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Australia: Fees and charges proposed for 2020–2021
Australia: Regulatory changes for software, personalised medical devices and IVD companion diagnostics, and reclassification of certain devices
Australia: Japan has been added to the list of foreign countries determined to be comparable overseas regulators
Australia: Certain nappy rash products are not classed as medical devices
Australia: New guidance issued on proposed IVD companion diagnostic regulations
Australia: Consultation held on draft revisions to guidance on export certification
Burundi: Draft East African Standards on surgical sutures and surgical suture needles circulated for comment
China: Updates to the lists of medical devices and IVD reagents exempt from clinical trials have been published
China: Technical guidance drafted on use of real-world data for clinical evaluation
China: Technical Guidelines for the clinical evaluation of medical devices are drafted
China: Opinions sought on ‘Basic Principles of Safety and Performance of Medical Devices’
India: Extension issued for compliance with new drug regulations
Kenya: Draft East African Standards on surgical sutures and surgical suture needles proposed for adoption
Korea (Republic of): Enforcement rules drafted to support implementation of IVD law
Korea (Republic of): Support for innovative medical devices has been proposed
Malaysia: New rules take effect in 2020 on distribution records, complaint handling, incident reporting, corrective and preventive actions, and recalls
Malaysia: New rules for advertising medical devices take effect on 1 July 2020
Malaysia: Post-market responsibilities for manufacturers and Authorised Representatives of orphaned medical devices are revised
Malaysia: Orphaned, obsolete and discontinued medical devices are redefined
Malaysia: Guidance issued to support import/supply of devices for demonstration for marketing or education
Rwanda: Draft East African Standards on surgical sutures and surgical suture needles proposed for adoption
Saudi Arabia: Implementation of new marketing authorisation fees is postponed
Saudi Arabia: Use of evidence of regulatory compliance in other jurisdictions is still permitted
Saudi Arabia: Ghad is the new electronic medical device application portal
Saudi Arabia: Guidance issued on UDI, classification, innovative devices, standards and QMSs
Singapore: Consultation held on regulatory guidelines for software medical devices
Singapore: Consultation held on revised guidance concerning change notifications
Singapore: Draft revisions circulated for guidance on IVD analysers
Taiwan: New guidelines issued for device manufacturers to address cybersecurity
Tanzania: Draft East African Standards on surgical sutures and surgical suture needles proposed for adoption
Thailand: Tighter controls for silicone breast implants
Thailand: Criteria established for using Concise Evaluation route
Uganda: Ugandan standards and Draft East African Standards on surgical sutures and surgical suture needles
Vietnam: New medical device management rules came into force on 1 January 2020
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