How does Japan PMDA classify Medical Devices - Classification Guidelines

Arnthor

Inactive Registered Visitor
#1
Dear all,

Do anyone know how does Japan PMDA classify medical device?

Does PMDA have similar guidance documents like EU MEDDEV for classification of medical device?

Best regards,

Arnthor
 

Ronen E

Just a person
Super Moderator
#2
Dear all,

Do anyone know how does Japan PMDA classify medical device?

Does PMDA have similar guidance documents like EU MEDDEV for classification of medical device?

Best regards,

Arnthor
Hi,

You may want to have a look at http://www.j-mdc.com/glossary.html

I am not aware of any English language guidance document for Japanese classification of medical device, available free of charge. As much as I could find, the corresponding official document is only available in Japanese as well.

Sorry,
Ronen.
 
Last edited:
R

RegGuy23

Guest
#3
Does anyone happen to have an English version of Japan's Implementation of Specially Controlled Medical Devices, Controlled Medical Devices, and General Medical Devices Designated by the Minister of Health, Labour and Welfare Pursuant to Article 2, Paragraphs 5 through 7 of the Law (Ministerial Notification) from 2004, i.e. the "Classification Notification"?
 
W

woudeniv

Guest
#6
Hello everybody,

I am new in the forum. Thus it looks like I cannot publish links yet. Anyway, a Ph.D. from PMDA gave the following talk on Understanding Japanese Medical Device Requirements in 2011 which has been published by PMDA: (sorry, I cannot publish it - URL on request). (It may not be that helpful any more as it was hold before the new PMDL was introduced in 2014.)

Furthermore, I found some useful information under (sorry, I cannot publish it - URL on request). But I could not find an English version of the Japanese Medical Device classifications. Does anybody know whether something like this has been published?

Greetings
woudeniv
 
W

woudeniv

Guest
#7
Hello again,

I am sorry - as this is only my second posting I cannot send PMs either. But if I go on posting like this I will soon reach the limit.

Greetings,
woudeniv
 
Top