• 2021-04-26 02:29:09

Health Sciences Authority (HSA) organized a webinar concerning the ISO 13485 Certification for licensed dealers last March 2, 2021. The information regarding accreditation of certification bodies (CBs) and future ISO 13485 requirement were provided.

• 2021-04-26 02:13:50

Health Sciences Authority (HSA) published “Medical Devices Product Classification Guide” draft comments. This document aims to help the stakeholders in determining whether a product is a medical device or not.

• 2021-04-26 02:04:12

Health Sciences Authority (HSA) introduced a new self – help tool for grouping of medical devices prior to registration. This new tool will aid in the reduction of the number of applications and will in turn reduce the cost and is applicable to different product types.

• 2021-04-20 03:47:45

The major impacts to TFDA's medical device regulations and fees are brought to you by Qualtech.

• 2021-03-22 06:21:15

After seeking for public and specialist opinions for a while. Finally, Thai FDA has announced the official-related announcements regarding a transition from policy-based classification to risk-based classification of medical devices.

• 2021-03-22 03:45:47

Thai FDA has announced the official medical device registration guidance for Licensed medical device and Notified medical device and Listing after promptly complete a transition from policy-based classification to risk-based classification of medical devices.

• 2021-03-22 02:30:57

Health Sciences Authority (HSA) released a draft guideline for 3D Printed Medical Devices. This announcement is to clarify current regulatory requirements for 3D printed medical devices and to hear comments from stakeholders. The consultation period for this document will be from January 25, 2021, to February 28, 2021.

• 2021-03-22 01:58:21

On February 25th, Qualtech organized a webinar and guided participants through the China medical device regulations. Our expert covered such topics as registration preparation, registration reviewing process, post-market process.

• 2021-03-22 01:22:59

The Medical Device Branch (MDB) of the Health Sciences Authority (HSA) has released a draft document entitled “Regulatory changes for software-based medical devices” and changes effective from 25 February 2021.
The purpose of the guideline is to update the classification of software-based medical devices according to the risks of harm from software and outlines transition arrangements available for devices that may need to be reclassified or that qualify for an exemption or exclusion from the Therapeutic Goods (Medical Devices) Regulations 2002.

• 2021-02-19 09:51:48

Asia’s elderly population is set to see tremendous growth, coupled with a rise in various geriatric and non-communicable health issues. To tackle these problems, rehabilitative and assistive medical devices market show great potential to become a major medical device segment in various Asia countries. In this issue of QT Analysis, we look at the market size for rehabilitative and assistive medical device and their registration requirements in some major Asian countries.