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

C

CBAL08

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).
 
R

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?
 
Soog1459

Soog1459

Involved In Discussions
English version becomes always problem.

I know only the new QMS Ordinance revised in 2014.
http://www.tuv-sud.jp/uploads/images/1415679416057318931160/revised-qms-ordinance.pdf


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.
 
M

MIREGMGR

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.
 
M

medic61

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!
Thanks!
 
B

BARBARKA

Hello,
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?
 
Soog1459

Soog1459

Involved In Discussions
BARBARKA,

I've checked MHLW and other web sites, but not yet !!

What I could find for the moment are the slides/materials to explain the new Act.
You are experts, so won't be satisfied with these ...


<PMDA>
http://www.pmda.go.jp/english/events/2014taiwan_sympo/14_Keynote1.pdf
http://www.pmda.go.jp/regulatory/file/english_presentation/biologics/CT-B-15kusakabe.pdf

<TUV-SUD>
http://www.tuv-sud.jp/uploads/images/1415637966058168050890/new-act-on-medical-devices-in-japan.pdf
http://www.tuv-sud.jp/uploads/images/1415638014061510810569/new-qms-requirements-in-japan.pdf
http://www.tuv-sud.jp/uploads/images/1415638062491974000921/software-as-medical-device-in-japan.pdf
http://www.tuv-sud.jp/uploads/images/1415638149727653530014/faqs-on-new-japanes-regulations.pdf
 
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