Asia, Africa, Middle East - Jan/Feb 2020

  • Australia: Fees and charges proposed for 2020–2021

  • Australia: Regulatory changes for software, personalised medical devices and IVD companion diagnostics, and reclassification of certain devices

  • Australia: Japan has been added to the list of foreign countries determined to be comparable overseas regulators

  • Australia: Certain nappy rash products are not classed as medical devices

  • Australia: New guidance issued on proposed IVD companion diagnostic regulations

  • Australia: Consultation held on draft revisions to guidance on export certification

  • Burundi: Draft East African Standards on surgical sutures and surgical suture needles circulated for comment

  • China: Updates to the lists of medical devices and IVD reagents exempt from clinical trials have been published

  • China: Technical guidance drafted on use of real-world data for clinical evaluation

  • China: Technical Guidelines for the clinical evaluation of medical devices are drafted

  • China: Opinions sought on ‘Basic Principles of Safety and Performance of Medical Devices’

  • India: Extension issued for compliance with new drug regulations

  • Kenya: Draft East African Standards on surgical sutures and surgical suture needles proposed for adoption

  • Korea (Republic of): Enforcement rules drafted to support implementation of IVD law

  • Korea (Republic of): Support for innovative medical devices has been proposed

  • Malaysia: New rules take effect in 2020 on distribution records, complaint handling, incident reporting, corrective and preventive actions, and recalls

  • Malaysia: New rules for advertising medical devices take effect on 1 July 2020

  • Malaysia: Post-market responsibilities for manufacturers and Authorised Representatives of orphaned medical devices are revised

  • Malaysia: Orphaned, obsolete and discontinued medical devices are redefined

  • Malaysia: Guidance issued to support import/supply of devices for demonstration for marketing or education

  • Rwanda: Draft East African Standards on surgical sutures and surgical suture needles proposed for adoption

  • Saudi Arabia: Implementation of new marketing authorisation fees is postponed

  • Saudi Arabia: Use of evidence of regulatory compliance in other jurisdictions is still permitted

  • Saudi Arabia: Ghad is the new electronic medical device application portal

  • Saudi Arabia: Guidance issued on UDI, classification, innovative devices, standards and QMSs

  • Singapore: Consultation held on regulatory guidelines for software medical devices

  • Singapore: Consultation held on revised guidance concerning change notifications

  • Singapore: Draft revisions circulated for guidance on IVD analysers

  • Taiwan: New guidelines issued for device manufacturers to address cybersecurity

  • Tanzania: Draft East African Standards on surgical sutures and surgical suture needles proposed for adoption

  • Thailand: Tighter controls for silicone breast implants

  • Thailand: Criteria established for using Concise Evaluation route

  • Uganda: Ugandan standards and Draft East African Standards on surgical sutures and surgical suture needles

  • Vietnam: New medical device management rules came into force on 1 January 2020


Click here for the full article on Global Regulatory Press.

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