In a letter to stakeholders TGA summarised the changes as:
- An alternative conformity assessment procedure for Class 4 in-house has been introduced.
- The Class 1-3 in-house IVD conformity assessment procedure has been modified to allow the acceptance of NATA accreditation to ISO 17025 for those laboratories that are considered to be non-medical testing laboratories, (e.g. animal health laboratories).
- The Class 1-3 in-house notification process has also been modified to allow laboratories to more easily identify the types of Class 1-3 in-house IVDs they are manufacturing and to only require re-notification when new Class 1-3 in-house IVDs are introduced.
- The reference to the Australian National Notifiable Disease Surveillance System List in classification rule 1.3 has been removed. As a consequence, a small number of Class 3 IVDs may be down classified to a Class 2 IVD.
While expected for some time – these updates bring in some necessary streamlining of the regulations as well as remove the overly prescriptive reference to the Notifiable Diseases List.
See more at the TGA website at https://www.tga.gov.au/amendments-regulatory-framework-vitro-diagnostic-medical-devices-ivds .
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