April, 6, 2023

Health Canada Medical Device System License Components Sold Separately

In general, components of a licensed medical device system can be sold separate from the system on the condition that the label of each component bears the system name. Also, strictly speaking based on Health Canada’s CMDR and guidance terminology and interpretations, additional conditions are that, to be covered by the Medical Device System license, 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.