Singapore’s Health Sciences Authority (HSA) is now a globally recognized reference agency, offering manufacturers a fast track into key Asia-Pacific markets. This article explains how HSA approval can streamline registration in Thailand, Australia, and Hong Kong, and how its WHO Stringent Regulatory Authority status boosts access for high-risk IVDs. Leveraging HSA can cut costs, reduce timelines, and accelerate international expansion.
Singapore’s Health Sciences Authority (HSA) has emerged as a key reference agency for medical device registration. Due to HSA’s high standards in medical device regulations, registration in Singapore can fast-track regulatory approval in other markets. This article will discuss how to leverage HSA medical device registration in Thailand, Australia, and Hong Kong.
Thailand’s Food and Drug Administration (FDA) operates a reliance-based program that allows it to use evaluation reports from HSA for medical devices already registered in Singapore. Launched in September 2020 as a pilot with just 12 reports, the program has since become a permanent regulatory pathway between Thailand FDA and Singapore HSA.
Thailand FDA officially recognizes HSA as a reference agency. In practice, this means that Class 2, 3, and 4 medical devices, as well as in vitro diagnostic devices (IVDs), with existing HSA registration can qualify for an expedited registration route in Thailand under this Reliance program. For eligible products, the average review time is reduced from 150 working days to just 60. Depending on the risk classification, registration costs may also be reduced by 53,000 baht, which is approximately US$1,454.
It is important to note that the technical dossier submitted to Thailand FDA must match the one submitted to HSA, including any updates or change notifications. This implies that the device should have been registered with HSA recently, since outdated documents could affect the eligibility and efficiency of the review process.
To sell medical devices in Australia, conformity assessment certification by the Therapeutic Goods Administration (TGA) is required for inclusion in the Australian Register of Therapeutic Goods (ARTG). However, TGA has accepted certification from Comparable Overseas Regulators (COR) and assessment bodies as evidence of compliance with its conformity assessment procedures. TGA selects its CORs based on:
Since October 2018, TGA’s COR list has included:
In 2022, HSA was added to this list. With this recognition, HSA became one of only five agencies acknowledged by TGA as a COR, joining the European Union, United States, Canada, and Japan. With COR status, medical devices evaluated and approved by HSA qualify for expedited registration pathways in Australia.
In June 2023, HSA was recognized by the World Health Organization (WHO) as a WHO stringent regulatory authority (SRA) for high-risk, Class C and D in vitro diagnostic medical devices (IVDs). Under the WHO’s criteria, an SRA is a national health products regulator that applies rigorous standards for quality, safety, and efficacy in its review of marketing authorization submissions. With this status, Class C and D IVDs registered with HSA are eligible for an abridged prequalification assessment by WHO.
Major international purchasers, such as United Nations agencies, rely on the WHO Prequalification Programme for product selection. As a result, IVD manufacturers with HSA-registered products may use SRA status to pursue expedited listing through WHO, which can serve as a valuable step toward faster registration in markets beyond Singapore.
This recognition places HSA among only six regulatory authorities to receive this designation and the first authority outside the GHTF founding members to earn this recognition.
In April 2024, the Hong Kong Medical Device Division (MDD) formally recognized Singapore as a reference agency.
Manufacturers pursuing medical device registration in Hong Kong are typically required to undergo conformity assessment by a Conformity Assessment Body (CAB). Alternatively, they can demonstrate that the device meets the Essential Principles of Safety and Performance of Medical Devices by presenting valid approvals from recognized reference markets. These include GHTF founding member countries, as well as Mainland China, South Korea, and now Singapore.
Class II, III, and IV products that have been approved by the HSA and another reference country may also qualify for Hong Kong’s Expedited Approval Scheme. To be eligible, there must be no reported deaths or serious injuries linked to the device either locally or globally. Additionally, there must be no active recalls, field safety corrective actions, or adverse incidents associated with the product. When these conditions are met, the application can proceed through an expedited review and approval process by the Hong Kong MDD.
Singapore’s Health Sciences Authority has solidified its position as a globally trusted regulator. For manufacturers, this means that HSA registration is no longer just a gateway to the Singapore market, it is a strategic asset that can significantly accelerate market access across multiple regions.
If your device is already registered with HSA, we can help you take the next step toward streamlined approvals in Thailand, Hong Kong, and Australia. If you are new to HSA registration, we can guide you through the process and position your product for success in both Singapore and other key international markets. Learn how we can support your regulatory strategy in Singapore and beyond.
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