• 2026-04-23 09:11:50

Singapore's Health Sciences Authority (HSA) has achieved the World Health Organization (WHO) Maturity Level 4 for medical device regulatory systems, the highest classification under WHO's global benchmarking framework. The recognition, announced on 10 March 2026 during the International Medical Device Regulators Forum (IMDRF) 29th session in Singapore, strengthens Singapore's position in global medical device regulation as a trusted reference authority for other regulators.

• 2024-06-20 05:49:36

In a significant step towards regional harmonization, the Hong Kong MDD announced on 2 April 2024, that they now recognize marketing approvals for Class II, III, and IV medical devices issued by Singapore's Health Sciences Authority (HSA) This means manufacturers with existing HSA approvals can now use them to support their applications for registration in Hong Kong, potentially saving significant time and resources.

• 2023-07-21 02:32:25

Singapore's Health Science Authority (HSA) is pleased to announce their status as a recognized Stringent Regulatory Authority (SRA) for Class C and D IVD by WHO. The SRA status means high-risk IVD products registered with HSA might obtain faster evaluation through WHO prequalification assessment, enabling manufacturers accelerated access to global markets.

• 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.

• 2021-08-02 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.

• 2021-04-26 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 02:30:57

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.