GreatNorthCollective/greatnorth-canada-federal-laws-text huggingface dataset:
Medical Devices Regulations — 68.36
68.36 (1) The Minister may add a licensed medical device, or a Class II, III or IV medical device for which the manufacturer holds an authorization, to column 2 of the List of Medical Devices for Expanded Use and an expanded use to column 3 only if the following conditions are met: (a) the Minister has reasonable grounds to believe that there is an urgent public health need for the expanded use of the device that is related to the corresponding medical condition that is set out in column 1; (b) the Minister has sufficient evidence to support the conclusion that the benefits associated with the expanded use outweigh the risks associated with it, having regard to (i) the uncertainties relating to those benefits and risks, and (ii) the urgent public health need for the device; and (c) the Minister determines that the health or safety of patients, users or other persons will not be unduly affected by the expanded use of the device. (2) In the case of a licensed medical device, sections 26 and 27, as they relate to an expanded use of the device, do not apply in respect of the importation, sale or advertisement of the device if (a) the medical condition to which the expanded use relates is set out in column 1 of the List of Medical Devices for Expanded Use ; (b) the device is set out in column 2 of that list; and (c) the expanded use of the device is set out in column 3 of that list. (3) In the case of a Class II, III or IV medical device for which the manufacturer holds an authorization, sections 27 and 68.13, as they relate to an expanded use of the device, do not apply in respect of the importation, sale or advertisement of the device if (a) the medical condition to which the expanded use relates is set out in column 1 of the List of Medical Devices for Expanded Use ; (b) the device is set out in column 2 of that list; and (c) the expanded use of the device is set out in column 3 of that list. SOR/2023-19, s. 7 SOR/2023-277, s. 22
Medical Devices Regulations — 68.37
68.37 The Minister shall publish on the Government of Canada website supplementary information pertaining to the expanded use, set out in column 3 of the List of Medical Devices for Expanded Use , of a licensed medical device — or a Class II, III or IV medical device for which the manufacturer holds an authorization —, set out in column 2 of that list, including (a) a statement of the expanded use; (b) a statement of the known and potential benefits and risks; and (c) any supplement to the directions for use, unless a supplement is not required for the device to be used safely and effectively. SOR/2023-19, s. 7 SOR/2023-277, s. 23
Medical Devices Regulations — 68.38
68.38 (1) The Minister may request from the holder of a medical device licence, in respect of the medical device that is set out in column 2 of the List of Medical Devices for Expanded Use for which the licence was issued, any information in relation to the expanded use that is set out in column 3 of that list that the holder possesses or to which they have reasonable access. (2) The Minister may request from the holder of an authorization, in respect of the Class II, III or IV medical device set out in column 2 of the List of Medical Devices for Expanded Use for which the authorization was issued, any information in relation to the expanded use set out in column 3 of that list that the holder possesses or to which they have reasonable access. (3) The holder of the licence or authorization shall submit to the Minister the information that the Minister requests within the time limit specified in the request. SOR/2023-19, s. 7 SOR/2023-277, s. 24
Medical Devices Regulations — 69
69 (1) This Part applies to custom-made devices and medical devices that are to be imported or sold for special access. (2) In this Part, special access means access to a medical device for emergency use or if conventional therapies have failed, are unavailable or are unsuitable.
Medical Devices Regulations — 70
70 No person shall import or sell a Class III or IV custom-made device or a medical device for special access unless the Minister has issued an authorization for its sale or importation.
Medical Devices Regulations — 71
71 (1) If a health care professional wishes to obtain a medical device referred to in section 70, the professional shall apply to the Minister for an authorization that would permit the manufacturer or importer of the device to sell, or to import and sell, the device to that professional. (2) The application shall contain the following: (a) the name of the device, its class and its identifier, 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; (b) the number of units required; (c) the name and address of the manufacturer or importer; (d) the name, title and telephone number of the representative of the manufacturer or importer to contact for any information concerning the device; (e) the diagnosis, treatment or prevention for which the device is required; (f) a statement that sets out (i) the reasons the device was chosen for the diagnosis, treatment or prevention, (ii) the risks and benefits that are associated with its use, and (iii) the reasons the diagnosis, treatment or prevention could not be accomplished using (A) a licensed medical device that is available for sale in Canada, or (B) a medical device for which the manufacturer of that device holds an authorization issued under section 68.12 and that is available for sale in Canada; (g) the name and address of each health care facility at which the device is to be used by that professional; (h) the known safety and effectiveness information in respect of the device; (i) a written undertaking by the health care professional that the professional will inform the patient for whom the device is intended of the risks and benefits associated with its use; (j) the directions for use, unless directions are not required for the device to be used safely and effectively; and (k) in the case of a custom-made device, a copy of the health care professional’s written direction to the manufacturer giving the design characteristics of the device. SOR/2023-19, s. 8
Medical Devices Regulations — 72
72 (1) The Minister shall issue an authorization referred to in subsection 71(1) to a manufacturer or importer if the Minister determines that (a) the benefits that may be obtained by the patient through the use of the device outweigh the risks associated with its use; (b) the health or safety of patients, users or other persons will not be unduly affected; (c) a licensed device that would adequately meet the requirements of the patient is not available in Canada; (c.1) a medical device for which the manufacturer of that device holds an authorization issued under section 68.12 and that would adequately meet the requirements of the patient is not available for sale in Canada; and (d) the authorization is not being used by the manufacturer or importer to circumvent the requirements of Part 1 or 1.1. (2) The authorization issued under subsection (1) shall specify (a) the number of units of the device authorized to be imported; (b) the number of units of the device authorized to be sold; and (c) the name of the health care professional to whom the manufacturer or importer may sell the device. SOR/2023-19, s. 9
Medical Devices Regulations — 73
73 If the information and documents submitted in respect of an application made pursuant to section 71 are insufficient to enable the Minister to determine whether the conditions set out in subsection 72(1) have been met, the manufacturer, importer or health care professional shall, at the request of the Minister, submit any further information relevant to the application that the Minister may request.
Medical Devices Regulations — 74
74 The Minister may, in respect of an authorization that has been issued, (a) request the manufacturer, importer or health care professional to submit information in respect of the device if the Minister believes on reasonable grounds, after reviewing a report or information brought to the Minister’s attention, that the device for which the authorization has been issued no longer meets the conditions set out in subsection 72(1); and (b) issue a written cancellation of the authorization, giving reasons, if (i) the Minister determines that the conditions set out in subsection 72(1) are no longer met, or (ii) the information referred to in paragraph (a) has not been submitted.
Medical Devices Regulations — 75
75 No person shall import or sell a medical device in respect of which an authorization has been issued pursuant to section 72, or a Class I or II custom-made device, unless the device has a label that (a) sets out the name of the manufacturer; (b) sets out the name of the device; and (c) specifies whether the device is a custom-made device or is being imported or sold for special access.
Medical Devices Regulations — 76
76 The manufacturer or importer of a medical device in respect of which an authorization has been issued pursuant to section 72 shall maintain a distribution record in respect of the device in accordance with sections 52 to 56.
Medical Devices Regulations — 77
77 The health care professional referred to in subsection 71(1) shall, within 72 hours after becoming aware of an incident that involves the medical device for which an authorization has been issued under section 72 and that meets the following conditions, report the incident to the Minister and to the manufacturer or importer of the device and specify the nature of the incident and the circumstances surrounding it: (a) the incident is related to a failure of the device or a deterioration in its effectiveness or any inadequacy in its labelling or in its directions for use; and (b) the incident has led to the death or a serious deterioration in the state of health of a patient, user or other person or could do so were the incident to recur. SOR/2020-262, s. 19
Medical Devices Regulations — 78
78 Sections 66 to 68 apply in respect of an implant that is imported or sold for special access. SOR/2002-190, s. 7
Medical Devices Regulations — 79
79 This Part applies to medical devices that are to be imported or sold for investigational testing involving human subjects.
Medical Devices Regulations — 80
80 (1) Subject to subsections (2) and (3), no person shall import or sell a medical device for investigational testing. (2) A manufacturer or importer of a Class II, III or IV medical device may sell the device to a qualified investigator for the purpose of conducting investigational testing if the manufacturer or importer holds an authorization issued under subsection 83(1) and possesses records that contain all the information and documents required by section 81. (3) A manufacturer or importer of a Class I medical device may sell the device to a qualified investigator for the purpose of conducting investigational testing if the manufacturer or importer possesses records that contain all the information and documents required by section 81.
Medical Devices Regulations — 82
82 An application for an authorization referred to in subsection 80(2) shall be made in writing to the Minister and shall contain (a) in the case of a Class II medical device or a Class III or IV in vitro diagnostic device that is not used for patient management, not including a near-patient in vitro diagnostic device, the information set out in paragraphs 81(a), (b) and (h) to (j); and (b) in the case of a Class III or IV medical device that is not covered by paragraph (a), the information and documents set out in section 81. SOR/2002-190, s. 8
Medical Devices Regulations — 83
83 (1) The Minister shall issue an authorization referred to in subsection 80(2) to a manufacturer or importer if the Minister determines that (a) the device can be used for investigational testing without seriously endangering the life, health or safety of patients, users or other persons; (b) the investigational testing is not contrary to the best interests of patients on whom the testing will be conducted; and (c) the objective of the testing will be achieved. (2) The authorization referred to subsection (1) shall specify (a) the name of any qualified investigator to whom the device may be sold; (b) the type of diagnosis or treatment for which the device may be sold; (c) the number of units of the device that are authorized to be sold; and (d) the protocol according to which the investigational testing is to be conducted.
Medical Devices Regulations — 84
84 If the information and documents submitted in respect of an application made pursuant to section 82 are insufficient to enable the Minister to determine whether the conditions set out in subsection 83(1) have been met, the manufacturer or importer shall, at the request of the Minister, submit any further information relevant to the application that the Minister may request.
Medical Devices Regulations — 85
85 (1) The Minister may, in respect of a medical device in relation to which investigational testing is being conducted, request the manufacturer or importer of the device to submit information in respect of the testing if the Minister believes on reasonable grounds, after reviewing a report or information brought to the Minister’s attention, that one of the following conditions may exist: (a) the testing seriously endangers the life, health or safety of patients, users or other persons; (b) the testing is contrary to the best interests of patients on whom the testing is being conducted; (c) the objective of the testing will not be achieved; (d) the qualified investigator who is conducting the testing is not respecting the undertaking required by paragraph 81(k); or (e) the information submitted in respect of the testing is false or misleading. (2) If the information requested pursuant to subsection (1) is not submitted, or if it is submitted and the Minister determines after reviewing it that a condition identified in that subsection exists, the Minister may, by written notice giving reasons, (a) in the case of a Class I device, direct the manufacturer or importer of the device to stop selling the device to any qualified investigator named in the notice; or (b) in the case of a Class II, III or IV device, cancel the authorization referred to in subsection 83(1), in whole or in part.
Medical Devices Regulations — 86
86 No person shall import or sell a medical device for investigational testing unless the device has a label that sets out (a) the name of the manufacturer; (b) the name of the device; (c) the statements “Investigational Device” and “ Instrument de recherche ”, or any other statement, in English and French, that conveys that meaning; (d) the statements “To Be Used by Qualified Investigators Only” and “ Réservé uniquement à l’usage de chercheurs compétents ”, or any other statement, in English and French, that conveys that meaning; and (e) in the case of an IVDD, the statements “The performance specifications of this device have not been established” and “ Les spécifications de rendement de l’instrument n’ont pas été établies ”, or any other statement, in English and French, that conveys that meaning.
Medical Devices Regulations — 87
87 No person shall advertise a medical device that is the subject of investigational testing unless (a) that person holds an authorization issued under subsection 83(1) to sell or import the device; and (b) the advertisement clearly indicates that the device is the subject of investigational testing, and the purpose of the investigational testing.
Medical Devices Regulations — 88
88 The requirements set out in the following provisions apply to medical devices to which this Part applies: (a) sections 52 to 56 with respect to distribution records; (b) sections 57 and 58 with respect to complaint handling; (c) sections 59 to 61.1 with respect to reports on incidents; (d) sections 63 to 65.6 with respect to recalls; and (e) sections 66 to 68 with respect to implant registration. SOR/2002-190, s. 9 SOR/2020-262, s. 21 SOR/2024-136, s. 20
Medical Devices Regulations — 88.1
88.1 Subsections 61.2(2) and (3) and section 61.3 apply in respect of medical devices to which this Part applies except that the references to a holder of a therapeutic product authorization in those provisions shall be read as references to a holder of an authorization issued under subsection 83(1). SOR/2020-262, s. 22
Medical Devices Regulations — 89
89 (1) For the purposes of section 37 of the Act, Schedule 3 sets out the form to be used for an export certificate for medical devices. (2) The export certificate shall be signed and dated by (a) where the exporter of the device is a corporation, (i) the exporter’s senior executive officer in Canada, (ii) the exporter’s senior regulatory officer in Canada, or (iii) the authorized agent of the person referred to in subparagraph (i) or (ii); or (b) where the exporter of the device is an individual, (i) the exporter, or (ii) the exporter’s authorized agent.
Medical Devices Regulations — 90
90 No person shall sign an export certificate that is false or misleading or that contains omissions that may affect its accuracy and completeness.
Medical Devices Regulations — 91
91 The exporter of a device shall maintain, at their principal place of business in Canada, records that contain the completed export certificates and shall, when requested to do so by an inspector, submit the export certificates for examination.
Medical Devices Regulations — 92
92 The exporter of a device shall retain the export certificate for a period of not less than five years after the date of export.
Medical Devices Regulations — 93
93 For the purposes of sections 94 and 95, old regulations means the Medical Devices Regulations , C.R.C., c. 871, and Director has the meaning assigned to it by those regulations.
Medical Devices Regulations — 94
94 (1) Subject to subsection (2), if an application for a notice of compliance has been submitted with respect to a medical device pursuant to Part V of the old regulations but has not been processed by the Director as of June 30, 1998, an application for a medical device licence shall be made pursuant to these Regulations. (2) For the purposes of an application for a medical device licence, the information and documents required by paragraphs 32(2)(a) to (e), (3)(a) to (i) or (4)(a) to (o) are deemed to have been submitted if a notice of compliance with respect to the device had been issued under the old regulations.
Medical Devices Regulations — 95
95 (1) A medical device that, on June 30, 1998, is being sold in Canada pursuant to the old regulations is not required to be licensed until February 1, 1999, if, (a) in the case of a device that is subject to Part V of the old regulations, the manufacturer (i) has a notice of compliance in respect of the device that is in effect on June 30, 1998, or (ii) does not have a notice of compliance in respect of the device that is in effect on June 30, 1998, but has met, during the period beginning on October 8, 1982, and ending on March 31, 1983, the requirements for device notification pursuant to Part II of the old regulations in respect of the device; and (b) in the case of a device that is not subject to Part V of the old regulations, the manufacturer has, by June 30, 1998, furnished the Director with the notification required in subsection 24(1) of the old regulations in respect of the device. (2) If an initial application for licensing of a medical device that is referred to in subsection (1) is submitted before February 1, 1999, the information and documents required by paragraphs 32(2)(a) to (e), (3)(a) to (i) or (4)(a) to (o) are deemed to have been submitted if (a) in the case of a device that is subject to Part V of the old regulations, the manufacturer (i) has a notice of compliance in respect of the device that is in effect on June 30, 1998, or (ii) does not have a notice of compliance that is in effect on June 30, 1998, in respect of the device, but has met, during the period beginning on October 8, 1982, and ending on March 31, 1983, the requirements for device notification pursuant to Part II of the old regulations in respect of the device; (b) in the case of a device that is not subject to Part V of the old regulations, the manufacturer has, by June 30, 1998, furnished the Director with the notification required in subsection 24(1) of the old regulations in respect of the device. (3) Subsections (1) and (2) cease to apply in respect of a medical device if a change described in section 34 is made in respect of the device or if the notice of compliance is suspended or cancelled under section 40 of the old regulations. (4) For the purposes of this section, a notice of compliance may be suspended or cancelled under section 40 of the old regulations as if that section were still in force.
Medical Devices Regulations — 97
97 (1) Subject to subsections (2) to (5), these Regulations come into force on July 1, 1998. (2) Section 32, except paragraphs (2)(f), (3)(j) and (4)(p), comes into force (a) in the case of a medical device referred to in section 94 or 95, on September 1, 1998; (b) in the case of any other medical device, on July 1, 1998. (3) Paragraphs 32(2)(f), (3)(j) and (4)(p) come into force on January 1, 2003. (4) Sections 43 and 44 come into force on January 1, 1999. (5) Sections 45 to 51 come into force on November 1, 1998. SOR/2001-217, s. 1
Medical Devices Regulations — (1)
Rule 1 : (1) Subject to subrules (2) and (3), all surgically invasive devices are classified as Class II. (2) A surgically invasive device that is intended to diagnose, monitor, control or correct a defect of the central cardiovascular system or the central nervous system or of a fetus in utero is classified as Class IV. (3) A surgically invasive device that is intended to be absorbed by the body, or that is normally intended to remain in the body for at least 30 consecutive days, is classified as Class III.
Medical Devices Regulations — (1)
(1) Subject to subrules (2) and (3), all surgically invasive devices are classified as Class II.
Medical Devices Regulations — (2)
(2) A surgically invasive device that is intended to diagnose, monitor, control or correct a defect of the central cardiovascular system or the central nervous system or of a fetus in utero is classified as Class IV.
Medical Devices Regulations — (3)
(3) A surgically invasive device that is intended to be absorbed by the body, or that is normally intended to remain in the body for at least 30 consecutive days, is classified as Class III.
Medical Devices Regulations — (1)
Rule 2 : (1) Subject to subrules (2) to (4), all invasive devices that penetrate the body through a body orifice or that come into contact with the surface of the eye are classified as Class II. (2) A device described in subrule (1) that is intended to be placed in the oral or nasal cavities as far as the pharynx or in the ear canal up to the ear drum is classified as Class I. (3) A device described in subrule (1) that is normally intended to remain in the body or in contact with the surface of the eye for at least 30 consecutive days is classified as Class III. (4) A device described in subrule (1) that is intended to be represented as preventing the transmission of infectious agents during sexual activities or reducing the risk thereof is classified as Class III.
Medical Devices Regulations — (1)
(1) Subject to subrules (2) to (4), all invasive devices that penetrate the body through a body orifice or that come into contact with the surface of the eye are classified as Class II.
Medical Devices Regulations — (2)
(2) A device described in subrule (1) that is intended to be placed in the oral or nasal cavities as far as the pharynx or in the ear canal up to the ear drum is classified as Class I.
Medical Devices Regulations — (3)
(3) A device described in subrule (1) that is normally intended to remain in the body or in contact with the surface of the eye for at least 30 consecutive days is classified as Class III.