Australia Therapeutic Goods (Medical Devices) Regulations 2002 r8.1A-8.1: Answer information notices under section 41JA within the set period and keep manufacturing records for 5 years and distribution records for 10 years (Class III and implantable Class IIb) or 5 years (others) so they can be produced

What does r8.1A-8.1 require?

The Secretary may by written notice require a sponsor to give information or documents on matters including whether the products are medical devices, their intended purpose, correct classification, the written agreement with the manufacturer to obtain conformity information, prohibited import substances, exclusive-use purposes, accuracy of the application, low-value turnover and annual charge waivers, complaints and problems however minor, adverse event matters, compliance with inclusion conditions and the formulation of ingredients. The notice period that applies is 5 years for manufacturing records and, for distribution records, 10 years for Class III and implantable Class IIb devices and 5 years for others, which sets how far back the sponsor must be able to produce records.