Asia, Africa & Middle East - Mar 2019

March 29, 2019

  • Australia: Reclassification of surgical mesh devices and publication of associated guidance

  • Australia: Proposed fees and charges for 2019–2020

  • Australia: Consultation held on changes to definitions and scope of device regulations

  • Australia: Potential reclassification of active medical devices for diagnosis and patient therapy

  • Australia: Proposed introduction of a Unique Device Identification (UDI) system

  • Australia: New guidance on menstrual cups is released

  • Australia: Guidance drafted on medical device cybersecurity

  • Australia: ‘Therapeutic Goods Advertising Code (No 2) 2018’ now in effect

  • China: Special review procedure for innovative medical devices

  • China: New checklist designed to improve clinical trial data and guide inspections

  • China: Creation of a voluntary record filing system for Device Master Files proposed

  • Hong Kong: Listing of Class B and Class C IVDs starts in February 2019

  • India: Four new medical devices to be included in definition of drugs

  • India: Surgical gowns and drapes could become notified medical devices

  • India: Electronic instructions for use now accepted

  • India: Guidance on Certificates of Free Sale for notified medical devices

  • Israel: SI 798 Part 1, dealing with spectacle lenses for ophthalmic optics, is to be replaced

  • Malaysia: Updated guidance on medical device labelling has been published

  • Malaysia: Guidance explains requirements for a CFS application for an export only device

  • Malaysia: Change notification guidance is updated for a third time

  • New Zealand: Proposal for increased medical device regulatory controls

  • Saudi Arabia: Updated timeframes/criteria for deleting MDMA applications

  • Saudi Arabia: New final and draft guidance documents released

  • Singapore: Updated guidance drafted on preparation of a product registration submission

 

 

 

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