Asia, Africa & Middle East - February 2018

  • Australia: ‘Therapeutic Goods (Manufacturing Principles) Determination 2018’

  • Australia: Implementation of new Uniform Recall Procedure for Therapeutic Goods

  • Australia: Guidance on priority review designations for medical devices, including IVDs

  • Australia: Regulatory changes proposed for personalised and 3D printed medical devices

  • China: New rules on the supervision and management of online medical device sales

  • China: Plans to abolish mandatory in-China type testing, accept international clinical trial data, and conduct more overseas inspections

  • China: Consultation held on proposed amendments to the ‘Regulations on the Supervision and Administration of Medical Devices’

  • China: ‘Guiding Principles on the Registration of Mobile Medical Devices’ published

  • China: Numerous technical guidelines have been published by the CFDA

  • China: Six new industry standards published; two repealed

  • EAEU: Proposed modifications to the requirements for products subject to sanitary and epidemiological control

  • India: Classification of medical devices and IVDs under the ‘Medical Devices Rules, 2017’

  • India: Import process clarifications for medical devices and IVDs should ease delays

  • Israel: Standard for colour coded identification of single-use hypodermic needles updated

  • Japan: Partial amendment proposed for Standard for Ruminant-Derived Ingredients

  • Kenya: Parts 1 and 2 of Kenya Standard DKS 2612 on prostheses proposed for adoption

  • Kenya: New standard developed to set quality specifications for neck and spinal orthoses

  • Korea: Several regulatory amendments affecting medical devices were published in late 2017

  • Korea: Agreement to support the marketing of advanced and innovative medical devices

  • Korea: Ministry of Food and Drug Safety joins International Medical Device Regulators Forum (IMDRF)

  • Malaysia: Extension of the moratorium on the registration of medical devices

  • Pakistan: ‘Medical Devices Rules, 2017’ published

  • Philippines: New procedure for applications to amend existing Certificates of Product Registration

  • Philippines: New rules for obtaining customs clearance of radiation devices

  • Saudi Arabia: Draft guidance on requirements for following up and closing medical device Field Safety Notices (FSNs)

  • Vietnam: New guidance released on Class B, C and D medical device

Click here for the full article on Global Regulatory Press.

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