Lecture 3: Medical Device Classification

Question 1

Why was ARGMD developed?

Answer 1

• to assist sponsors in meeting regulatory requirements
• ensure that MD applications to TGA meet legislative requirements
• enhance clarity and transparency of processes

Question 2

Scope of ARGMD?

Answer 2

to describe the information to be supplied with applications to: manufacture; supply and export (referred to as sponsors in this series of lectures) Medical Devices in Australia. Also post-market requirements

Question 3

Elements of Medical Device Regulatory Scheme?

Answer 3

• product requirements
• compliances with EPs
• standards use
• ongoing monitoring
• regulatory controls
• ARTG
• penalties
• corrective actions

Question 4

4 ways to access unapproved MDs?

Answer 4

clinical trials
authorised prescribers
special access scheme
personal importation

Question 5

EPs?

Answer 5

The Essential Principles set out the requirements relating to the safety and performance characteristics of medical devices

Question 6

General principles?

Answer 6

1. not to compromise health and safety
2. to conform to safety principles
3. to be suitable for intended purpose
4. built for Long‐term safety
5. not to be adversely affected by transport or storage
6. Benefits to outweigh any side effects

Question 7

Principles about design and construction considerations?

Answer 7

7. Chemical, physical and biological properties
8. Infection and microbial contamination
9. Construction and environmental properties
10. Medical devices with a measuring function
11. Protection against radiation
12. Medical devices connected to or equipped with an energy source
13. Information to be provided with medical devices.
14. Clinical evidence
15. Principles applying to IVD medical devices only

Question 8

What is a legislative instrument?

Answer 8

an instrument in writing of a legislative character made in the exercise of a power delegated by the Parliament

Question 9

Classification rules based on?

Answer 9

manufacturer’s intended use
level of risk
degree of invasiveness
duration of use

Question 10

Classifications of Medical Devices based on level of risk

Answer 10

Class I
low

Class I—supplied sterile
Class I—incorporating a measuring function
Class IIa
low–medium

Class IIb
medium–high

Class III
high risk

Active implantable medical devices (AIMD)
high risk

Question 11

Classification rules?

Answer 11

Classification Rule 1: Transient, short‐term and long‐term use
Classification Rule 2: Non‐Invasive Medical Devices
Classification Rule 3: Invasive Medical Devices
Classification Rule 4: Active medical devices
Classification Rule 5: Special Rules

Question 12

List some special rules

Answer 12

-