Revision of Japan's Pharmaceutical Affairs Law (PAL) in 2014



Re: Revision of Pharmaceutical Affairs Law (PAL) in 2014

It is said that standd alone software will also be regulated in the presentation but says FUTURE. Does anyone know when the regualtions will be implemented for Stand - alone Software (s).

RA Princess

Does anyone have a copy of the new regulations in English or could point me in the direction of where I could find them please?


Starting to get Involved
English version becomes always problem.

I know only the new QMS Ordinance revised in 2014.

My colleague's comments who talked with our Registered Certification Body (RCB);
- Chapter 3, which is not included in ISO13485, is surely assessed by RCB, although not known if on-site or off-site audit.
- Assessment of the other part could be replaced by periodical audit report if it is based on ISO 13485:2003.

Hope this helps.


It might be relevant to this discussion that Japan is considering joining the harmonization initiative that US FDA calls "Medical Device Single Audit Program". Presumably if Japan was part of MDSAP, a device maker in one of the other member countries (Australia, Brazil, Canada, USA) could submit their most recent MDSAP-compliant ISO 13485 audit report to Japan to demonstrate conformance with Japanese expectations for their QMS.


Involved In Discussions
I know I am asking a lot but has anyone done a gap analysis or prepared a matrix of the differences between the old and new ordinance? I am not being lazy, it is just a lack of time and these old eyes!


Actually I have already started to compare these 2 ordinance, but this is a lot of time to do it detaily and properly...

Have anybody the link or scna ot sth with English translation the PMDL?? I cannot find, The only thing is the updated Ordinance 169. But what about the whole new text of new Pharmaceutical Medical Device Law?
Anybody has seen?

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