• 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 06:03:13

HSA has recently approved provisional authorization for new COVID-19 breathalyzers ‘BreFence Go COVID-19 Breath Test System’ and ‘TracieX Breathalyzer’. These breathalyzers detect COVID-19 infection by analyzing breath samples from individuals and report the results in 1 – 2 minutes.

• 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.

• 2021-03-22 02:43:02

Health Sciences Authority (HSA) launched Pandemic Special Access Route (PSAR) for important therapeutic products essential for pandemic response. HSA defined the group of products that can apply via this route and the requirements/criteria for submission.

• 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.

• 2021-01-19 03:44:00

HSA has introduced the regulatory requirements for non-contact/contactless thermometers. These devices are intended to be used for fever screening and prove significant, especially during this pandemic. HSA has shared different guidance pertaining to classifying, manufacturing, importing or supplying this device in Singapore, along with safe usage.

• 2020-12-24 11:09:03

Health Sciences Authority (HSA) – Medical Devices Branch had organized a webinar regarding an introduction to Medical Device Unique Device Identification (UDI) System last October 19, 2020. In addition, the webinar includes the phased implementation plan for UDI in Singapore.

• 2020-06-16 08:03:29

HSA announces a provisional authorization route for devices that decontaminate single use respirators used for COVID – 19 response. In addition, guidelines for healthcare institutions and other facilities that decontaminate respirators have also been published.