Lecture 2: Medical Device Regulations

Question 1

Regulatory body and associates?

Answer 1

TGA

• TCA
• SAI Global

Question 2

What are the 3 Statutory committees and what are they responsible for?

Answer 2

Medical Devices Evaluation Committee
Therapeutic Goods Committee
National Coordinating Committee of Therapeutic Goods

Question 3

What is a Standard?

Answer 3

A Standard is a published document which sets out specifications and procedures that are designed to ensure that a material, product, method or service is fit for its purpose and consistently performs the way it was intended to.

Question 4

TGA medical device definition? Not?

Answer 4

disease
injury
physiological process
conception

Question 5

What can TGOs do?

Answer 5

add to TG Act and define working items

Question 6

Explain what happen with IVD Devices

Answer 6

-

Question 7

Explain the risk management process

Answer 7

risk identification
risk analysis (level of risk?)
risk evaluation (acceptable or not with risk criteria)
monitoring & reviewed

Question 8

Micro/Macroshock?

Answer 8

-

Question 9

Electric risk?

Answer 9

For a patient that is an element in the electrical patient
circuits of Medical Devices that monitor and/or
transmit electrical energy from/to the patient,
there is a real physical risk of electric shock.

Question 10

Mechanical risk examples?

Answer 10

Blood Pressure monitors and Ventilators make mechanical circuits with patient and there are risks of bursting blood vessels and/or rupturing lung tissue

Question 11

Radiation hazards?

Answer 11

non-ionisation

ionisation

Question 12

Thermal hazards?

Answer 12

Fluids, electrical, fire