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Australia: Reclassification of surgical mesh devices and publication of associated guidance
Australia: Proposed fees and charges for 2019–2020
Australia: Consultation held on changes to definitions and scope of device regulations
Australia: Potential reclassification of active medical devices for diagnosis and patient therapy
Australia: Proposed introduction of a Unique Device Identification (UDI) system
Australia: New guidance on menstrual cups is released
Australia: Guidance drafted on medical device cybersecurity
Australia: ‘Therapeutic Goods Advertising Code (No 2) 2018’ now in effect
China: Special review procedure for innovative medical devices
China: New checklist designed to improve clinical trial data and guide inspections
China: Creation of a voluntary record filing system for Device Master Files proposed
Hong Kong: Listing of Class B and Class C IVDs starts in February 2019
India: Four new medical devices to be included in definition of drugs
India: Surgical gowns and drapes could become notified medical devices
India: Electronic instructions for use now accepted
India: Guidance on Certificates of Free Sale for notified medical devices
Israel: SI 798 Part 1, dealing with spectacle lenses for ophthalmic optics, is to be replaced
Malaysia: Updated guidance on medical device labelling has been published
Malaysia: Guidance explains requirements for a CFS application for an export only device
Malaysia: Change notification guidance is updated for a third time
New Zealand: Proposal for increased medical device regulatory controls
Saudi Arabia: Updated timeframes/criteria for deleting MDMA applications
Saudi Arabia: New final and draft guidance documents released
Singapore: Updated guidance drafted on preparation of a product registration submission
Click here for the full article on Global Regulatory Press.
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