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Application requirements for medical devices - preliminary assessment

20 August 2018

Applications for the inclusion of medical devices (including IVDs) in the ARTG must meet certain requirements in order to pass preliminary assessment. The requirements include providing conformity assessment documents that are appropriate for the category and Class of device.

To pass preliminary assessment, an application must meet the requirements in section 41FDB of the Therapeutic Goods Act 1989 (the Act). The TGA will carry out an assessment of whether the requirements have been met for each application. Applications that do not pass preliminary assessment will be refused by the TGA.

Specifically these requirements include that:

An application that passes preliminary assessment will either proceed to the decision for the device to be included in the ARTG or application to be selected for audit.

The requirement to provide certain documentation with the application applies to all classes of medical device except Class I, Class I (Export Only), Class 1 IVD and Class 1 IVD (Export Only).

This documentation is to accompany the device application as Manufacturer Evidence or as an attachment to the application form, as specified in the guidance document.

Application forms in TBS

The Manufacturer Evidence and Medical Device/IVD application forms in TBS will be updated so that the required documentation can be provided in the application.

In addition, the text of the declaration in the application form for certifying the matters in section 41FD of the Act has been amended to accommodate the use of comparable overseas regulators and assessment bodies.