AUSTRALIA: Auditing of Medical Device Applications, including IVD Medical Devices – February, 2022
- 2022-02-18 07:40:24
Application audit may be conducted during the procedure of inclusion of a medical device in the Australian Register of Therapeutic Goods (ARTG). In some applications, audit may be selective under the legislation, however, others may be selected for an audit at the discretion of the delegate. Here we list out the devices that require mandatory auditing under Regulation 5.3. To conclude, a summarised view of the audit process will be provided.
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