Australia: Consultation on scope of regulated software-based products
Bangladesh: New rules proposed for WEEE and RoHS that will affect medical equipment
China: Transfer of production of imported devices to Chinese enterprises
China: Guidance issued on process for correcting submission deficiencies
China: Tighter controls announced for supervision and inspection of sterile and implantable devices
China: Revision plan for medical device industry standards
China: Consultations held on three medical electrical equipment standards
Egypt: Sterile hypodermic syringes with re-use prevention feature are subject of new draft standard
Egypt: Standard drafted in line with ISO 23908 on sharps protection features
Hong Kong: Trial to assess acceptance of Korean marketing approvals in support of an MDACS listing application has been extended
India: All medical devices to be regulated as ‘drugs’ and the Medical Devices (Amendment) Rules, 2020
Israel: Proposed revision of mandatory standard on cardiac defibrillators
Korea (Republic of): Changes to rules for exemption from import requirements
Korea (Republic of): Provisions for supply of rare and urgently needed medical devices
Korea (Republic of): Regulation proposed on operation of medical device software pre-certification programme
Kuwait: Several new medical device related standards are circulated for public comment
Malaysia: Guidance on notification process for orphaned medical devices
Malaysia: Guidance provided on submitting notifications for obsolete and discontinued medical devices
Malaysia: Guidance drafted on IVD product groupings for registration purposes
Malaysia: Comments sought on draft guidance concerning IVD classification
Malaysia: Guidance drafted on notification of refurbished medical devices
Philippines: New fees and charges proposed for implementation in 2020
Philippines: Initial implementation phase for device authorisation under AMDD
Russian Federation: Rules for registration to be aligned with EAEU under new proposal
Saudi Arabia: Recognised standards for medical masks
Saudi Arabia: Recognised standards for ventilators, ventilator tubing connectors and accessories
Saudi Arabia: Draft guidance released on medical device FSCAs
Taiwan: Framework for regulation of medical devices has been released
Taiwan: ‘Medical Device Quality Management System Regulations’ are drafted
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