NATA News Archive
- Published: 13 February 2015
Following a consultation process the Therapeutic Goods Administration (TGA) proposes a number of changes to the regulatory framework for ‘in-house’ in vitro diagnostic medical devices (IVDs). Overall, the amendments aim to reduce some of the regulatory burden introduced by the new framework as well as provide a more flexible approach for laboratories that manufacture in-house IVDs. New deadlines have also been set for laboratories to meet their regulatory obligations.
Changes to the conformity assessment procedure for Class 4 in-house IVDs
Under the proposed reforms, a new conformity assessment procedure will apply to laboratories that develop Class 4 in-house IVDs, including those developed de novo or modified from a registered commercial IVD. Laboratories that develop Class 4 in-house IVDs will be able to choose to obtain any of the following as evidence of an acceptable quality manufacturing system (QMS):
- NATA accreditation as a medical testing laboratory to ISO 15189; or
- TGA Good Manufacturing Practice (GMP) licence; or
- TGA conformity assessment certification.
Class 4 in-house IVDs will still be required to be included in the Australian Register of Therapeutic Goods (ARTG). On application for inclusion in the ARTG, laboratories that opt to use NATA accreditation or TGA GMP as evidence of an acceptable QMS will undergo a mandatory application audit to assess the compliance of their in-house IVD with the essential principles for safety and performance (ie, TGA evaluation of the validation data).
Changes to the conformity assessment procedures for Class 1-3 in-house IVDs
Unlike Class 4 in-house IVDs, Class 1-3 in-house IVDs are not required to be included in the ARTG. However, changes are also being proposed to the conformity assessment procedure for laboratories that develop these devices:
- The TGA will accept NATA accreditation to ISO 15189 and ISO 17025 (for non-medical testing laboratories) as evidence of an appropriate QMS.
- The notification process will require laboratories to describe the 'kinds' of Class 1-3 in-house IVDs manufactured rather than identify individual tests.
- Laboratories will only be required to renotify the TGA when a new kind of Class 1-3 in-house IVD is introduced.
More information on the consultation process and the proposed amendments to the new regulatory framework for in vitro diagnostic medical devices (IVDs) is available at the TGA website.
Extension to the timeframe for the transition to the IVD regulatory framework
The TGA has set new deadlines for laboratories to demonstrate compliance with the IVD regulatory framework for their in-house IVDs that are summarised in the table below.
Transitioning Class 4 in-house IVDs are those that are in use in the laboratory prior to 30 June 2016. Transitioning Class 1-3 in-house IVDs are those that are in use in the laboratory prior to 30 June 2017. More information is available on the TGA website.
|Deadline||Requirement for transitioning in-house IVDs|
30 June 2016
Deadline for laboratories that do not have NATA accreditation to ISO 15189 or a TGA GMP licence to submit an effective application for TGA conformity assessment certificate for transitioning Class 4 in-house IVDs
30 June 2017
Deadline for laboratories that have NATA accreditation to ISO 15189 or a TGA GMP licence to submit an effective application for inclusion in the ARTG for transitioning Class 4 in-house IVDs; and
*Note that any new Class 4 in-house IVDs developed by laboratories after 30 June 2016 must be included in the ARTG before they can be used to issue patient test results.
In circumstances where access is needed to therapeutic goods that are not on the ARTG, the TGA may approve exemptions for laboratories to use unapproved IVDs, including Class 4 in-house IVDs, where there is a public health need to deal with an emergency situation or where there is an unmet clinical need (and no suitable approved IVD).