Moving on.
The EU has moved (is moving slowly) to MDR from CE Mark to regulate medical devices.
Presumably Oncosil will need to get that new certification.
However, when it does, it's possible that TGA might look at it more favorably given the following guidelines
https://www.tga.gov.au/sites/default/files/2023-11/use-market-authorisation-evidence-comparable-overseas-regulators-assessment-bodies-medical-devices-including-ivds.pdf
Thing is, the company is listed here. If it got TGA and then got an item number from MSAC (the application is still on the public record) Australia could reimburse the product. That would help patients, doctors and investors.
Moving on.The EU has moved (is moving slowly) to MDR from CE...
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