Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations (SOR/2022-18)

Interpretation

Marginal note:Definitions

1 The following definitions apply in these Regulations.

Act

Act means the Food and Drugs Act. (Loi)

COVID-19

COVID-19 means the coronavirus disease 2019. (COVID-19)

COVID-19 drug

COVID-19 drug means a drug for human use that is manufactured, sold or represented for use in relation to COVID-19. (drogue utilisée en lien avec la COVID-19)

COVID-19 drug authorization

COVID-19 drug authorization means an authorization to do any of the following activities:

• (a) import or sell a COVID-19 drug that is to be tested in a clinical trial;

• (b) conduct a clinical trial in respect of such a drug. (autorisation relative à une drogue utilisée en lien avec la COVID-19)

COVID-19 medical device

COVID-19 medical device means a medical device that is manufactured, sold or represented for use in relation to COVID-19. (instrument médical utilisé en lien avec la COVID-19)

COVID-19 medical device authorization

COVID-19 medical device authorization means an authorization to do any of the following activities:

• (a) import or sell a COVID-19 medical device that is to be tested in a clinical trial;

• (b) conduct a clinical trial in respect of such a device. (autorisation relative à un instrument médical utilisé en lien avec la COVID-19)

incident

incident means any incident that involves a COVID-19 medical device tested in a clinical trial and that

• (a) is related to a failure of the device or a deterioration in its quality or effectiveness or any inadequacy in its labelling or its directions for use; or

• (b) has led to the death or a serious deterioration in the state of health of a clinical trial subject, user or other person or could do so were it to recur. (incident)

qualified investigator

qualified investigator means a person who is a member in good standing of a professional association of persons entitled under the laws of a province to provide health care under their licence in that province and who

• (a) conducts a clinical trial; or

• (b) in the case of a clinical trial conducted by a team, is the responsible leader of that team. (chercheur compétent)

research ethics board

research ethics board means a body that is not affiliated with an applicant for a COVID-19 medical device authorization or a COVID-19 drug authorization, or a holder of such an authorization, and whose principal mandate is to approve the initiation of, and conduct periodic reviews of, biomedical research involving human subjects in order to ensure the protection of their rights, safety and well-being. (comité d’éthique de la recherche)

Marginal note:Words and expressions

• 2 (1) Unless the context requires otherwise, words and expressions used in these Regulations have the same meaning as in the Medical Devices Regulations and the Food and Drug Regulations, as applicable.

• Marginal note:Definition of clinical trial

  (2) However, clinical trial has the same meaning as in section 2 of the Act, except as otherwise provided.

Application

Marginal note:Application

• 3 (1) These Regulations apply to the importation and sale of a COVID-19 medical device, other than a Class I device, that is to be tested in a clinical trial, to the importation and sale of a COVID-19 drug, other than a drug that is described in Schedule C to the Act, that is to be tested in a clinical trial and to the conduct of a clinical trial in respect of such a device or drug.

• Marginal note:Non-application — COVID-19 medical device

  (2) The Medical Devices Regulations, other than sections 6 and 7 and Schedule 1, do not apply to the importation or sale of a COVID-19 medical device that is to be tested in a clinical trial or to the conduct of a clinical trial in respect of such a device if a COVID-19 medical device authorization has been issued for that device and the authorization has not been revoked in whole.

• Marginal note:Non-application — COVID-19 drug

  (3) The following regulations do not apply to the importation or sale of a COVID-19 drug that is to be tested in a clinical trial or to the conduct of a clinical trial in respect of such a drug if a COVID-19 drug authorization has been issued for that drug and the authorization has not been revoked in whole:

  • (a) the Food and Drug Regulations, other than sections A.01.022 to A.01.024, A.01.026, A.01.041, A.01.042, A.01.050, A.01.067, A.01.068, C.01.015, C.01.036, C.01.037 to C.01.040, C.01.040.2, C.01.051, C.01.064 to C.01.067, C.01.070, C.01.131, C.01.133 to C.01.136 and C.01.435 and Divisions 2 and 4 of Part C; and

  • (b) the Blood Regulations.

PART 1COVID-19 Medical Devices

Marginal note:Application

• 4 (1) An application for a COVID-19 medical device authorization must be submitted to the Minister in the form and manner specified by the Minister.

• Marginal note:Content

  (2) The application must contain sufficient information and material to enable the Minister to determine whether to issue the authorization and must include the following:

  • (a) the name and contact information of the applicant and, if applicable, the importer;

  • (b) the name and class of the device;

  • (c) a description of the device and of the materials used in its manufacture and packaging;

  • (d) a description of the features of the device that permit it to be used for the medical conditions, purposes and uses for which it is manufactured, sold or represented, including its performance specifications if those specifications are necessary for proper use;

  • (e) the identifier of the device, including 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;

  • (f) the name and contact information of the manufacturer as they appear on the device label;

  • (g) the address where the device is manufactured, if the address is different from the one provided in the contact information under paragraph (f);

  • (h) the diagnosis, treatment, mitigation or prevention for which the device is required;

  • (i) a list of the countries other than Canada where the device has been sold, the total number of units sold in those countries and a summary of any reported problems with the device and of any recalls of the device in those countries;

  • (j) the known information in relation to the quality, safety and effectiveness of the device;

  • (k) the directions for use, unless directions are not required for the device to be used safely and effectively;

  • (l) an attestation by the applicant that documented procedures are in place in respect of distribution records, complaint handling, incident reporting and recalls;

  • (m) a copy of the label of the device;

  • (n) the name of the qualified investigator and their qualifications, including their training and experience;

  • (o) the name and contact information of the institution at which the clinical trial is proposed to be conducted;

  • (p) the protocol of the proposed clinical trial, including the number of clinical trial subjects, the number of units of the device proposed to be used for the clinical trial, the hypothesis for and objective of the clinical trial, the period of time during which the clinical trial will be conducted and a copy of the informed consent form;

  • (q) a written undertaking from the qualified investigator to

    • (i) conduct the clinical trial in accordance with the protocol provided by the applicant,

    • (ii) inform each 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, and

    • (iii) not permit the device to be used by any other person except under the direction of the qualified investigator; and

  • (r) in the case of a Class III or IV device, for each clinical trial site, the name and contact information of the research ethics board that approved the protocol and informed consent form referred to in paragraph (p), if known at the time of submitting the application.

• Marginal note:Class II devices

  (3) Despite subsection (2), if the application for the authorization is in respect of a COVID-19 medical device that is a Class II device, the information and material set out in paragraphs (2)(c), (h) to (j), (n) and (q) may be omitted from the application.

Marginal note:Issuance

5 The Minister must issue a COVID-19 medical device authorization if the following requirements are met:

• (a) the applicant has submitted to the Minister an application that meets the requirements set out in section 4;

• (b) the applicant has submitted to the Minister any additional information or material requested under subsection 10(1) in the time, form and manner specified under subsection 10(2); and

• (c) the Minister determines that

  • (i) the use of the device that is to be tested in the clinical trial will not unduly affect the health or safety of clinical trial subjects, users or other persons,

  • (ii) the clinical trial is not contrary to the best interests of clinical trial subjects, and

  • (iii) the objectives of the clinical trial are achievable.

Marginal note:Research ethics board approval

6 A holder of a COVID-19 medical device authorization must not import or sell a COVID-19 medical device for which the authorization has been issued or conduct a clinical trial in respect of such a device unless the holder has obtained, for each clinical trial site, the approval of a research ethics board in respect of the protocol and informed consent form referred to in paragraph 4(2)(p).

Marginal note:Terms and conditions

7 The Minister may, at any time, impose terms and conditions on a COVID-19 medical device authorization or amend those terms and conditions.

Marginal note:Prohibition

• 8 (1) Subject to subsection (2), if the substance of any of the information or material referred to in paragraphs 4(2)(a) to (d), (f), (h), (j), (k) and (p) and, if applicable, submitted under subsection 10(1) is significantly different from the substance of the information or material contained in the application for a COVID-19 medical device authorization,

  • (a) the conduct of the clinical trial referred to in the authorization that is issued as a result of that application is no longer authorized for the purposes of section 3.1 of the Act; and

  • (b) the holder of the authorization must not import or sell the COVID-19 medical device for which the authorization was issued.

• Marginal note:Amendment

  (2) Subsection (1) does not apply if

  • (a) the holder of the COVID-19 medical device authorization has submitted to the Minister an application to amend the authorization;

  • (b) the Minister determines that the requirements set out in subparagraphs 5(c)(i) to (iii) are met;

  • (c) the holder has submitted to the Minister any additional information or material requested under subsection 10(1) in the time, form and manner specified under subsection 10(2); and

  • (d) the Minister amends the authorization.

Marginal note:Suspension

• 9 (1) The Minister may suspend, in whole or in part, a COVID-19 medical device authorization by notice, giving reasons, if

  • (a) the Minister determines that any of the requirements set out in subparagraphs 5(c)(i) to (iii) is no longer met;

  • (b) the holder of the authorization has not submitted to the Minister any additional information or material requested under subsection 10(1) in the time, form and manner specified under subsection 10(2); or

  • (c) the holder of the authorization has contravened these Regulations or any provisions of the Act relating to the device.

• Marginal note:Reinstatement

  (2) The Minister must reinstate a COVID-19 medical device authorization if the holder of the authorization submits to the Minister, in the time, form and manner specified by the Minister, information or material that demonstrates that the situation giving rise to the suspension did not exist or has been corrected.

Marginal note:Additional information and material

• 10 (1) The Minister may request that an applicant for a COVID-19 medical device authorization or a holder of such an authorization submit any additional information or material, including samples, that is necessary to enable the Minister to determine whether to issue, amend or suspend the authorization.

• Marginal note:Time, form and manner

  (2) The applicant or holder must submit the information or material in the time, form and manner specified by the Minister.

Marginal note:Discontinuance

11 If a holder of a COVID-19 medical device authorization discontinues, in whole or in part, the clinical trial for which the authorization has been issued, the holder must, without delay,

• (a) notify the Minister, in writing, of the discontinuance and the reasons for it;

• (b) inform all qualified investigators, in writing, of the discontinuance and the reasons for it and advise them, in writing, of any potential risks to the health of clinical trial subjects, users or other persons; and

• (c) in respect of each clinical trial site at which the trial is discontinued, stop the importation or sale of the device as of the date of the discontinuance and take all reasonable measures to ensure the recovery of all unused quantities of the device that have been sold.

Marginal note:Discretionary revocation

• 12 (1) The Minister may revoke, in whole or in part, a COVID-19 medical device authorization by notice, giving reasons, if the holder of the authorization has not submitted to the Minister, in the time, form and manner specified by the Minister, the information or material referred to in subsection 9(2).

• Marginal note:Mandatory revocation

  (2) The Minister must revoke, in whole or in part, the authorization if the Minister has received a notice of discontinuance referred to in paragraph 11(a).

Marginal note:Labelling

• 13 (1) A person must not import or sell a medical device for which a COVID-19 medical device authorization has been issued or conduct a clinical trial in respect of such a device unless the device has a label that sets out the following information:

  • (a) the name of the device;

  • (b) the name and contact information of the manufacturer;

  • (c) the identifier of the 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;

  • (d) in the case of a Class III or IV device, the control number;

  • (e) if the contents are not readily apparent, an 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;

  • (f) a statement indicating that the device is sterile, if the device is to be sold in a sterile condition;

  • (g) the expiry date of the device, if applicable;

  • (h) the medical conditions, purposes and uses for which the device is manufactured, sold or represented, including its performance specifications if those specifications are necessary for proper use;

  • (i) the directions for use, unless directions are not required for the device to be used safely and effectively;

  • (j) any special storage conditions applicable to the device;

  • (k) a statement indicating that the device is an investigational device;

  • (l) a statement indicating that the device is to be used by qualified investigators only; and

  • (m) in the case of an in vitro diagnostic device, a statement indicating that the performance specifications of the device have not been established.

• Marginal note:Presentation of information

  (2) The information required by subsection (1) to be set out on the label must be in English and in French.