Health Canada classifies application types for non-in vitro diagnostic medical devices (non-IVDDs) into five categories: Single, Family, Group, Group Family and System. Below is a detailed explanation of the eligibility criteria.Definition: A single medical device assigned a unique name by the manufacturer. This is the most basic application type, where one licence covers only one device identifier.Key easily overlooked details:- Multiple packaging configurations may be combined. Where the same medical device is sold in multiple packaging sizes, one licence may cover one device identifier plus multiple device identification codes. For example, condoms sold in packs of 8, 12 or 20 units qualify as long as labelling on each individual pouch meets requirements.
- Sale together with non-device accessories still counts as Single. A single medical device licence may cover a medical device sold bundled with accessories that are not themselves medical devices. Example: hearing aids sold with generic off-the-shelf batteries (e.g. size 312 batteries).
- Pre-assembled, co-packaged multiple components qualify as Single. If multiple components/accessories are packed in one package, represented by one device identifier and physically connected at the point of sale, they are treated as one single medical device. Example: guide wire preloaded and co-packaged with catheter qualifies as Single. If sold in separate packaging, they fall under System, as both qualify as independent medical devices.
Definition：Medical devices manufactured by the same manufacturer, differing only in shape, colour, flavour or size, with identical design and manufacturing processes and the same intended use.Family is the most widely used but frequently misapplied application type. A product series can only be classified as a Family if all four criteria are satisfied simultaneously:- Produced by the same manufacturer
- Identical design and manufacturing processes
- Same intended use
Differences limited to shape, colour, flavour or size
Brand names may differ, but none of the four criteria can be waived.
Four dimensions for Family assessment：Design：Design rationale must be validated through key testing of the representative device(s) that support all other devices within the family.Materials：Key testing of the representative device(s) must cover all devices within the product series.Intended use：One overall intended use applies to the whole medical device family. While individual family members may have more specific indications, these indications must be clinically equivalent.Manufacturing process：Identical manufacturing processes shall be adopted, complying with identical manufacturing process validation requirements.
Definition：A set of multiple medical devices sold under a single name, such as a surgical pack or instrument tray.Core difference between Group and Family：A Family refers to different sizes/variants of the same product, while a Group consists of different products bundled together for sale.Variants require distinct device identifiers.One Group licence corresponds to one device identifier and one fixed kit configuration. Changes to kit configuration (component quantity or component specifications) constitute separate variants and cannot be included in a standard Group. Such variants shall use the Medical device group-family application type, where each variant retains its own device identifier under the Group-Family licence.Devices within a Group cannot be sold separately outside the Group scope.A device licensed under a Group may not be sold or distributed outside the Group unless it holds an independent Single or Family licence.Pre-licensed devices may be bundled into a Group for sale.Pursuant to section 31(1) of the regulations, if all medical devices forming a medical device group already hold independent licences, the group itself is deemed licensed and does not require a separate application. This allows manufacturers to bundle routinely sold standalone products into promotional kits.（四）Medical device group familyDefinition：Medical device groups manufactured by the same manufacturer, sharing a common generic name indicating intended use, differing only in the quantity and combination of constituent products across groups.Group Family is the "Family version" of Group: multiple Groups sharing the same intended use and differing only in product quantity and component combinations may be combined in one application.Eligibility criteria：- Manufactured by the same manufacturer
- Share a common generic name (clearly stating intended use)
- Differences exist only in the quantity and combination of products forming each Group
Example：Pro-Pack surgical kit series is a Group Family. It contains multiple medical devices and other items, customised to meet surgical requirements of different hospitals and surgical specialties. All internal components are selected from the medical device list submitted together with the group licence application.Definition：A medical device consisting of multiple components or parts intended to be used together (not necessarily simultaneously) to achieve part or all of the device’s intended function.Difference between System and Group：A Group is a bundle of devices for sale, which do not necessarily work collaboratively. A System is a combination of components that must operate together to achieve the intended function.Identified and sold under a unified system name.The name may be a generic system name (e.g. gynaecology ultrasound system) or a trademark/brand name.Components must be used together to achieve overall function.If components carry different names but must be used together within a defined system, they shall be included under one system licence where labelling specifies use as a combined system.All system components must be manufactured by a single manufacturer.All components listed under a System licence must have the System licence holder as their legal manufacturer. If a component is labelled with another manufacturer’s brand (third-party legal manufacturer), that component cannot be included in this System licence and requires independent licensing. OEM components (where legal manufacturer remains the System applicant) are permitted within the System.Compatible components must be listed on all applicable system licences.Components manufactured by the same manufacturer that are compatible with other systems must be listed on each system licence and marked for compatible use.Replacement parts, spares and consumables must also be included in the licence.- All Class II, III or IV system components that are medical devices, intended for import and/or sale in Canada, must be covered within the licence or authorisation, including replacement units, spare parts and consumables supplied to customers or end users.
Selection between System and Family：Normally, multiple devices sold as a system require separate licences. In rare cases, complex device combinations sold as a system may fall under a Family licence, provided the manufacturer documents compliance with Family eligibility requirements.Scenario suitable for Family：Device A with functions X, Y, Z; Device B with functions X, Y; Device C with only function X. If scientific evidence from Device A also supports Devices B and C, all may be authorised under one licence.Scenario requiring separate System licence：System A with functions X, Y, Z; System B with functions X, Y; System C with only function X. They may be authorised under one licence for combined use, provided A, B and C have equivalent safety and effectiveness evidence.
三、Practical Pitfalls to Avoid
Based on guidance and real-world application experience, below are the most frequent mistakes in application type determination.（一）Treating visually similar products as a FamilyFamily classification has strict four mandatory criteria: same manufacturer, identical design and manufacturing process, same intended use, differences limited to shape/colour/flavour/size. Failure to meet any criterion disqualifies products from Family status.
The most common error is grouping products simply because they look similar, ignoring differences in design principle, working mechanism, indications or manufacturing processes. Examples: intraocular lenses with different optical designs, infusion pumps with different pumping mechanisms, or products with different sterilisation methods cannot be grouped as a Family.（二）Intending standalone sales for Group components without separate licensingA device licensed under a Group cannot be sold/distributed outside the Group unless it holds an independent Single or Family licence.Many manufacturers submit a surgical pack as a Group application, only to find re-licensing required later when wishing to sell one component individually. If standalone sales are anticipated in the future, apply for a separate Single or Family licence for that component at the initial registration stage.（三）Including third-party-manufactured components in a SystemAll components within a System must be produced by a single manufacturer. If a component in the system bears the name of another manufacturer, that component requires separate licensing.Common scenario: third-party compatible accessories (e.g. breathing circuits, foot switches) used in a system. If the third party is merely an OEM, and the legal manufacturer remains the System applicant with no third-party branding on labels, the accessory may be included in the System licence. If the component’s legal manufacturer is a third party and labelled with their brand, it cannot be included in the system licence and must obtain its own licence.（四）Future changes to family models impacting the whole licenceIf one model within a Family may undergo a major change while other models will not be modified concurrently, those models should not be placed under the same Family licence from the start.The modified model may no longer satisfy Family eligibility criteria and require a separate licence. Therefore, planning product lifecycles and change pathways is a critical, often overlooked part of application type determination.
四、Decision Framework for Application Type
For a new product or product series, follow these sequential steps to determine the correct application type:（一）Distinguish IVDD vs non-IVDD. This defines which set of classification rules applies.（二）Evaluate the relationship between products.Decision pathway for non-IVDDIs it a single device, or a combination of multiple products?- If single device → Single
- If variants of the same product → Verify four Family criteria (same manufacturer, identical design & manufacturing, same intended use, differences only in shape/colour/flavour/size) → Qualified = Family
- If different products bundled for sale → Check if sold under a common name and whether components need collaborative operation. No collaborative requirement = Group; collaborative operation required = System
- If multiple Groups combined → Check same manufacturer, common generic name, differences only in component quantity and combination → Qualified = Group Family
（三）Verify boundary conditions. Confirm whether packaging specifications, accessories, compatible components, future changes and other special circumstances affect classification results.（四）Confirm representative models and evidence coverage. For Family or Group Family applications, verify representative models fully cover the full specification range and the evidence package supports all members.
Sound application type determination is not a last-minute task for form-filling. It is a strategic decision to be considered at the product planning stage.It requires comprehensive assessment incorporating product design, intended use, manufacturing processes, evidence package, sales model and future change pathways.
For further enquiries, please contact Wiselink.
