• 2022-03-25 11:49:26

The Medical Device Authority (MDA) produced this new Guidance Document to assist the medical device industry and healthcare practitioners in complying with the Medical Device Act (Act 737) and its regulations.

• 2022-01-26 10:34:06

Previously Japan's PMDA has been accepting MDSAP reports to substitute PMDA's Quality Management System Inspection. However, this move will become official starting April 1st, 2022.

• 2021-12-27 06:12:43

MDA now recognizes MHRA, UK is now an additional recognized foreign regulatory agency by the MDA and its approval type for Great Britain and Northern Ireland can be used for medical devices to undergo a simplified registration route (by conformity assessment) in Malaysia.

• 2021-12-27 05:35:39

The Japan Federation of Medical Devices Association (JFMDA) has arranged the Japanese “Adverse Event Glossary” and created a mapping chart to match with IMDRF's Adverse Event terminologies.

• 2021-10-27 07:06:19

Effective from June 17, 2021, MDA now allows multiple authorized representatives for each medical device (brand name) placed in the market. On the other hand, they will restrict to requiring individual establishment licenses to carry out role/activity of various economic operators, as prescribed in the Medical Device Regulations 2012.

MDA Circular Letter No. 1/2014 contains two components, which are the establishment that acts as an authorized representative (AR) and the establishment that carries out various activities.

• 2021-08-30 01:11:33

The Medical Device Division (MDD) will continue the trial to study the feasibility for Local Responsible Persons (LRP) to prove their medical device conform the “Essential Principles of Safety and Performance of Medical Devices” by providing marketing approval from China's National Medical Products Administration (NMPA) and Korea's Ministry of Food and Drug Safety (MFDS).

• 2021-08-26 12:40:18

HSA released a draft guideline for consultation on the classification of Standalone Medical Mobile Applications and Qualification of Clinical Decision Support Software (CDSS) based on similar guidance released by IMDRF for Software as a Medical Device (SaMD) This guideline provides information on the qualification of CDSS as MDs as well as the regulatory approach for such.

• 2021-08-02 06:36:08

On June 30th, Qualtech and ISS AG jointly hosted an online event informing far more than 100 different medical device manufacturers from all around the globe about China’s New Regulations. Qualtech’s team thereby detailed the important updates that the new RSAMD will bring, including the new obligations for product registrants under the nationwide adopted MAH system.

• 2021-08-02 04:25:55

Back in December 2020, MDA had published a new guidance document on grouping in-vitro diagnostic medical devices. This guidance is an extension of the MDA/GD/0005 Guidance Document of Product Grouping focused on IVD devices.

• 2021-06-29 11:30:23

On 25th June, Qualtech and ISS AG jointly hosted an enriching webinar session on the newly implemented Medical Device Regulation MDR (EU) 2017/745 (MDR) and the dynamic European medical device landscape. In this article, we are looking at the important points discussed.