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Asia: Raft of guidance documents endorsed at 21st Annual Meeting of the AHWP
Australia: Regulatory reform consultations
Australia: MTAA appoints new CEO
China: Priority review and approval procedure effective 1 January 2017
China: Tighter rules proposed for the management of medical device recalls
China: Administrative measures on adverse event monitoring and evaluation re-drafted
China: Lower import tariffs for 30 medical device types
Korea: IVD technical documentation review requirements now in force
Korea: Process for preliminary review of medical device advertisements
Korea: Scope and application of medical device consignment certification/notification
Korea: Harmonisation of specifications for self-test blood glucose monitoring systems with international standards
Malaysia: Guidance published on change of ownership for device registration
Malaysia: Guidance on change notifications for registered medical devices
Malaysia: Minor changes made to Conformity Assessment Procedures for medical devices approved by recognised countries
Malaysia: Draft guidance circulated on drug-device/device-drug combination products
Myanmar: Trade restrictions lifted on hospital equipment
Russia: List of implantable medical devices revised and expanded
Saudi Arabia: Storage, handling and transportation recommendations for medical devices
Saudi Arabia: Process for importing medical devices in national emergency situations is clarified
Saudi Arabia: Guidance on the importation requirements for personal use and custom-made medical devices
Saudi Arabia: Guidance on obtaining an importation licence and clearance for a non-medical IVD
South Africa: Department of Health publishes regulations on medical devices and IVDs
South Africa: Guidance on oversight and monitoring of clinical trials
Taiwan: Partial amendment of Regulation for Registration of Medical Devices drafted
Thailand: Medical device reporting criteria, methods and conditions are stipulated
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