PMS Requirements by Class
Post-market surveillance obligations for Australian medical device manufacturers and sponsors, including what PMS must cover and how requirements scale with device class.
Annual Reports (Class III, AIMD, IIb Implants)
Mandatory annual reporting requirements for sponsors of Class III, AIMD, and implantable Class IIb medical devices in Australia.
Distribution Records
Requirements for sponsors to maintain distribution records for medical devices supplied in Australia, to enable effective recalls when required.