Advertising as MDEL (Medical Device Establishment Licensed)

K

Kymmie

We were granted our MDEL license (YAY!). Now I am wondering about letting our potential client base know that. I can't seem to find any "rules" about how we are allowed to advertise. Does anyone know if we can put a Health Canada flag on our webpage and state that we are MDEL licensed? Thanks in advance!:agree1:
 
K

Kymmie

Well of course! :D It would be nice to advertise it on the webpage though to catch those folks wandering by that we haven't talked to yet. LOL.
 
M

MIREGMGR

I'm not aware that Health Canada has any specific rules regarding marketing communications in relation to an MDEL or MDL that you validly hold, as long as you don't communicate something blatantly false.
 
Y

yana prus

Does anyone know if we can put a Health Canada flag on our webpage and state that we are MDEL licensed?

Hi Kymmie,

Guidance Document GD207: Guidance on the Content of ISO 13485 Quality Management System Certificates Issued by Health Canada Recognized Registrars
http://www.hc-sc.gc.ca/dhp-mps/md-im/qualsys/cmdcas_scecim_accep_cert13485_gd207-eng.php
states that "Registrars and Manufacturers shall not use any logos or symbols associated with the Canadian Federal Identity Program on their certificates (or other documentation)". I would suggest consulting Quality Systems Section @ Medical Devices Bureau regarding putting Health Canada flag on your website to ensure you don't violate any of Health Canada regulations. They can be contacted at:

Phone: (613) 952-8250
Fax: (613) 946-6758
E-mail: [email protected]

Good Luck,
Yana
 
M

MIREGMGR

Note however in regard to GD207 that its scope is specifically limited to CMDCAS certificates. GD207 makes no mention of websites, and no mention of MDEL licenses.
 
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