Application audit (technical file review) of IVD medical device applications
Information
Type
Guidance
Regulated products
IVDMD, Medical Devices
Topics
In Vitro Diagnostic Medical Devices (IVDs)
Published
July 24, 2023
Last updated
March 27, 2024
Description
Prepare for a technical file review as part of your application to include an in vitro medical device in the Australian Register of Therapeutic Goods.
Tags
Organization
Country / Region
Australia
License
Other (Non-Commercial)