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Australia: Articles that alter the pH of body fluids are not medical devices
Australia: Up-classification of surgical mesh and provision of patient information
Australia: Guidance on pre-submission meetings with the TGA updated
China: New classification catalogue will take effect on 1 August 2018
China: Five new technical review guidelines for registration published
China: Consultation held on policies to encourage medical device and pharmaceutical innovation
China: Seven new industry standards published
India: Essential Principles drafted to support ‘Medical Devices Rules, 2017’
India: Severe price caps introduced on knee implants
Israel: Proposed revision of standard for colour coded identification of single-use hypodermic needles
Korea: Consultation held on proposed changes to safety and adverse event reporting requirements
Malaysia: Medical device registration requirements to be enforced fully from 1 January 2018
Malaysia: Guidance on change notifications for registered medical devices updated
Malaysia: IMR to report on clinical evidence/performance evaluation for conformity assessment purposes
Russia: Draft amendments to the procedures for the registration of medical products
Saudi Arabia: Expedited pathway for marketing low-risk (non-sterile and non-measuring) devices is announced
Saudi Arabia: Guidance published on shipment clearance procedures
Singapore: Final guidance and FAQs document published on telehealth products
Singapore: Consultation held on guidance concerning IVD analysers
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