Therapeutic Goods Act 1989
Approval under section 42DF for use of restricted representations by Zimmer Biomet Pty Ltd
I, Rowena Love, as a delegate of the Secretary to the Department of Health, on receipt of an application from Zimmer Biomet Pty Ltd have approved under section 42DF of the Therapeutic Goods Act 1989 (the Act) the restricted representations described in paragraph (A), for use in consumer advertising of the product identified in paragraph (B),
- Restricted representations that refer, expressly, or by implication to one or more serious joint conditions (including but not limited to 'osteoarthritis' and 'orthopaedic procedures') in the context of providing accurate and balanced information about the key functionality of the mymobility app, when used in conjunction with the statement, prominently displayed or communicated,[1] to the effect that the Device can only be used under the direction of a health professional.
- Product marketed as "mymobilty app" under the following entry in the Australian Register of Therapeutic Goods (ARTG):
- Zimmer Biomet Pty Ltd - Patient rehabilitation interactive software (ARTG 323752).
Dated this 9th day of June 2021
Signed electronically
Rowena Love
Delegate of the Secretary to the Department of Health
Advertising and Compliance Education and Policy Section Regulatory Compliance Branch
| [1] | As defined in the applicable version of the Therapeutic Goods Advertising Code, as amended from time to time. |
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