• 2022-02-18 08:51:05

Health Sciences Authority (HSA) addresses issues about the creation of new Product Owners (PO) by applicants even though there is an existing one. HSA shares the steps in changing the PO ID number via Change Notification. HSA reminds applicants to search first for the existing PO ID before creating a new one.

• 2022-01-26 10:55:53

The Health Sciences Authority (HSA) has published an update on the Regulatory Fees for Health Products. This is to ensure that the evaluated products meet the required standards of quality safety and efficacy. It is also necessary to recover part of the costs for the services rendered to businesses.

• 2022-01-26 10:47:58

Recently, HSA has finalized the "Medical Devices Product Classification Guide" after concluding the discussion with stakeholders. This document aims to help the stakeholders in determining whether a product is a medical device or not.

• 2021-11-24 03:19:40

A golden opportunity has opened for manufacturers or importers to shorten the duration of Medical Device Registration of those under Class4 with Thailand FDA and HSA Singapore Regulatory Reliance.

• 2021-10-27 06:53:26

HSA communicated to the public regarding a cybersecurity vulnerability named "BrakTooth". It affects various IOT devices, which includes medical devices that use specific Bluetooth Link Manager Protocols. HSA shared steps to shareholders to avoid or address issues pertaining to BrakTooth.

• 2021-09-29 00:33:56

HSA recently issued updates to some pre-market registration-related guidance documents and technical reference documents. Specifically, the GN-15, GN-17, GN-18, TR-01, and TR-02 were updated. The changes mainly deal with the addition of cybersecurity requirements for medical devices. This is a very important update since it is imperative to protect devices that are used in the healthcare industry from hackers and other cyberthreats.

• 2021-08-02 04:41:50

HSA has recently released the “Guidance on the Medical Device Unique Device Identification (UDI) System”. From 2022 in transitioning phases, HSA requires medical devices to be marketed in Singapore to be equipped with UDI-DI.

• 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.