Asia, Africa and the Middle East - Aug 2020

  • 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  • Malaysia: Comments sought on draft guidance concerning registration of medical gas systems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  • Saudi Arabia: Draft guidance on adverse incident reporting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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