Medical Device Definition & Control

Question 1

What defines a device as a medical device

Answer 1

made with the intention to diagnose and/or treat through means that are not pharmacological, immunological, or metabolic.

Question 2

Three Stages of Medical Device Regulation & Control

Answer 2

Premarket, Placing on market & Post-market

Question 3

Premarket

Answer 3

Conception & Development, Manufacture, Packaging & Labelling

Question 4

Placing on Market

Answer 4

Advertising, Sale, Registration

Question 5

Post-Market

Answer 5

Use, Disposal, Compliance, Surveillance, Vigilance

Question 6

Key Organizations

Answer 6

WHO, GHTF>IMDRF, APEC, AHC ASEAN, AHWP>GHWP

Question 7

GHTF (now IMDRF)

Answer 7

Canada, United States of America, European Union, Japan and Australia

Question 8

IMDRF

Answer 8

Australia, Brazil, Canada, China, Europe, Japan, Russia, Singapore, South Korea and the United States

Question 9

AHWP

Answer 9

Asia, Middle East, Africa, Latin America, Singapore

Question 10

GHWP

Answer 10

Asia, Africa, Middle East and South America

Question 11

ACCSQ

Answer 11

Brunei, Cambodia, Malaysia, Laos, Singapore, Vietnam, Philipines, Thailand, Indonesia, Myanmar

Question 12

What year did the countries start regulating their medical devices

Answer 12

US: 1976
EU: 1993
Singapore: 2010

Question 13

ISO 13485

Answer 13

EU, Australia, Canada, Singapore and Malaysia

Question 14

Reasons for classifying risks

Answer 14

1. Patients
2. Product Owner
3. Regulatory Body

Question 15

Main Factors of Risk Classification

Answer 15

1. Intended Use/ Purpose

2. Indications

Question 16

Factors Influencing Risk Classification

Answer 16

• Duration of Contact
• Degree of Invasiveness
• Delivery
• Biological Effect