Class 4 House Ivds Using Online Application AND Notification Forms
TGA (CWLTH) resource. Rules Mate indexes this as part of the Australian compliance corpus. Click through for the regulator's primary source.
https://www.tga.gov.au/products/medical-devices/vitro-diagnostic-devices/application-and-market-authorisation/class-4-house-ivds-using-online-application-and-notification-forms
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