• 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.

• 2021-06-04 09:34:53

In this webinar, you will learn more about Brexit and how Geopolitics affects medical device regulations. Our expert will introduce you to UKCA. Moreover, Ms. Fatehi will discuss the transitioning out period and will outline how the future for the U.K. market will look like.

• 2021-05-22 03:59:29

The Australian Therapeutic Goods Administration (TGA) has implemented reforms to the regulation of software based medical devices. These regulations commenced on February 25, 2021 for new applications for inclusion in the Australian Register of Therapeutic Goods (ARTG). The clarification of the boundary for software-based products regulated as medical devices in Australia is important to ensure sponsors and manufacturers of software-based products are not subject to unnecessary regulatory oversight. Certain software-based medical devices have been carved out (through either an exemption or exclusion) from the scope of the TGA regulation. The transition period (ending November 1, 2024) applies to sponsors of eligible medical devices already included in the ARTG, or included in the ARTG because of an application lodged before 25 February 2021.

• 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 01:22:59

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.

• 2020-10-28 02:13:28

With Overseas Medical Equipment Technical Assistants (OMETA), Qualteh has held an online seminar about regulatory updates in ASEAN on 27th October, where we covered major updates in the Philippines, Thailand, and Malaysia.

• 2020-05-12 07:39:23

Health Sciences Authority (HSA) ensure the availability of respiratory devices for COVID – 19 patients. HSA placed flexible regulations such as allowing the use of emergency ventilators, clarifying the applicable change notification category that will not require approval and demonstrating the means for adding new model of respiratory devices.

• 2020-04-14 02:41:07

Qualtech will update you on the new expedite registration channels in China, Singapore, Malaysia, and Indonesia in the context of the COVID-19. While also introducing the existing regular fast tracks for urgently needed medical devices.

• 2020-03-18 10:32:08

The ASEAN Common Submission Dossier Template (CSDT) makes it significantly easier to penetrate the ASEAN markets collectively. Therefore, do not miss the chance to learn about the benefits of the CSDT and what documentations are required for developing the Common Submission Dossiers.

• 2020-02-21 07:28:02

Due to the novel coronavirus pneumonia epidemic and its impact on China, the NMPA, local testing center and clinical sites have been given priority to emergency medical device approvals in epidemic situations. As a result, the progress of ordinary cases may be delayed