• 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.

• 2021-02-22 02:00:00

Qualtech Consulting Corporation is happy to announce that our client Shimadzu Corporation, Japan has obtained provisional authorisation from the Health Sciences Authority (HSA) in Singapore for its Ampdirect 2019-nCoV Detection Kit.

• 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.

• 2020-09-15 06:44:21

Singapore remains one of the most important medical device hubs in the Asian region, growing to be on par with developed first world nations. With the medical technology industry being one of the major driving forces for the country’s booming economy, in this edition of QT Analysis, we delve deep into the reasons why it is a MedTech Giant in Asia and how you shouldn’t miss out on the great business opportunities it offers.

• 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.

• 2020-06-11 10:00:48

Health Sciences Authority (HSA) is informed to the increased demands for medical products relevant to COVID – 19. Various establishments have considered 3D printing (3 – DP) to address the issue of limited supply of medical products.