Regulatory Open Forum

Hello everyone,

I am working on product registration in Canada. I have a quick question. Our company products were registered in Canada as a SYSTEM that contain several components. Can these components be sold and shipped separately? I appreciate your help.

Thank you,

Linda

Yes indeed on the condition that the label of each component bears the system name.

Hello everyone,

I am working on product registration in Canada. I have a quick question. Our company products were registered in Canada as a SYSTEM that contain several components. Can these components be sold and shipped separately? I appreciate your help.

Thank you,

Linda

Thank you for responding promptly. I have some more questions regarding a previous SYSTEM product registration. This SYSTEM registration includes multiple components, including a pump set that is comprised components not explicitly listed in the license. One of these components in the pump set is a purge cassette. Can this component be shipped out independently for the same medical purpose? the pump set is listed in the license. If not, what steps should be taken?

Thank you very much,

Linda

Yes indeed on the condition that the label of each component bears the system name.

Hello everyone,

I am working on product registration in Canada. I have a quick question. Our company products were registered in Canada as a SYSTEM that contain several components. Can these components be sold and shipped separately? I appreciate your help.

Thank you,

Linda

Thanks for providing those additional details.  Strictly speaking, I'd say probably not based on Health Canada's CMDR and guidance terminology and interpretations.  Specifically, in order to be covered by the Medical Device System license, then here are some important rules regarding the System's components:

• "Component" means one of several possibly unequal subdivisions into which something is or is regarded as divided and which together constitute the whole. A component may also be referred to as a part or an accessory.
  
  
• Components not sold under the System name cannot be licensed with the System, even when they are intended to be used together.
  
  
• All the Components of a System must be listed on the license application by Medical Device Name and by Identifiers (e.g., Catalog Number, etc.).  This means they must also appear on the System license via those identifiers.
  
  
• The application must provide documentation and information on all Components of the System.
  
  

But if one were aiming to deviate from these strict interpretations (for example by claiming that a subcomponent is just a replacement/consumable part), then it would be best to first consult Health Canada for permission regarding such deviations. Otherwise, such subcomponents will need their own dedicated Device License(s), either by way of amending the current System license to add the additional descriptors, or else by getting a new individual device license(s) depending on further details of the scenario.

Thank you for responding promptly. I have some more questions regarding a previous SYSTEM product registration. This SYSTEM registration includes multiple components, including a pump set that is comprised components not explicitly listed in the license. One of these components in the pump set is a purge cassette. Can this component be shipped out independently for the same medical purpose? the pump set is listed in the license. If not, what steps should be taken?

Thank you very much,

Linda

Yes indeed on the condition that the label of each component bears the system name.

Hello everyone,

I am working on product registration in Canada. I have a quick question. Our company products were registered in Canada as a SYSTEM that contain several components. Can these components be sold and shipped separately? I appreciate your help.

Thank you,

Linda

Hello Linda,

You might have seen this already, but Health Canada has provided some additional text and explanation regarding system, group, family https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/guidance-interpretation-sections-28-31-licence-application-type.html.  While I like that Health Canada has done this to help with some of the more complex medical devices being sold, it does provide a little determination to properly understand how a system is put together.  Also as Kevin says, contact Health Canada to inquire - they are quite receptive and help organisations answer questions like these.

Thanks for providing those additional details.  Strictly speaking, I'd say probably not based on Health Canada's CMDR and guidance terminology and interpretations.  Specifically, in order to be covered by the Medical Device System license, then here are some important rules regarding the System's components:

• "Component" means one of several possibly unequal subdivisions into which something is or is regarded as divided and which together constitute the whole. A component may also be referred to as a part or an accessory.
  
  
• Components not sold under the System name cannot be licensed with the System, even when they are intended to be used together.
  
  
• All the Components of a System must be listed on the license application by Medical Device Name and by Identifiers (e.g., Catalog Number, etc.).  This means they must also appear on the System license via those identifiers.
  
  
• The application must provide documentation and information on all Components of the System.
  
  

But if one were aiming to deviate from these strict interpretations (for example by claiming that a subcomponent is just a replacement/consumable part), then it would be best to first consult Health Canada for permission regarding such deviations. Otherwise, such subcomponents will need their own dedicated Device License(s), either by way of amending the current System license to add the additional descriptors, or else by getting a new individual device license(s) depending on further details of the scenario.

Thank you for responding promptly. I have some more questions regarding a previous SYSTEM product registration. This SYSTEM registration includes multiple components, including a pump set that is comprised components not explicitly listed in the license. One of these components in the pump set is a purge cassette. Can this component be shipped out independently for the same medical purpose? the pump set is listed in the license. If not, what steps should be taken?

Thank you very much,

Linda

Yes indeed on the condition that the label of each component bears the system name.

Hello everyone,

I am working on product registration in Canada. I have a quick question. Our company products were registered in Canada as a SYSTEM that contain several components. Can these components be sold and shipped separately? I appreciate your help.

Thank you,

Linda

Hi Kevin and Richard, 

I appreciate your insightful reply.
Could you please clarify whether components or subcomponents of a system must be listed on the license in order to be shipped separately? For instance, suppose we have acquired a system license for HeartABC, which includes components A, B, and C. Component A is a set that comprises subcomponents e and d, which can be used as replacement parts. Can we include both the components (A, B, C) and subcomponents (e, d) on the system license, provided that we name them correctly using the System name-component name convention?

Best regards, 

Linda

Hello Linda,

You might have seen this already, but Health Canada has provided some additional text and explanation regarding system, group, family https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/guidance-interpretation-sections-28-31-licence-application-type.html.  While I like that Health Canada has done this to help with some of the more complex medical devices being sold, it does provide a little determination to properly understand how a system is put together.  Also as Kevin says, contact Health Canada to inquire - they are quite receptive and help organisations answer questions like these.

Thanks for providing those additional details.  Strictly speaking, I'd say probably not based on Health Canada's CMDR and guidance terminology and interpretations.  Specifically, in order to be covered by the Medical Device System license, then here are some important rules regarding the System's components:

• "Component" means one of several possibly unequal subdivisions into which something is or is regarded as divided and which together constitute the whole. A component may also be referred to as a part or an accessory.
  
  
• Components not sold under the System name cannot be licensed with the System, even when they are intended to be used together.
  
  
• All the Components of a System must be listed on the license application by Medical Device Name and by Identifiers (e.g., Catalog Number, etc.).  This means they must also appear on the System license via those identifiers.
  
  
• The application must provide documentation and information on all Components of the System.
  
  

But if one were aiming to deviate from these strict interpretations (for example by claiming that a subcomponent is just a replacement/consumable part), then it would be best to first consult Health Canada for permission regarding such deviations. Otherwise, such subcomponents will need their own dedicated Device License(s), either by way of amending the current System license to add the additional descriptors, or else by getting a new individual device license(s) depending on further details of the scenario.

Thank you for responding promptly. I have some more questions regarding a previous SYSTEM product registration. This SYSTEM registration includes multiple components, including a pump set that is comprised components not explicitly listed in the license. One of these components in the pump set is a purge cassette. Can this component be shipped out independently for the same medical purpose? the pump set is listed in the license. If not, what steps should be taken?

Thank you very much,

Linda

Yes indeed on the condition that the label of each component bears the system name.

Hello everyone,

I am working on product registration in Canada. I have a quick question. Our company products were registered in Canada as a SYSTEM that contain several components. Can these components be sold and shipped separately? I appreciate your help.

Thank you,

Linda