section 28 canada

No, is this a component for a system produced by another manufacturer? In regard to this COMPONENT, the answer to question A1.2 is NO, and the MANUFACTURER of the hand-piece will have to apply for a separate licence. Unless a significant change is made to all devices, any device within the family, that is significantly changed, can no longer be included on the family licence as part of that family and therefore requires its own licence. The majority decision written by Justice Cromwell, determined that in the context of a search of a premises, the objectives of the section would be fulfilled as long as a member of the search team possessed the â¦ For example, an application as a system may contain the ABC HIV-1/-2 EIA, the ABC anti-HCV, the ABC PSA EIA, the ABC CA125 EIA, and the ABC CK-MB with the ABC ANALYZER. 31.1 For the purposes of Article 28 of the Refugee Convention, a designated foreign national whose claim for refugee protection or application for protection is accepted is lawfully staying in Canada only if they become a permanent resident or are issued a temporary resident permit under section 24. Each of the constituent devices in this MEDICAL DEVICE GROUP is manufactured by GLU Corporation and is already licensed for sale. Can this group be assigned to a group family? No, additional licences not required. The application must identify all the constituent devices of the group by device name. â¦ Answer: If the answer is YES, then the MANUFACTURER can apply to obtain a licence of a SYSTEM. Section 30 states that when one member of a MEDICAL DEVICE FAMILY is licensed, all other devices identified on the licence application are deemed licensed. All the reagents or articles of the TEST KIT that are produced by the same MANUFACTURER are deemed to be licensed when the kit is licensed. From B2. Act current to 2020-11-17 and last amended on 2019-06-21. The Flowchart in Appendix 4 provides a diagram of these points. No, A2, is this a medical device group? Devices deemed to be licensed in a MEDICAL DEVICE GROUP cannot be sold outside the group without a SINGLE MEDICAL DEVICE licence. If the response to question B1.2 is NO, the COMPONENTS or IVDD items will have to be licensed separately by their MANUFACTURERS. In the IVDD industry, the reference to system often designates automated ANALYZERS and their respective reagents or TEST KITS. For the purpose of this document these devices are referred to as a single medical device. The devices in a MEDICAL DEVICE GROUP are not required to have the same MANUFACTURER or to be labelled with the name of the group. Single application for a system to obtain a licence. Yes, single licence application required for each device name and manufacturer. Therapeutic Products Directorate This guidance document is intended to provide guidance to MANUFACTURERS in determining whether certain MEDICAL DEVICESincluding components and parts can be combined together and submitted as one device licence application as set out in sections 28 to 31 of the Regulations. Protocols. Protocol replacing the North American Free Trade Agreement with the Agreement between Canada the United States of America, and the United Mexican States (November 30, 2018); Protocol of amendment to the Agreement between Canada, the United States of America, and the United Mexican States (December â¦ A single IVDD can be identified by a unique name for that MANUFACTURER and is sold as a distinct entity. Previous Versions. Example: The XYZ Vision Corporation wishes to provide a special promotional retail pack of their contact lens care products for the holiday season. Any TEST KIT or reagents not sold under the system name must be licensed individually. As part of the government's Open for Business initiative, the Ontario Ministry of Natural Resources (MNR) is proposing regulatory amendments to Section 28 of the Conservation Authorities Act to streamline conservation authority permitting process. Rules 28-700 to 28-714 apply to hermetic refrigerant motor-compressors, and supplement or amend some of the other rules of this section. A device family can be submitted as one licence application, which would contain the device names and associated catalogue detail of all constituent devices. Example: Software Solutions Inc. manufactures a software program, 3D MagicR, which can be used with a number of CT scanners produced by other manufacturers. Yes, B2.2, are the reagents or articles sold separately labelled with the same manufacturerâs name as test kit? The TotalTM Phacoemulsification System, except for the above hand-piece, is the subject of one application, as a SYSTEM. An application as a SINGLE MEDICAL DEVICE is required for the software program. However, when COMPONENTS are used in more than one SYSTEM and are not sold under the SYSTEM name, they can not be licensed with the IVDD SYSTEM. No, reagents or articles deemed licenced with test kit. If the response to this question is YES, the MANUFACTURER must submit a SINGLE MEDICAL DEVICE licence application for the COMPONENT. O. Please refer to "Guidance for the Interpretation of Significant Change, GD001.". To ensure compliance with section 28, a public body's efforts or those of a person acting on behalf of a public body must be thorough and comprehensive. (2) If the Minister is of the opinion that the report is well-founded, the Minister may refer the report to the Immigration Division for an admissibility hearing, except in the case of a permanent resident who is inadmissible solely on the grounds that they have failed to comply with the residency obligation under section 28 and except, â¦ ABC Surgical Supply Company may submit one licence application for the Pro-Pack Surgical Kits as a MEDICAL DEVICE GROUP FAMILY. The family can reflect only one overall purpose as per the definitions of INTENDED USE and INDICATIONS FOR USE. Otherwise, an application for a SINGLE MEDICAL DEVICE must be submitted for each reagent or article made by another MANUFACTURER (see question B4). From B3. The MANUFACTURERS of the various constituent devices also offer these devices for sale individually. It does not, however, create an equality rightâ¦ Regardless of the interest that is taken, there are numerous requirements and issues that must be overcome before the interest will be granted, including Environmental Assessment(s) under the Canada Environmental â¦ ... Canada. The SINGLE MEDICAL DEVICE could be a COMPONENT not deemed licensed as part of a SYSTEM. This SYSTEM contains seven TEST KITS, each for the resolution of a different locus (DRB generic, DR1, DR2, DRB3, DR4, DR52, DRB5). Yes, A1.2, are all of the components and parts labelled with the manufacturerâs name? Example: A search for "1 franc" is more precise than 1 franc.. You may use an asterisk as a wildcard. Subject: Guidance For the Interpretation of Sections 28 to 31: Licence Application Type. MENTAL HEALTH SERVICES M-13.1 REG 1 FORM K Order for Transfer [Section 28 of The Mental Health Services Act]CANADA PROVINCE OF SASKATCHEWAN To _____ , officer in charge of _____ _____ , (mental health centre) If the device family has not yet been licenced, the MANUFACTURER may apply using one licence application for a MEDICAL DEVICE FAMILY and making sure to provide the information described in Section 32 of the Medical Devices Regulations. This group contains a number of devices packaged together for convenience to meet a specific purpose (e.g. Profits and gains of business or profession 1The following income shall be chargeable to income- tax under the head" Profits and gains of business or profession",- (i) the profits and gains of any business or profession which was carried on by the assessee at any time during the â¦ Open PDF in â¦ Under section 26 of the Medical Devices Regulations, the MANUFACTURER of a Class II, III or IV MEDICAL DEVICE must hold a licence or an amended licence for a device before it can be sold in Canada. It can consist of reagents or articles, or any combination of these, that are used together to conduct a specific test. Yes, submit an amended licence application to add device to the family. Example II: The INFECTION EIA random access ANALYZER (closed) and six TEST KITS (CMV, Rubella, Toxo-M, Chlamydia, HCV and HIV) are manufactured by XYZ Industries. Answer: This question seeks to determine if the IVDD under consideration is composed of numerous reagents or articles intended to be used together to conduct a specific test. In this case, the answer would be NO, which leads to question A2. Yes, A2.3, are all of the constituent devices licensed? Subsection 31(1) states that a MEDICAL DEVICE GROUP is deemed licensed if all the devices that constitute the group are made by a single MANUFACTURER and are individually licensed. The SYSTEM name appears on all components. Yes, B4.1, is this IVDD part of a medical device family? These Regulations were published in Canada Gazette II on May 27, 1998, and implementation began on July 1, 1998. B3. As a principle, materials, labelling , manufacturing processes, design and performance specifications cannot be significantly different between the members of the family. Both provisions are therefore capable of coexisting without recourse to s. 28âs non obstante clause. (1) Where a person who is authorized to execute a warrant to arrest believes, in good faith and on reasonable grounds, that the person whom he arrests is the person named in the warrant, he is protected from criminal responsibility in respect thereof to the same extent as if that person were the â¦ 2 The office of the registrar is a â¦ Example I: The HLA Typing System is manufactured by ABO Industries Inc. The instructions in this document apply only to MEDICAL DEVICES that are subject to both the Food and Drugs Act and the Medical Devices Regulations. Alternatively, two applications could be submitted. Answer: If YES, then the MANUFACTURER of that constituent device must license it separately. Therapeutic Products Programme Guidance Document, Date Prepared / Draft Number January 12, 1999 (apptype.wpd), Supersedes February 13, 1998 (how2det.wpd), Date Transmitted for Internal Consultation, Date Transmitted for External Consultation, Document Code/Revision Number GD002/Rev00-MDB, Medical Devices Bureau The application must identify all the constituent devices of the group by device name. wound closure). No, A2.2, are all of the constituent devices manufactured by the groups manufacturer? No, investigate need to comply with other federal or provincial requirements. Yes, one licence application as a system. This will be further discussed at question A3.3. requires a TEST KIT licence. Individual device names may contain additional descriptive phrases. Section 28.2 (1) of the Patent Act explicitly codifies the novelty requirement. Identify all components by device name and device identifiers. No, is this a Class I medical device? the manufacturing process, facility or equipment; the manufacturing quality control procedures, including the methods, tests or procedures used to control the quality, purity and sterility of the device or of the materials used in its manufacture; the design of the device, including its performance characteristics, principles of operation and specification of materials, energy source, software or accessories; and. Therefore, Infusion Inc. can apply using one licence application for a MEDICAL DEVICE GROUP, but each device will also require a licence for each SINGLE MEDICAL DEVICE by the individual manufacturers. If the answer is YES, go to question A2.1. COMPONENTS of the SYSTEM that are made by another MANUFACTURER must be licensed separately. Nonetheless, the overwhelming emphasis and ethical arc of Canada remains the integration of equality for all peoples and persons in the nation. In this case, the requirements for Class IV IVDDs would apply to all constituents. It can also be inferred from both the promotion and the circumstances surrounding the distribution of the device. No, B2, is this a test kit? If the devices cannot be assigned to a MEDICAL DEVICE FAMILY, then a licence application is required for each individual MEDICAL DEVICE. Is this an In vitro Diagnostic Device (IVDD) system? These items may be offered for sale separately as replacement items for the kit. Yes, a medical device licence application is required by the manufacturer of devices sold outside the medical device group. Is this a device system? If the response to A3.1 is YES, the reader should go to question A3.2. Example II: ABO Industries is developing a software program for the automation of another MANUFACTURER'S blood-screening assay on an open-ended ANALYSER in use in some blood centres. An application for a Class IV licence submitted as a SYSTEM can be made for all TEST KITS and the ANALYZER or, alternatively, two licence applications can be submitted for two systems, one for the analyzer and the Class IV assays (HIV and HCV) and one for the analyzer and the Class III assays (CMV, Rubella, Toxo-M and Chlamydia). Yes, A3.2, is this a medical device family? COMPONENTS that are made by another MANUFACTURER under a contractual arrangement can be licensed with the SYSTEM, provided that the MANUFACTURER whose name appears on the SYSTEM label accepts responsibility for the quality systems requirements. A3, is this a single medical device? Answer: A SINGLE MEDICAL DEVICE can be identified by a unique device name for that MANUFACTURER and is sold as a distinct entity. (i) if they have been a permanent resident for less than five years, that they will be able to meet the residency obligation in respect of the five-year period immediately after they became a permanent resident; (ii) if they have been a permanent resident for five years or more, that they have met the residency obligation in respect of the five-year period immediately before the examination; and. Constituent devices are deemed licensed under the same licence application for the MEDICAL DEVICE GROUP only when they are sold, advertised or imported as part of the group. Example I: The Bacteria EIA Test Kit is manufactured by XYZ Industries Inc. If the response to question A1.2 is NO, the COMPONENTS will have to be licensed separately by their MANUFACTURERS. Example I: The FUNGITM Sensitivity disc, manufactured by ACME Inc., is a SINGLE MEDICAL DEVICE available in a number of different sizes, antibiotics and concentrations. Effective July 2, 2013, primary responsibility for Passport Canada and the administration of the Canadian Passport Order and the Order Respecting the Issuance of Diplomatic and â¦ Yes, single licence application required for each device name and manufacturer. The assay itself has a valid licence with the Therapeutic Products Programme. Answer: If the IVDD under consideration is composed of numerous COMPONENTS (e.g. A NO response to A2.2 means that the MANUFACTURER should apply using one licence application for the MEDICAL DEVICE GROUP. No, link to A3. In a device licence application for a SYSTEM, the MANUFACTURER is required to list the name and IDENTIFIERS of the analyzer and kit(s)/reagents(s). Apply for a medical device group family. All of the devices identified and listed on the licence application for the MEDICAL DEVICE GROUP will be deemed licensed with the group. 8, s. 2). For Class III or IV devices, documentation and information need only be provided for a representative member of the family. Depository for the wills of living persons. If the response to B4.1 is YES, the reader should go to question B4.2. COMPONENTS not sold under the SYSTEM name cannot be licensed with the SYSTEM, even when they are intended to be used together. Answer: The answer is yes if the group consists of devices sold together under one name, proceed to question B3.1. Therefore the group is deemed licensed. No, is this product a medical device under the Act? However, products do not vary in material, and the range is consistent with a single INDICATION FOR USE. The following is a question-and-answer discussion of each decision point of the Flowchart in Appendix 3: MEDICAL DEVICES that are not IVDDs. Example: The TotalTM Phacoemulsification System manufactured by ABC Industries Inc. contains a number of COMPONENTS, including five interchangeable hand-pieces, up to fifteen models of coagulation accessories and numerous disposable supply packs. The land management function of Aboriginal Affairs and Northern Development Canada (AANDC) involves the provision of land management services to over 600 First Nations and covers 2,366 reserves with 2.7 million hectares of reserve land across Canada. If the COMPONENTS or parts are used in more than one SYSTEM and are not sold under the SYSTEM name, then the answer is NO, and the COMPONENTS can not be licensed as part of the SYSTEM. Answer: If the device family has been licensed, an amended licence application, specifying the device name and IDENTIFIERS, is required to add the new family member. 28.28 Despite section 13.2 (1) (a), a fixed ladder existing on or before January 1, 2006, and not conforming to the current or an earlier edition of ANSI Standard A14.3-1992, Safety Requirements for Fixed Ladders, may remain in use subject to any modifications considered necessary by the Board. The constituent devices in the MEDICAL DEVICE GROUP must be listed by device name and IDENTIFIER on the licence application form. Family name is considered the device is a single entity, for an! Of coexisting without recourse to s. 28âs non obstante clause made and labelled by a different.! The software program licensed as single IVDDs ( see question B4 ) views of s. 29 by GLU Corporation is! Group family is licensed, no need for additional application published in Canada different of! 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In packages of 8, 12 and 20 not a SYSTEM produced by another MANUFACTURER, under a contractual.!, that are used together to conduct a specific purpose ( e.g articles or reagents sold. Material, and supplement or amend some of the constituent devices also these... Access or investigational testing as a distinct packaged entity with other federal or provincial requirements labelling detailed.