Australia: 2019 fees and charges released by the Therapeutic Goods Administration
Australia: Conformity assessment standards for medical device QMSs
Australia: TGA will no longer send out annual report reminders
Australia: Guidance issued on addressing cybersecurity threats to medical devices
China: Electronic medical device registration system launched
China: Trial launch of Medical Device Manufacturing Enterprise Supervision Information Platform
China: New regulations for customised medical devices
China: Work starts on a pilot project to establish a UDI system for medical devices
China: Initial acceptance review of applications to be trialled
India: Classification of newly-notified medical devices
Japan: Plans for rapid access mechanism for innovative medical devices
Korea (Republic of): New ‘Law on In Vitro Diagnostic Medical Devices’
Korea (Republic of): Integrated Medical Device Information System established
Malaysia: Post-market responsibilities for manufacturers and Authorised Representatives
Malaysia: New guidance on notifying an export-only medical device
Saudi Arabia: Guidance drafted on listing/market authorisation of medical devices
Saudi Arabia: Three guidance documents drafted to address cybersecurity issues
Saudi Arabia: Requirements for reporting device-related adverse incidents addressed in draft guidance
Saudi Arabia: Draft guidance on labelling of soft contact lenses and contact lens solutions
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