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COVID 19 Exception and MDSAP

Ed Panek

Ed Panek

QA RA Small Med Dev Company
Trusted Information Resource
#1
#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?
 
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M

mohaddese

Registered
#4
#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
 
D

DannyK

Trusted Information Resource
#5
#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.
 
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