Establishment Licence Labeling Requirements in Canada for Class I Medical Devices

Q

qremsg26

Hi all,

Can anyone give me the following information:

what are the requirements and process for obtaining establishment licence in canada (for class I medical device)? Does each state or any state has different labelling requirements? How long does it take for review and approval process and the fees involved?

Thanks in advance!
 
Last edited by a moderator:

Stijloor

Leader
Super Moderator
Hi all,

Can anyone give me the following information:

what are the requirements and process for obtaining establishment licence in Canada (for class I medical device)? Does each state or any state has different labelling requirements? How long does it take for review and approval process and the fees involved?

Thanks in advance!

Can someone help?

Thank you!!

Stijloor.
 
Y

yana prus

qremsg26; said:
what are the requirements and process for obtaining establishment licence in canada (for class I medical device)!

Hi,

There is a great guidance for the Medical Device Establishment Licence in Health Canada:
http://www.hc-sc.gc.ca/dhp-mps/alt_...li-conform/gui_mdel-doc_aeim_20051117-eng.pdf
(Page 9 refer to the fees and page 10 refers to the labeling requirements).

Link to a form that should be filled out - Medical Device Establishment Licence Application Form
http://www.hc-sc.gc.ca/dhp-mps/alt_...compli-conform/frm_mdel-leim_20051216-eng.pdf

Hope that helps.

Yana
 

DannyK

Trusted Information Resource
Health Canada have made chanages to the Establishment License program and have increased its fees for establishment licenses to $7200 Canadian.
I have attached the latest communication.
 

Attachments

  • ELU Poster Upcoming Changes_ Attachment 1.pdf
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