Australia Therapeutic Goods (Medical Devices) Regulations 2002 r5.8-5.8A: Automatic condition: hold and give, when required, information on any malfunction, deterioration, design, labelling, instruction or advertising inadequacy or use that led to any complaint however minor, and after a 48-hour, 10-day or 30-day report give a written follow-up report within 120 days

What does r5.8-5.8A require?

The information the sponsor must be able to give the Secretary covers anything it knows about malfunction or deterioration of the kind of device, inadequacy in its design, manufacture, labelling, instructions or advertising, or use within or outside the intended use, that has led to any complaint or problem no matter how minor, plus any section 41MP(2) adverse event information. Where the sponsor reported an event within the 48-hour, 10-day or 30-day period, it must give the Secretary a written report within 120 days of that first report that updates the information, describes what the sponsor or manufacturer did to investigate the event and to reduce its impact on patients and users, and sets out similar events known to it over the past 3 years.