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Whereas the Minister of Health believes that immediate action is required to deal with a significant risk, direct or indirect, to health, safety or the environment;
Therefore, the Minister of Health, pursuant to subsection 30.1(1)Footnotea of the Food and Drugs ActFootnoteb, makes the annexed Interim Order No. 2 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19.
Ottawa, March 1, 2021
Patricia Hajdu,
Minister of Health
1 (1) The following definitions apply in this Interim Order.
COVID-19 medical device means a medical device that is manufactured, sold or represented for use in relation to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). (instrument médical destiné à être utilisé à l’égard de la COVID-19)
foreign regulatory authority means a government agency or other entity outside Canada that has a legal right to control the manufacturing, use or sale of medical devices within its jurisdiction and that may take enforcement action to ensure that medical devices marketed within its jurisdiction comply with the applicable legal requirements. (autorité réglementaire étrangère)
incident means any incident involving a COVID-19 medical device that
List of Medical Devices for Expanded Use means the List of Medical Devices for Expanded Use in Relation to the COVID-19 Pandemic that is published by the Government of Canada on its website, as amended from time to time. (Liste d’instruments médicaux destinés à un usage supplémentaire)
Regulations means the Medical Devices Regulations. (Règlement)
(2) Unless the context requires otherwise, words and expressions used in this Interim Order have the same meaning as in the Regulations.
2 (1) Part 1 of the Regulations, with the exception of the provisions set out in subsection (2), does not apply to the importation or sale of a COVID-19 medical device if the following conditions are met:
(2) The following provisions of the Regulations apply in respect of the importation or sale of a COVID-19 medical device if the conditions set out in paragraphs (1)(a) to (d) are met:
(3) Despite paragraph (2)(a), subsection 44(3) of the Regulations does not apply to a person who imports a Class I COVID-19 medical device from the manufacturer of that device.
3 An importer or distributor must not import or sell a COVID-19 medical device if their establishment licence has been
4 (1) An application for the authorization for importation or sale of a COVID-19 medical device must contain sufficient information and material to enable the Minister to determine whether to issue the authorization and must include the following:
(2) An application in respect of a Class III or IV COVID-19 medical device must contain, in addition to the information and material referred to in subsection (1), the following:
(3) Despite subsection (1) and, if applicable, subsection (2), the application need not include the information and material referred to in paragraph (1)(g) and, if applicable, subsection (2) if the applicant provides information that demonstrates that the sale of the COVID-19 medical device is authorized by a foreign regulatory authority and that authorization has not been suspended.
5 The Minister must issue the authorization for importation or sale if the following requirements are met:
6 A person must not sell a COVID-19 medical device in respect of which an authorization for importation or sale has been issued and has not been cancelled if any of the matters referred to in subsection 4(1) and, if applicable, subsection 4(2) are significantly different from the information or material contained in the application, unless
7 The Minister may, at any time, impose terms and conditions on the authorization for importation or sale of a COVID-19 medical device or amend those terms and conditions.
8 The Minister may cancel the authorization for importation or sale of a COVID-19 medical device by written notice, giving reasons, if
9 The Minister may request a person who has submitted an application for an authorization for importation or sale of a COVID-19 medical device or a holder of such an authorization to submit any additional information or any material, including samples, that is necessary to enable the Minister to determine whether to issue, amend or cancel the authorization.
10 A person must not import or sell a COVID-19 medical device unless the device has a label that sets out the following information:
11 (1) Subject to subsection (3), the information required by section 10 must, as a minimum, be in either English or French.
(2) Subject to subsection (3), if the directions for use are supplied in only one official language at the time of sale, directions for use in the other official language must be made available by the manufacturer as soon as possible at the request of the purchaser.
(3) In respect of a COVID-19 medical device to be sold to the general public, the information required by paragraphs 10(a) and (e) to (j) must, as a minimum, be in both English and French.
12 Each shipment of a COVID-19 medical device that is imported into Canada must be accompanied by a copy of the authorization for importation.
13 The holder of an authorization for importation or sale of a COVID-19 medical device must, within 10 days after becoming aware of an incident in Canada, report the incident to the Minister and specify the nature of the incident and the circumstances surrounding it.
14 Part 1 of the Regulations does not apply to the importation or sale of a medical device or a COVID-19 medical device that is set out in column 1 of the List of Medical Devices for Expanded Use for the expanded use set out in column 2 if the following conditions are met:
15 The Minister must publish on a Government of Canada website supplementary information pertaining to the expanded use of a medical device or a COVID-19 medical device, including
16 (1) The Minister may request from the holder of a medical device licence or the holder of an authorization for importation or sale of a COVID-19 medical device, in respect of a device set out in column 1 of the List of Medical Devices for Expanded Use, any information in relation to its expanded use set out in column 2 that the holder possesses or to which they have reasonable access.
(2) The holder of the licence or authorization must provide the requested information electronically in a format specified by or acceptable to the Minister within the time limit specified by the Minister. The time limit must not be less than 24 hours after the request is made unless the Minister has reasonable grounds to believe that there is a serious and imminent risk of injury to human health.
Definition of Interim Order No. 1
17 In subsection 18(2) and sections 20 to 27, Interim Order No. 1 means the Interim Order Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19, made by the Minister on March 18, 2020 and published in the Canada Gazette, Part I, on March 28, 2020.
18 (1) A person need not comply with section 11 during the period beginning on the day on which this Interim Order is made and ending six months after that day.
(2) Despite subsection (1), a person, other than a manufacturer, may, during the period beginning six months after the day on which this Interim Order is made and ending nine months after that day, sell a COVID-19 medical device that is not labelled in accordance with subsections 11(1) and (3), if it is labelled in accordance with Interim Order No. 1 as it read immediately before the day on which this Interim Order is made.
19 An importer or distributor need not comply with sections 44 and 45, subsection 46.1(1) and sections 48 and 57 to 61 of the Regulations during the period beginning on the day on which this Interim Order is made and ending six months after that day.
20 An application for an authorization for importation or sale of a COVID-19 medical device that was submitted to the Minister under Interim Order No. 1 before the day on which this Interim Order is made and in respect of which no decision has been made before that day is deemed to be an application for an authorization for importation or sale of a COVID-19 medical device submitted under this Interim Order.
21 An authorization for importation or sale of a COVID-19 medical device that was issued by the Minister under Interim Order No. 1 before the day on which this Interim Order is made and has not been cancelled before that day is deemed to be an authorization for importation or sale of a COVID-19 medical device issued under this Interim Order.
22 An application to amend an authorization for importation or sale of a COVID-19 medical device that was submitted to the Minister under Interim Order No. 1 before the day on which this Interim Order is made and in respect of which no decision has been made before that day is deemed to be an application to amend an authorization for importation or sale of a COVID-19 medical device submitted under this Interim Order.
23 An authorization for importation or sale of a COVID-19 medical device that was amended by the Minister under Interim Order No. 1 before the day on which this Interim Order is made and has not been cancelled before that day is deemed to be an authorization for importation or sale of a COVID-19 medical device amended to the same extent under this Interim Order.
24 Any terms and conditions that were imposed on an authorization for importation or sale of a COVID-19 medical device by the Minister under Interim Order No. 1 before the day on which this Interim Order is made are deemed to be terms and conditions imposed on the authorization for importation or sale of a COVID-19 medical device under this Interim Order.
25 A request that was made by the Minister under Interim Order No. 1 before the day on which this Interim Order is made for additional information or material, including samples, is deemed to be a request for additional information or material under this Interim Order.
26 A medical device or a COVID-19 medical device, its expanded use and the supplementary information pertaining to that use that were set out in the List of Medical Devices for Expanded Use under Interim Order No. 1 before the day on which this Interim Order is made are deemed to be set out in that List under this Interim Order.
27 A request that was made by the Minister under Interim Order No. 1 before the day on which this Interim Order is made for information in relation to the expanded use of a medical device or a COVID-19 medical device set out in the List of Medical Devices for Expanded Use is deemed to be a request for information in relation to the expanded use under this Interim Order.
28 The Interim Order Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19, made by the Minister of Health on March 18, 2020 and published in the Canada Gazette, Part I, on March 28, 2020, is repealed.
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