Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations — 4
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. 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. 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.