Australia TGA Changes ARTG Inclusion Process for Class 1 IVD Medical Devices

On 4 December 2020, the TGA inclusion process for Class 1 in vitro diagnostic (IVD) medical devices in the Australian …

read more...

Australia TGA Published Regulatory Changes for Software Based Medical Devices

Australia TGA published a summary of regulatory changes to the regulation of software-based medical devices (including software as a medical …

read more...

Philippines FDA Issues Implementation Schedule and Guidelines on Standards for Medical Devices

The Philippines FDA issued Circular no. 2021-002 on 4th January 2021, which contains the implementation schedule of the Administrative Order …

read more...

Vietnam MOH Issues Official Letter to Guide the Preparation of Applications for Medical Device Registration

The letter states that the Ministry of Health has received, processed, and appraised applications for medical device registration and in …

read more...

Thailand’s New Notification Regarding Rules, Methods and Condition for Display of Labels and Package Inserts of Medical Devices 2020

On 22 September 2020, Notification of the Thai Ministry of Public Health Re: Rules, Methods and Condition for Display of …

read more...

China’s NMPA Signs MoU on Regulatory Cooperation with Italian Medicines Agency

China’s NMPA signs MoU on regulatory cooperation of medicines, medical devices, cosmetics with Italian Ministry of Health, Italian Medicines Agency. …

read more...

Australia TGA Designs a New Regulatory Framework for Personalized Medical Devices (Including 3D-Printed Devices)

Under the current medical devices, regulatory framework custom-made medical devices are exempt from the requirement to be included in the …

read more...

Singapore HSA Singapore Launches New Digital Health Webpage

HSA launched this webpage in December 2020 as a one-stop portal to encourage innovation in the area of digital health …

read more...

Hong Kong DoH has updated the Guidance Notes for Overview of the Medical Device Administrative Control System

On 4 November 2020, the Hong Kong Department of Health has issued a new version of Guidance Notes: GN-01 Overview …

read more...

More News