ISO 13485:2016 Australia: Therapeutic Goods (Medical Devices) Regulations, 2002, Schedule 3, Part 1 (excluding Part 1.6) – Full Quality Assurance System Brazil: RDC ANVISA nº 665/2022, RDC ANVISA nº 551/2021, RDC ANVISA nº 67/2009 Canada: Medical Devices Regulations – Part 1- SOR 98/282 Japan: MHLW Ministerial Ordinance No.169 (2004), as amended by MHLW Ministerial Ordinance No.60 (2021) Japan PMD Act (as applicable) USA: 21 CFR Part 803 – Medical Device Reporting / 21 CFR Part 806 – Reports of Corrections and Removals 21 CFR Part 807 (Subparts A to D) – Establishment Registration and Device Listing 21 CFR Part 820 – Quality System Regulation / 21 CFR Part 821 – Device Tracking