ARCHIVED Guidance on applications for medical device clinical trials under the interim order: Application guidelines and process
Notice to Reader:
We have replaced the Interim Order No. 2 respecting clinical trials for medical devices and drugs relating to COVID-19. See the regulations notice about the Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations.
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Pre‐clinical trial stage
If you have a general enquiry about conducting a COVID-19 medical device clinical trial, please email the Investigational Testing Division of the Medical Devices Directorate by email at email@example.com.
If you have specific questions about your COVID-19 medical device clinical trial application, especially if it involves novel Class III and IV devices, you should ask for a pre‐clinical trial meeting. These are held via teleconference. Submit your request in writing by emailing the Investigational Testing Division of the Medical Devices Directorate at firstname.lastname@example.org.
We will prioritize requests for advice related to COVID-19 clinical trials.
Submitting an application
Under this interim order, an application may be submitted for an authorization to:
- import or sell a COVID-19 medical device that is to be tested in a clinical trial and
- conduct a clinical trial using the COVID-19 device
Manufacturers and importers as well as clinicians, academia, contract research organizations and so on may submit an application.
For all applications, the applicant's senior official should complete, sign and date the submission.
The information can be submitted electronically, in whatever format you choose. Applicants are welcome to use standard document submission guidelines (the IMDRF table of contents format) or a "question and answer" format using the criteria specified below as headers.
Email your application to: email@example.com.
The cover letter accompanying the application must clearly indicate the direct use of the device in relation to the SARS-CoV-2 virus. Direct use includes the active role the device plays in diagnosing, treating, mitigating or preventing COVID-19, the disease caused by the virus. Be sure the application has enough information to help Health Canada make a decision on whether to issue a clinical trial authorization.
Detailed information required in an application filed in accordance with the interim order follows. Please note that the information to be submitted is dependent on the risk of the device. However, for the purposes of this interim order, you must submit all required information for Class II to IV COVID-19 medical devices unless otherwise stated.
Applicants and qualified investigators must keep records of all of the information and documents required under the interim order. You must keep these records while the interim order is in force.
Name and contact information of applicant and importer, if applicable
The name and the contact information of the applicant and importer (if different from the applicant) should include:
- the formal mailing address
- telephone number(s)
- the email address
Name and class of device
The device name is the name that appears on the labelling and for which the authorization is issued under the interim order. It includes information that helps the user identify the device and distinguish it from similar devices.
The class of device is established according to the rules set out in Schedule 1 of the Medical Devices Regulations. If a COVID-19 medical device can be classified into more than 1 class, the class representing the higher risk applies.
Description of device and materials used
A description of the device and materials used is required for Class III and Class IV COVID-19 medical devices, but is optional for Class II COVID-19 medical devices.
The description of the device should always include the physical parameters. Please supply photos and diagrams, if available. If the device is based on a previously authorized device, summarize the differences in specifications between the current device and the previous version.
List the materials used to manufacture and package the device. Also include an assessment of whether the material will come into contact with the patient or user for any period of time.
Biocompatibility testing of those materials may be required before the Minister can decide whether to issue an authorization.
Description of device features
A description of the device's features is required for Class III and Class IV COVID-19 medical devices but is optional for Class II COVID-19 medical devices.
Describe the features of the device that permit it to be used for the medical conditions and purposes for which it will be sold by the manufacturer. Provide a brief description of the device's design philosophy and performance specifications. Be sure to make a connection to the objectives of the proposed clinical trial.
You must provide the identifier of the device. This includes the identifier of any medical device that is part of a system, test kit, medical device group, medical device family or medical device group family.
Provide the name and address of the manufacturer as it appears on the device label, including the address where the device is manufactured, if different. This should be the legal manufacturer of the device.
Diagnosis, treatment, mitigation or prevention information for which the device is required
This information is required for Class III and Class IV COVID-19 medical devices but is optional for Class II COVID-19 medical devices.
The following information should be included:
- intended purpose, mechanism of action, indications for use, conditions for which the device is used
- the intended use statement should be verbatim as it appears on the device labelling
- patient population for which the device is intended, including age range, if applicable, and specific diagnoses
- anatomical and physiological details related to the patient using the device, if applicable
- if the device uses an energy source and whether energy is transferred to the patient
- document version number and the date where the formal intended use appears
A marketing history is required for Class III and Class IV COVID-19 medical devices but is optional for Class II COVID-19 medical devices.
Provide a list of countries other than Canada where the device has been sold and the total number of units sold in those countries. Also provide a summary of any reported problems with the device and any recalls of the device in those countries.
Quality, safety and effectiveness information
Information on quality, safety and effectiveness is required for Class III and Class IV COVID-19 medical devices but is optional for Class II COVID-19 medical devices.
Health Canada will ask for additional information if the information you provide is deemed insufficient to grant an authorization.
The following list is provided as a guide:
- clear description of the device, including how it works, any accessories to be used with it and diagrams/photos
- copy of the manufacturer's Quality Management System Certificate, evidence of good manufacturing practices or other
- discussion of whether any components are manufactured using additive manufacturing (for example, 3D printing, laser sintering, bioprinting)
- evidence of biological safety if the device is manufactured from or incorporates animal or human tissue or their derivative
- summary of any mechanical/bench testing data performed for the device
- summary of any animal testing and clinical investigations carried out with the device
- summary of any biocompatibility testing performed with the device, if applicable
- summary of the evidence of shelf-life and packaging validation testing, if applicable
- summary of electrical safety and electromagnetic compatibility (EMC) testing, if applicable
- marketing materials if the device is intended to be used at point of care or sold directly to a consumer
- description of the sterilization method and a summary of sterilization validation testing performed if the device is intended to be sold in a sterile condition
- list of applicable standards used in the design/manufacture of the device
- incidents with a discussion of each event and response from the manufacturer
- comparison table outlining technological differences between this device and predecessors that are or were licensed in Canada, if applicable
- comparison table outlining technological differences between the proposed medical device and any available (authorized) comparators, to the applicant's knowledge
- discussion of the software validation testing performed if the device is or includes software
- analytical validation studies if the medical device is or includes an in vitro diagnostic device, such as
- specimen validation testing
- sample preparation validation
- the limit of detection, when applicable
- cross reactivity (in silico analysis and cross reactivity testing)
- preliminary precision results, if applicable
- stability of samples
- preliminary reagent stability
- clinical validity studies
If the in-vitro diagnostic device involves a serological test, please refer also to the guidance document Requirements for serological antibody tests submitted under the COVID-19 interim order.
Directions for use
The applicant must provide the directions for use, unless directions are not required for the device to be used safely and effectively. For some complex, active or powered devices, the directions for use may require a special surgeon's instruction manual, operator's manual or user's manual.
A control or version number should be clearly indicated in the document.
Attestation for post-market oversight
The applicant must provide an attestation that documented procedures are in place for distribution records, handling complaints, reporting incidents and recalls. We have provided an example of an attestation form.
The device label should be legible, permanent, displayed prominently and easily understood by users.
If a package is too small to display all of the required information, the directions for use must be included. They do not need to be on the outside of the package or visible.
Information on the qualified investigator is required for Class III and Class IV COVID-19 medical devices but is optional for Class II COVID-19 medical devices.
The applicant must provide the name of the qualified investigator and their qualifications, including training and experience. An academic or clinical curriculum vitae along with evidence of membership in good standing with a health care professionals' regulatory body are suitable.
If a clinical trial is conducted by a team, provide the name of the responsible leader (qualified investigator) of that team. It is not necessary to provide the names and credentials of the other qualified investigators at other trial sites.
However, you must keep this information. Health Canada may ask for this information if there is a safety issue that requires the medical device to be traced.
The applicant must provide the name and contact information of the institution where the qualified investigator is conducting the clinical trial. The contact information should include the formal mailing address, telephone number(s) and email address.
Also required is the protocol of the proposed clinical trial. This protocol should indicate the following:
- number of human subjects
- number of units of the device proposed to be used for the clinical trial
- hypothesis for and objective of the clinical trial
- period of time during which the clinical trial will be carried out
The applicant must also provide a copy of the informed consent form.
A written undertaking is required for Class III and Class IV COVID-19 medical devices but is optional for Class II COVID-19 medical devices.
The applicant must provide a written agreement from the lead qualified investigator to:
- conduct the clinical trial in accordance with the protocol provided by the applicant
- inform a clinical trial subject of any risks and benefits associated with the use of the device and obtain the subject's informed consent for its use
- not permit the device to be used by any other person except under the direction of the qualified investigator
The applicant and the lead qualified investigator should have this information but the applicant does not need to submit it.
Research ethics board contact information
This information applies to Class III and Class IV COVID-19 medical devices.
For each trial site, the applicant must provide the name and contact information of the research ethics board that approved the protocol and informed consent form, if known at the time of submitting the application.
The contact information should include the formal mailing address, telephone number(s) and email address.
Other pertinent information
Applicants should follow the principles of the Declaration of Helsinki and the Tri‐Council Policy Statement: Ethical Conduct for Research Involving Humans. They should also conform to good clinical practices as set out by ISO 14155, Clinical investigation of medical devices for human subjects. The ISO 14155 standard is generally consistent with the definitions and requirements of the interim order. Where there are inconsistencies, the interim order takes precedence.
Applications for devices that were previously authorized for investigation under a different study protocol can be cross‐referenced for device specific information. The results of the previously authorized study should be provided, if available at the time the application is submitted.
For Class II, III and IV devices, the applicant and qualified investigator must keep records of all the information and documents required under the interim order while the interim order is in force.
Note: Any application that was outstanding when IO No. 1 was repealed will still be deemed to be an application under IO No. 2. Health Canada has the authority to request more information about a COVID-19 clinical trial submission at any time.
Issuing an authorization
Health Canada is committed to reviewing clinical trial applications and clinical trial application amendments for COVID-19 medical devices within 14 days. Additional information and material, including samples, that we request is encouraged to be submitted within 2 calendar days of the request.
For more information on the review/authorization process, please consult the Applications for medical device investigational testing authorizations guidance document.
The authorization holder may not import or sell COVID-19 medical devices or conduct a clinical trial with that device unless they have obtained approval from a research ethics board at each clinical trial site.
Note: A COVID-19 medical device authorization issued by Health Canada under IO No. 1 and not revoked in whole is authorized under IO No. 2. Therefore, research ethics board approval received under IO No. 1 is considered an approval under this interim order.
Terms and conditions
At any time, Health Canada may impose or amend terms and conditions on the authorization for the importation or sale of COVID-19 medical devices for the purpose of clinical trials. This authority allows for flexibility in allowing a trial to proceed while attaching additional conditions or limitations on the authorization.
Terms and conditions would be applied on a case-by-case basis and only to ensure appropriate oversight or to manage uncertainties or risks.
Examples of terms and conditions include:
- requiring additional reporting or safety measures, such as limiting the population tested based on emerging information
- monitoring specific populations because of potential increased risk (for example, children)
- requiring new information to characterize and mitigate new risk
Information on the fulfilment of terms and conditions that fall outside the amendment process should be submitted in the form of a notification. Be sure to include a cover letter and any supporting documentation. We will review the notification and documentation to determine whether the conditions have been met.
Once we are satisfied that all the terms and conditions of the original authorization have been met, we will issue a letter indicating that the terms and conditions have been fulfilled.
Note: Any terms and conditions that were imposed under IO No. 1 will remain in effect.
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