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.

Health Canada: Licence Amendment vs New Licence Application

Knowing whether an existing Canadian Medical Device Licence can be amended or an entirely new Medical Device Licence is required depends on a number of critical factors/variables.  Those critical factors/variables include, but may not be limited to, the licence/device class, licence type, and the specifics of the change.  Those details need to be known in order to unravel and apply Health Canada’s corresponding licence amendment requirements.

Some changes can be made via relatively abbreviated amendments using an abbreviated mechanism/format offered by Health Canada, while other amendments need a full amendment using Health Canada’s full amendment format, while still other changes will indeed demand a whole new licence application altogether.  These amendment variables aren’t driven by the manner in which you keep your internal technical documentation or file; instead, they are driven by the nature of the variables themselves.

Also of note, when doing applications for new or amended Canadian Medical Device Licences, we don’t “designate” the applications via a cover letter; instead, we must choose and select the appropriate application type and Health Canada format corresponding to the nature of the change.  Indeed, the application type and format are what intrinsically identify the type of application.  In other words, if an applicant is planning on just using a cover letter and the applicant’s own format for the Canadian licence application rather than the proper corresponding format(s) established by Health Canada, then the application will be rejected.

Health Canada Medical Device Importer Requirements for DTC Sales

When dealing with Health Canada’s medical device regulatory requirements (i.e., SOR/98-282 as amended from time to time, hereinafter the “CMDR”), there are four device classes: I, II, III, and IV.  Therefore, when adapting a regulatory strategy from surrounding jurisdictions, be sure to consider the unique differences in Canada’s device classification scheme, such as with respect to the EU’s class IIa category, or such as with respect to the USA, which only has three risk classes.

The CMDR don’t demand that an importer be designated for each imported shipment or device.  Rather, it has been my experience that a person automatically becomes an importer based on whether the person engages in activities that meet Health Canada’s definition for importer.  Oddly enough, neither the CMDR nor its statutory counterpart (the Canadian Food and Drugs Act) define importer.  But in guidance (see GUI-0016), ‘importer’ is defined as a person in Canada, other than the manufacturer of a medical device, who is responsible for the medical device being brought into Canada for sale.

In the case of internet sales directly to consumers for personal home use, Health Canada has expressed to me in prior correspondence that such a consumer is viewed to be the importer.  However, for that type of importer, neither the importer MDEL requirements (nor any other CMDR importer requirements) apply because of CMDR subsection 2(b).  For example, GUI-0016 states an MDEL exemption for “any person who imports a medical device for his/her own personal use”.

Health Canada CMDR Updates 2021

Here’s a quick recap of Health Canada’s changes to the Medical Devices Regulations (SOR/98-282) that started coming into force on 23 June 2021:

1. 1. Effective 23 June 2021, Health Canada has additional authorities to require us to do certain analyses and make certain information available to them upon request regarding device risks/problems, etc.  Generally, this won’t require any changes in our QMSs, but we can certainly add QMS coverage voluntarily to assure the organization is ready to cooperate in the event such Health Canada demands are made.

    

   2. Effective 23 June 2021, Canada’s Mandatory Problem Reporting requirements change in three ways and we need to have our Mandatory Problem Reporting procedures revised accordingly:

    

   1. Canadian “Mandatory Problem” reporting is now Canadian “Incident” reporting.
   2. Foreign incident reporting is now limited to Class I devices; yet
   3. Class II, III, and IV foreign incident reporting has been replaced with a new process called “Foreign Risk Notification”.

    

   3. Effective 23 December 2021, Health Canada will require a certain type of post-market surveillance and a report called a “Summary Report” which may in certain circumstances require submission to Health Canada within 72 hours.  An associated seven-year record keeping requirement is included.  Corresponding procedures should be integrated into our QMS procedures for PMS.  I found that Canada’s new PMS requirements can be met by leveraging certain PMS tasks already being done for the EU MDR, and then adding a few tweaks.  I also recommend a designated “Summary Report” template be used for the Canadian Summary report, as the particular conclusions and analyses required for Canada are unique compared to the EU MDR’s PMSR and PSUR.

    

   4. The aforesaid changes were brought about via a SOR/2020-262 which conveys the series of regulatory amendments for SOR/98-282 (as well as for the Food and Drug Regulations C.R.C., c. 870). The SOR/98-282 changes that took effect on 23 June 2021 are expected to be incorporated into the Justice Laws website version within a couple weeks.  The SOR/98-282 changes that will take effect 23 December 2021 will likewise be integrated in due course thereafter. The title of SOR/98-282 (Medical Devices Regulations) will remain unchanged.

    

   A good place to document consideration of applicable new or revised regulations is during management review.  For example, consideration of such regulatory changes is required as a management review input under ISO 13485 clause 5.6.2(l); a similar approach can certainly be applied even if it is not an ISO 13485 QMS.  It would be sufficient to record a high-level summary of such changes, and then a general implementation plan/timeline.  This would also be a good place to state the aforesaid relationship between SOR/2020-262 and SOR/98-282.