Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello Team, 

We have an IVD class II that we want to file to Canada. 

The IVD comes in two forms single pack and multipack. The content are the same just the quantity. only difference would be labelling one states as a single pack and the other multipack..

When filling for MDL, do we chose Test kit for license application type or medical device group? 

IF "Test kit" do we just list all the reagent, standards, controls ... in the device identifier?

Any guidance would be helpful.

Thank you!

Greetings,

In my experience you could do either, though I generally submitted under Test kit for IVD products.  This would also be quite true in your case because if only the quantities differ, the content of the kit is the same, then it would be appropriate as a Test kit.  The view being the "sellable" quantity can be up to the manufacturer on 1, 10, or 20 in a kit, but the content of the kit would be the same.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 24-Aug-2022 11:13
From: Anonymous Member
Subject: IVD MDL class II- license type

This message was posted by a user wishing to remain anonymous

Hello Team,

We have an IVD class II that we want to file to Canada.

The IVD comes in two forms single pack and multipack. The content are the same just the quantity. only difference would be labelling one states as a single pack and the other multipack..

When filling for MDL, do we chose Test kit for license application type or medical device group?

IF "Test kit" do we just list all the reagent, standards, controls ... in the device identifier?

Any guidance would be helpful.

Thank you!

This message was posted by a user wishing to remain anonymous

Thank you Richard! Since both the single and bulk kit have different ID names. Do I just add both the names under the filling?
Original Message:
Sent: 25-Aug-2022 03:01
From: Richard Vincins
Subject: IVD MDL class II- license type

Greetings,

In my experience you could do either, though I generally submitted under Test kit for IVD products.  This would also be quite true in your case because if only the quantities differ, the content of the kit is the same, then it would be appropriate as a Test kit.  The view being the "sellable" quantity can be up to the manufacturer on 1, 10, or 20 in a kit, but the content of the kit would be the same.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 24-Aug-2022 11:13
From: Anonymous Member
Subject: IVD MDL class II- license type

This message was posted by a user wishing to remain anonymous

Hello Team,

We have an IVD class II that we want to file to Canada.

The IVD comes in two forms single pack and multipack. The content are the same just the quantity. only difference would be labelling one states as a single pack and the other multipack..

When filling for MDL, do we chose Test kit for license application type or medical device group?

IF "Test kit" do we just list all the reagent, standards, controls ... in the device identifier?

Any guidance would be helpful.

Thank you!

Maybe, but it is a bit difficult to answer without seeing the specific information.  Recommend looking at the guidance for submission content and other guidance to ensure the correct approach is being used.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 25-Aug-2022 08:06
From: Anonymous Member
Subject: IVD MDL class II- license type

This message was posted by a user wishing to remain anonymous

Thank you Richard! Since both the single and bulk kit have different ID names. Do I just add both the names under the filling?
Original Message:
Sent: 25-Aug-2022 03:01
From: Richard Vincins
Subject: IVD MDL class II- license type

Greetings,

In my experience you could do either, though I generally submitted under Test kit for IVD products.  This would also be quite true in your case because if only the quantities differ, the content of the kit is the same, then it would be appropriate as a Test kit.  The view being the "sellable" quantity can be up to the manufacturer on 1, 10, or 20 in a kit, but the content of the kit would be the same.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 24-Aug-2022 11:13
From: Anonymous Member
Subject: IVD MDL class II- license type

This message was posted by a user wishing to remain anonymous

Hello Team,

We have an IVD class II that we want to file to Canada.

The IVD comes in two forms single pack and multipack. The content are the same just the quantity. only difference would be labelling one states as a single pack and the other multipack..

When filling for MDL, do we chose Test kit for license application type or medical device group?

IF "Test kit" do we just list all the reagent, standards, controls ... in the device identifier?

Any guidance would be helpful.

Thank you!