MEDICAL DEVICE CLASSIFICATION WORKSHOP

Training and Workshops

COURSE STRUCTURE

The workshop consists of real-world case scenarios with mock-up advertising/ promotional materials and labels which require the participant to consider the:

  • Medical device manufacturer’s intended use of the device;
  • Level of risk to patients and other users;
  • Degree of invasiveness in the human body
  • Most critical specified use of the devices; and
  • Duration of use.
Training and Workshops

AIM

To build competence in the submission of appropriate device applications for specific classes of top medical devices companies to the Therapeutic Goods Administration (TGA).

TOPICS COVERED

  • Avoiding the submission of an incorrect device application for a specific medical device classification;
  • Information required from the medical device manufacturer before submitting a device application to the TGA;
  • Why all classification rules need to be considered when confirming the classification of a device; and
  • Application of the appropriate classification rule to a procedure pack, system or any other medical device.

DURATION: HALF DAY