Asia, Africa & Middle East - April 2017

April 6, 2017

  • Asia: Raft of guidance documents endorsed at 21st Annual Meeting of the AHWP

  • Australia: Regulatory reform consultations

  • Australia: MTAA appoints new CEO

  • China: Priority review and approval procedure effective 1 January 2017

  • China: Tighter rules proposed for the management of medical device recalls

  • China: Administrative measures on adverse event monitoring and evaluation re-drafted

  • China: Lower import tariffs for 30 medical device types

  • Korea: IVD technical documentation review requirements now in force

  • Korea: Process for preliminary review of medical device advertisements

  • Korea: Scope and application of medical device consignment certification/notification

  • Korea: Harmonisation of specifications for self-test blood glucose monitoring systems with international standards

  • Malaysia: Guidance published on change of ownership for device registration

  • Malaysia: Guidance on change notifications for registered medical devices

  • Malaysia: Minor changes made to Conformity Assessment Procedures for medical devices approved by recognised countries

  • Malaysia: Draft guidance circulated on drug-device/device-drug combination products

  • Myanmar: Trade restrictions lifted on hospital equipment

  • Russia: List of implantable medical devices revised and expanded

  • Saudi Arabia: Storage, handling and transportation recommendations for medical devices

  • Saudi Arabia: Process for importing medical devices in national emergency situations is clarified

  • Saudi Arabia: Guidance on the importation requirements for personal use and custom-made medical devices

  • Saudi Arabia: Guidance on obtaining an importation licence and clearance for a non-medical IVD

  • South Africa: Department of Health publishes regulations on medical devices and IVDs

  • South Africa: Guidance on oversight and monitoring of clinical trials

  • Taiwan: Partial amendment of Regulation for Registration of Medical Devices drafted

  • Thailand: Medical device reporting criteria, methods and conditions are stipulated

 

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