The Health Canada, the Canadian regulating authority in the sphere of medical devices, issued an interim order and guidance document concerning the importation and marketing of medical devices during the outbreak of the Coronavirus Disease 2019 (COVID-19) caused by the virus “SARS-CoV-2” or the “novel coronavirus.” The order is intended to address the urgent needs that the medical device industry has faced during the pandemic, mostly associated with the complications and respiratory illnesses caused by the novel coronavirus
Health Canada Order in Brief
The order provides the definitions of the most important specific terms used in the sphere, namely:
- COVID-19 medical device, defined as one manufactured, marketed or intended to be used to address the impact of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2);
- Foreign regulatory authority – another national regulating authority in the sphere of medical devices, entitled to implement regulatory measures in its jurisdiction (outside Canada),
- Incident – an event occurred in relation to the medical device (e.g. failure of the device or consequences of its use in the form of harm caused to the patient’s health).
Importation and Marketing Rules and Requirements
Health Canada states that certain provisions of the medical device regulations, should not be applied to COVID-19 medical devices. If there is a public need for the device in question, the appropriate application of the authorization should be duly submitted by the manufacturer, while the Ministry has already authorized the importation or marketing of the device and such authorization has not been revoked.
In order to be allowed to import or market its medical device in Canada, the manufacturer shall submit the appropriate application form, containing the following information:
- The name of the device in question,
- The class of the device in accordance with the risk-based classification,
- The indication of the identifier of the device,
- Details about the manufacturer as indicated on the labeling of the device, including the name and address,
- Details of the manufacturing site producing the device in case if it differs from the address of the manufacturer,
- The intended purpose of the device (e.g. diagnosis or treatment of certain conditions),
- Important information on the safety and performance of the device,
- The instructions for use, except in cases when the device could be used without them,
- The confirmation of compliance with the post-market surveillance requirements, including handling the complaints, reporting on incidents and advert events associated with the use of the device, and also the recalls or withdrawals when it is required under the applicable regulations,
- A sample of the labeling.
In the case of Class III and IV medical devices in accordance with the risk-based classification, the manufacturer shall also provide additional information due to the higher risks associated with the use of such devices. Thus, the applications for Class III and IV COVID-19 medical devices should additionally be supplemented with:
- Information about the materials the device itself and its packaging are composed of,
- The marketing history of the device, including information about other countries where the device in question has been already placed on the market, along with accumulated and summarized information about adverse events and corrective or preventive actions taken by the manufacturer.
At the same time, for low-risk medical devices, the manufacturer is not obliged to provide the information about the validity of the marketing authorization issued in the country of origin.
The authorization requested by the manufacturer could be issued providing that:
- The application submitted by the manufacturer meets all applicable requirements,
- The manufacturer has also provided all additional information,
- The evidence presented by the manufacturer is sufficient to confirm that the benefits of using the device are more significant than the appropriate risks associated thereto,
- The authority determines that the use of the device would not expose the health of the patients to the undue risks.
The interim order issued by Health Canada also provides additional rules and requirements that medical device manufacturers shall comply with in order to be allowed to import and market its devices on the Canadian market.
- Change notification. If the COVID-19 medical device, already authorized by the authority for importing and marketing, has been subject to significant changes, the manufacturer shall apply for amendments to the authorization. Upon the receipt of such an application, the regulating authority must evaluate the compliance of the modified medical device to the applicable safety and performance requirements and issue the amendments to the authorization.
- The authority is entitled to introduce additional rules and requirements regarding the authorization for importation or marketing of the medical devices intended to be used to address the impact of the coronavirus disease. According to the order, each shipment of the device should be accompanied by a copy of the appropriate authorization.
- The authorization allowing to import and market the device could be canceled by the regulating authority if the device no longer meets the applicable safety and performance requirements or the additional terms and conditions, or when the marketing authorization issued in the country of origin of the medical device in question has been canceled by the appropriate foreign regulatory authority.
- Additional requests. The authority is entitled to require the medical device manufacturer applying for authorization for a COVID-19 medical device, or already holding such authorization, to provide additional information or materials (e.g. samples) that are reasonably necessary for the authority to be able to make a proper determination.
- All adverse events associated with the use of the COVID-19 device should be duly reported by the manufacturer no later than 10 days from the day that the manufacturer became aware of such incidents. The notification submitted by the manufacturer shall include the name of the device, the information about the nature of the adverse event, and the circumstances it occurred in.
Health Canada Labelling Requirements for COVID-19 Medical Devices
The interim order issued by Health Canada also includes detailed labeling requirements. According to these requirements, the labeling of the device should contain the following information:
- The name of the device,
- Details of the manufacturer (its name and address),
- The identifier of the device
- The control number (for Class III or IV medical devices),
- Indications of the content of a package, including information on the size, weight, other dimensions of the device, and the number of units,
- The indication “STERILE” (if applicable),
- Indications of the shelf life of the device and the expiry date (if applicable), based on the components with the shortest shelf life,
- Indications for use and performance specifications, when it is reasonably necessary to ensure the use of the device in a safe and effective way,
- Indications of specific storage conditions (if applicable).
Summarizing the information provided hereabove, the interim order issued by the Health Canada implements additional rules and requirements applicable to medical devices intended to be used in the context of the COVID-19 outbreak.
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