Australia: New fees and charges took effect on 1 July 2020; reduced annual charges for devices on prostheses list
Australia: Delayed commencement of certain medical device regulatory changes
China: Withdrawal/re-submission procedure for devices/IVD reagents up-classified from Class II to Class III
China: Guidance issued on evaluating changes to raw materials used to manufacture passive medical devices
China: Draft list of Class III devices requiring clinical trial approval
China: Three standards developed concerning X-ray equipment
Egypt: Six-month transition period for compliance with standards on sterile hypodermic syringes and sharps injury protection
Hong Kong: Trial extended on expedited approval of Class II/III/IV general medical device listing applications
Korea (Republic of): Manufacturing and import permits will require renewal every five years
Korea (Republic of): Proposed changes to specifications for LED masks and medical gloves
Malaysia: Implementation of ‘Medical Device (Advertising) Regulation 2019’ effectively postponed by 18 months
Malaysia: New guidance on medical device recalls
Malaysia: FCAs subject of new guidance document
Malaysia: Complaint handling system outlined in new guidance
Malaysia: Mandatory problem reporting requirements clarified in new guidance
Malaysia: Guidance provided on establishing and maintaining distribution records
Malaysia: Comments sought on draft guidance concerning registration of medical gas systems
New Zealand: Mercury-containing thermometers and sphygmomanometers to be banned
Saudi Arabia: Guidance on listing/market authorisation of medical devices
Saudi Arabia: Guidance on medical device Field Safety Corrective Actions (FSCAs)
Saudi Arabia: Requirements drafted for shipment clearance at ports of entry
Saudi Arabia: Draft guidance on adverse incident reporting
Singapore: Provisional authorisation pathway open to devices used for the decontamination of single-use respirators
Taiwan: ‘Regulations on Good Clinical Practice for Medical Devices’ are drafted
Taiwan: Proposed rules for the inspection of QMSs and issuing of manufacturing licences
Taiwan: Quality of imported medical masks to be examined
Uganda: Three Ugandan standards published for face masks
Ukraine: Rules drafted for exceptional use authorisation of medical devices, IVDs and active implantable devices
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