GreatNorthCollective/greatnorth-canada-federal-laws-text huggingface dataset:
Medical Devices Regulations — Medical Devices Regulations
Rule 9 : Despite rules 1 to 8, an IVDD set out in column 1 of an item of the table to this rule is classified as the class set out in column 2 of that item. TABLE Item Column 1 Column 2 IVDD Class 1 Near patient in vitro diagnostic device for the detection of pregnancy or for fertility testing II 2 Near patient in vitro diagnostic device for determining cholesterol level II 3 Microbiological media used to identify or infer the identity of a microorganism I 4 IVDD used to identify or infer the identity of a cultured microorganism I
Medical Devices Regulations — Medical Devices Regulations
Despite rules 1 to 8, an IVDD set out in column 1 of an item of the table to this rule is classified as the class set out in column 2 of that item. TABLE Item Column 1 Column 2 IVDD Class 1 Near patient in vitro diagnostic device for the detection of pregnancy or for fertility testing II 2 Near patient in vitro diagnostic device for determining cholesterol level II 3 Microbiological media used to identify or infer the identity of a microorganism I 4 IVDD used to identify or infer the identity of a cultured microorganism I
Medical Devices Regulations — 3
3 Active implantable device systems (a) all models of implantable pacemakers and leads; (b) all models of implantable defibrillators and leads; (c) artificial heart; (d) implantable ventricular support system; and (e) implantable drug infusion system
Medical Devices Regulations — (a)
(a) all models of implantable pacemakers and leads;
Medical Devices Regulations — (b)
(b) all models of implantable defibrillators and leads;
Medical Devices Regulations — (d)
(d) implantable ventricular support system; and
Medical Devices Regulations — 4
4 Devices of human origin (a) human dura mater; and (b) wound covering containing human cells
Medical Devices Regulations — (b)
(b) wound covering containing human cells
Medical Devices Regulations — 1
UNDER THE Medical Devices Regulations I, , certify that I have knowledge of all matters contained in this certificate and that 1 I am ( check applicable box ) (a) where the medical device described in this certificate is exported by a corporation ☐ the exporter’s senior executive officer, ☐ the exporter’s senior regulatory officer, ☐ the authorized agent of the exporter’s senior executive officer, or ☐ the authorized agent of the exporter’s senior regulatory officer; and (b) where the medical device described in this certificate is exported by an individual ☐ the exporter, or ☐ the exporter’s authorized agent. , ( State name and address of exporter or, if a corporation, name and address of principal place of business in Canada ). 2 On the day of , , a package containing ( description of device, including serial number, model name, lot number and quantity, as applicable; if additional space required, attach as Appendix “A” ) is/will be consigned to ( name and address of consignee ). 3 The package is marked in distinct overprinting with the word “Export” or “Exportation”. 4 The medical device was not manufactured for consumption in Canada. 5 The medical device is not sold for consumption in Canada. 6 The package and its contents do not contravene any known requirement of the law of the country of ( state country of consignee ). 7 All relevant information is contained in this certificate and no relevant information has been knowingly withheld. Signature Position title , Date
Medical Devices Regulations — 1
I, , certify that I have knowledge of all matters contained in this certificate and that 1 I am ( check applicable box ) (a) where the medical device described in this certificate is exported by a corporation ☐ the exporter’s senior executive officer, ☐ the exporter’s senior regulatory officer, ☐ the authorized agent of the exporter’s senior executive officer, or ☐ the authorized agent of the exporter’s senior regulatory officer; and (b) where the medical device described in this certificate is exported by an individual ☐ the exporter, or ☐ the exporter’s authorized agent. , ( State name and address of exporter or, if a corporation, name and address of principal place of business in Canada ). 2 On the day of , , a package containing ( description of device, including serial number, model name, lot number and quantity, as applicable; if additional space required, attach as Appendix “A” ) is/will be consigned to ( name and address of consignee ). 3 The package is marked in distinct overprinting with the word “Export” or “Exportation”. 4 The medical device was not manufactured for consumption in Canada. 5 The medical device is not sold for consumption in Canada. 6 The package and its contents do not contravene any known requirement of the law of the country of ( state country of consignee ). 7 All relevant information is contained in this certificate and no relevant information has been knowingly withheld. Signature Position title , Date
Medical Devices Regulations — 1
1 I am ( check applicable box ) (a) where the medical device described in this certificate is exported by a corporation ☐ the exporter’s senior executive officer, ☐ the exporter’s senior regulatory officer, ☐ the authorized agent of the exporter’s senior executive officer, or ☐ the authorized agent of the exporter’s senior regulatory officer; and (b) where the medical device described in this certificate is exported by an individual ☐ the exporter, or ☐ the exporter’s authorized agent. , ( State name and address of exporter or, if a corporation, name and address of principal place of business in Canada ).
Medical Devices Regulations — (a)
(a) where the medical device described in this certificate is exported by a corporation ☐ the exporter’s senior executive officer, ☐ the exporter’s senior regulatory officer, ☐ the authorized agent of the exporter’s senior executive officer, or ☐ the authorized agent of the exporter’s senior regulatory officer; and
Medical Devices Regulations — ☐
☐ the exporter’s senior executive officer,
Medical Devices Regulations — ☐
☐ the exporter’s senior regulatory officer,
Medical Devices Regulations — ☐
☐ the authorized agent of the exporter’s senior executive officer, or
Medical Devices Regulations — ☐
☐ the authorized agent of the exporter’s senior regulatory officer; and
Medical Devices Regulations — (b)
(b) where the medical device described in this certificate is exported by an individual ☐ the exporter, or ☐ the exporter’s authorized agent.
Medical Devices Regulations — Medical Devices Regulations
, ( State name and address of exporter or, if a corporation, name and address of principal place of business in Canada ).
Medical Devices Regulations — 2
2 On the day of , , a package containing ( description of device, including serial number, model name, lot number and quantity, as applicable; if additional space required, attach as Appendix “A” ) is/will be consigned to ( name and address of consignee ).
Medical Devices Regulations — 3
3 The package is marked in distinct overprinting with the word “Export” or “Exportation”.
Medical Devices Regulations — 4
4 The medical device was not manufactured for consumption in Canada.
Medical Devices Regulations — 5
5 The medical device is not sold for consumption in Canada.
Medical Devices Regulations — 6
6 The package and its contents do not contravene any known requirement of the law of the country of ( state country of consignee ).
Medical Devices Regulations — 7
7 All relevant information is contained in this certificate and no relevant information has been knowingly withheld.
Medical Devices Regulations — 6
6 The manufacturer of a medical device for which a medical device licence has been issued before the coming into force of these Regulations shall, before November 1, 2003, submit to the Minister, together with the statement required by subsection 43(1) of the Medical Devices Regulations , a copy of the quality system certificate referred to in paragraph 32(2)(f), (3)(j) or (4)(p) of those Regulations, as applicable.]
Medical Devices Regulations — 2
2 (1) Despite subsection 43.12(1) of the Medical Devices Regulations , information in respect of a clinical study or investigational testing , as defined in section 43.11 of those Regulations, that is confidential business information and that is contained in an application with respect to which one of the following circumstances occurred before the day on which these Regulations come into force ceases to be confidential business information on the day on which these Regulations come into force: (a) the Minister issued a licence under paragraph 36(1)(a) of the Medical Devices Regulations ; (b) the Minister amended a licence under paragraph 36(1)(b) of the Medical Devices Regulations ; (c) the Minister refused to issue or amend a licence under section 38 of the Medical Devices Regulations . (2) Subsection (1) does not apply to information referred to in subsection 43.12(2) of the Medical Devices Regulations .
Medical Devices Regulations — 10
10 (1) In this section and in sections 11 to 15, Exceptional Importation and Shortages Interim Order No. 2 means the Interim Order No. 2 Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19 , made by the Minister of Health on March 1, 2021 and published in Part I of the Canada Gazette on March 20, 2021. (2) In sections 11 to 15, designated biocide , designated drug , designated food for a special dietary purpose , designated hand sanitizer and designated medical device have the same meaning as in the Exceptional Importation and Shortages Interim Order No. 2.
Medical Devices Regulations — 13
13 (1) Section 62.31 of the Medical Devices Regulations applies in respect of a designated medical device that was imported under the Exceptional Importation and Shortages Interim Order No. 2. (2) Section 62.32 of those Regulations applies to the holder of an establishment licence in respect of a designated medical device that they imported under that Interim Order.
Medical Devices Regulations — 15
15 A person who, immediately before the Exceptional Importation and Shortages Interim Order No. 2 ceased to have effect, was permitted, under subsection 30(2) of that Interim Order, to conduct an activity in respect of a designated hand sanitizer may continue to do so without holding an establishment licence that authorizes them to do so until the earliest of (a) the occurrence of one of the circumstances referred to in paragraphs 30(2)(a) to (c) of that Interim Order, and (b) September 1, 2023.
Medical Devices Regulations — 10
10 (1) In sections 11 to 19, Interim Order No. 3 means Interim Order No. 3 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 , made by the Minister on February 21, 2022 and published in the Canada Gazette , Part I, on March 12, 2022. (2) Unless the context requires otherwise, words and expressions used in sections 11 to 19 have the same meaning as in the Medical Devices Regulations . (3) For the purposes of sections 11 to 19, a reference to “instrument médical destiné à être utilisé à l’égard de la COVID-19” in the French version of Interim Order No. 3 and the List of Medical Devices for Expanded Use in Relation to the COVID-19 Pandemic shall be read as “instrument médical contre la COVID-19”.
Medical Devices Regulations — 11
11 Despite subsection 68.11(1) of the Medical Devices Regulations , 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. 3 before the day on which these Regulations come into force and in respect of which no decision has been made before that day is deemed to be an application for an authorization submitted under section 68.11 of the Medical Devices Regulations .
Medical Devices Regulations — 12
12 (1) An authorization for importation or sale of a COVID-19 medical device that was issued by the Minister under Interim Order No. 3 before the day on which these Regulations come into force and has not been cancelled before that day is deemed to be an authorization issued under section 68.12 of the Medical Devices Regulations . (2) Any terms and conditions of an authorization for importation or sale referred to in subsection (1) are deemed to have been imposed by the Minister under section 68.19 of the Medical Devices Regulations on the other authorization referred to in that subsection.
Medical Devices Regulations — 13
13 A COVID-19 medical device for which the manufacturer of the device holds an authorization and that is not labelled in accordance with subsection 21(2) of the Medical Devices Regulations in the six-month period that begins on the day on which these Regulations come into force the device may, despite that subsection, be sold during that period.
Medical Devices Regulations — 14
14 Section 68.35 of the Medical Devices Regulations shall be read without reference to subsection 21(2) of those Regulations in regard to any portion of the period referred to in that section that falls within the period referred to in section 13.
Medical Devices Regulations — 15
15 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. 3 before the day on which these Regulations come into force and in respect of which no decision has been made before that day is deemed to be an application to amend an authorization submitted under section 68.14 of the Medical Devices Regulations .
Medical Devices Regulations — 16
16 An authorization for importation or sale of a COVID-19 medical device that was amended by the Minister under Interim Order No. 3 before the day on which these Regulations come into force and has not been cancelled before that day is deemed to be an authorization that is amended to the same extent under section 68.15 of the Medical Devices Regulations .
Medical Devices Regulations — 17
17 A request that was made by the Minister under Interim Order No. 3 before the day on which these Regulations come into force for additional information or material, including samples, is deemed to be a request for additional information or material under section 68.23 of the Medical Devices Regulations .
Medical Devices Regulations — 18
18 (1) In the case of a COVID-19 medical device that is not a UPHN medical device on the day on which these Regulations come into force, a reference in subparagraphs 68.21(1)(h)(i), (i)(i) and (ii) and (j)(i) and (ii) of the Medical Devices Regulations to “the device ceases to be a UPHN medical device” shall be read as “the Regulations Amending the Medical Devices Regulations (Interim Order No. 3 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19) come into force”. (2) Subsection (1) ceases to apply in respect of a COVID-19 medical device referred to in that subsection if the device becomes a UPHN medical device.
Medical Devices Regulations — 19
19 A request that was made by the Minister under Interim Order No. 3 before the day on which these Regulations come into force for information in relation to the expanded use of a COVID-19 medical device or another medical device set out in the List of Medical Devices for Expanded Use in Relation to the COVID-19 Pandemic , referred to in the definition List of Medical Devices for Expanded Use in subsection 1(1) of the Interim Order, is deemed to be a request for information in relation to the expanded use under subsection 68.38(1) or (2) of the Medical Devices Regulations , as the case may be.
Medical Devices Regulations — 27
27 (1) In this section, authorization has the same meaning as in section 68.01 of the Medical Devices Regulations . (2) In respect of an authorization for a medical device that is issued before the day on which these Regulations come into force, paragraph 68.17(a) of the Medical Devices Regulations is to be read as follows: (a) COVID-19; (3) Section 68.17 of the Medical Devices Regulations , as it read immediately before the day on which these Regulations come into force, applies in respect of an application to amend an authorization that was submitted under section 68.14 of the Medical Devices Regulations before the day on which these Regulations come into force and in respect of which no decision has been made before that day.
Medical Devices Regulations — 21
21 Unless the context requires otherwise, the words and expressions used in sections 22 and 23 have the same meaning as in the Medical Devices Regulations .
Medical Devices Regulations — 22
22 A person who has submitted an application for an establishment licence under section 45 of the Medical Devices Regulations before the day on which section 7 comes into force and in respect of which no decision has been made before that day must not be issued the licence unless, by that day and in the form established by the Minister, the person provides the Minister with the information referred to in paragraph 45(b) of the Medical Devices Regulations , as amended by these Regulations.
Medical Devices Regulations — 23
23 The holder of an establishment licence that was issued under section 46 of the Medical Devices Regulations before the day on which section 7 comes into force must, by that day and in the form established by the Minister, provide the Minister with the contact information, other than the telephone number, of the representative of the establishment to contact for information concerning the licence.
Medical Devices Regulations — 50
50 Any terms and conditions that, immediately before the day on which section 41 of these Regulations comes into force, are set out in a medical device licence referred to in subsection 36(1) of the Medical Devices Regulations are deemed to be imposed by the Minister under subsection 36(2) of the Medical Devices Regulations , as that subsection reads as of that day.
Medical Devices Regulations — 14
14 Subsection 3(2) of the Medical Devices Regulations 2 is replaced by the following: 2 SOR/98-282 (2) Subsection (1) does not apply to (a) a drug listed in Schedule E or F to the Act; (b) a drug listed in any of the schedules to the Controlled Substances Regulations ; or (c) a drug containing cannabis , as those terms are defined in subsection 1(2) of the Cannabis Regulations and subsection 2(1) of the Cannabis Act , respectively.
Direction to the CRTC (Reservation of Frequencies for Toronto) Order — Direction to the CRTC (Reservation of Frequencies for Toronto) Order
Whereas it is anticipated that the Canadian Broadcasting Corporation will no longer use frequencies 740 kHz in Toronto and 93.5 MHz in Peterborough, Ontario;
Direction to the CRTC (Reservation of Frequencies for Toronto) Order — Direction to the CRTC (Reservation of Frequencies for Toronto) Order
Whereas there is public demand for another radio station on the FM band and public pressure for a timely response to that demand;
Direction to the CRTC (Reservation of Frequencies for Toronto) Order — Direction to the CRTC (Reservation of Frequencies for Toronto) Order
Whereas, at the public hearing that led to Decision CRTC 97-362 of July 29, 1997, the joint use of frequencies 740 kHz on the AM band and 93.5 MHz on the FM band was discussed;
Direction to the CRTC (Reservation of Frequencies for Toronto) Order — Direction to the CRTC (Reservation of Frequencies for Toronto) Order
Whereas the possible joint use of 740 kHz on the AM band and 93.5 MHz or any other appropriate frequency on the FM band remains an option to be explored;
Direction to the CRTC (Reservation of Frequencies for Toronto) Order — Direction to the CRTC (Reservation of Frequencies for Toronto) Order
And whereas, pursuant to subsection 26(4) of the Broadcasting Act a , the Minister of Canadian Heritage has consulted with the Canadian Radio-television and Telecommunications Commission with regard to the annexed Direction to the CRTC (Reservation of Frequencies for Toronto) Order ;
Direction to the CRTC (Reservation of Frequencies for Toronto) Order — Direction to the CRTC (Reservation of Frequencies for Toronto) Order
Therefore, His Excellency the Governor General in Council, on the recommendation of the Minister of Canadian Heritage, pursuant to paragraph 26(1)(b) of the Broadcasting Act a , hereby makes the annexed Direction to the CRTC (Reservation of Frequencies for Toronto) Order .
Direction to the CRTC (Reservation of Frequencies for Toronto) Order — 1
1 The Canadian Radio-television and Telecommunications Commission is hereby directed to reserve frequency 93.5 MHz or any other appropriate frequency on the FM band and frequency 740 kHz on the AM band, for the use of radio services in Toronto which will contribute to the achievement of the objectives of the Canadian broadcasting policy set out in subparagraph 3(1)(d)(iii) of the Broadcasting Act .
Direction to the CRTC (Reservation of Frequencies for Toronto) Order — 2
2 This Order comes into force on May 7, 1998.
Order Designating the Province of Manitoba for the Purposes of the Definition “applicable guidelines” in subsection 2(1) of the Divorce Act — a
Whereas the Province of Manitoba has established comprehensive guidelines for the determination of child support that deal with the matters referred to in section 26.1 a of the Divorce Act b ; a S.C. 1997, c. 1, s. 11 b R.S., c. 3 (2nd Supp.)
Order Designating the Province of Manitoba for the Purposes of the Definition “applicable guidelines” in subsection 2(1) of the Divorce Act — c
Therefore, His Excellency the Governor General in Council, on the recommendation of the Minister of Justice, pursuant to subsection 2(5) c of the Divorce Act b , hereby makes the annexed Order Designating the Province of Manitoba for the Purposes of the Definition “applicable guidelines” in subsection 2(1) of the Divorce Act . c S.C. 1997, c. 1, s. 1(4)
Order Designating the Province of Manitoba for the Purposes of the Definition “applicable guidelines” in subsection 2(1) of the Divorce Act — 1
1 The Province of Manitoba is hereby designated for the purposes of the definition applicable guidelines in subsection 2(1) of the Divorce Act .
Order Designating the Province of Manitoba for the Purposes of the Definition “applicable guidelines” in subsection 2(1) of the Divorce Act — 2
2 For the purposes of subsection 2(5) of the Divorce Act , the law that constitutes the comprehensive guidelines for the Province of Manitoba is the Child Support Guidelines Regulation , Man. Reg. 58/98.
Order Designating the Province of Manitoba for the Purposes of the Definition “applicable guidelines” in subsection 2(1) of the Divorce Act — 3
3 This Order comes into force on June 1, 1998.
Definition of “Wireless Transmission System” Regulations — a
His Excellency the Governor General in Council, on the recommendation of the Minister of Industry, pursuant to subsection 68.1(5) a of the Copyright Act , hereby makes the annexed Definition of “Wireless Transmission System” Regulations. a S.C. 1997, c. 24, s. 45
Definition of “Wireless Transmission System” Regulations — 1
1 For the purposes of section 68.1 of the Copyright Act , wireless transmission system means a system operated by a terrestrial radio station that transmits in analog or digital mode a signal containing performers’ performances of musical works or sound recordings embodying the performers’ performances, in analog or digital form, whether in the A.M. or F.M. frequency band or in any other range assigned by the Minister under section 5 of the Radiocommunication Act , without artificial guide for free reception by the public.
Definition of “Wireless Transmission System” Regulations — 2
2 These Regulations come into force on May 28, 1998.
Theratronics International Limited Divestiture Regulations — a
His Excellency the Governor General in Council, on the recommendation of the President of the Treasury Board, pursuant to subsections 9(3) a and (4) of the Nordion and Theratronics Divestiture Authorization Act b , hereby makes the annexed Theratronics International Limited Divestiture Regulations . a S.C. 1992, c. 46, s. 90 b S.C. 1990, c. 4