Notification form: Lapses in medical device conformity assessment certification

Overview

Please use this form to notify the TGA of any lapsing or lapsed manufacturer’s conformity assessment certification for your medical device(s).

Conformity assessment certification may lapse due to the certification expiring, or if it has been suspended or revoked. Notifying the TGA of any lapse in certification is a legal requirement.

Changes to the medical device directive (93/42/EEC) and the IVD Directive (98/79/EC) along with disruptions due to the COVID-19 pandemic, has resulted in difficulty for some medical device manufacturers to maintain the currency of their conformity assessment certification used to support their medical device inclusions in the Australian Register of Therapeutic Goods (ARTG).

Under the Australian legislation, medical devices included in the ARTG must have appropriate conformity assessment procedures applied to, and sponsors must ensure that the manufacturer holds appropriate conformity assessment certification for their devices. There are criminal and civil penalty sanctions if a sponsor fails to notify the TGA within 60 days of becoming aware that conformity assessment certificate used to support the application for inclusion in the ARTG (other than a conformity assessment certificate issued by the TGA) has been restricted, suspended, revoked or is no longer in effect.

To read more on this please refer to the guidance document: The TGA's approach to delays in medical device conformity assessment recertification | Therapeutic Goods Administration (TGA)

About this form:

Please complete and submit this form for all medical device ARTG entries with lapsing or lapsed conformity assessment certification. You can use one form to notify for multiple ARTG entries only if each ARTG entry has the same manufacturer, sponsor, and conformity assessment certification.

Please complete one page (i.e. ARTG entry - 1) for each affected ARTG entry as the fields on each ARTG page collects information related to one ARTG entry only. Once completed, click 'Continue' to return to the landing page titled 'Contents'. From here, you can select another ARTG page for listing the details related to additional ARTG entries. One notification form can be used to notify for up to 20 ARTG entries (with space on each page to list up to 20 models per ARTG entry). If an affected ARTG entry has more than 20 models, you can list these additional models on the subsequent ARTG entry page(s). For example, if ARTG entry -1 has 30 models, you can list the first 20 models on the ‘ARTG entry – 1’ page and then list the remaining 10 models on the ‘ARTG entry – 2’ page. Please ensure that the ARTG number and name is entered on all pages with model information related to the ARTG entry. We have developed a guidance document to help step you through the completion of the notification form and this can also be found in the ‘Related Documents’ section below.

If you need to notify the TGA of lapsing/lapsed conformity assessment certification for more than 20 ARTG entries, please submit multiple notification forms or contact the TGA at dvs@health.gov.au to discuss.

Please note: This form is being hosted on a consultation platform, however it is not a consultation and information provided in the form will not be published.  

This form, when completed, will be classified as 'For official use only'. For guidance on how your information will be treated by the TGA see: Treatment of information provided to the TGA.