Regulatory Knowledge

Question 1

MHLW

Answer 1

Japan’s Ministry of Health, Labor and Welfare - the regulatory body that oversees food and drugs in Japan

Question 2

PMDA

Answer 2

the Pharmaceutical and Medical Device Agency - an independent agency (in Japan) that is responsible for reviewing drug and medical device applications. The PMDA works with the MHLW

Question 3

Japan Medical Device Classification

Answer 3

General Medical Device (Class I), Controlled Medical Device (Class II), or a Specially Controlled Device (Class III and Class IV)

Question 4

Japan General Medical Devices

Answer 4

only a notification/self-declaration is required, and the product does not need to undergo the approval process by the MHLW and PMDA

Question 5

Japan Controlled Medical Devices

Answer 5

Required to be certified by an authorized third-party certification party or reviewed by the PMDA

Question 6

Japan Specially Controlled Medical Devices

Answer 6

must be reviewed and approved by the PMDA and MHLW.

Question 7

JIS T

Answer 7

Japanese Industrial Standards

Question 8

JSA

Answer 8

Japanese Standards Association. Publisher of the Japanese Industrial Standards (JIS), which are created by the Japanese Industrial Standards Committee (JISC)

Question 9

JISC

Answer 9

Japanese Industrial Standards Committee. They organize and create all the Japanese Industrial Standards (JIS). They are a member of the ISO Council and propose standards regularly

Question 10

ISO 14971

Answer 10

Risk Management

Question 11

ISO 10993

Answer 11

Biological Evaluation of Medical Devices

Question 12

ISO 10555

Answer 12

Intravascular Catheters

Question 13

ISO 13485

Answer 13

Quality Management Systems for Medical Devices

Question 14

ISO 9001

Answer 14

Quality Management Systems in Business

Question 15

ISO 27186

Answer 15

Four-pole connector standard for cardiac devices. (DF4/IS4)