Update from Regulatory Affairs Committee 31 March 2021

Update from Regulatory Affairs Committee:

  • RAC members were briefed on the recent Reg Tech meeting in relation to the reclassification of Medical Devices, Adverse Event reporting timelines, Orthopaedic Loan Kits, clarification on off-label use of approved products, impact of EU MDR related changes, and exemptions from PIC/PIL;
  • RAC members were asked to respond to the TGA’s questions in relation to UDIs, responses are being compiled and will be sent to the TGA by the deadline;
  • Discussion of EU MDR changes, responses are being compiled to be discussed during the workshop;
  • RAC asked to participate in the TGA Digital Transformation Workshop.