Asia, Africa and the Middle East - May 2020

  • Australia: Consultation on scope of regulated software-based products

  • Bangladesh: New rules proposed for WEEE and RoHS that will affect medical equipment

  • China: Transfer of production of imported devices to Chinese enterprises

  • China: Guidance issued on process for correcting submission deficiencies

  • China: Tighter controls announced for supervision and inspection of sterile and implantable devices

  • China: Revision plan for medical device industry standards

  • China: Consultations held on three medical electrical equipment standards

  • Egypt: Sterile hypodermic syringes with re-use prevention feature are subject of new draft standard

  • Egypt: Standard drafted in line with ISO 23908 on sharps protection features

  • Hong Kong: Trial to assess acceptance of Korean marketing approvals in support of an MDACS listing application has been extended

  • India: All medical devices to be regulated as ‘drugs’ and the Medical Devices (Amendment) Rules, 2020

  • Israel: Proposed revision of mandatory standard on cardiac defibrillators

  • Korea (Republic of): Changes to rules for exemption from import requirements

  • Korea (Republic of): Provisions for supply of rare and urgently needed medical devices

  • Korea (Republic of): Regulation proposed on operation of medical device software pre-certification programme

  • Kuwait: Several new medical device related standards are circulated for public comment

  • Malaysia: Guidance on notification process for orphaned medical devices

  • Malaysia: Guidance provided on submitting notifications for obsolete and discontinued medical devices

  • Malaysia: Guidance drafted on IVD product groupings for registration purposes

  • Malaysia: Comments sought on draft guidance concerning IVD classification

  • Malaysia: Guidance drafted on notification of refurbished medical devices

  • Philippines: New fees and charges proposed for implementation in 2020

  • Philippines: Initial implementation phase for device authorisation under AMDD

  • Russian Federation: Rules for registration to be aligned with EAEU under new proposal

  • Saudi Arabia: Recognised standards for medical masks

  • Saudi Arabia: Recognised standards for ventilators, ventilator tubing connectors and accessories

  • Saudi Arabia: Draft guidance released on medical device FSCAs

  • Taiwan: Framework for regulation of medical devices has been released

  • Taiwan: ‘Medical Device Quality Management System Regulations’ are drafted

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