ISO 13485 : 2003 - When must the transition be completed in Japan?

[Paul22]

Does anybody know when transition to ISO 13485:2003 must be completed in Japan?

Thanks!

Paul

 

[Laurie Anderson]

ISO13485:2003 in Japan

Paul,

As the new regulations come into force in Japan next year (sorry can't be more precise) I guess it would the the appropriate time for the introduction of 13485:2003 with some sort of time frame to comply.

Am searching for this very information myself. When I find it I will definitely pass it on.

Laurie

 

[Laurie Anderson]

ISO 13485:2003 in Japan

This is from TUV Rheinland Japan

ISO 13485:2003 - Medical device- Quality management systems- Requirements for regulatory purposes has been published. ISO 13485 is the quality management system standard for design & development, production, selling and other activities of medical devices. It is internationally used as regulatory requirement for the medical devices, e.g., in EU, Canada, Australia. Revised Pharmaceutical Affairs Law (PAL) that will come into force in Japan in 2005 will require a legally registered manufacturer and ensuring confirming the quality system on the basis of ISO 13485.
TUV Rheinland has globally performed ISO 13485 certification for leading medical device manufacturers. TUV Rheinland performs ISO 13485 certification as required in the revised PAL.

Thsi looking for precise info

Laurie

 

[Paul22]

Dear Laurie,


Thanks very much for your information.
As I understand transition to, and implementation of ISO 13485:2003 must be completed before April 1st 2005 for medical devices on the Japanese market. On that date the PAL will be active.
Am I right??

Meanwhile, I found some information on:
https://bsi-americas-temporary.bsi-global.com/MedicalDevices/Updates/index.xalter

Regards, Paul

 

[Laurie Anderson]

ISO 13485:2003 in Japan

Paul,

You are right with the 1st April 2005

And it appears you are required to have ISO 13485:2003 accreditation to be compliant with the new laws.

Laurie