DECLARATIONS OF CONFORMITY WORKSHOP

Training and Workshops

COURSE STRUCTURE

The workshop consists of real-world case scenarios, supported by a series of mock-up manufacturer’s Declaration of Conformity templates based on the requirements of the Australian legislation and Medical Device Regulations.

Training and Workshops

AIM

To build competence in providing the TGA with an appropriate manufacturer’s Declaration of Conformity for a specific class of medical device.

TOPICS COVERED

  • The correct submission of a manufacturer’s Declaration of Conformity based on device classes;
  • The significance of a declaration made in accordance with the requirements of Clause 1.8, 3.5,4.7,6.6 and 7.5 of Schedule 3 of the Australian Therapeutic Goods Medical Devices Regulations 2002;
  • The importance of ensuring that all the information contains in the declaration supports the medical device, for example:
    • Unique Product Identifier (eg product name or model number);
    • Schedule for multiple products;
    • Classification of the device;
    • GMDN Code and Term;
    • Scope of the Application; and
    • Record of Conformity Assessment procedures.​

DURATION: HALF DAY