Who needs a Medical Devices Establishment License (MDEL)?

[PL.]

Hi there,

I am so confused on who should apply for[FONT=&quot] [/FONT][FONT=&quot]Medical Devices Establishment License (MDEL) [/FONT]after reading related guidance and document...

In the case of following supply chain, who should apply for MDEL??

[FONT=&quot]Manufacturer (outside Canada) --> [/FONT][FONT=&quot] Distributor (outside Canada) [/FONT]--> [FONT=&quot] Local company (in Canada) [/FONT]--> [FONT=&quot]end user (in Canada)[/FONT]

p.s. the medical devices in question are class II and class III. And, the manufacturer already owns those licenses in Health Canada.


Many thanks!

 

[DannyK]

If you are distributing class 1, 2, 3 or 4 medical devices in Canada you need an MDEL. If you are the manufacturer and distributor for class II, III or IV, you do not need an MDEL. You need a medical device license.
If you are a manufacturer and distributor of class I medical devices, you need an MDEL. It does not matter where you are located.

 

[PL.]

Thank you Danny.
I still don't get it...
To be more specific, we are the distributor (outside Canada), distributing licensed class II and class III device to Canada from the manufacturer (outside Canada).
(1) Do we need MDEL?
(2) Do our downstream distributor in Canada need MDEL?

 

[DannyK]

Thank you Danny.
I still don't get it...
To be more specific, we are the distributor (outside Canada), distributing licensed class II and class III device to Canada from the manufacturer (outside Canada).
(1) Do we need MDEL?
(2) Do our downstream distributor in Canada need MDEL?

1. Yes you need an MDEL
2. Yes your distributor in Canada needs an MDEL

 

[Ajit Basrur]

Thanks for the info DannyK.

PL. - did you refer the FAQs on MDEL here - http://www.hc-sc.gc.ca/dhp-mps/compli-conform/licences/ren-doc/faq-eng.php ?

 

[PL.]

Thank you both.

The FAQs is quite usefull!
It describes that:
Any person who imports into Canada, or sells in Canada, a medical device for human use requires an establishment licence.

Although we are distributor, we neither import into Canada nor sell in Canada (what we do is actually selling devices to the importer). In the case, we do not need MDEL, right? Am I mistaken?

 

[DannyK]

Thank you both.

The FAQs is quite usefull!
It describes that:
Any person who imports into Canada, or sells in Canada, a medical device for human use requires an establishment licence.

Although we are distributor, we neither import into Canada nor sell in Canada (what we do is actually selling devices to the importer). In the case, we do not need MDEL, right? Am I mistaken?

The definition for distributor is from the MDEL is:

Distributor: for the purposes of this guidance document, a distributor is a person, other than a manufacturer, an importer or a retailer, who sells a medical device in Canada for the purpose of resale or use, other than for personal use. A person outside of Canada selling medical devices into Canada is also considered to be a distributor.

If you do not fit the definition of Distributor or Importer- you do not need the MDEL.

The company that imports the product from you will need the MDEL.

To be sure, contact Health Canada. In my experience they were very helpful.

 

[anttoni]

Hey all,

We're a company based in Finland looking to 1) Buy a class III medical device from Canada and 2) use a distribution company to ship the medical device to the US to the end user (personal use). Do We OR/AND the distribution company need to have an MDEL?

Thanks in advance!

 

[DannyK]

Hi,
You only need an MDEL if you distribute the device in Canada.
If you are distributing the device in USA, you need to conform to the FDA requirements.