Kirk Zeller , DBA


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JAPANESE APPROVAL OF MEDICAL DEVICES
There have been a number of changes regarding medical device regulations and approval in recent years. In April 2004 the Pharmaceutical and Medical Devices Agency (PMDA) became a third body review body and in April 2005 Revised Pharmaceutical Affairs Law (Revised PAL) went into effect. The responsility for Revised PAL compliance is now on the Marketing Authorization Holder in Japan and the approval system is now a marketing approval based system (previously was manufacturing approval based) with license renewal every 5 years.

There are still four classes of medical devices in Japan which have been lumped into three categories General Medical Devices (Class I), Controlled Medical Device (Class II), and Highly Controlled Medical Device (Class III and Class IV).

1) CLASS I
Requires a simple product registration, this would include many types of instrumentation and many products not directly used in treatment.

2) CLASS II
Class two devices generally require a basic shonin without clinicals. Products in this category would include slightly more invasive items used to perform procedures. These devices are now reviewed under a third party agency similar to the notified bodies used in the EU.

3) CLASS III
a)Shonin without clinicals
This would include such things as PTCA balloons
b)Shonin with clinicals
This can also include non-life critical implantables. Class II devices are reviewed by PMDA.


4) CLASS IV
Class IV device would require shonin with clinical trials. Heart valves, pacemakers and other such life critical devices would be included in this category. Class IV applications are reviewed by PMDA.

Materials testing is generally required for all applications other than Class I product registration.


Post Market Survelliance (PMS)
JMHLW requires post market survelliance (PMS), which is a type of second evaluation system. It is designed to reconfirm a productís effectiveness and safety by comparing data from the clinical trial to data collected during the PMS. In addition patient tracking of certain implantable devices is required in Japan after approval.


Copyright © 2004 Kirk Zeller, All rights reserved