Asia, Africa & Middle East - May 2018

May 23, 2018

  • Australia: Changes to the therapeutic goods advertising framework

  • Australia: Guidance on updating an existing Class 1–3 in-house IVD notification

  • Australia: Guidance for labelling medical devices to comply with the Poisons Standard

  • Bahrain: Draft GCC rules on the restriction of the use of hazardous substances in EEE

  • China: Work of the CFDA to be undertaken by a new State Market Regulatory Administration as part of institutional reforms

  • China: Draft rules for implementing UDI

  • China: Proposed rules for the registration of 3D printed medical devices

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

  • China: Regulator announces two-year plan for medical device standards development

  • Hong Kong: Examples published of in vitro diagnostic medical devices classified into classes A–D

  • Hong Kong: Use of Chinese marketing approvals to satisfy MDACS listing requirements to be trialled

  • India: Fees to be charged by Notified Bodies are published

  • India: New frequently-asked-questions document on the ‘Medical Devices Rules, 2017’

  • India: Grouping guidelines for medical device licence applications

  • India: List of notified medical devices to be expanded

  • Israel: Two revised medical electrical equipment standards awaiting publication

  • Kuwait: Draft GCC rules on the restriction of the use of hazardous substances in EEE

  • Malaysia: New address for the Medical Device Authority

  • Malaysia: Implementation dates announced for guideline on registration of combination products

  • Malaysia: Licensing and device registration for Original Equipment Manufacturers (OEMs)

  • Malaysia: Import and/or supply of unregistered devices for the purpose of demonstration for marketing or for education

  • Malaysia: Updated guidance on requirements for medical device labelling

  • New Zealand: Higher fee proposed for Regulatory Statements to Foreign Governments

  • Oman: Draft GCC rules on the restriction of the use of hazardous substances in EEE

  • Philippines: New medical device registration requirements published based on ASEAN Medical Device Directive

  • Qatar: Draft GCC rules on the restriction of the use of hazardous substances in EEE

  • Saudi Arabia: Eight medical device guidance documents finalised and three undergoing consultation

  • Saudi Arabia: Draft GCC rules on the restriction of the use of hazardous substances in EEE

  • Singapore: Proposed amendments to the ‘Health Products (Medical Devices) Regulations’

  • South Africa: Clarification and guidance on medical device establishment licensing requirements

  • UAE: Draft GCC rules on the restriction of the use of hazardous substances in EEE

  • Uganda: Two standards drafted on surgical suture specifications; three on surgical suture needles

  • Uganda: Standard drafted on stainless steel used in surgical instruments

  • Yemen: Draft GCC rules on the restriction of the use of hazardous substances in EEE

     

     

     

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