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

The Association of Southeast Asian Nations (ASEAN) have published the following two documents under the section of Harmonisation of...

Executive Summary: The latest Asian Medtech Associations Regulatory Networking discussions extended to news from Malaysia, Vietnam,...

With effective as of 2 January 2019, Medical Devices Authority will make the following changes: Malaysia MDA also recently introduced 2...

MDA shed the light on the following statistics: Total establishment license: 2,300 Establishments; Manufacturers: 230 Authorized...

The AMDTC is working on the following two key work items: Classification of products as Medical Device or Non-Medical Device in the...

Malaysia: MDA has released a recent announcement on the full enforcement of the need to register medical devices under section 5 of the...

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

Malaysia: The Medical Device Authority has decided for implementation of an additional 3 year transition period for establishments to...

ASEAN: The Meeting was attended by delegates from Brunei Darussalam, Cambodia, Indonesia, Lao PDR, Malaysia, Myanmar, Philippines,...

Malaysia: Medical Device-Drug-Cosmetic Interphase (MDDCI) Products are those products that are not clearly defined as a medical device or...

ASEAN: This month's ASIAN MEDTECH ASSOCIATION's REGULATORY networking discussions cover the current progress of the Thai medical device...

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

Questions for ASEAN General Can we have the slides from the regulators update? What changes can to AMDD can be expected with EU MDR and...

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...

Refering to the announcement issued by the Medical Devices Authority (PBPP) regarding the full enforcement of medical device registration...

THE FIRST MEDTECH ASSOCIATIONS REGULATORY NETWORKING discussion, hosted by Medtech Insight and sponsored by the ARQon consultancy...

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

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