The article highlights the key points related to the regulatory status of in vitro diagnostic medical devices.
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Health Canada, the Canadian healthcare product regulatory authority, has released a draft guidance on determining medical device application types.
This document outlines the criteria for choosing the appropriate application type, along with regulatory requirements and recommendations for compliance.
It’s important to note that the guidance is not legally binding, and it doesn’t create new rules or obligations. Health Canada also retains the right to update the guidance if needed to align with legislative changes.
In particular, the document describes the specific criteria to be applied and also highlights the key aspects associated thereto when it comes to in vitro diagnostic medical devices (IVDDs).
Single Medical Device Criteria and Licensing
The authority mentions that medical device criteria emphasize that only one device should be contained within a single medical device license or authorization.
This means, for example, if the manufacturer applies for authorization for a generic standalone analyzer or a single FISH Probe, the final license will consist of just one device ID and one device identifier.
However, there is a notable exception for devices that come in varying package sizes. For instance, glucose test strips sold in packs of 10, 50, or 100 can still be registered under one single medical device application.
It is important to mention that medical device components, which cannot be linked to a system, test kit, or a medical device family, must be individually licensed.
This also applies to components that are not manufactured by the main device or system’s producer.
Test Kit Criteria
In vitro diagnostic test kits can be listed under the same license or authorization given they meet several specific conditions, including:
- Having the same intended use and design,
- Using the same reagent formulation,
- Only differing in size configuration or other non-significant differences in instrument-specific characteristics.
However, if there is a major change to one test kit on a license that contains multiple kits, it will affect all the kits under that license.
For instance, various formats of at-home pregnancy tests, even if they aim to determine the same thing, cannot be grouped under one license since they have different test designs.
The authority additionally emphasizes that while test kits can be manufactured by the same company and might even include reagents compatible with other test kits, the license does not cover any instrumentation required to conduct the test.
It is further clarified that any separate reagents or test kit components should have their names and device identifiers included in the licensing application.
Medical Device Family Criteria
According to the guidance, “medical device family” refers to products created by the same manufacturer, possibly differing in size, concentration, or brand names.
However, significant differences in manufacturing processes, designs, or intended use between family members are not permissible.
Furthermore, while analyzers with similar designs but different throughput, software, or performance characteristics might be acceptable under the same family application, they must still comply with Health Canada’s regulations.
Medical Device System for IVDDs Criteria
Medical device systems are compilations of components designed to function together for a specific purpose.
Each system should have a unified name, and its labeling must reflect how every component is essential for the device’s overall function.
However, devices with various test strips measuring different elements cannot be considered a system, even if they share the same brand name.
All components of a system need to originate from a single manufacturer.
Regarding system licenses, Health Canada requires that every medical device must have its Unique Device Identifier showcased on the final license to be considered legal.
The guidance further provides several examples illustrating the approach described hereabove. According to the document, manufacturers have the flexibility to combine various IVD devices as described in several scenarios:
Blood Grouping Reagents
These can be grouped by phenotype/group antigen if they share the same reagent type. An example would be ABO determination reagents being bundled under a single application, while Kell phenotype reagents would need a separate application.
Tissue typing/HLA Typing Reagents
They can be grouped by class specificities. Reagents for Class I typing might require one family license, whereas Class II reagents would require a separate one.
Drugs of Abuse Panel Tests
These tests, used for detecting drug presence, can be grouped by format. Their device identifiers should distinctly represent each drug.
Thus, the final license should list each drug’s specific identifier, ensuring the product labeling lists all relevant device identifiers.
It is vitally important to understand and correctly adhere to the specific criteria when seeking licensing or authorization for medical devices, test kits, and systems.
Each category has its unique set of guidelines to ensure standardization, safety, and efficacy.
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