AHWP: Guidance on labelling for in vitro diagnostic medical devices
Australia: Application fee change for export only medical devices
Australia: Updated requirements specified for preliminary assessment of applications for inclusion in the ARTG
Australia: TGA to make greater use of overseas marketing approvals
Australia: Certificates of Free Sale and Export Certificates
Australia: Comments solicited on proposed regulation of IVD companion diagnostics
Australia: Guidance issued on electronic IFU for professional users of medical devices
China: Regulation drafted to control Chinese agents of imported medical devices
Egypt: Use of ES 1595-1 on single-use, sterile rubber surgical gloves is now mandatory
Hong Kong: Web-based IVD classification programme developed by MDCO
India: Comprehensive reference document on device regulations prepared by IPC
Israel: Two Parts of SI 1268 on syringes and needles are proposed for revision
Korea (Republic of): Adoption of ISO 13485:2016 proposed
Malaysia: Transition period for meeting medical device labelling requirements extended by three years
Malaysia: Registration exemption for export only medical devices
Malaysia: Rule for devices imported from/exported to countries without diplomatic ties with Malaysia
Malaysia: Borderline and combination product classification examples
Saudi Arabia: ‘Guidance for the Medical Devices Samples for Laboratory Testing’
Singapore: Regulatory fees for medical devices to increase from 2 April 2019
Uganda: Draft standard on sterile surgical blades
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