Frequently asked questions (FAQs) on reclassification of medical devices
Reclassification of medical devices frequently asked questions.
Notifications and transitioning 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.
No. The 25 May 2022 deadline for submitting a notification is a legislated due date; there is no provision for late notifications. If you have identified that your device will require reclassification under the amended regulations and you did not submit a notification, the device will not be eligible for the transition period, and you will need to cancel your ARTG entry and cease supply of the device. It is strongly recommended you submit an Application for Inclusion in the Australian Register for Therapeutic Goods (ARTG) for the device under the appropriate classification in accordance with the Therapeutic Goods (Medical Devices) Regulations 2002 (the Regulations) as soon as possible. The TGA will commence regulatory action, including asking for further information, from 25 May 2022, for ARTG entries that appear to require reclassification but a notification was not received.
If you have notified the TGA that your device is affected by the reclassifications, you can continue to supply your device at the current classification under your current ARTG entry until a decision is made (approval or rejection) on your new application at the higher classification. Once a decision is made on your new application, you must cancel your current ARTG entry. If the new application is rejected, you must cease supply of the product under the lower class ARTG entry.
Sponsors with an approved consent application for an ARTG entry that has been reclassified should contact the TGA at email@example.com with details of the relevant consent application number and ARTG entries. You do not need to reapply for consent. The TGA will provide you with an approval for the new ARTG entry for the same approved duration.
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
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.
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 change your ARTG entry to amend or add product names, you will need to submit a DCR application. The DCR application will then follow the usual process. There will not be a mandatory audit, however the TGA may ask you to submit evidence to support the changes.
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.