Which version of ISO 13485 would be considered for MDSAP certificate?

Yasuaki

Starting to get Involved
#1
In "Notice: Medical Device Single Audit Program (MDSAP) Transition Plan – Frequently Asked Questions (FAQ)",
Health Canada said
"Licences not supported by a valid MDSAP certificate as of January 1, 2019, will be subject to suspension. Holding a valid quality systems certificate is a regulatory requirement for a manufacturer to have an active medical device licence. All device licence applications and F202 notifications received after January 1, 2019, must contain a MDSAP certificate; a manufacturer’s CMDCAS certificate will not be accepted. "

ISO 13485:2003 will be replaced by ISO 13485:2016.

Can anyone tell which version of ISO 13485 is applied for MDSAP certificate?
 
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Yasuaki

Starting to get Involved
#3
Re: Which versdion of ISO 13485 would be considered for MDSAP certificate?

Thank you for your comment.

Does anyone know by when 13485:2016 become standard for MDSAP certificate?

Because, unifying changing fromCAMCAS to MDSAP and changing from 13485:2003 to 13485:2016 seems to be better than separately changings.
 

Mark Meer

Trusted Information Resource
#4
Re: Which versdion of ISO 13485 would be considered for MDSAP certificate?

I'm in the same situation.

I asked our auditor, and he said that there is no date at present (...mind you, this was some months back).

My plan is to transition to 13485:2016 in a "backward compatible" way. The national requirements (FDA, HC, TGA, ANVISA, MHLW) aren't going to change, so as long as the national requirements of the current MDSAP continue to be met, I don't see a problem with beginning the transition to ISO 13485:2016.
 
#5
We were recently told by our notified body auditor that Canada is implementing MDSAP as a mandatory program and will be in effect from 2018. Not sure to what extent the information is reliable.

The weird thing is FDA would authorize these notified bodies to go audit the companies if you are in the MDSAP program. So, imagine how it would be once it is mandated for all companies.
 

Mark Meer

Trusted Information Resource
#6
We were recently told by our notified body auditor that Canada is implementing MDSAP as a mandatory program and will be in effect from 2018. Not sure to what extent the information is reliable.
It is true. As of January 1, 2019, Health Canada will require MDSAP (CMDCAS will no longer be acceptable).

See: http://www.hc-sc.gc.ca/dhp-mps/md-im/activit/int/mdsap-trans-notice-avis-eng.php


The question is whether to do it now (at big expense - MDSAP is Waaayy more expensive - but potentially beat the rush, and inevitable certification body backlog), or wait until closer to the deadline...
 
J

Jhnpx

#8
Apparently, they will publish an update of the audit companion in January 2017 including the ISO 13485:2016 requirements though they can have some delay due to the review/comments by all the participating authorities.
Besides, the transition date should be aligned to the ISO 13485:2016 transition.

Hope this helps!
 
M

MikeKen

#9
01-Mar-18 will be the point where ISO13485:2016 will be used for all ISO13485 assessment including MDSAP. Prior to that it is up to your company - it can be to either depending if you ready for ISO13485:2016 or not..
 
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