The Health Canada, the Canadian authority responsible for medical devices regulation, issued guidance describing the way the Interim Order on medical devices, recently issued by the authority, should be applied. The initial document implements a set of additional rules and requirements concerning medical devices used in the context of Coronavirus Disease 2019 (COVID-19) caused by the virus “SARS-CoV-2” or the “novel coronavirus.”
Scope of Health Canada Guidance
The present document is intended to provide medical device industry representatives and other parties involved with the additional information necessary to maintain compliance with the new rules and requirements temporarily introduced by the new order. The document describes the general approach the aforementioned requirements should be applied, while the authority reserves the right to require additional information or implement additional requirements that would be reasonably necessary to ensure public health protection during the pandemic.
The scope of the Health Canada guidance covers the most important regulatory aspects related to the import and placing on the market the devices intended to be used in the context of treating complications caused by the COVID-19, as well as respiratory illnesses associated thereto.
The initial Interim Order contains the definition of a COVID-19 medical device. According to the guidance, the manufacturer should explicitly indicate that the device is intended to be used for diagnosis, treatment, or mitigation of the coronavirus disease caused by the aforementioned virus.
The document also describes in detail all other responsibilities of the manufacturers and importers on all steps of a medical device lifecycle, including the obligations in the field of post-marketing surveillance and recalls.
In accordance with the Interim Order, the manufacturer or importer of the device in question shall apply for authorization by submitting the appropriate application to the national regulating authority – the Health Canada. It is important to mention that the regulating authority additionally evaluates whether the device subject to review is reasonably needed for patients and healthcare professionals.
The accelerated import and marketing authorization procedure, introduced by the Interim Order, could be applied in the following cases:
- Initial authorization of an entirely new medical device related to the COVID-19,
- Authorization to use the already licensed medical device for the purposes related to the COVID-19,
- Authorization of COVID-19 medical devices properly authorized by another (foreign) national regulating authority.
It is explicitly stated that the new regulatory framework could not be applied to previously authorized medical devices that had its license suspended due to concerns related to compliance with the applicable safety and effectiveness requirements. The authority granted under the Interim Order should remain valid only for the initial validity period of 1 year, while the authority reserves the right to extend the period the Interim Order remains effective. In such a case, the validity of authorization granted under the Interim Order would be extended also.
Canadian COVID-19 Medical Device Regulation in Detail
According to the Interim Order, COVID-19 medical devices could be exempted from the general marketing authorization procedure set forth by the Medical Devices Regulations. To benefit from the exemption, the manufacturer or the importer of a medical device intended to be used in the context of the coronavirus disease should obtain the appropriate authorization from Health Canada. Such authorization allows manufacturers to import or market medical devices in Canada before the appropriate Medical Device License would be received. It is also important to mention that any administrative fees should be paid for the submission of the application for authorization under the Interim Order.
Another important aspect related to flexibilities introduced by Health Canada relates to the Quality Management System to be implemented by the manufacturer. According to the guidance, the manufacturer may waive the requirement to provide an MDSAP certificate before applying for authorization as it is required under the general rule. In case of accelerated authorization under the Interim Order, it would be sufficient to confirm that the device in question complies with the applicable quality requirements by providing technical documentation (technical file).
The application for authorization to be submitted by the manufacturer or importer should include the following information:
- The name of the device allowing users to distinguish the device from other devices of the same kind.
- The indication of the class of the device in accordance with the risk-based classification. In case if due to the nature of the device several classes are applicable, the highest one should be indicated.
- The identifier of the device, including the details necessary if the device is a part of a system, test kit, a family, or a group of medical devices.
- The information about the manufacturer of the device, including its name and address in a way it would be indicated in labeling. It is also necessary to indicate the actual address of the production site where the device is being manufactured.
- The intended use of the device, including its mechanism of action, indications for use, the information on patients the device is intended for, the details on the energy source used (if applicable).
- The information on quality, safety and performance of the device, including a description of the device itself, a relevant copy of the QMS Certificate, the indications of using additive manufacturing or human tissue and its derivatives, as well as the information on all testing the device was subject to (e.g. biocompatibility or bench testing), references to the standards used, the comparison to similar devices already present on the market.
- The directions for use necessary to the patients or healthcare professionals to be able to use the device in a safe and efficient way. It is also stated that all information the directions for use contain should be provided in a manner suitable for potential users due to their level of qualification.
- Attestation for post-market oversight confirming that the applicant duly maintains compliance with all applicable requirements in the sphere of post-market surveillance, including incident reporting and handling complaints.
- The sample of a label of the device. According to the Health Canada guidance, in case if the whole scope of information required under the Interim Order could not be including in label due to its size, all information including the directions for use should be provided separately in a leaflet supplied together with the device.
- The description of materials used. The authority also states that it may require the applicant to provide additional information regarding biocompatibility.
- Marketing history of the device, including the information on adverse events related to the device.
- The marketing approval issued by a foreign medical device regulating authority. It is important to mention that Health Canada explicitly indicates that an approval issued on a state level would be admissible too.
Import and Marketing Authorization Cancellation
The guidance also describes the cases creating grounds for cancellation of the import or marketing (sale) authorization previously granted by Health Canada, namely:
- The use of the medical device in question exposes the health of patients to the undue risks,
- The device does not meet the terms and conditions set forth by the regulating authority,
- The device becomes licensed in accordance with the general procedure,
- The foreign authority suspends or withdraws the authorization of the medical device in the country of origin.
Summarizing the information provided hereabove, Health Canada guidance dedicated to COVID-19 medical devices describes in detail the requirements medical device manufacturers shall comply with in order to be allowed to place their devices on the Canadian market.
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