Asia, Africa & Middle East - Aug 2019

August 30, 2019

  • 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  • Saudi Arabia: Requirements for reporting device-related adverse incidents addressed in draft guidance

  • Saudi Arabia: Draft guidance on labelling of soft contact lenses and contact lens solutions












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