Asia, Africa & Middle East - Nov 2019

December 4, 2019

  • Australia: Proposed changes to the Essential Principles for safety and performance

  • Australia: Proposed changes to the requirements for systems and procedure packs

  • Australia: Feedback sought on the regulation of certain self-testing IVDs in Australia

  • Bahrain: Draft ‘Technical Regulation for Medical Devices and Accessories’

  • China: CMDE expands list of medical devices exempt from clinical trials

  • China: New UDI requirements have come into force

  • China: Mandatory national standard on ophthalmometers circulated for comment

  • Hong Kong: Medical Device Control Office renamed

  • Hong Kong: Expedited approval of Class II/III/IV general medical device listing applications is trialled

  • Hong Kong: Trial assesses acceptance of Korean marketing approvals in support of an MDACS listing application

  • India: All medical devices to be regulated as drugs under new proposal

  • Indonesia: Halal product certification for medical devices to start in October 2021

  • Korea (Republic of): Proposed amendments to ‘Medical Devices Act’

  • Korea (Republic of): Changes proposed to ‘Enforcement Regulation of the Medical Devices Act’

  • Malaysia: Control of orphaned, obsolete and discontinued medical devices

  • New Zealand: New fee for Regulatory Statements to Foreign Governments

  • New Zealand: Changes are made to the medical device adverse event reporting process

  • Philippines: Pilot study to evaluate capability of companies to comply with ASEAN technical requirements for product registration

  • Russia: New quality control and safety monitoring requirements for medical activities

  • Saudi Arabia: New marketing authorisation fees effective 1 December 2019

  • Saudi Arabia: Evidence of regulatory compliance in other jurisdictions no longer applicable after 1 January 2020

  • Saudi Arabia: New guidance published on adverse event reporting

  • Saudi Arabia: Content of labelling for soft contact lenses and contact lens solutions

  • Saudi Arabia: Guidance on electronic instructions for use (e-IFU)

  • Saudi Arabia: Expedited approval process proposed for innovative medical devices

  • Saudi Arabia: Draft guidance on criteria for bundling/grouping medical devices

  • Saudi Arabia: Proposed list of SFDA-recognised standards

  • Singapore: Requirements for the registration of next generation sequencing in vitro diagnostic medical devices (NGS IVDs) are drafted

  • South Africa: SAHPRA is on track to initiate product registration

  • Taiwan: Changes to classification names/descriptions in The Regulations for Governing the Management of Medical Device

     

     

     

     

     

     

     

     

     

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