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APAC Security Pty Ltd - Clungene Covid-19 Antigen Rapid Test (Self Test) (Cancellation from the ARTG under subsection 41GN(1)(b) of the Act)
Product name
Clungene Covid-19 Antigen Rapid Test (Self Test)
Sponsor
ARTG details
- 333341
Date action takes effect
Compliance action
Medical device cancellation
Type of action
Cancellation from the ARTG under subsection 41GN(1)(b) of the Therapeutic Goods Act 1989
Grounds for regulatory action
The sponsor did not comply with the conditions of inclusion to which the inclusion of the Device in the ARTG is subject to per paragraph 41GN(1)(b) of the Act.
Those conditions are that the sponsor must have at all times while the Device is in the ARTG:
Available sufficient information to substantiate compliance with the Essential Principles set out in Schedule 1 of the Therapeutic Goods (Medical Devices) Regulations 2002 (the Regulations) (subparagraph 41FN(3)(a)(i) of the Act).