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Who needs a MDEL (Medical Device Establishment License)?

racglobal

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#1
Hi everyone,

I am still not 100% clear on who needs an MDEL. A medical device manufacturer who holds Medical Device Licenses (Class II-IV) and sells directly to customers do not need an MDEL. I understand this. But what happens if this manufacturer sells its devices through other parties or distributors in Canada and in other countries? It's not selling directly but through other channels. Does this make the manufacturer a distributor now of its own devices so it has to declare itself now as a distributor and pay the establishment licensing fee?

Thanks. I appreciate this.
 
#2
I looked at HC guidance on medical device establishment licensing:
Screen Shot 2019-08-23 at 8.51.42.png
The way I read 44(2)(c) is that as long as you are the manufacturer of a the medical device and have a medical device license to show for it - you are exempt from medical device establishment licensing, regardless of how you market or distribute your product.

Screen Shot 2019-08-23 at 9.03.19.png


You - the manufacturer - hold a Medical Device License and the distributor/importer holds a MDEL. This way the regulator knows who's who in the zoo...
 
#3
Hi Ronen,

The company distributing the medical device needs to get the MDEL.
The manufacturer does not need to get an MDEL to sell class II, III or IV devices in Canada.
The definition of a manufacturer is the company that has its name on the medical device.

Danny
 
#4
However, it is our understanding that if you take on a Class I device, you then have to get a MDEL, despite having licences for the Class II-IV devices. I am not sure why the MDEL is necessary since you are doing all the same due diligence anyway. Perhaps someone could answer this.
 

racglobal

Involved In Discussions
#5
The MDEL would then only apply to the Class I, if you are a manufacturer/distributor of that Class I. But my understanding from reading others' posts is that the MDEL requirements would not apply for the Class II-IV devices that you actually manufacture and sell under your name. Therefore, you would not have report revenue for sales of Class II-IV, which you sell to the public. On the MDEL form, you would not be checking off distribution for Class II-IV. Somebody please confirm. Thanks.
 
#6
Ronen- you are correct.
Edward- MDEL is necessary since class I devices do not require an ISO 13485:2016 quality system but requires procedures for distribution records, recall, mandatory problem reports, servicing and installation. Class II, III and IV require an ISo 13485:2016 MDSAP quality system.
 
#7
I recognize that, but how is this requirement necessary when one also must have MDSAP (which covers all of the same material)? Health Canada makes MDSAP a mandatory requirement for medical device sales in Canada, yet also requires the MDEL solely for Class I devices.
 
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