MDSAP cert covers AU TGA MD Regulations since some manufacturers are choosing the scope of the certification based on revenue projections.
Regarding chances of a level 1 audit, it depends on the complexity of the device and whether the submitted information has some deficiencies or gaps requiring clarifications. If you believe the submitted documentation is accurate and complete then chances of an audit are minimal.
Due to Covid, applications are taking much longer to be approved by the TGA but on an average, a class IIa inclusion application should not take more than 2-3 months, of course depending upon if the application is selected for an audit or not.
The overall timeframe from submission to approval of the application (assuming application is audited) will depend upon how soon the response to "request for further information' is submitted.
Original Message:
Sent: 24-Feb-2022 21:57
From: Anonymous Member
Subject: TGA Timing for application

This message was posted by a user wishing to remain anonymous

We are submitting an application to TGA for a IIa device, and have MDSAP Cert and FDA 510k clearance.  We have a Business Services acct and are in Australia, so no Sponsor needed.   Need some benchmarking information.

2 questions:

1) What are people experiencing re: application audits.  Do you agree it is likely (what probability do you think for IIa)?

2) Once submitted, what time frame if TGA decides an audit is not required are people currently experiencing to receive a TGA decision ?
     If you have had a request for Level 1 audit of the application for this class of device - what time frames are you currently experiencing?
     Same question if you have had a Level 2 for a IIa  (personally we think this is unlikely, but would love all feedback)

Thanks!

This message was posted by a user wishing to remain anonymous

Hi,

You can use either MDSAP or FDA 510k clearance as evidence to support your device inclusion application. First, you need to apply for a Manufacturer's Evidence (ME) from your TGA eBS Account, using either the MDSAP or the 510k clearance. The TGA usually review and accept the ME within one week. Once the ME is accepted, you can submit your inclusion application. It is unlikely that the TGA will select a Class IIa for application audit. The TGA approval process takes 1-2 months for Class IIa devices.

More information of TGA medical device inclusion process can be found from:
Medical device inclusion process | Therapeutic Goods Administration (TGA)
Original Message:
Sent: 24-Feb-2022 21:57
From: Anonymous Member
Subject: TGA Timing for application

This message was posted by a user wishing to remain anonymous

We are submitting an application to TGA for a IIa device, and have MDSAP Cert and FDA 510k clearance.  We have a Business Services acct and are in Australia, so no Sponsor needed.   Need some benchmarking information.

2 questions:

1) What are people experiencing re: application audits.  Do you agree it is likely (what probability do you think for IIa)?

2) Once submitted, what time frame if TGA decides an audit is not required are people currently experiencing to receive a TGA decision ?
     If you have had a request for Level 1 audit of the application for this class of device - what time frames are you currently experiencing?
     Same question if you have had a Level 2 for a IIa  (personally we think this is unlikely, but would love all feedback)

Thanks!

Class IIa devices may be selected for non-compulsory audit. This selection is typically based on the risk of the device, technology and quality of information provided to the TGA as part of the application. Recently, sponsors are experiencing delays with class I (non-sterile, non-measuring devices) approx. 2-6 months. This is also due to staffing issue within the TGA.

Typically, for a class IIa devices which has not been selected for a non-compulsory audit can be included in the ARTG within 20 working days. If selected for an audit, it can take 2-4 months.

------------------------------
Romit Singh
RA/QA Manager - ANZ
Frenchs Forest NSW
Australia
------------------------------

Original Message:
Sent: 24-Feb-2022 21:57
From: Anonymous Member
Subject: TGA Timing for application

This message was posted by a user wishing to remain anonymous

We are submitting an application to TGA for a IIa device, and have MDSAP Cert and FDA 510k clearance.  We have a Business Services acct and are in Australia, so no Sponsor needed.   Need some benchmarking information.

2 questions:

1) What are people experiencing re: application audits.  Do you agree it is likely (what probability do you think for IIa)?

2) Once submitted, what time frame if TGA decides an audit is not required are people currently experiencing to receive a TGA decision ?
     If you have had a request for Level 1 audit of the application for this class of device - what time frames are you currently experiencing?
     Same question if you have had a Level 2 for a IIa  (personally we think this is unlikely, but would love all feedback)

Thanks!