Health Canada has published a guidance dedicated to the applications for medical devices under the Interim Order for use in relation to the COVID-19. Interim Order (IO) constitutes a special document issued to accelerate the implementation of vitally important rules and requirements, as well as special flexibilities reasonably necessary to address certain issues faced by the healthcare sphere. The present IO refers to the issues related to the outbreak COVID-19.
Regulatory Background
The present document is intended to assist the medical device manufacturers, healthcare institutions, and other parties involved in operations with medical devices by providing them with certain recommendations to be considered. Due to its legal nature, the guidance does not establish any binding requirements to be followed, and an alternative approach could be applied, providing that such an approach has been agreed with and approved by the regulating authority prior to its actual implementation.
It is also important to mention that the regulating authority is entitled to request the parties involved to provide additional information and documentation, providing that it is reasonably necessary for the authority to assess the case.
The present Interim Order is intended to simplify and accelerate the regulatory procedures related to placing on the market the medical devices that are vitally important in the context of the COVID-19 outbreak. In particular, it describes the way the medical device manufacturers shall apply for permission to import or placed medical devices on the Canadian market. The authority mention that the scope of this Interim Order covers only the devices intended to be used for diagnosis, treatment, mitigation, or prevention of COVID-19. Moreover, the appropriate purpose should be explicitly indicated by the medical device manufacturer.
The guidance also describes the obligations of the medical device manufacturers in the sphere of adverse event reporting, as well as recalls.
Authorization to Import or Sell COVID-related Medical Devices
According to the guidance, the medical device manufacturer intended to import or sell COVID-related medical devices shall apply for the approval to be issued by the regulating authority.
The aforementioned Interim Order outlines the scope of the information to be provided by the medical device manufacturer applying for such an authorization.
The authority additionally emphasizes that an authorization under this Interim Order will be granted only if Health Canada determines that there is a public need for the importation or sale of the COVID-19 medical device submitted.
The special regulatory framework introduced by the virtue of the present Interim Order could be applied in the following cases:
- Marketing approval for the entirely new medical devices intended to be used in the COVID-19 context,
- Approval of a new COVID-related use for medical devices already placed on the market either under the general framework (set forth by the Medical Device Regulations) or under the Interim Order,
- COVID-related medical devices already cleared and approved for marketing by a foreign regulating authority.
However, the present framework cannot be applied for medical devices withdrawn from the market due to the suspension of the appropriate license based on safety-related issues. Such a device could not be imported or listed.
It is also important to mention that the special regulatory framework for importation and sale of COVID-related medical devices introduced by the present Interim Order shall remain valid only during the term of validity of the Interim Order itself. Thus, certain flexibilities introduced by the virtue of the present Interim Order are of a temporary nature.
According to the guidance, in order to facilitate importation and sale of COVID-related medical devices, and consequently to ensure and expand their availability during the pandemic, the regulating authority announces that all fees associated with the medical devices imported and placed on the market under this framework could be waived.
Applying for Authorization
As it is stated by Health Canada, the medical device manufacturer applying for authorization with regard to the COVID-related medical device shall provide the information sufficient for the regulating authority to assess the request and determine whether the requested authorization could be granted. The initial scope of information to be submitted is described in the Interim Order itself. It is also important to mention that the use of the application form developed by Health Canada is not mandatory – the regulating authority would accept the submissions made in any format suitable for the applicant, while the use of a special application form would definitely simplify all regulatory procedures.
Besides the medical device manufacturer itself, the application for authorization for importing or sale of medical devices intended to be used in the context of the COVID-19 outbreak could be also submitted by the importer or distributor, providing that they are duly authorized by the manufacturer to act on its behalf. For this purpose, the manufacturer shall indicate its authorized representatives in the appropriate field in the application form. However, the application form itself should be signed only by a senior official of the manufacturer. At the same time, an authorized representative would be entitled to carry out all further communications with the regulating authority with regard to the application and medical device in question.
According to the guidance, the manufacturer shall indicate the following information:
- The name of the medical device subject to review (the same that would be indicated in the labeling),
- The class of the medical device under the risk-based classification (in case if several classes are applicable, the highest one should be used),
- The identifier of the medical device,
- The details about the medical device manufacturer (the same that would be indicated in the labeling), including its name, address, and also the actual address of the manufacturing facilities,
- The intended use (as it was mentioned before, it should be related to the diagnosis, treatment, mitigation, or prevention of COVID-19 or complications associated thereto), including such details as the intended purpose, targeted patient population, anatomical and physiological particulars, as well as the indications regarding the use of any source of energy and the document version and number.
The medical device manufacturer shall also provide the information confirming that the COVID-related medical device in question complies with the applicable safety, quality, and effectiveness requirements. As it was already mentioned before, the regulating authority reserves the right to request additional information when deems necessary. The applicant shall also provide the directions for use, except the cases when it is not required due to the nature of the device.
Summarizing the information provided here above, the Interim Order issued by Health Canada describes the temporary and extraordinary measures introduced by the regulating authority in order to ensure and expand the availability of medical devices intended to be used in the context of the COVID-19 outbreak, while the guidance associated thereto provides additional clarifications and recommendations to be considered by medical device manufacturers applying for authorization. The guidance also outlines the scope of information and documents to be submitted to the regulating authority when applying for authorization for importation and sales of medical devices.
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