On 9 March 2023, the Australian Therapeutic Goods Administration (TGA) decreed that the Health Sciences Authority of Singapore (HSA) – Singapore’s Ministry of Health – will join the Comparable Overseas Regulator (COR), the body for the evaluation of Medical Devices.
The Health Science Authority of Singapore (HSA) thus joins the European Notified Bodies, FDA, Health Canada and the Japanese Ministry of Health (PMDA and MHLW).
The entry of the HSA into the COR has a significant consequence for Manufacturers of Medical Devices and In-Vitro Diagnostic Devices (IVDs) who wish to market in Australia and already hold an HSA licence, namely faster registration of devices in the Australian Register of Therapeutic Goods (ARTG).
In fact, Australian Sponsors may also submit, along with the necessary additional documentation, licences issued by the Regulatory Authority in Singapore, as proof of the efficacy and safety of the device, in addition to or instead of CE certification, Marketing Clearance, Medical Device Licence or Japanese authorisations (e.g. Shonin).
To understand which devices will benefit from recognition, it is necessary to preface this with the fact that the classification criteria between Australia and Singapore are similar, and both use a risk-based approach. In Singapore, Medical Devices and IVDs are classified as Class A, B, C and D (in order of increasing risk). In Australia, Medical Devices are classified as Class I, IIa, IIb and III.
IVDs follow a similar approach with Classes 1, 2, 3 and 4.
The amendment creates an advantage in particular for manufacturers in possession of:
- Singapore approvals for Class B, C and D Medical Devices that can be used to support Australian ARTG Class IIa, IIb and some Class III applications respectively;
- Singapore approvals for Class B and C IVDs that can be used to support Australian ARTG Class 2 and Class 3 applications respectively.
It should be noted that the approval must be for the same device (i.e. same design, same intended purpose and indications for use) that the Australian Sponsor intends to include in the ARTG.
In conclusion, the almost unique but common feature of the regulatory system in Australia and Singapore is therefore the possibility of using foreign approvals to support device applications, unlike other regulatory authorities, in order to speed up patient and user access to devices.
If you liked this article, subscribe to Thema NEWSLETTER to receive updates on the Australian regulatory framework.
>> Through Thema’s strategic-regulatory consulting and registration support services with the Therapeutic Good Administration, Thema can assist in meeting Australian regulatory requirements.
Contact us for information.
Sources:
https://www.hsa.gov.sg/medical-devices/registration/overview
