Asia, Africa & Middle East - Dec 2018

  • AHWP: Guidance on labelling for in vitro diagnostic medical devices

  • Australia: Application fee change for export only medical devices

  • Australia: Updated requirements specified for preliminary assessment of applications for inclusion in the ARTG

  • Australia: TGA to make greater use of overseas marketing approvals

  • Australia: Certificates of Free Sale and Export Certificates

  • Australia: Comments solicited on proposed regulation of IVD companion diagnostics

  • Australia: Guidance issued on electronic IFU for professional users of medical devices

  • China: Regulation drafted to control Chinese agents of imported medical devices

  • Egypt: Use of ES 1595-1 on single-use, sterile rubber surgical gloves is now mandatory

  • Hong Kong: Web-based IVD classification programme developed by MDCO

  • India: Comprehensive reference document on device regulations prepared by IPC

  • Israel: Two Parts of SI 1268 on syringes and needles are proposed for revision

  • Korea (Republic of): Adoption of ISO 13485:2016 proposed

  • Malaysia: Transition period for meeting medical device labelling requirements extended by three years

  • Malaysia: Registration exemption for export only medical devices

  • Malaysia: Rule for devices imported from/exported to countries without diplomatic ties with Malaysia

  • Malaysia: Borderline and combination product classification examples

  • Saudi Arabia: ‘Guidance for the Medical Devices Samples for Laboratory Testing’

  • Singapore: Regulatory fees for medical devices to increase from 2 April 2019

  • Uganda: Draft standard on sterile surgical blades

Click here for the full article on Global Regulatory Press.

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