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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