The Ministry of Health of Vietnam (MOH) recently issued Decree No. 04/2025/ND-CP, introducing amendments and supplements to Decree No....

On behalf of the Ministry of Health of Vietnam, the Infrastructure and Medical Device Administration (IMDA) has requested all related...

Pursuant to the Law on the Government Organization dated 19/06/2015; in consideration of the proposal of the Minister of Health, the...

The Vietnamese MOH has released the proposed amendment at the end of 2019 to the Vietnamese medical device industry while waiting for the...

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

Executive Summary: Part 1 of this month's Asian Medtech Associations Regulatory Networking discussions features Asean medtech market...

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,...

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

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

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

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...

DMEC had a meeting with Vietnam MOH where the 1 year extension of new decree implementation has been approved. The medical device in the...

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

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