Chinese Regulators Revamp Innovative Medical Device Review Process

China – Chinese Regulators Revamp Innovative Medical Device Review Process

EMERGO SUMMARY OF KEY POINTS: The Chinese National Medical Products Administration (NMPA) has published revised requirements for its innovative medical device review program. NMPA...
South Korean MFDS Plans Greater Alignment of Quality Requirements with ISO 13485:2016

South Korea – South Korean MFDS Plans Greater Alignment of Quality Requirements with ISO...

EMERGO SUMMARY OF KEY POINTS: South Korea’s MFDS to harmonize Korea Good Manufacturing Practice (KGMP) quality system regulations to ISO 13485:2016. Aligning KGMP to...
TGA Proposes Regulation on IVD Companion Diagnostics

Australia – TGA Proposes Regulation on IVD Companion Diagnostics

Australia’s Therapeutic Goods Administration (TGA) issued a consultation paper on Tuesday to propose a new framework for the regulation of companion in vitro diagnostic (IVD) devices. The framework proposes...
Patient implant cards and consumer device information leaflets

Australia – Patient implant cards and consumer device information leaflets

From 1 December 2018, manufacturers of all new permanently implantable devices (other than those exempted) will need to provide patient implant cards and have...
Chinese Regulators Continue Adding Medical Devices, IVDs to Clinical Trial Exemption List

China – Chinese Regulators Continue Adding Medical Devices, IVDs to Clinical Trial Exemption List

EMERGO SUMMARY OF KEY POINTS: China’s National Medical Products Administration (NMPA) has expanded its list of medical devices and IVDs exempt from clinical trial...
Australia Expands Range of Acceptable Foreign Regulators for Device Applications

Australia – Expands Range of Acceptable Foreign Regulators for Device Applications

Beginning this month, Australia’s Therapeutic Goods Administration (TGA) will expand its range of acceptable international assessments and approvals on medical device applications. TGA said Monday...
TGA Seeks to Support Software as a Medical Device, Develop Cybersecurity Guidance

Australia – TGA Seeks to Support Software as a Medical Device, Develop Cybersecurity Guidance

Australia’s Therapeutic Goods Administration (TGA) is calling on industry to help tackle existing regulatory challenges in the medical device areas of software and cybersecurity. “To...

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