Regulatory Affairs

Question 1

What is ISO 13485?

Answer 1

Its the industry standard for quality manufacturing system in a medical device company.
To obtain ISO13458 certification, you must comply with the standard and document the manufacturing process.

Mostly relates to managing production and distribution.

MUST BE TRACEABLE

Question 2

What is ISO9001

Answer 2

standard for ordinary (non medical) manufactuing companies: Bottles, tools, nails

Question 3

What does the TGA do?

Answer 3

The Therapeutic Goods Administration determines the classification of a device, determines whether a device/drug passes the phase 3 trial

Question 4

What is the ARTG

Answer 4

Australian Register of therapeutic goods.

Question 5

What is a class 1 drug?

Answer 5

Have the least regulatory control. Present mnimal risk for harm to the user. e.g bandaids, gloves

Question 6

What is a class 2 drug?

Answer 6

general controls alone are insufficient to ensure safety and effectiveness. In addition to complying with general controls, Class 2 devices also abide by special controls.

e.g. wheelchairs, surgical drapes

Question 7

What is a class 3 drug?

Answer 7

support/sustain life or are substantially important in preventing impairment of human health. Most implants are in this category. They also require PMA (premarket approval)

Question 8

What is an IDE

Answer 8

Investigational Device Exemption.
allows new device to be used in a clinical study in the USA in order to collect safety and effectiveness data required to support a PMA application [510(k)] application.
It’s a licence to conduct clinical trials in the US medical system in order to obtain data for a PMA or 510(k) marketing approval.