ARCHIVED Guidance on applications for medical device clinical trials under the interim order: Post-authorization requirements
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.
On this page
- Submitting an amendment to a clinical trial authorization
- Suspending a clinical trial
- Discontinuing a clinical trial
- Revoking a clinical trial authorization
Submitting an amendment to a clinical trial authorization
An amendment to a clinical trial authorization is required if significant changes are made to any information submitted to the Minister (section 4(2) of the IO) or as a response to a request for additional information (section 10).
Please refer to section 2.5 of the Applications for medical device investigational testing authorizations guidance document for examples of significant changes.
Under the interim order, the addition or removal of an institution where the trial is being conducted or a change to the list of qualified investigators doesn't require an amendment to an authorization. These 2 changes can be implemented immediately and do not need to be submitted to Health Canada. Applicants must keep records of such changes on file.
Note: Any application to amend an authorization that was outstanding when IO No. 1 was repealed is considered to be an application under IO No. 2.
Suspending a clinical trial
Health Canada may suspend, in whole or in part, the authorization under the IO at any time.
For example, we have the ability to suspend an arm, or treatment group, of a multi-arm trial, if needed. The rest of the trial would proceed, ensuring that other patients can continue to receive a promising therapy.
We may take this action if we have reasonable grounds to believe that:
- any of the requirements of the original authorization are no longer met
- if requested information was not submitted in the time, form and manner requested or
- if the authorization holder has contravened the interim order or the Food and Drugs Act
Note: All suspensions, in whole or part, for clinical trials issued under IO No. 1 will remain in effect.
Health Canada must reinstate a suspended trial if the holder of the suspended authorization provides the required information or material in the time, form and manner specified. This information must demonstrate that the situation giving rise to the suspension did not exist or has been corrected.
Additional information and material
The authorization holder must supply Health Canada with additional information, materials or samples that we request. We use this information to decide whether to issue, amend or suspend a COVID-19 medical device clinical trial authorization.
Note: A request made by Health Canada under IO No. 1 continues to be in effect under IO No. 2.
Discontinuing a clinical trial
The authorization holder must notify Health Canada as soon as possible, but no later than 15 calendar days, if a COVID-19 clinical trial, in whole or part, has been discontinued.
For information on what to include in the notification, please refer to the Applications for medical device investigational testing authorizations guidance document.
A new application is required if the authorization holder wishes to resume the trial later.
Note: A notice of discontinuance provided to Health Canada in IO No. 1 continues to be in effect under IO No. 2.
Revoking a clinical trial authorization
When we receive a notice of discontinuance, we must cancel, in whole or in part, the authorization for importation or sale of the COVID-19 medical device used for the clinical trial.
Health Canada may cancel, in whole or in part, the authorization for importation or sale of COVID-19 medical devices for the purpose of clinical trials at any time. We will do this if the authorization holder fails to provide satisfactory information following a suspension.
Failure to provide satisfactory information includes the following examples:
- the requested information under section 9(2) of the IO has not been provided in the specified timeframe
- Health Canada determines the information does not demonstrate that the situation giving rise to the suspension did not exist or has not been corrected
Notice/transparency of revocation
Following a mandatory or discretionary cancellation, we issues a cancellation letter to the authorization holder. We either confirm receipt of notice of discontinuation (mandatory cancellation) or give reasons for the cancellation (discretionary cancellation).
We also update the information published on the authorized COVID-19 clinical trial database.
Note: A COVID-19 medical device authorization that was revoked in part by Health Canada under IO No. 1, and has not been revoked in whole since, will continue to be revoked in part under IO No. 2.
The labelling must include the following information:
- name of device
- name and contact information of manufacturer
- identifier of device, including the identifier of any medical device that is part of a system, test kit, medical device group, medical device family or device group family
- control number, if a Class III or Class IV device
- indication of what the package contains, expressed in terms appropriate to the device, such as the size, net weight, length, volume or number of units, if the contents are not readily apparent
- indication that the device is sterile, if the manufacturer intends the device to be sold in a sterile condition
- expiry date, if the device has one, to be determined by the manufacturer on the basis of the component that has the shortest projected useful life
- medical conditions, purposes and uses for which the device is manufactured, sold or represented, as well as the performance specifications of the device if those specifications are necessary for proper use (unless self-evident to users)
- directions for use (unless directions are not required) for the device to be used safely and effectively
- special storage conditions
- indication that the device is an investigational device
- indication that the device is to be used by qualified investigators only
- indication that the performance specifications of the device have not been established, if an in vitro diagnostic device
The labelling must be provided in both English and French.
For more information on the labelling requirements for COVID-19 medical devices to be imported or sold for use in a clinical trial, please refer to the Applications for medical device investigational testing authorizations guidance document.
Each shipment of a COVID-19 medical device imported into Canada must be accompanied by a copy of the authorization to import. We will issue this document to the applicant upon authorization.
Report a problem or mistake on this page
- Date modified: