Guidance for determining medical device application type: Application type for non-IVDDs

On this page

• Single medical device criteria
• Medical device family criteria
• Medical device group criteria
• Medical device group family criteria
• Medical device system criteria

Single medical device criteria

A single medical device application type should only ever contain 1 device.

The medical device licence or authorization will only include 1 device ID and 1 device identifier. However, medical devices that vary in package sizes can be included on a single medical device licence or authorization. In cases where there is one medical device with multiple packaging sizes, there would be 1 device ID and multiple device identifiers on the same licence or authorization.

Example:

• Condoms sold in packages of 8, 12 and 20, as long as the individual pouch labelling satisfies the labelling requirements for products sold to the general public

A single medical device licence or authorization can include a medical device that is sold with accessories, as long as they do not qualify as medical devices in their own right.

Example:

• A hearing aid sold with generic, off-the-shelf batteries (for example, size 312 batteries)

A single medical device licence or authorization can include multiple components or accessories if all the parts are sold within one package and are represented by a single device identifier, and are physically connected at the time of sale.

Example:

• A guidewire and catheter that are pre-loaded and packaged together are considered a single medical device. However, a guidewire and a catheter that are packaged separately are considered a medical device system, as the guidewire and catheter qualify as 2 separate medical devices.

Additional information

Medical devices, parts or components that cannot be assigned to a system, medical device family, medical device group or medical device group family must each be licensed or authorized as a single medical device. This includes components or parts that are not sold under the manufacturer's name or are not sold with the systems with which they can be connected.

Medical device family criteria

Medical device family members:

• are made by the same manufacturer
• have the same design and manufacturing process
• have the same intended use
• differ only in shape, colour, flavour or size
• may have different brand names

Certain family members may serve as representative devices against which all key testing can be completed to support claims for all other devices in the family. Typically, these representative devices encompass the full range of possible specifications across the family. As such, the safety and effectiveness of the representative devices completely support all safety and effectiveness claims of all other devices in the family.

Example:

• For a family of stents, representative devices may include models with the smallest length and diameter and the model with the largest length and diameter (for instance, shortest thinnest, shortest thickest, longest thinnest, longest thickest – commonly known as four corner testing). Other dimensions, materials, intended use and manufacturing processes are identical.

Design

The design philosophy of family devices should be supported by key testing of the representative devices that supports all other devices in the family.

Device family members

Examples:

• Cardiac resynchronization therapy devices that differ from each other only in minor software features (for example, increased number of programmable A/V pacing delays), where at least one model includes all of the available features
• Heart valves with sizes different from those already authorized on the same medical device licence or authorization (even though the introduction of these would be deemed a significant change and require a review of clinical evidence)
• Patient monitors that differ in combinations of optional input sockets (for example, support for connection to third party modules such as ECG, SpO2, CO2) or, for a given input, differ in vendor support (for example, ABC SpO2 input vs. XYZ SpO2 input)
• Patient monitors that differ only in feature sets enabled by software, where at least one model includes the full set of available features
• Bare esophageal stents made of the same material and that only differ in length or diameter of the stents and for which all stents are indicated for narrowing due to benign tumor

Not device family members

Examples:

• Any combination of toric, non-toric, monofocal, bifocal, extended depth, or trifocal intraocular lenses, as they have different optical designs and/or indications for use
• Infusion pumps with different pumping control mechanisms (for instance, syringe-based pump versus a peristaltic pump), as they do not share the same control mechanism
• Therapeutic ultrasound systems that rely on different operating principles, such as through thermal damage versus cavitation, to achieve their therapeutic effect
• Different left atrial appendage devices with design differences in structure (for example, fine mesh design versus fabric covered solid construction)
• Different models of endoprosthesis that use an alternate expansion mechanism (for example, nitinol self-expansion vs. balloon expansion)
• Cardiac resynchronization therapy devices from different generations of models with physical design differences or different software features that are not common across the different generations of models

Materials

Key testing of the representative devices should support all devices in the family.

Device family members

Examples:

• Dental materials that only differ in colour
• A difference in the material of an external, non-patient contacting accessory (for example, the operator handle on a non-invasive ultrasound transducer)

Not device family members

Example:

• Esophageal stents of varying lengths and diameters, where some are bare and others are covered or partially covered, as the covering introduces a different key material

Intended use

The medical device family may have only 1 overall intended use. While individual family members may have more precise indications for use, in general they should be clinically equivalent.

The intended use is determined from the medical device labelling and may also be inferred from the promotional material for that medical device. For information on labelling medical devices and defining intended use/indication for use, consult the following guidance documents:

• Labelling of medical devices, not including IVDDs
• Labelling of in vitro diagnostic devices

Device family members

Examples:

• Hearing aids that are intended to amplify sound and transmit sound to the ear for adults at different amplitudes for different frequencies to enhance hearing, and only differ in colour
• Bone plates that have the same intended use and indications for use, but vary in shape and size
• A single model of intra ocular lenses (IOLs) that have the same optical design, intended use and indications for use, and only differ in diopter
• Dual-chamber implantable cardioverter defibrillators and single-chamber implantable cardioverter defibrillators that have the same intended use and the same base software. In such cases, the dual-chamber device includes all functionality available in the single-chamber device and differs only in the number of cardiac leads. In this case, the specific indication for use for the single-chamber and dual-chamber devices may be different.

Not device family members

Examples:

• Wire guide A intended for use in the delivery of percutaneous catheters into the peripheral vasculature and wire guide B intended for use in the delivery of percutaneous catheters into the gastrointestinal tract and urinary tract
• Medical devices which have the same design, manufacturing process and materials, but do not have a clinically equivalent intended use
• Dermal fillers that are sold under the same broad general intended use, for example, intended for injection into the dermis or subcutaneous tissue to temporarily restore facial volume, but where model alpha is indicated for correcting deep nasolabial folds, and model beta is indicated for nasolabial folds and augment lips, cheeks and chin
• Drug-coated balloons/stents indicated for different anatomical targets (for example, below the knee vs. coronary) where safety and effectiveness are based on different clinical study data
• Implantable cardioverter defibrillators and cardiac resynchronization therapy devices have different intended uses (for instance, different patient populations)

Manufacturing process

In general, family devices must have the same manufacturing process. This involves being supported by the same manufacturing process validation requirements.

Device family members

Examples (where all other medical device family criteria are met):

• Devices released from the sterilization process by either biological indicators or parametric release
• Devices that are sterilized using the same type of sterilization process (for example, ethylene oxide) but are subject to different manufacturing specifications (for example, cycles optimizations)

Not device family members

Examples:

• Devices sterilized using different sterilization methods (for example, ethylene oxide vs. steam)
• Sterile and non-sterile devices
• Devices where some are laser-cut from a solid Nitinol tube, and some are cast in a mold of the same geometry.
• Dermal fillers with different levels of cross-linking

Additional information

Under Section 30 of the Medical Devices Regulations (regulations), it is Health Canada's interpretation that each medical device must have its respective device identifier appear on the final licence or authorization in order to be licensed or authorized. However, only evidence concerning representative members of the medical device family may be needed during the application review process.

If a device, or subset of devices, listed on a family licence undergo a significant change and those same changes are not applied to the other devices on that licence, this may impact the eligibility of the changed device(s) on the family licence and may require a separate licence.

Medical device group criteria

A medical device group may only be labelled with a single device identifier that represents a collection of devices. Examples of medical device groups may include procedure kits and first aid kits. The Global Medical Device Nomenclature (GMDN) Agency has a complete definition of these terms.

Example:

• One cardiovascular procedure kit

Components of a medical device group do not have to be fabricated by the same entity. However, the person who meets the definition of manufacturer as set out in section 1 of the regulations must hold the medical device licence or authorization.

The devices within the medical device group may be labelled individually or provided in bulk form. However, the entire medical device group must be labelled and sold under a single name.

Example:

• An Acme Suture Tray, manufactured by Medical Devices Ltd., is a medical device group
  • This group contains a number of devices packaged together (for example, needles, suture thread, drapes, swabs, needle holder and other single-use disposable devices) for convenience to meet a specific purpose (for instance, wound closure).
  • Medical Devices Ltd., as the manufacturer of the group holds the licence, even when the group contains devices fabricated by others.

Devices licensed or authorized in a medical device group cannot be sold nor distributed outside the context of the group without a single or family medical device licence or authorization.

Example:

• An orthopedic implant instrumentation set contains disposable reamers, tibial spacers, screwdriver, drill guide and driver. If the manufacturer wishes to sell the disposable reamers separately, then the component must have its own single or family medical device licence.

Additional information

Under Section 31(1) of the regulations, a medical device group is deemed licensed if all the devices that constitute the group are individually licensed. Similarly, under section 68.09(1), a medical device group is deemed authorized if all the devices that constitute the group are individually authorized.

This allows a manufacturer to bundle some of their products, normally offered for sale individually, into promotional packages without needing additional licences or authorizations. Under these conditions, the individual medical devices must maintain the labelling and integral packaging (for instance, sterility) detailed in their licences or authorizations.

Medical device group family criteria

A medical device group family is composed of a collection of medical device groups that must:

• be made by the same manufacturer
• have the same generic name specifying their intended use, including the same intended use
• differ only in the number and combination of products that comprise each group

Examples of a medical device group family can include procedure kits and first aid kits. The GMDN Agency has a complete definition of these terms.

Examples:

• A medical device group family licence of Polyglycolic Acid Suture packs consisting of the suture, needle, scalpel, scissors and gauze are indicated for general soft tissue approximation and/or ligation. A similar pack with the same combination of medical devices that include a suture is indicated for superficial soft tissue approximation of the skin and mucosa only (not general). This pack cannot be included on the medical device group family licence as the 2 sutures do not have the same indications for use.
• Pro-Pack Surgical Kits are manufactured by ABC Surgical Supply Company. The kits are medical device groups containing a number of medical devices and other items (which are not medical devices) within them such as swabs, povidine-iodine sticks, gauze, sutures and needles, of varying size and shapes. Although these components are individually packaged and labelled, most of these items are bought in bulk from their manufacturers to be sold only as part of the kits. ABC Surgical Supply Company may submit 1 licence application for the Pro-Pack Surgical Kits as a medical device group family. The kits are customized for various hospitals and different surgical procedures, but the inner components (medical devices included within the kits) are selected from a list of medical devices submitted with the group family licence application. This list is typically included in the cover letter or device description document.

Generic packs/trays sold without a defined intended use that are grouped for an indication (for example, obstetrics, cardiovascular) can be included under 1 medical device group family licence or authorization. The various medical device group family members may exist under a general overarching indication (for example, medical specialty), presuming that the generic packs/trays are otherwise the same.

Example:

• Procedure packs all indicated for use in cardiovascular procedures (for example, intended for use in major vascular procedures such as abdominal aortic aneurysms, femoral angiography), would be considered medical device group family members, presuming the pack design, indications for use (for example, medical specialty), materials and manufacturing process are the same and supported by the same body of evidence.
• A medical device group family can include a variety of devices with different sizes, such as peripheral stents. Each packaged device can be considered a group, as it includes accessories with a main balloon catheter and implantable stent. The different packs come with different peripheral stents that vary in diameter and length. Although the names of the devices may be different, they should share a similar family name (for example, ACME 99 stiff and ACME 99 flex). Minor design differences may include catheters that differ in dimensions to accommodate different guidewires (0.014" and 0.035") and implantable stents that come in an array of different diameters and lengths.

Additional information

The medical device name indicated for the medical device group family must appear, at least in part, on the label of each group. This can be a brand name or a generic name. Individual medical device names may contain additional descriptive phrases.

Under Section 30 of the regulations, it is Health Canada's interpretation that each medical device must have its respective device identifier appear on the final licence in order to be licensed. Similarly, under section 68.08, it is Health Canada's interpretation that each medical device must have its respective device identifier appear on the final authorization in order to be authorized.

However, only information concerning representative members of the medical device group family may be needed during the application review process.

Medical device system criteria

A medical device system is a medical device that includes a number of components or parts intended to be used together, but not necessarily all at the same time, to fulfil some or all of the medical device's intended functions.

A medical device system should be represented and sold under a common "system" name. This could be a generic system name (such as gynecological ultrasound system) or a trademarked/brand name (such as ABC Ultrasound System 1). It is recommended that the system name appear on the medical device labelling.

Example:

• ABC Implants manufactures the XYZ Implant as well as the AA delivery system. This delivery system must be used to deliver the XYZ implant. The instructions for use, provided with the XYZ implant, describe how to deliver the implant using the AA delivery system. The medical devices have different names, but because they constitute a dedicated system, they must reside on the same system licence.

A medical device system has a single overarching intended use statement.

Medical device system

Example:

• A radiofrequency (RF) ablation system consisting of an RF generator, 2 RF electrodes and a power cart. The system's intended use is to cut and coagulate tissue. However, the RF generator also has an intended use of "for generation of RF on the ABC system"; the RF electrodes state they are "intended for soft tissue and bone"; and the power cart is intended "to provide battery back to the ABC system".

Not a medical device system

Example:

• The ABC shoulder system includes humeral stems, humeral heads, screws and glenoids for anatomic shoulder replacement, as well as humeral cups, humeral liners and glenospheres for reverse shoulder replacement. These should not be on the same system licence. The reverse shoulder components are not expected to be used together with the anatomic components and have unique indications (they are indicated for use only when the rotator cuff is non-repairable).

There can only be 1 manufacturer for all system components. Components or parts of a medical device system that are labelled under a different manufacturer's name must be licensed or authorized separately.

Example:

• A breathing circuit device and tubing with the legal manufacturer, ABC Company, is compatible with ventilator systems from several different legal manufacturers, ABC Company and XYZ Company. Since the breathing circuit is compatible with ventilator systems from multiple legal manufacturers, it would be licensed separately. It would still be considered a compatible device and should be listed as such on the application form along with the related licence number.

Systems manufactured by the same manufacturer may include components that are also compatible with other systems made by that same manufacturer. The components need to appear on each system licence.

Examples:

• A foot-switch by manufacturer ABC may be compatible with multiple x-ray systems by manufacturer ABC. In these instances, the foot-switch should be listed on all system licences for which it is designed and labelled for use.
• Abutments by manufacturer XYZ may be compatible with multiple dental implant systems. The abutments should be listed on all dental implant system licences for which they are designed and labelled for use.

Additional information

All Class II, III and/or IV system components that are medical devices in their own right and are to be imported and/or sold in Canada are to be included on the licence or authorization. This includes replacement and spare device components, as well as consumables that may be available to the customer or end user.

In general, multiple devices sold as systems need to be licensed or authorized separately. In limited cases, complex groupings of devices sold as systems may reside on a family licence or family authorization. In these cases, the manufacturer is responsible for documenting clearly how they qualify for this option based on the family licence or authorization criteria.

Examples where a family licence or authorization is needed:

• Full featured Device A with features X, Y, Z, Device B with features X, Y and Device C with only feature X would be allowed on the same licence, provided the scientific evidence for Device A also covers Device B and C. There is 1 identifier for Device A, 1 for Device B and 1 for Device C. Any accessories are sold and always packaged together under the identifier for A, B or C only.
• Identical medical devices that differ only by software feature availability, as long as the differences in features do not confer any difference in intended use, associated risks, or the risk mitigations applied.

Examples where a separate system licence or authorization is needed:

• Full featured System A with features X, Y, Z, System B with features X, Y and System C with only feature X would be allowed on the same licence, provided that A, B and C have equivalent safety and effectiveness evidence. There is 1 identifier for System A, 1 for System B and 1 for System C, and any components, parts, or accessories that qualify as devices in their own right are sold and packaged under their own identifiers.
• A CT scanner system is designed such that different models are marketed with access to a different subset of the identical features as controlled solely by software configuration (controlled by the manufacturer). All other aspects are identical, including intended use. Compatible accessories can be sold separately with their own identifiers.