Expired CMDCAS Certificate - Registrar has yet to send the new CMDCAS certificate

A

Arnthor

#1
Hi all,

I am facing a situation here, my company's ISO 13485:2003 CMDCAS cert is going to be expires next week and the Registrar had yet to send the new CMDCAS cert over.

Health Canada had already sent me a notification asking for the new CMDCAS cert.

I had email my Registrar today and they said that will expedite the CMDCAS cert immediately.

The question I would like to ask is, are there any regulatory impacts or penalty if my CMDCAS cert had expired and my company had yet to receive the new CMDCAS cert?

Best regards,
Arnthor
 
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somashekar

Staff member
Super Moderator
#2
Re: Expired CMDCAS cert

I had email my Registrar today and they said that will expedite the CMDCAS cert immediately.
:) ...
Don worry.
Your CMDCAS recognized registrars know this better and your CMDCAS ISO 13485 new certificate will not show a break in dates. You can share to HC a copy of the certificate as and when issued to you. You may be aware that you will get two copies of the original CMDCAS ISO13485 certificate from your CB.
Globally ISO 13485 CB's seems to be facing hardship in getting qualified auditors and keeping up to scheduled timelines, same time customers are increasing.
 
A

Arnthor

#3
Re: Expired CMDCAS cert

Dear Somashekar,

Thank you for your reply.

Will Health Canada suspend my company medical device licences if my CMDCAS cert is expired and they did not recevied the new CMDCAS before the expiry date?

Best regards,
Arnthor
 

somashekar

Staff member
Super Moderator
#4
Re: Expired CMDCAS cert

Dear Somashekar,

Thank you for your reply.

Will Health Canada suspend my company medical device licences if my CMDCAS cert is expired and they did not recevied the new CMDCAS before the expiry date?

Best regards,
Arnthor
Yes. This could happen.
Keep HC informed and ask them the consequences. However do also let us know if this delay is purely from your CB, or there has been delay in your responses to open audit findings.
 

RA Guy

Involved In Discussions
#5
Re: Expired CMDCAS cert

The rsgistrar should be able to issue a bridge letter if the issue is certificate issuance vs. CMDCAS compliance. If you passed your recent audit and are only waiting on the administrative release of the cert. this should not be a problem. I would run this past HC first before blindly dropping a letter on them.

In hindsight wondering if you shceduled the recert audit far enough in advance to avoid a gap in your certificate validity.
 
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