Health Canada, the country’s regulating authority in the sphere of healthcare products, has published a guidance document dedicated to medical device license application types.
Apart from the general description of existing medical device application types, the document also contains a Q&A section which provides more details on the most important questions related to the matter. The guidance provides non-binding recommendations to be considered by medical device manufacturers intending to place their products on the Canadian market. Thus, in case of any discrepancies with the provisions of the applicable legislation, the latter should prevail.
First, the authority explicitly states that the scope of the present guidance covers only medical devices subject to regulation under both the Food and Drug Act and the Medical Devices Regulations. Certain products may only be subject to regulation by the first (e.g., veterinary devices).
Additionally, there are some categories of medical devices for which the requirement to obtain a license could be waived. This rule applies to:
- Custom-made medical devices,
- Medical devices intended to be imported or sold for special access, or
- Medical devices for investigations testing involving human subjects.
These products are regulated under the Medical Devices Regulations and are currently exempted from licensing requirements, together with the low-risk Class I medical devices.
Medical Devices (non-IVDDs)
The first section provides clarifications regarding general (other than in vitro diagnostic) medical devices. In particular, Health Canada describes a step-by-step process to be followed in order to determine the appropriate medical device license application type to be used for the particular product in question.
For this purpose, the responsible entity shall consider the following:
1.Whether the device in question is a system. According to the document, a system is a product comprised of several components. If the answer is positive, one should additionally consider whether all the components of the system are intended to be marketed under the name of the system and labeled with the name of the same medical device manufacturer. In this regard, the authority also mentions that some of the components could be manufactured by another manufacturer. However, the system manufacturer should remain responsible for compliance with the quality system requirements. Otherwise, each of the manufacturers would have to apply for a license separately.
2.Whether it is a medical device group. As mentioned in the initial guidance, a medical device group stands for a medical device that is composed of a collection of medical devices, such as a procedure pack or tray, that is labelled and sold under a single name. If the answer is positive, one should further consider whether the device group in question could be assigned to a medical device group family, which is a collection of medical device groups that are made by the same manufacturer, have the same generic name specifying their intended use, and differ only in the number and combination of products that comprise each group. If the answer is positive, all components could be covered by the scope of the same application for the family, while the medical device group family name will be used as a general name. The authority additionally emphasizes that such a name should match the intended use of the medical device groups the family subject to review contains. Another important aspect relates to the licensing of individual medical devices of which the medical device group is comprised. In particular, should all the medical devices the group contains already be licensed, the group itself will be deemed licensed as well. Otherwise, the applicant will have to provide detailed information about any and all medical devices the medical device group contains. Moreover, if such devices are also offered separately, they should be licensed separately as well. According to the applicable regulatory requirements, medical devices could be covered by the scope of a single medical device group application only provided they are placed on the market only as parts of the group and are not available separately.
3.Whether the product subject to review is a single medical device. According to the guidance, every single medical device has its unique device name and is placed on the market as an independent product. If the device in question belongs to a medical device family that is already licensed, an applicant shall add such device as a new family member. For this purpose, an applicant shall submit an amended license application containing such details as the name of a medical device and necessary identifiers. If a medical device subject to review cannot be attributed to any medical device family duly licensed in Canada, such a device should be licensed as a separate product, and a new license application for a single medical device will be required. If the device is a component of a system manufactured by a third-party manufacturer, it should be explicitly included in the application submitted.
In Vitro Diagnostic Devices
The guidance further highlights the most important aspects related to license applications for in vitro diagnostic medical devices. The questions to be considered in this regard include the following:
1.Whether the product in question is an IVDD system. According to the guidance, an IVDD system usually comprises several components, including collection devices, test kits, and an automated analyzer. The regulatory approach to be applied in the case of IVDD systems is similar to the one applied for general medical device systems. At the same time, the authority emphasizes that if components [of an IVDD system] are used in more than one system and are not sold under the system name, they cannot be licensed with the IVDD system. Moreover, all components of an IVDD system should be labeled with the same medical device manufacturer name. As in the case with general medical device systems, the system manufacturer should be fully responsible for the components manufactured by third parties.
2.Whether the product is a test kit comprised of numerous reagents or articles intended to be used together to conduct a specific test. If these reagents are not placed on the market separately, they could be covered by the scope of a single application for a test kit. However, in certain cases, some of the reagents could be available separately.
3.Whether it is a medical device group. The rules to be applied in this regard are similar to those used for general medical device groups.
4.Whether the product in question is a single in vitro diagnostic medical device, which has its unique name and is intended to be marketed as a separate item. The authority also mentions that the single IVDD could be a reagent or article not deemed licensed as part of a system or a test kit.
In summary, the present Health Canada document dedicated to medical device license application types provides detailed guidelines intended to assist medical device manufacturers in determining the appropriate type to be used. The Q&A section of the guidance outlines the main criteria to be taken into consideration by the applicant prior to submission.
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