Asia, Africa & Middle East - Aug/Sep 2018

  • Australia: 2018 fees and charges released by the Therapeutic Goods Administration

  • Australia: Application fee now charged for a Class I medical device ARTG entry

  • Australia: Therapeutic Goods Advertising Code 2018

  • Australia: Proposed regulatory changes to personalised and 3D printed medical devices put on hold

  • Australia: Guidance on the regulatory requirements for in-house IVDs is updated

  • China: Proposals to relax certain requirements for renewals, clinical trial applications and Ethics Committee approvals

  • China: Significant and wide ranging changes proposed to medical device regulations

  • China: Electronic Regulated Product Submission system proposed

  • Egypt: All medical devices to be registered from 1 September 2018

  • Hong Kong: Updates made to the ‘Guidance Notes for Listing of Importers of Medical Devices’

  • India: Draft guidelines on the Essential Principles for safety and performance of medical devices

  • India: Confirmation of effective date for IS/ISO 15197 affecting glucometer test strips

  • India: DTAB proposes amendments to Medical Devices Rules, 2017, including more notified medical devices

  • Kenya: Device standards expected to be adopted in September 2018

  • Korea (Republic of): MDITAC renamed as NIDS

  • Korea (Republic of): Adverse event reporting requirements to be strengthened under proposed changes

  • Korea (Republic of): Criteria set for medical devices using virtual or augmented reality technology

  • Korea (Republic of): Smart Healthcare Cybersecurity Guide issued by MSIT

  • Malaysia: Medical device registration requirements now fully enforced

  • Malaysia: Exemption from registration for export-only medical devices

  • Malaysia: Recognition and listing of institutes or laboratories capable of providing clinical evidence or performance evaluation data for conformity assessment

  • Malaysia: Control of orphaned, obsolete and discontinued medical devices

  • Philippines: New draft fee schedule for medical device licensing and registration

  • Saudi Arabia: Registration deadline for low-risk Class I devices extended

  • Saudi Arabia: Guidance updated on shipment clearance procedures

  • Saudi Arabia: Guidance on requirements for listing non-sterile, non-measuring, low-risk medical devices

  • Singapore: Legislative changes offer faster access to medical devices and improved clarity on regulatory controls

  • Singapore: Consultations held on nine medical device guidance documents

Click here for the full article on Global Regulatory Press.

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