EMERGO SUMMARY OF KEY POINTS: Australia’s Therapeutic Goods Administration (TGA) plans to begin accepting certifications and approvals from additional foreign medical device regulators in addition to European CE Marking from market applicants. TGA will recognize registrations and certifications from US FDA, Health Canada, the Japanese Pharmaceutical and Medical Devices Agency (PMDA) and Medical Device Single Audit Program (MDSAP) auditing organizations. Australian market applicants may leverage approvals and registrations from these agencies for expedited TGA premarket reviews.