Asia, Africa & Middle East - Jun 2019

  • Australia: Proposed reclassification of spinal implantable medical devices

  • Australia: Proposed regulatory scheme for personalised medical devices, including 3D-printed devices

  • Australia: Consultation held on regulation of software, including Software as a Medical Device

  • Australia: Proposed alignment with EU rules for classification of transient/short-term surgically invasive devices used in direct contact with the heart, CCS or CNS

  • Australia: Proposed new medical device classification for substances introduced into the body via a body orifice or applied to the skin

  • Australia: Proposed medical device classification for human cells, tissues and organs storage solutions and IVF media

  • Australia: Changes to the classification of active implantable medical devices and their accessories are proposed

  • Australia: New classification rule proposed for devices that administer medicines or biologicals by inhalation

  • Australia: Guidance on use of market authorisation evidence from comparable overseas regulatory bodies for medical devices

  • Australia: ‘Action Plan for Medical Devices’ is released

  • China: Draft amendments to the ‘Regulations for the Supervision and Administration of Medical Devices’

  • Hong Kong: Proposed Guidance Notes for the listing of Local Responsible Persons

  • India: Eight medical device types to be classed as drugs from April 2020

  • India: Six medical device Quality Control Orders circulated for public comment

  • Japan: Fee increases took effect on 1 April 2019

  • Japan: MDSAP participation extended until the end of March 2020

  • Korea (Republic of): ‘Medical Device Act Enforcement Regulation’ to be amended

  • Korea (Republic of): Proposed amendments to ‘Regulations on standard specification of medical devices’

  • Malaysia: ‘How to apply for medical device registration under Medical Device Act 2012 (Act 737)’ is updated

  • Malaysia: New guidance on notification of medical devices for special access

  • Malaysia: Draft guidance issued on notification of export-only medical devices

  • Philippines: Labelling requirements drafted in line with ASEAN MDD

  • Philippines: Rules are drafted in line with the AMDD for authorising IVDs placed on the market in the Philippines

  • Philippines: Guidelines drafted on the conduct of clinical investigations of medical devices for human subjects

  • Saudi Arabia: Five new guidance documents released

  • Singapore: Guidance updated on establishment licensing, product registration and change notification

  • Singapore: Launch of Online Safety, Compliance Application and Registration System (OSCAR)

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

  • Uganda: Draft Uganda Standard for umbilical cord clamps created

  • Uganda: New standard drafted for medical ultrasound gel

  • Uganda: Use of the ISO 7886 and ISO 7864 standards for hypodermic syringes and hypodermic needles

  • Uganda: Six new DUSs on surgical instruments and materials adopted

  • Vietnam: New regulatory requirements for medical devices

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