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Gelpal (NSW)

Regulatory activities for this sponsor.

Type

Date

1 result(s) found, displaying 1 to 1

  • Compress, hot/cold pack, reusable (Cancelled under s.41GN(1)(f))

    Cancellation or suspension
    Regulatory action due to As the device labelling did not comply with the essential principles, the certification made under s.41FD (d) was incorrect.As the sponsor failed to provide evidence that conformity assessment procedure has been applied to the device, the certifications made under s.41FD(f) and (g) were incorrect.As the promotional material did not comply with the Therapeutic Goods Advertising Code 2007, the certification made under s.41FD(h) was incorrect., effective 24/09/2013

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