TGA has an updated list of the medical devices that need to go under mandatory application audit, except the following circumstances:
- TGA conformity assessment certificate
- EU MDR 2017/745
- EU IVDR 2017/746 certification that has not been suspended or revoked, or is included in the ARTG as an export-only medical device, including export-only IVD medical devices.
When sponsors (such as Qualtech) submit an application for medical device inclusion through the Australia Register of Therapeutic Goods (ARTG), an application audit may be conducted.
Therapeutic Goods (Medical Devices) Regulations 2002 Part 5, Subdivision C, clause 5.3, listed out devices that are required to go through the application audit process:
a. a medical device (other than a condom) that is a barrier indicated for contraception or prevention of the transmission of disease in the course of penile penetration during sexual intercourse;
b. a medical device that is an implantable contraceptive device;
c. a medical device that is a spinal fusion implantable device;
Note: Examples of spinal fusion implantable devices include screws, cages, plates, hooks or rods that are intended to be used during spinal fusion surgical procedures.
d. a medical device that is specifically intended by the manufacturer to be used for disinfecting another medical device; […e. & f.…]
g. a medical device that is an implantable intraocular lens;
h. a medical device that is an intraocular viscoelastic fluid;
i. a Class III medical device that has not been assessed under the EC Mutual Recognition Agreement or the EFTA Mutual Recognition Agreement;
j. any IVD medical devices listed in clause 5.3.
Lastly, in brief summary, the audit processes are as follows:
Step 1 - The application audit process:
You will be informed within 20 days of paying your application fee via a notification letter issued under section 41FH of the Therapeutic Goods Act 1989 (the Act) if your application is selected for audit.
● a. Time frames for providing documentation: 10-20 working days;
● b. Presentation of requested documentation: all requested information in English;
● c. List of supporting documentation for medical device application audit: Level 1 and Level 2 for medical device (excluding IVD) applications. The TGA will determine what level of audit assessment is appropriate for your application. The requested documents will depend on the level of audit assessment.
Step 2 – Fees associated with the audit assessments
No audit assessment fee should be paid if your application has been selected for audit at the discretion of the delegate; however, there is an audit assessment fee for an application that must be selected for audit under 5.3 of the Regulations. You will then receive an invoice if it is required for you to pay an audit assessment fee.
Step 3 – Time frames for conducting audits
Unfortunately, there are no legislative timeframes for application audits in Australia.
Step 4 – Application audit outcome
You will receive an outcome notification of your application audit assessment once your application audit assessment is completed and a decision is made. If a decision is made to include the kind of medical device in the ARTG, then you will receive an e-mail notification outlining the decision to include your medical device in the ARTG. You can then print your own ARTG certificate and perform the ongoing responsibilities such as post-market vigilance and monitoring.
Auditing of medical device, including IVD medical device, applications
Therapeutic Goods (Medical Devices) Regulations 2002