{"id":27694,"date":"2023-05-11T10:45:17","date_gmt":"2023-05-11T08:45:17","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=27694"},"modified":"2023-05-09T16:41:09","modified_gmt":"2023-05-09T14:41:09","slug":"australia-faster-registration-if-there-is-authorisation-in-singapore","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2023\/05\/11\/australia-faster-registration-if-there-is-authorisation-in-singapore\/","title":{"rendered":"AUSTRALIA: faster registration if there is authorisation in Singapore"},"content":{"rendered":"

On 9 March 2023, the Australian Therapeutic Goods Administration (TGA) decreed that the Health Sciences Authority of Singapore (HSA)<\/strong> – Singapore’s Ministry of Health – will join the Comparable Overseas Regulator (COR), the body for the evaluation of Medical Devices.<\/strong><\/h2>\n

The Health Science Authority of Singapore (HSA) <\/strong>thus joins the European Notified Bodies, FDA, Health Canada and the Japanese Ministry of Health (PMDA and MHLW).<\/p>\n

The entry of the HSA into the COR<\/strong> 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).<\/strong><\/p>\n

In fact, Australian Sponsors may also submit<\/strong>, along with the necessary additional documentation, licences issued by the Regulatory Authority in Singapore<\/strong>, 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).<\/p>\n

To understand which devices will benefit from recognition<\/strong>, it is necessary to preface this with the fact that the classification criteria between Australia and Singapore are similar<\/strong>, 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.<\/strong><\/p>\n

IVDs follow a similar approach with Classes 1, 2, 3 and 4.<\/strong><\/p>\n

 <\/p>\n

The amendment creates an advantage in particular for manufacturers in possession of:<\/p>\n