Intellectual Property
What is the device classification for a potential harm level of “low to moderate”?
Class IIa
What is the name of the organization that regulated medical devices in Australia?
The Australian Register of Therapeutic Goods (ARTG)
Is direct-to-consumer marketing legal in Australia?
No
Failure of a company to warn their customers of a potential failure mode or the intended risks may result in ___?
A negligence lawsuit
What is the drinking age in Australia?
18+
How many countries are a part of the PCT?
157
Name two avenues for the importation into and/or supply in Australia of 'unapproved' therapeutic goods for use in a clinical trial.
Clinical Trial Notification (CTN) scheme; and
Clinical Trial Approval (CTA) scheme.
What does the TGA stand for?
Therapeutic Goods Advertising
What are the 5 P’s of Good Manufacturing Practices?
People, products, processes, procedures, premises
What reef is located near Australia?
The Great barrier reef
Where do sponsors of a medical device report adverse events or near adverse events?
TGA Incident Reporting and Investigation Scheme (IRIS)
What organization reviews the scientific validity of the trial design?
Human Research Ethics Committee (HREC)
How many steps are in the recall process?
11
Sponsors of medical devices are required to report if the product is a threat to the life of a single person within how much time?
10 days
What is the country’s animal?
Red kangaroo
What classification does biologicals fall under within the recall process?
Step 1: immediate recalls
Whose responsibility is it to determine whether a product is considered an 'unapproved' therapeutic good?
Australian clinical trial sponsor
What step(s) of the recall process does product tampering need to follow?
1
What code of practice did the MTAA create?
Medical Technology Industry Code of Practice (MTIC)
What percentage of people live on the coast?
90%
What certification do overseas devices need Before they can be sold in Australia?
Is animal testing legal in Australia?
No
Who has the power to mandate sponsors to recall therapeutic goods to protect public health?
A TGA delegate of the Secretary of the Australian Government Department of Health
Class IVDs require type of certification before being sold?
TGA Conformity Assessment Certification
How many wine regions does Australia have?
60+