Medispec Australia Pty Ltd

Regulatory activities for this sponsor.

4 result(s) found, displaying 1 to 4

Disinfectant hospital grade [9950] (Cancellation from the ARTG under subsection 41GN(1) of the Act)

1 September 2020

Cancellation or suspension

Regulatory action due to The product is not a medical device. Therefore, the certification made by the sponsor under paragraph 41FD(a) of the Act in the application for inclusion is incorrect., effective 01/09/2020
Medical device aerosol disinfectant [58082] (Cancellation from the ARTG under subsection 41GN(1) of the Act)

1 September 2020

Cancellation or suspension

Regulatory action due to The product is not a medical device. Therefore, the certification made by the sponsor under paragraph 41FD(a) of the Act in the application for inclusion is incorrect., effective 01/09/2020
Mask, surgical, single use (Medispec Australia Pty Ltd)

Face mask cancellation

TGA cancellation
Mask, surgical, single use (Medispec Australia Pty Ltd )

Face mask market action

Product defect alert following review of quality, effectiveness and regulatory compliance.

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