Asia, Africa and the Middle East - May 2021

• Australia: TGA’s proposed fees and charges for 2021–2022

• Australia: TGA issues expectations for clinical performance requirements and risk mitigation strategies for certain self-test IVDs

• Australia: TGA consults on potential changes to requirements for nanomaterials

• Australia: Draft guidance issued for clinical decision support software

• Australia: TGA answers frequently asked questions on personalised medical devices

• Botswana: Medical device listing requirements

• China: Newly revised ‘Regulations on the Supervision and Administration of Medical Devices’ to be implemented on 1 June 2021

• China: New medical devices and IVDs to be exempt from clinical trials

• China: Procedure for voluntary registration of a medical device Master File

• Egypt: Product registration and import approvals mandatory for IVD reagents

• Egypt: Standards for injection containers and accessories

• India: Eight medical device types classed as drugs from April 2021

• India: American Standard Test Methods could be permitted for demonstrating product conformity

• Kenya: Standard drafted for disposable surgical caps

• Korea (Republic of): Use of phthalates to be banned in extracorporeal circuits

• Malaysia: Guidance issued on content and authorisation of medical device advertisements

• Philippines: Full implementation of device authorisation under AMDD

• Singapore: Compulsory accreditation for certification bodies issuing ISO 13485 certificates

• Singapore: Guideline drafted on considerations for 3D printed medical devices

• Singapore: Medical device product classification guide drafted and circulated for comment

• Singapore: New medical device grouping tool is launched

• Taiwan: New regulations for medical devices to take effect on 1 May 2021

• Taiwan: Effective date set for rules for the inspection of QMSs and issuing of manufacturing licences

• Taiwan: UDI requirements for medical devices come into force in May 2021

• Thailand: New, more burdensome regulatory controls in line with ASEAN MDD

• Thailand: Compulsory standards for single-use hygienic face masks and single-use medical examination gloves

• Uganda: Comments solicited on two Draft Ugandan Standards concerning thermometers

• Ukraine: Rules for exceptional use authorisation of medical devices, IVDs and active implantable devices enter into force

• Vietnam: Certain devices now subject to inspection/testing of safety and technical features

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