Asia, Africa & Middle East - May 2017

  • Australia: Therapeutic Goods Amendment (2016 Measures No 1) Bill 2016

  • Australia: Consultation held on future regulation of low risk products, including certain Class I medical devices

  • Australia: Guidance issued on clinical evidence for medical devices

  • China: Medical equipment inspection fees abolished

  • China: Revised rules for the supervision and management of medical device recalls took effect on 1 May 2017

  • China: Review timeframes could be reduced for certain submissions under new proposals

  • China: CFDA makes minor adjustments to classification rules for in vitro diagnostic reagents

  • China: Technical guidelines published on the security of medical device networks

  • China: New standard for medical device Quality Management Systems in force from 1 May 2017

  • India: Medical Devices Rules, 2017 are a first step towards full medical device regulation

  • India: Enforcement action to be taken against medical devices notified as drugs that fail to display Maximum Retail Price

  • Japan: Four new innovative devices able to receive support through Sakigake Designation

  • Korea: Medical device sales blocking system introduced to aid product recalls

  • Malaysia: Export-only devices exempt from conformity assessment and labelling requirements

  • Malaysia: New guidance issued on registration of combination products

  • Malaysia: Notification of exemption from registration for medical devices intended for clinical research or performance evaluation

  • Saudi Arabia: New guidance on importing medical devices, including IVDs, and non-medical IVDs for educational or non-clinical research purposes

  • Saudi Arabia: Requirements for importing distillation apparatus are specified in a new guidance document

  • South Africa: Licensing timeframes specified for manufacturers, wholesalers and distributors of medical devices and IVDs

  • Taiwan: Amendments proposed to annexes to Regulations for Governing the Management of Medical Devices

  • Vietnam: Registration now required for all imported medical devices

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