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

Non-corrective contact lens is regulated as medical devices by the Medical Device Authority (MDA). According to the Medical Device...

MDA announced the training for competency module (regulatory requirements) for biomedical technical personnel. The module is designed to...

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

Circular Letter No. 1 Year 2019: Post-market Responsibility for Manufacturer and Authorized Representative Who Have Closed Their...

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

SINGAPORE: HSA Informs Public Regarding Risk of Breast Implants BIA-ALCL is a cancer of the immune system and not a type of breast...

On 24 Apr, Malaysia MDA made an announcement regarding the placement in the market and use of non-registered device without clinical...

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,...

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...