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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 product’s 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
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