JGMP and ISO 13485:2003 - The Japan GMP related to medical device

[jonathan]

Hi, all

The Japan GMP related to medical device was published. Do anyone can provide the suggestion or documents to implement the Japan GMP in my company? Or any instruction which describe the difference between JGMP and ISO 13485? The background of my company is: certified with ISO 9001:2000, ISO 13485:2003, CMDCAS, and EC.
Thanks.

 

[Marc]

Anyone with information which could help out with this?

 

[Wes Bucey]

Hi, all

The Japan GMP related to medical device was published. Do anyone can provide the suggestion or documents to implement the Japan GMP in my company? Or any instruction which describe the difference between JGMP and ISO 13485? The background of my company is: certified with ISO 9001:2000, ISO 13485:2003, CMDCAS, and EC.
Thanks.

BSI (a global registrar to various Standards) publishes a page in Chinese which discusses JGMP and offers a one day seminar on JGMP as well.
Here is a link to the page.
https://asia.bsi-global.com/China+Training/MD+series/index.xalter

 

[Toshi]

Hi! All,

My name is Toshi working for US capital company in JP.
I think the web site blow can help you guys question.
TUV will have seminor for JP revised PAL including JGMP.

https://www.tuvamerica.com/tuvnews/seminars/japanese.cfm

Thanks

 

[Roland Cooke]

SGS Japan is a recognised certification body under the new PAL.

We intend to offer some training etc in due course, on a global basis. The new Japanese regulations are simpler - but that is a long way from simple!

If your company is interested in exporting to Japan under the PAL, we would be pleased to assist.

Roland Cooke
Medical Devices Certification Manager