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Malaysia: Draft guidance issued on notification of export-only medical devices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