In July 2013, The Medical Device Centralised Online Application System, abbreviated as MeDC@St, was introducedas a system to manage...

Australia: Consultation on scope of regulated software-based products Bangladesh: New rules proposed for WEEE and RoHS that will affect...

Australia: Fees and charges proposed for 2020–2021 Australia: Regulatory changes for software, personalised medical devices and IVD...

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

Australia: 2019 fees and charges released by the Therapeutic Goods Administration Australia: Conformity assessment standards for medical...

Australia: Proposed reclassification of spinal implantable medical devices Australia: Proposed regulatory scheme for personalised medical...

Australia: Reclassification of surgical mesh devices and publication of associated guidance Australia: Proposed fees and charges for...

AHWP: Guidance on labelling for in vitro diagnostic medical devices Australia: Application fee change for export only medical devices...

Australia: 2018 fees and charges released by the Therapeutic Goods Administration Australia: Application fee now charged for a Class I...

Australia: Changes to the therapeutic goods advertising framework Australia: Guidance on updating an existing Class 1–3 in-house IVD...

Australia: ‘Therapeutic Goods (Manufacturing Principles) Determination 2018’ Australia: Implementation of new Uniform Recall Procedure...

Australia: Articles that alter the pH of body fluids are not medical devices Australia: Up-classification of surgical mesh and provision...

Executive Summary: China is Making Additions to its medtech regulatory system, and Southeast Asian nations are making progress towards...

Australia: Therapeutic Goods Amendment (2016 Measures No 1) Bill 2016 Australia: Consultation held on future regulation of low risk...

Australia: Guidelines on Compounded Medicines and Good Manufacturing Practice (GMP) Australia: Guidelines on Code of Practice for...

Executive Summary: All eyes are on Vietnam, which is on the threshold of a new regulatory system for medical devices. But the smaller...

Executive Summary: Regulatory and Market Access Improvements for medtech products were on the agenda at last month's Health Products...

The proposal of regulation on medical devices used in the beauty trade has been submitted by the Department of Health (DoH) to Hong...

Medical devices distributed in Japan are subject to the Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices,...

Asia: Raft of guidance documents endorsed at 21st Annual Meeting of the AHWP Australia: Regulatory reform consultations Australia: MTAA...