Asia, Africa & Middle East - December 2017

January 1, 2018

  • Australia: Articles that alter the pH of body fluids are not medical devices

  • Australia: Up-classification of surgical mesh and provision of patient information

  • Australia: Guidance on pre-submission meetings with the TGA updated

  • China: New classification catalogue will take effect on 1 August 2018

  • China: Five new technical review guidelines for registration published

  • China: Consultation held on policies to encourage medical device and pharmaceutical innovation

  • China: Seven new industry standards published

  • India: Essential Principles drafted to support ‘Medical Devices Rules, 2017’

  • India: Severe price caps introduced on knee implants

  • Israel: Proposed revision of standard for colour coded identification of single-use hypodermic needles

  • Korea: Consultation held on proposed changes to safety and adverse event reporting requirements

  • Malaysia: Medical device registration requirements to be enforced fully from 1 January 2018

  • Malaysia: Guidance on change notifications for registered medical devices updated

  • Malaysia: IMR to report on clinical evidence/performance evaluation for conformity assessment purposes

  • Russia: Draft amendments to the procedures for the registration of medical products

  • Saudi Arabia: Expedited pathway for marketing low-risk (non-sterile and non-measuring) devices is announced

  • Saudi Arabia: Guidance published on shipment clearance procedures

  • Singapore: Final guidance and FAQs document published on telehealth products

  • Singapore: Consultation held on guidance concerning IVD analysers

     

Click here for the full article on Global Regulatory Press.

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