Japan's PMDA Response to Question on Trade Show Display of Non-approved Device

G

GordonHarnack

#1
I recently Email Japan's PMDA regarding Japan's policy/regulations on a device manufacturer's ability to display their non-approved device at Japanese Trade Shows.

Both U.S. FDA and the EU allow trade show displaying PRIOR to approval if the devices are clearly labeled as not cleared or approved and not available for sale.

Does anyone have any experience in dealing with Japan's PMDA? What should someone expect in terms of a timeline for a response? One week? Two weeks, One month? Two months? Never?

Additionally, does anyone know the answer to the question I poised to PMDA...that is, what is their policy/regulation on a manufacturer displaying their medical device PRIOR to being reviewed and approved by PMDA?

I would appreciate any information or references.
 
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A

arios

#2
Hi Gordon,

First of all, please accept my apologies. I could not find an straight answer this time like yesterday :nope:. I have been searching in my files looking for guidance but so far nothing has came out, but since I am also intrigued about the possible answer I will keep looking.

Meanwhile take a look at this presentation:
http ://www .jpma.or.jp/english/parj/pdf/2009_ch03.pdf - OBSOLETE BROKEN 404 LINK(s) UNLINKED - PLEASE HELP - REPORT POSTS WITH BROKEN LINKS

I know it is not enough, but possibly just something to start with

Blessings!
Alberto
 
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G

GordonHarnack

#3
Alberto:

Thomas Fuller said "All things are difficult before they are easy."

Thanks for your information...searched in vain for an answer.:applause:

Such is life in the world of quality systems.

Gordon
 
R

Reiko Shiratori

#5
Hi Gordon,

I don't think it will help you, but there is a guideline for non-approved medical devices' exhibition, written in Japanese.

Your trade show organizer might have better information.

Since you are a foreign manufacturer, there will be more procedures than Japanese domestic manufacturers.

Have you received the 'Exhibit Request' from the organizer?
(Sorry for my poor English translation.)

Contact the organizer. They will answer more quickly than PMDA.:yes:

Good luck.


Reiko
 
G

GordonHarnack

#6
Reiko:

Thanks for the post. Could you supply a link to the Japanese language "guideline for non-approved medical devices' exhibition?" Perhaps I can find a translator.

This issue was raised by a prospective client who would like to understand if they can have their non-Japanese approved medical device at any exhibition in Japan? As this time there is no specific trade show or exhibition.

Thanks again, :thanx:

Gordon
 
A

arios

#7
Hi Gordon

If possible if you get the document translated please have a copy available to share

Reiko-san: mo ichido domo arigato gozaimasu. Watashi mo wa kono mondai ni suite ga naritai desu
 
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R

Reiko Shiratori

#8
Hi Gordon and Alberto,

Here's the link: http :// www .jfmda.gr.jp/information/pdf/gaidorain.pdf - OBSOLETE BROKEN 404 LINK(s) UNLINKED - PLEASE HELP - REPORT POSTS WITH BROKEN LINKS

I wish I had time to translate, being busy in next three months.:(

Let me know if you need my help again.


Reiko:bigwave:
 
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A

arios

#9
It looks like with some patience Google translator will work. Here is a sample:

"This fine print, see the About Participation in exhibitions and unapproved medical devices (February 1989 SAN 月 13 th Pharmaceutical Association 127 Health and Welfare, Pharmaceutical Affairs Bureau Notification No.) (the "Director notice" he said.). According to approved unapproved drugs and in vitro diagnostic medical devices (the "unapproved products," said.) intended to be smooth and proper operation of the exhibition of medical equipment Affiliate Council of Japan (Japan Medical Device Industry Association current Medical JMF below) and (Company), Association of Clinical Laboratory Medicine (co 臨薬) under the guidance of the Ministry of Health, the voluntary standards established by management.
Therefore, those who intend to exhibit products and exhibitions is not approved, in principle, "Rules and guidelines for medical devices not approved exhibits (the" Rules "he said.)" Shall be exhibited along.
The operation without significantly changing the bylaws to be the case, prior medical office JMF (see end) and should be consulted. The exhibition of products not approved when the Pharmaceutical Affairs Act (Act No.135 of 1961) of Article 68 (Prohibition of advertising of pharmaceuticals for pre-approval) must be careful to not conflict with the subject not."


Now, with long texts, it is necessary to be careful because the translation may look funny, but at least is a beginning

Many, many thanks Reiko-san. You are our hero!!!! :thanx:
 
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