Auditing of medical device, including IVD medical device, applications
Information
Type
Guidance
Regulated products
IVDMD, Medical Devices
Topics
Australian Register Of Therapeutic Goods (ARTG), Medical Devices Safety, Regulatory Compliance, Therapeutic Goods Regulation, In Vitro Diagnostic Medical Devices (IVDs)
Published
July 12, 2023
Last updated
July 12, 2023
Description
Guidance for sponsors who have submitted applications for inclusion of medical devices including in vitro diagnostics (IVDs), in the Australian Register of Therapeutic Goods (ARTG).
Tags
Organization
Country / Region
Australia
License
Other (Non-Commercial)