NOTIFICATION FORM: Clinical decision support software exemption - Page 1 of 3 - Therapeutic Goods Administration

Information about submitter and device

1. Name of sponsor (supplier)

Name (Required)

2. Name of contact person

Name (Required)

3. Role of contact person

(Required)

4. Contact email address

By entering your email address, you will automatically receive an acknowledgement email when you submit this form. The TGA strongly suggests that you use a company email address (i.e., not a personal email address) and retain a copy of the acknowledgement email for your own records.

Email (Required)

Please confirm your email address (Required)

5. What is the full name of the manufacturer of the clinical decision support software?

(Required)

6. What is the product name for your device?

(Required)

7. Please provide a brief description of the device and its intended functionality (may include links) (max 200 words)

8. I declare that all information provided in this form is true and correct at the time of submission. Important note: Providing information that is false or misleading to a Commonwealth entity or in connection with a Commonwealth law is a serious offence subject to criminal penalties under the Criminal Code Act 1995.

(Required) Yes No