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Australian TGA to recognise approvals from Singapore’s HSA

Published by Alec Denniff, Medical Device Paralegal on

Australia’s Therapeutic Goods Administration, the national regulator for medical devices, has announced that it is to recognise Singapore’s Health Sciences Authority (HSA) as a comparable overseas regulator. The TGA announced this news by updating its “use of market authorisation evidence from comparable overseas regulators / assessment bodies for medical devices (including IVDs)" guidance. 

This now means that approvals from the HSA in Singapore will be recognised in Australia for certain classes of medical devices and IVDs. Whilst the classification schemes between Australia and Singapore are broadly similar, with both adopting a risk-based rules approach, there are differences. Singapore classifies medical devices and IVDs as Class A, B, C, and D (in order of increasing risk) - there is no different classification scheme for IVDs compared to medical devices. This approach is similar to that used by Health Canada. By contrast, Australia classifies medical devices as Class I, IIa, IIb and III, and IVDs as Class I, 2, 3 and 4. The TGA’s amendment to include HSA as a comparable overseas regulator will benefit manufacturers of medical devices and IVDs that have:

  • Singaporean approvals for Class B, C and D medical devices. These can now be used to support Class IIa, IIb and Class III Australian Register of Therapeutic Goods (ARTG) applications in Australia. 
  • Singaporean approvals for Class B and Class C IVDs, which can be used to support Class 2 and Class 3 ARTG applications in Australia. 

Manufacturers seeking to take advantage of their existing approvals from Singapore for ARTG applications will need to provide evidence of the device’s entry in the Singapore Register of Health Products. In addition, as always when using evidence from overseas regulators, manufacturers must ensure that the approval sought is for the same device, in terms of its design, intended purpose, indications, etc, as that which they wish to include in the ARTG. 

In addition to the Singaporean HSA, the TGA had already recognised medical device approvals from Europe, Japan, Brazil, Canada and the USA to support ARTG applications. The TGA’s growing list of comparable overseas regulators should not come as a surprise. Statistics from TGA’s regulatory update from May 2022, had already noted that the vast majority (95%) of ARTG entries (excluding Class I devices) rely on approvals from comparable overseas regulators, with over 85% of these relying on EU approvals. Given the stretched capacity of EU Notified Bodies under the EU’s MDR / IVDR framework, the growing list of comparable overseas regulators will be beneficial to manufacturers, as they may have alternative overseas approvals which are valid for entry into the Australian market.

The TGA’s latest amendment to the list of comparable overseas regulators will come as great news for manufacturers and importers as it provides an additional route for market entry and commercialisation of medical devices in Australia. The inclusion of HSA has already come into effect, as the Therapeutic Goods (Overseas Regulators) Amendment (Singapore) Determination 2022, has amended the Therapeutic Goods (Overseas Regulators) Determination 2018, and the HSA is now listed in Section 5 of the 2018 determination. 

To learn more about the classification process in Australia, or which regulatory requirements apply to which classes of devices, sign up for our guide to the medical devices regulations, below. Our guided assessment incorporates all official updates to the regulations, and will be able to guide you through the regulatory maze.