Asia, Africa and Middle East - Feb 2021

  • Australia: Regulatory changes for custom-made devices apply from 25 February 2021

  • Australia: Reforms to the regulation of software-based medical devices effective 25 February 2021

  • Australia: Updated guidance published on medical device patient information leaflets and implant cards

  • Australia: Guidance released to support submission of Declaration of Conformities for Class I non-sterile, non-measuring medical devices and Class 1 IVDs

  • Australia: Guidance on priority applicant determinations is updated

  • China: New updates to ‘Medical Device Classification Catalogue’

  • China: ‘Regulations on the Supervision and Administration of Medical Devices (Revised Draft)’ passed

  • China: Technical guidelines drafted on use of overseas IVD clinical trial data

  • China: ‘Technical Guidance on Real-World Data for Clinical Evaluation of Medical Devices (Trial Implementation)’

  • China: Five general naming guidelines issued

  • China: Technical review guidelines issued for the registration of seven types of IVD

  • China: Comments sought on draft standards for copper-bearing contraceptive intrauterine devices and certain medical electrical equipment

  • Egypt: Standard drafted for external limb prostheses and external orthoses

  • Hong Kong: Trial extended on expedited approval of Class II/III/IV general medical device listing applications

  • Hong Kong: Trials to assess acceptance of Chinese or Korean marketing approvals in support of an MDACS listing application have been extended

  • India: Six-month grace period for certain existing importers/manufacturers of nebulisers, blood pressure monitoring devices, digital thermometers and glucometers

  • India/UK: MoU on co-operation in the field of medical product regulation

  • Japan: QMS Ministerial Order to align with ISO 13485

  • Japan: Partial revision of the ‘Regulation for Enforcement of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices’

  • Kenya: New standard sets specifications for kidney trays

  • Korea (Republic of): Proposed amendments of the rules concerning GMP for medical devices and IVDs

  • Malaysia: New guidance on medical face masks and respirators

  • Malaysia: Draft guidance on general medical device groupings

  • Saudi Arabia: Detailed fees that apply to MDMA variations

  • Saudi Arabia: Marketing authorisation applications may still be submitted via GHTF route

  • Singapore: UDI implementation to start in 2022

  • South Africa: New fees payable to SAHPRA

  • Taiwan: On-site inspections of foreign manufacturers postponed due to COVID-19

  • Taiwan: Rules drafted for issuing medical device licences, listings, and annual declarations

  • Taiwan: ‘Enforcement Rules of Medical Device Act’ have been drafted

  • Taiwan: Comments solicited on draft UDI requirements for medical devices

  • Taiwan: Regulations drafted for border inspections and examination of imported condoms and medical masks

  • Uganda: Draft standards for medical cotton swabs, adhesive plasters, alcohol swabs, and medical safety goggles

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