Regulatory Open Forum

Dear all,

We have a medical device kit that includes the main device which is manufactured by us; 3 from other medical device companies and several non-medical devices. We put them in a case and do not label them. All the devices are individually registered with Health Canada, and in this case, do we still need to register the kit?

My opinion is that we do not have to and the only reference I could find from the guidance is as below:

Question A1.2: Are all the COMPONENTS labelled with the same MANUFACTURER'S name?

Answer: In order for the COMPONENTS to be licensed with the SYSTEM, they must be labelled with the same MANUFACTURER'S name and identified on the application by individual medical device names and IDENTIFIERS.

COMPONENTS that are made by another MANUFACTURER under a contractual arrangement can still be licensed with the SYSTEM, provided that the SYSTEM MANUFACTURER whose name appears on the label accepts responsibility for the quality systems requirements.

If the response to question A1.2 is NO, the COMPONENTS will have to be licensed separately by their MANUFACTURERS.

Example: The TotalTM Phacoemulsification System manufactured by ABC Industries Inc. contains a number of COMPONENTS, including five interchangeable hand-pieces, up to fifteen models of coagulation accessories and numerous disposable supply packs. All but one of the above COMPONENTS are labelled with the head office address of ABC Industries, though the individual COMPONENTS may be manufactured at different branch manufacturing sites. One of the handpieces is made and labelled by a different MANUFACTURER. In regard to this COMPONENT, the answer to question A1.2 is NO, and the MANUFACTURER of the hand-piece will have to apply for a separate licence. The TotalTM Phacoemulsification System, except for the above hand-piece, is the subject of one application, as a SYSTEM.

My question to the community is do we have to register the kit? and is the reference I cited strong enough to support my opinion as not registering the kit?

We also noticed that we put a label that has the manufacturing symbol on it. Should we keep it here? would it be an issue being the fact that we are not the only manufacturing site.

Thank you.

Hello Lulu,

I would refer you back to the Health Canada guidance on Families, Groups, Systems, etc., of medical devices which are registered in Canada - though sure you are familiar as you are citing some text.  First, be careful about applying a label(s) at a "System" or "Kit" level because if the packaging level with your organisation identified as the Manufacturer could have issues later.  Indeed the Components of a Kit which are manufactured by different (legal) Manufacturer's is up to their responsibility to license those products with Health Canada.  If your organisation is taking your own registered medical device, some other Manufacturers medical device(s), and non-medical components putting them all together as a "kit" or commonly referred to as a convenience kit, then each component needs to have its own license.  If you put your name on a label as the Manufacturer for everything "inside" the kit, then you might become the legal and responsible manufacturer.  So just be careful with how you are labelling the packaging for the kit and identification of all the components inside the kit or system.

Dear all,

We have a medical device kit that includes the main device which is manufactured by us; 3 from other medical device companies and several non-medical devices. We put them in a case and do not label them. All the devices are individually registered with Health Canada, and in this case, do we still need to register the kit?

My opinion is that we do not have to and the only reference I could find from the guidance is as below:

Question A1.2: Are all the COMPONENTS labelled with the same MANUFACTURER'S name?

Answer: In order for the COMPONENTS to be licensed with the SYSTEM, they must be labelled with the same MANUFACTURER'S name and identified on the application by individual medical device names and IDENTIFIERS.

COMPONENTS that are made by another MANUFACTURER under a contractual arrangement can still be licensed with the SYSTEM, provided that the SYSTEM MANUFACTURER whose name appears on the label accepts responsibility for the quality systems requirements.

If the response to question A1.2 is NO, the COMPONENTS will have to be licensed separately by their MANUFACTURERS.

Example: The TotalTM Phacoemulsification System manufactured by ABC Industries Inc. contains a number of COMPONENTS, including five interchangeable hand-pieces, up to fifteen models of coagulation accessories and numerous disposable supply packs. All but one of the above COMPONENTS are labelled with the head office address of ABC Industries, though the individual COMPONENTS may be manufactured at different branch manufacturing sites. One of the handpieces is made and labelled by a different MANUFACTURER. In regard to this COMPONENT, the answer to question A1.2 is NO, and the MANUFACTURER of the hand-piece will have to apply for a separate licence. The TotalTM Phacoemulsification System, except for the above hand-piece, is the subject of one application, as a SYSTEM.

My question to the community is do we have to register the kit? and is the reference I cited strong enough to support my opinion as not registering the kit?

We also noticed that we put a label that has the manufacturing symbol on it. Should we keep it here? would it be an issue being the fact that we are not the only manufacturing site.

Thank you.