Japanese Regulations for Medical Devices - Three Questions

H

Haroula

#1
Hi everyone!
I am new in this forum and I have a few questions for anyone who has experience with Japanese regulations for medical devices.

1. Are devices classified based on their quality systems only, following a CE mark approach, or do the claims of intented use affect the classification?
e.g. If the same device has intended use of adjunct to a standard diagnostic method will it be classified differently if the intended use is for an independent diagnostic device?

2. Would clinical trials in the EU (specifically UK and Greece) be accepted for review from the Japanese health system or would we need to conduct new ones there?

3. Is it true that for a class I the distributor and not the manufacturer needs an ISO 13485? What happens for class II?

Well these are my questions...Any help would be appreciated!
 
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Al Rosen

Staff member
Super Moderator
#2
Haroula said:
Hi everyone!
I am new in this forum and I have a few questions for anyone who has experience with Japanese regulations for medical devices.

1. Are devices classified based on their quality systems only, following a CE mark approach, or do the claims of intented use affect the classification?
e.g. If the same device has intended use of adjunct to a standard diagnostic method will it be classified differently if the intended use is for an independent diagnostic device?

2. Would clinical trials in the EU (specifically UK and Greece) be accepted for review from the Japanese health system or would we need to conduct new ones there?

3. Is it true that for a class I the distributor and not the manufacturer needs an ISO 13485? What happens for class II?

Well these are my questions...Any help would be appreciated!
Does anyone have an answer to these? I'm attending a conference the last week in November and can probably find the answers then. In the meantime can anyone else help with this?
 
R

RA Princess

#3
Hi Haroula

We are currently undergoing registration of some of our medical device products in Japan.

As far I understand under the new PAL regulations foreign companies selling medical devices in Japan are required to appoint a MAH (Market Authorisation Holder)/ The MAH may be either a distributor, other third party entity or the company may designate themselves if they have an office in Japan.

As a foreign manufacturer we have also had to apply for foreign manufacturer certificate by submitting a dossier which included:-

- past employment / experience of our top management and also self certifications stating they do not take illegal drugs and do not have a mental disorder! :biglaugh:
- detailed descriptions of the medical devices to be exported
- our manufacturing process for those devices
- a list of manufacturing equipment used
- copies of our current certification held with our home country

This foreign manufacturers certificate is valid for five years and gets submitted to the PMDA through our MAH.

There are also changes to the labeling of the devices that you need to be aware of. The Japanese classification of the device must be listed on the Instructions For Use as well as the address where the marketing of the device is handled, manufacturers address and the contact details for the MAH. This needs to be in place by 31st March 2006.

Heres a link to website containing a useful article. (hope the link works still , if not I can fax over a copy)

http://www.advamed.org/business-solutions/gross_weintraub_article_2005.shtml


Sorry I havent answered your questions directly but I hope this helps.

Regards
Leeanne
 

Jim Wynne

Staff member
Admin
#4
RA Princess said:
past employment / experience of our top management and also self certifications stating they do not take illegal drugs and do not have a mental disorder! :biglaugh:
They had to lie, in other words? :lmao:
 
R

Roland Cooke

#6
Count yourselves lucky - the Japanese were originally demanding an independent (i.e doctor's) certification of sanity and general morality. No moral turpitude*. :mg:





Whenever I fly to the States I always have to attest that I won't commit acts of moral turpitude. I still have absolutely no idea what that word means. :tg:

But I went to Vegas once, so I'm probably considered to be lying on the form by default! :cool:
 
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