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Frequently asked questions (FAQs) on reclassification of medical devices
Notification forms for reclassification of medical devices
There are a range of devices that will be reclassified from 25 November 2021. This includes the following:
- active medical devices for therapy with a diagnostic function
- spinal implants for motion preservation
- devices in direct contact with the heart, central circulatory system, central nervous system
- devices that administer medicines or biologicals by inhalation
- active medical devices
- substances introduced into the body, body orifice or applied to the skin
The guidance documents on the TGA website provide more detailed information about what devices are being reclassified and what you need to do.
Yes. You must notify the TGA if you wish to qualify for transitional arrangements that allow you to continue to supply your device at the current classification under your current ARTG entry while you apply for inclusion of your medical device at the new classification.
Notification forms for ARTG entries that will be reclassified are available at Medical devices reforms: Reclassification of certain medical devices. You will need to fill in a separate notification form for each category of reclassification as the forms are specific to each device category.
For example - if you need to reclassify a spinal implantable medical device, and a medical device that administers medicine via inhalation, you will need to use different notification forms for each of your these. Each notification form allows the input of up to 10 different ARTG inclusions.
You need to notify the TGA by COB 24 May 2022 that you have a medical device being reclassified. If you do not notify the TGA, you will not be eligible for the transition period and therefore, you will need to cancel your ARTG entry and cease supply of the device from 25 May 2022.
Once you have submitted your notification form you will then be eligible for the reclassification transition period. You then have until 30 October 2024 to submit an application for inclusion in the ARTG at the new classification.
If you have notified the TGA that your device is being reclassified, you can continue to supply your device at the current classification under your current ARTG entry until your new application at the higher classification has been approved. Once your new application has been approved, you must cancel your current ARTG entry.
For devices with an inclusion date prior to 25 November 2021, you will not be eligible for the transition arrangements and cannot continue to supply your device. You must cancel your ARTG entry immediately.
The TGA will commence cancelling ARTG entries from 25 May 2022 where no notification was received.
If you have notified the TGA before 25 May 2022 that that you have a medical device that will be reclassified, but do not submit an application for inclusion at the appropriate classification by 30 October 2024, you must cancel your ARTG entry immediately.
The TGA will undertake a review of the ARTG and commence cancelling ARTG entries from 1 November 2024, if a new application at the appropriate classification was not received.
Class IIb spinal fusion devices
For existing ARTG entries, the new 'Class IIb product name variation' form requires you to list all product names for existing devices within an ARTG entry. This form is now available through your TGA Business Services (TBS portal).
When class IIb is selected in a new application seeking inclusion in the ARTG, the question 'Is this a Class IIb spinal fusion device' will appear. If the radio button 'Yes' is selected, the requirement to input product names will be made available.
No. For existing ARTG entries, the new 'Class IIb product name variation' form is only for the provision of product names for devices covered within the ARTG entry. The workflow for this is automated with no review by a delegate.
If sponsors are seeking to amend their ARTG entry, a Device Change Request (DCR) or Variation will need to be submitted.
The product names should uniquely identify the devices covered under an ARTG entry, akin to Unique Product Identifiers (UPIs). i.e. one product name for each device covered under the ARTG entry.
Yes. The legislative requirement is that information on product names of the devices must be given to the Secretary no later than 20 business days before the intended import, supply or export of the device. The TGA takes a risk-based approach to regulatory enforcement and strongly encourages all sponsors to notify the TGA of product names at the earliest opportunity.
If you want to add or amend product names of the same kind of device in the ARTG, you can use the 'Class IIb product name variation' form.
If you want to amend your ARTG entry for anything other than amending product names, you will need to submit a DCR application. The DCR application will then follow the usual process and there will not be a mandatory audit.
The TGA requests that class IIb spinal devices be accompanied by a one page document including the following:
- intended purpose of the device
- whether the device is a spinal fusion or motion preserving device
- applicable information relating to the consideration of the classification rules.
This one page document is a requested to limit any confusion and additional correspondence with the Sponsor that may delay assessment of the application. You do not have to submit a one page document with every application. However, you are encouraged to do so.
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