• 2023-01-19 06:29:59

Qualtech's internal Southeast Asia regulatory training and our End of the Year Party 2022 have been successfully completed. As the borders have gradually reopened and travel restrictions have been lifted, Qualtech has invited its members from the various ASEAN countries as well as from Japan to gather in our headquarter in Taipei. The accomplishments of the gathering include the exchange of regulatory information, the fostering of better communication, and the strengthening of our teamwork across the various Qualtech branch offices.

• 2023-01-19 01:28:15

As we are easing into the first quarter of 2023, we are thus simultaneously entering into the last phase of Thai FDA grace period regarding the transition to the risk-classification approach. Thus, Thai FDA has published a summary of the medical device categories on their official website instructing medical device registration via Full CSDT submission and Partial 2 Submission route.

• 2022-12-27 05:30:57

To promote an effective reviewing procedure, Thai FDA granted that therapeutic medical devices shall be classified and registered under Listing (Class 1 medical device), in effect from 3rd December 2022 onward.

• 2022-11-29 03:04:45

As based on Japan's Ministry of Health, Labor and Welfare notice from September 20, 2022 the Essential Principles for certain Class II medical devices are amended.

• 2022-11-29 01:33:07

During quarter 4 of 2022, Thai FDA has announced the registration certificate renewal protocol and procedures. Medical devices with specific announcements for which CSDT have been practiced under the old policy-based regulation, will expire on 31st December 2022 and shall timely proceed with license renewal accordingly.

• 2022-10-25 06:47:43

MDCG 2022-14 is aimed to propose solutions to improve the efficiency of application of the regulatory requirements, rather than reducing, avoiding or removing requirements, in particular in relation to safety.

• 2022-10-25 03:59:10

PFDA announced that alcohol swab product registrations will be transferred to the Center for Drug Regulation Research (CDRR). In the same month, PFDA also published a circular that aims to provide guidelines on the use of the FDA eServices Portal System for LTO applications of retailers of Medical Devices.

• 2022-10-25 03:34:27

To provide a better understanding of the classification of medical-related software devices, TFDA has updated the existing guidance with some examples of SaMD and non-SaMD software. This article provides you with a quick insight into defining medical-related software devices.

• 2022-10-24 09:56:11

TFDA has recently announced a specific product registration guidance for AI/ML-based computer-assisted detection (CADe) and computer-assisted diagnosis (CADx) software. Through the application of AI and ML-based technologies in detective or diagnostic medical devices, these kinds of products could be essential for medical personnel by decreasing required reading time with better diagnostic performance.

• 2022-09-27 09:03:07

The pandemic has exposed supply chain vulnerabilities and issues in the medical device supply chain that were once insignificant. In this article, we compile the industry’s best practices towards achieving sustainability and resilience in the medical supply chain.