Therapeutic Goods Information Sharing Information About House Vitro Diagnostic Medical Devices Specification 2017
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/resources/legislation/therapeutic-goods-information-sharing-information-about-house-vitro-diagnostic-medical-devices-specification-2017
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