COVID 19 Exception and MDSAP

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
#1
For emergency use in Canada under COVID-19 rules for temporary use is MDSAP required or is FDA clearance and ISO 13485 certification enough?
 
Elsmar Forum Sponsor
#4
hi Danny,
I saw your response to a person who was asking you about
Who needs a MDEL?
and you told him to send him a private message. Would you please send me the requirements for getting a MDEL?
thanks in advance
 

DannyK

Trusted Information Resource
#5
Hi Mohaddese,
An MDEL is for class I medical devices and for distributing licensed medical devices that are class II, III and IV.
There are some procedures required for the the MDEL.
The application form is pretty straightforward. It is here.
Medical Device Establishment Licence (MDEL) application: instructions (FRM-0292) - Canada.ca

If you have any issues you can send me a PM.
Health Canada will perform an audit (virtual) to ensure that you are meeting the requirements within a few months of receiving the MDEL so it is important that the procedures are well written.
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
#6
I am receiving conflicting guidance for the term of approval under the Interim Order. One source is telling me that once approved under IO it's valid for 4 years thereafter. Another source is telling me its over once the IO is removed.

My real question for our business is "Does having this IO approval assist us once we apply for regular approval for a Class IIa device?" We submitted quite a bit of documentation for this approval and I would think the burden is not as high as a brand new submission.
 
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