This guidance document provides advice on how to submit a notification for lapsing or lapsed manufacturer’s conformity assessment certification for your medical device(s). The notification form is located on the Therapeutic Goods Administration (TGA) Consultation Hub.
Conformity assessment certification may no longer be valid 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 because of 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 entry in the Australian Register of Therapeutic Goods (ARTG).
Under the Australian legislation, sponsors of medical devices included in the ARTG must be able to demonstrate that the manufacturer holds, and has applied, appropriate conformity assessment processes to 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 certification (other than a conformity assessment certificate issued by the TGA) has been restricted, suspended, revoked, or is no longer in effect.
Contents
- Introduction
- Notification form