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WorksheetsJapan PMDA Reg Quiz
Total questions: 10
Worksheet time: 6mins
When do medical device registrations expire?
Never
5 Years
2 Years
10 Years
What was the first IGT-D product approved in Japan?
Guidelight
Quick-Cross
CVX-300 Excimer laser system
LLD
How long is a Foreign Manufacturer Registration (RMR) active?
5 yrs
2 yrs
10 yrs
20 yrs
What are Certification Criteria vs Approval Criteria?
CC: Forms appropriately filed
AC: Device Registration
CC: Validation Requirements
AC: Regulated by the FDA
CC: Regulated Privately
AC: Includes customer data
CC: Compliance assessed by registered certification bodies
AC: Composed of ISO or IEC standards
The "review guidelines" are specified by MHLW and describe the major technical requirements and/or the acceptance criteria, etc. necessary to evaluate the safety and efficacy of medical devices, although no specific performance limits are determined for each technical requirement. The guidelines contribute to more efficient PMDA reviews of medical devices. For which medical devices do review guidelines apply for?
Medical devices which are new the the market and not previously approved
Medical devices which are substantially equivalent to precedent products in the Japanese market and improved medical devices
Medical Devices approved in other countries not yet marketed in Japan
All Medical Devices
How does the PMDA categorize the reviewing applications for medical devices?
Specialty Devices, Modern Devices, Popular Devices
Developmental devices, Orphan Devices
New Medical Devices, Improved Medical Devices, Generic Medical Devices
Pre-Market, Post-Market
Which Class(es) may require a QMS certificate issued by the PMDA or your Registered Certified Body (RCB)?
Class II, Class III
Class X, Class XI, Class XII
Class II, Class III, Class IV
Class I
What are the PMDA’s key focuses?
Reduction in Risk
Safety
Profit
Relief
Which of the following changes occurred during the 2019 amendment of The Pharmaceutical and Medical Device Act?
UDI Compliance
Digitization of information
Precautionary Testing
Rapid Response Rules
A Marketing Authorization Holder (MAH) is responsible for obtaining the marketing license, as well as the supervision and management of the manufacturer, and ensures compliance with QMS of all manufacturing sites. Where should the MAH be based?
Where the manufacturer is based
U.S.
The same location as the company headquarters
Japan
