41 JA & 41 FD DOCUMENTATION WORKSHOP
Training and Workshops
COURSE STRUCTURE
The workshop consists of real-world case scenarios based on the requirements of the Australian legislation and medical device regulations for a specific class of medical device. Participants will be provided with mock-up advertising/ promotional material, labels, Manufacturer’s Declaration of Conformity and EC certification.
AIM
To build competence in preparing documentation in response to a request made by the TGA under Section 41JA and preparing documents which demonstrate compliance to matters certified made under Section 41FD.
TOPICS COVERED
- Documentation required to be held by a sponsor to demonstrate that the device is:
- a medical device;
- correctly classified;
- AND that the device complies with Essential principles and that appropriate conformity assessment procedures have been applied.
- What to look for to ensure that the classification of the medical device is supported by appropriate promotional and or advertising material, instructions for use and those appropriate conformity procedures have been applied; and
- Compilation of appropriate documents in response to requests made by the TGA.
DURATION: HALF DAY