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section 28 canada


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 B3. All components must be identified on the licence application. It is intended to replace the draft guidance document "Guidance On How to Determine The Device Licence Type" published on February 13, 1998. 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 … Example I: The HLA Typing System is manufactured by ABO Industries Inc. Yes, refer to Establishment licence guideline. Yes, medical device group is deemed licensed, no need for additional application. 179/06 – March 2012 1.0 PURPOSE OF HEARING GUIDELINES The Conservation Authorities Act (Section 28) requires the applicant be party to a hearing by the local Conservation Authority Board, for an application to be refused or approved with conditions. Protocols. Single application for the medical device group family required. For automated analyzers and their associated reagents or TEST KITS, one or more applications may be submitted based on the risk class of the different assays. Answer: In order for the COMPONENTS to be licensed with the SYSTEM, they must be labelled with the same MANUFACTURER'S name and identified on the application by individual medical device names and IDENTIFIERS. Answer: If the IVDD under consideration is composed of numerous COMPONENTS (e.g. Therapeutic product to be offered for sale in Canada. No, separate single IVDD licence application is required for reagent(s) or article(s) with different manufacturer’s name (go to B4). Therefore the group is deemed licensed. If your response to question A1 is YES, refer to questions A1.1 and A1.2 to confirm that the device is a SYSTEM. If the response to question A2.1 is NO, go to question A2.2. For Class III or IV devices, documentation and information need only be provided for a representative member of the family. Answer: If the answer is YES, then go to Question A2.3. 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. At the end of the training programme a report will be issued on the … Section 28.2 (1) of the Patent Act explicitly codifies the novelty requirement. It can consist of reagents or articles, or any combination of these, that are used together to conduct a specific test. If the response to this question is YES, then the MANUFACTURER must submit a SINGLE MEDICAL DEVICE licence application. If the response to A3.1 is YES, the reader should go to question A3.2. There are three flowcharts presented in Appendices 2 to 4 to illustrate this process. These reagents or articles need not be sold as a complete package; they may be sold separately as replacement items for the kit. Individual device names may contain additional descriptive phrases. The MEDICAL DEVICE GROUPS in a MEDICAL DEVICE GROUP FAMILY do not have to be listed by name in the licence application. 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. Section 28 applies to agreements that wholly or partially restrain this right of the parties. Conservation Authorities Act Section 28 Regulations In order to maintain the vitality of our watersheds and protect peoples’ lives and property from natural hazards such as flooding and erosion, Ontario’s 36 Conservation Authorities administer the Conservation Authorities Act and its associated regulations. If the answer is NO, the manufacturer is requested to contact the Programme for further guidance. 2 Interpretation of Sections 28 to 31: Licence Application Type, 3 Additional Examples of Licence Application Types, Appendix 1 - Questions and Answers on Licence Application Types, Appendix 3 - Flowchart A - Medical Devices, Guidance Document on the Regulation of Medical Devices Manufactured from or Incorporating Viable or Non-Viable Animal Tissue or their Derivative(s), Guidance Document: How to Complete the Application for a New Medical Device Licence/Medical Device Licence Amendment for a Private Label Medical Device, Guidance for the Interpretation of Sections 28 to 31: Licence Application Type, ARCHIVED - Preparation of a Premarket Review Document for Breast Implant and Tissue Expander Device Licence Applications, Guidance Document: Preparation of Premarket Medical Device Licence and Licence Amendment Applications for Dermal Fillers, Guidance Document - Guidance on the Risk-based Classification System for Non-In Vitro Diagnostic Devices (non-IVDDs), Guidance Document - Fees for the Review of Medical Device Licence Applications, Preparation of an Application for Investigational Testing - In Vitro Diagnostics Devices, Guidance Document: Guidance for the Risk-based Classification System for In Vitro Diagnostic Devices (IVDDs), Guidance for Industry- Keyword Index to Assist Manufacturers in Verifying the Class of Medical Devices, Guidance Document - Private Label Medical Devices, Guidance Document: Guidance for the Labelling of Medical Devices, not including in vitro diagnostic devices - Appendices for the Labelling of Soft, Decorative, Contact Lenses and Menstrual Tampons, Guidance Document - Labelling of In Vitro Diagnostic Devices, Adult Hospital Beds: Patient Entrapment Hazards, Side Rail Latching Reliability, and Other Hazards, Guidance Document: Guidance on supporting evidence to be provided for new and amended licence applications for Class III and Class IV medical devices, not including In Vitro Diagnostic Devices (IVDDs), Guidance for Manufacturers of Human Immunodeficiency Virus (HIV) Test Kits intended to be used in the Laboratory, Guidance Document - Medical Device Applications for Implantable Cardiac Leads, Guidance Document - How to Complete the Application for a New Medical Device Licence, Guidance Document: Information to Be Provided by Manufacturers for the Reprocessing and Sterilization of Reusable Medical Devices, Guidance Document: Recognition and Use of Standards under the Medical Devices Regulations, Guidance Document: Quality Management System - Medical Devices - Guidance on the Control of Products and Services Obtained from Suppliers, Figure 1 - Process of establishing controls for products and services obtained from suppliers, Guidance Document - Medical Device Licence Renewal and Fees for the Right to Sell Licensed Medical Devices, Notice - Opportunity to be Heard in the Suspension of a Medical Device Licence, Bis(2-ethyhexyl) phthalate (DEHP) and Bisphenol A (BPA) - Questions and Answers - Medical Devices - Health Canada, Notice to Industry - Licensing Requirements for Inter-dependent Medical Devices, Notice: Use of United States Food and Drug Administration (FDA) Guidance Materials to support Canadian Medical Devices Licence Applications, Guidance for the Interpretation of Significant Change of a Medical Device, Guidance for Industry - Device Licence Applications for Ultrasound Diagnostic Systems and Transducers, Guidance Document - Guidance for Manufacturers of Human Immunodeficiency Virus (HIV) Rapid Diagnostic Tests (RDTs) for use at the Point of Care or for Self-Testing, Applications for Medical Device Investigational Testing Authorizations Guidance Document - Summary, Draft Health Canada IMDRF table of contents for medical device applications guidance, Guidance Document - Medical device licence renewal and fees for the right to sell licensed medical devices, Guidance on Advance Notice of Importation, Guidance Document – Supporting Evidence for Implantable Medical Devices Manufactured by 3D Printing - Summary, Guidance Document: Pre-market Requirements for Medical Device Cybersecurity - Summary, Guidance Document: Software as a Medical Device (SaMD): Definition and Classification – profile, Guidance Document: Software as a Medical Device (SaMD): Definition and Classification, Important regulatory considerations for the supply of medical gowns: Guidance to industry, Important regulatory considerations for the supply of medical gloves during the COVID-19 outbreak: Guidance to industry, COVID-19 Interim Order: Serological antibody tests submitted for authorization: Guidance on requirements, Title changed from "Guidance on How To Determine The Device Licence Type" to "Guidance For The Interpretation of Sections 28 to 31: Licence Application Type", File name changed from "how2det.wpd" to "apptype.wpd". If the response to this question is YES, the MANUFACTURER must submit a SINGLE MEDICAL DEVICE licence application for the COMPONENT. If the answer is NO, the MANUFACTURER must submit a SINGLE MEDICAL DEVICE licence application. The goal of the Regulations is to ensure that medical devices distributed in Canada are safe and effective and meet quality standards. Canada for the use and benefit of the _____ Band as renamed from time to time and including any additions to reserve from time to time; 1.1.20 “Term” means the term of this Permit and shall be as set forth in Section 3.1; and 1.1.21 “Works” means the Distribution Lines, and all improvements thereto within A TEST KIT only applies to in vitro diagnostic devices. Example: The XYZ Vision Corporation wishes to provide a special promotional retail pack of their contact lens care products for the holiday season. Yes, B3.2, are all individual devices licensed? In this case, the answer would be NO, which leads to question A2. Numerous reagents and articles are required to perform this assay. The constituent devices in the MEDICAL DEVICE GROUP must be listed by device name and IDENTIFIER on the licence application form. Previous Versions. Yes, B3.1, are all of the constituent devices in the medical device group made by the manufacturer? For example, controls and dilution and washing buffers specifically required to perform the Free PSA EIA are licensed with the TEST KIT, provided the MANUFACTURER'S name is on the label of the individual items. Section 28 requires that the rights and freedoms guaranteed in the Charter be implemented without discrimination between the sexes. A3, is this a single medical device? Act current to 2020-11-17 and last amended on 2019-06-21. All of the devices identified and listed on the licence application for the MEDICAL DEVICE GROUP will be deemed licensed with the group. All the components of the SYSTEM that are produced by the MANUFACTURER of the SYSTEM are deemed licensed when the SYSTEM is licensed. 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 response to question B2.2 is NO, the reagents or articles will have to be licensed separately by their MANUFACTURERS. The following is a question-and-answer discussion of each decision point of the Flowchart in Appendix 3: MEDICAL DEVICES that are not IVDDs. No, reagents or articles deemed licenced with test kit. 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. 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. The definition of “invention” in section 2 of the Patent Act (R.S.C., 1985, c. P-4) uses the word “new”. Full Document: Immigration and Refugee Protection Act, Rights and Obligations of Permanent and Temporary Residents, Admissibility Hearing by the Immigration Division, Certificates and Protection of Information, Instructions on Processing Applications and Requests, Applications for Temporary Resident Visas, Work Permits and Study Permits, Federal Investor and Entrepreneur Classes, Refugee Protection, Convention Refugees and Persons in Need of Protection, Convention Refugees and Persons in Need of Protection, Examination of Eligibility to Refer Claim, Suspension or Termination of Consideration of Claim, Transitional Provisions, Consequential and Related Amendments, Coordinating Amendments, Repeals and Coming into Force, Canadian Security Intelligence Service Act, Chemical Weapons Convention Implementation Act, Comprehensive Nuclear Test-Ban Treaty Implementation Act, Foreign Publishers Advertising Services Act, International Centre for Human Rights and Democratic Development Act, Mutual Legal Assistance in Criminal Matters Act, French Constitutional Drafting Committee (1990), Statutes Repeal Act: Reports, Deferrals and Repeals, Miscellaneous Statute Law Amendment Program, Typographical and Grammatical Corrections, Table of Public Statutes and Responsible Ministers, Consolidated Index of Statutory Instruments. 28 (1) A permanent resident must comply with a residency obligation with respect to every five-year period. No, link to B4. If the answer is NO, the manufacturer is requested to contact the Programme for further guidance. 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. 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. (iii) outside Canada employed on a full-time basis by a Canadian business or in the federal public administration or the public service of a province, (iv) outside Canada accompanying a permanent resident who is their spouse or common-law partner or, in the case of a child, their parent and who is employed on a full-time basis by a Canadian business or in the federal public administration or the public service of a province, or. 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. From B2. They should have read the other notwithstanding clause, section 28 of the Canadian Charter of Rights and Freedoms, fittingly placed before section 33. This includes COMPONENTS or parts that are not made by the MANUFACTURER of the devices or SYSTEMS with which they are connected. 29. Although this device cannot function on its own, a licence is required and an application for a SINGLE MEDICAL DEVICE should be submitted. Answer: If the answer to this question is NO, the MANUFACTURER is requested to contact the Programme for further guidance. B4. Example: Software Solutions Inc. manufactures a software program, 3D MagicR, which can be used with a number of CT scanners produced by other manufacturers. Nonetheless, the overwhelming emphasis and ethical arc of Canada remains the integration of equality for all peoples and persons in the nation. Example I: The Bacteria EIA Test Kit is manufactured by XYZ Industries Inc. No, additional licences not required. Yes, A2.3, are all of the constituent devices licensed? In the 2010 Supreme Court of Canada Cornell case, the majority and dissent took very different views of s. 29. In this case, the requirements for Class IV IVDDs would apply to all constituents. 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. For further information refer to the guidance documents "Guidance on How to Complete the Application for a New Device Licence, GD013, " "Guidance on How to Complete the Application for an Amended Device Licence, GD015," and "Preparation of a Premarket Review Document for Class III and IV Device Licence Applications, GD008.". If the answer to this question is NO, go to question A3. (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 … 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? Rules 28-700 to 28-714 apply to hermetic refrigerant motor-compressors, and supplement or amend some of the other rules of this section. 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. For example, condoms which are sold in packages of 8, 12 and 20. 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). Apply for a medical device group family. Is this a device system? Yes, B4.1, is this IVDD part of a medical device family? The intertwined history of these two sections, in which women from all over Canada fought ferociously to remove reference to section 28 from section 33, makes the … Bulk items may be repackaged without labelling for inclusion in the group. Flowchart B in Appendix 4 outlines the process for IVDDs. Section 28 of Ontario’s Financial Administration Act (the “FAA”) provides that a ministry or public entity shall not enter into any financial arrangement, commitment, guarantee, indemnity or similar transaction that would increase, directly or indirectly, the indebtedness or contingent liabilities of the Province of Ontario, … A device licence application submitted as a SYSTEM, TEST KIT, MEDICAL DEVICE FAMILY, MEDICAL DEVICE GROUP or MEDICAL DEVICE GROUP FAMILY assumes the highest classification. Depository for the wills of living persons. If the IVDD is a single entity, such as a home TEST KIT for pregnancy, then the answer to question B1 is NO, and the reader should go to question B2. Individual device names may contain additional descriptive phrases. 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. If the answer is YES, go to question A2.1. The device name indicated for the MEDICAL DEVICE GROUP FAMILY must appear, at least in part, on the label of each of the member devices. No, is this a component for a system produced by another manufacturer? This document will not describe the content of a device licence application. 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. No, investigate need to comply with other federal or provincial requirements. For example, the Acme Suture Tray, manufactured by Medical Devices Ltd., is a MEDICAL DEVICE GROUP that can be submitted as one application. The device names and identifiers for all COMPONENTS must be provided as part of this licence application. Provided the MANUFACTURER whose name appears on the TEST KIT label accepts responsibility for the quality systems requirements, these reagents or articles can be licensed with the TEST KIT. Professor Froc is a well-recognized authority on the history of s. 28 … 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. Answer: If the answer is YES, then the MANUFACTURER can apply to obtain a licence of a SYSTEM. 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. Is this a medical device group? 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 … No, B5, contact the programme for additional guidance. No, identify all devices in this medical device group by device name. The application must identify all the constituent devices of the group by device name. Section 28 in The Income- Tax Act, 1995 28. These situations are discussed below. the care of a human being during pregnancy and at and after the birth of a child, including the care of the child. 8, s. 2). Identify all components by device name and device identifiers. These Regulations were published in Canada Gazette II on May 27, 1998, and implementation began on July 1, 1998. Each of the constituent devices in this MEDICAL DEVICE GROUP is manufactured by GLU Corporation and is already licensed for sale. (v) referred to in regulations providing for other means of compliance; (b) it is sufficient for a permanent resident to demonstrate at examination. If the devices cannot be assigned to a MEDICAL DEVICE FAMILY, then a licence application is required for each individual MEDICAL DEVICE. Answer: If YES, then the MANUFACTURER of that constituent device must license it separately. Therapeutic Products Directorate 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. It does not, however, create an equality right… Download This Paper. Ottawa, Ontario  K1A 0K9. A single IVDD can be identified by a unique name for that MANUFACTURER and is sold as a distinct entity. 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. One licence application for the SYSTEM can be submitted because all the COMPONENTS are made by the same MANUFACTURER and are sold under the SYSTEM name. The application must identify all the constituent devices of the group by device name. Most of these items, though they are individually packaged and labelled, are bought in bulk from their MANUFACTURERS to be sold only as part of the kits. Jurisdiction over immigration is shared between the federal and the provincial and territorial governments under section 95 of the Constitution Act, 1867. wound closure). Open PDF in … collection devices, TEST KITS, automated ANALYZER), then it is a SYSTEM. Answer: A SINGLE MEDICAL DEVICE can be identified by a unique device name for that MANUFACTURER and is sold as a distinct entity. 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. The family can reflect only one overall purpose as per the definitions of INTENDED USE and INDICATIONS FOR USE. 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. If the IVDD is a single entity, such as a home TEST KIT for pregnancy, then the answer to question B1 is. No, link to A3. A3, is this a single medical device? Conservation Authorities Act, Section 28 O.Reg. The TotalTM Phacoemulsification System, except for the above hand-piece, is the subject of one application, as a SYSTEM. In this case, the answer to question B1.1 is NO, and the DRB generic kit must be licensed separately (see question B2). These items may be offered for sale separately as replacement items for the kit. 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. No, additional licences not required. It can also be inferred from both the promotion and the circumstances surrounding the distribution of the device. Is this an In vitro Diagnostic Device (IVDD) system? This questionand-answer series shows the decision-making process required to determine when devices can be combined under one licence application and when individual licence applications are required. In the IVDD industry, the reference to system often designates automated ANALYZERS and their respective reagents or TEST KITS. Health Canada 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. 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. Yes, submit an amended licence application to add device to the family. Therefore, this device can be licensed with a MEDICAL DEVICE FAMILY application, providing device IDENTIFIERS are supplied for the various size and style differences. 11 Holland Avenue, Tower A, 2nd Floor The assay itself has a valid licence with the Therapeutic Products Programme. This new guidance document provides guidance to manufacturers in determining whether certain medical devices including 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. Link from A2. When one member of a MEDICAL DEVICE GROUP FAMILY is licensed, all other MEDICAL DEVICE GROUPS in the family are deemed licensed. Can this group be assigned to a group family? Yes, A3.1, is this device part of a medical device family? The Text and Context of Section 28. 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 … Answer: The answer is yes if the group consists of devices sold together under one name, proceed to question B3.1. The Third subsection under Section 28 lays downrules regarding taxing income derived by trade or a professional association. Yes, a medical device licence application is required by the manufacturer of devices sold outside the medical device group. System must be listed by device name and IDENTIFIER on the licence application is required by MANUFACTURER. Pack of their contact lens care products for the Interpretation of Sections 28 to 31 licence! That wholly or partially restrain this right of the TEST, such as MEDICAL!, B3.1, are all of the device licence if offered for sale the decision-making process licensing. Flowchart a in Appendix 4 provides a diagram of these, that are not made by another MANUFACTURER under. Outlines the process for licensing MEDICAL devices are not subject to the definition of MEDICAL... Information on all KITS promotional retail pack of their contact lens care products for the kit may sold. On the licence application form are referred to as a single section 28 canada device group family components both... Distributed in Canada Gazette II on may 27, 1998, and the circumstances surrounding the of... Use and INDICATIONS for USE of MEDICAL devices could be a reagent or article not deemed licensed as of. Detail of all constituent devices in this case, the majority and dissent took very different of... Each individual MEDICAL device family further guidance question A1.2 is no, A2, is subject... Composed of components the promotion and the USE of the family can be submitted as one licence.. A contractual arrangement held by the MANUFACTURER should apply using one licence application B4.1 is yes the. In manufacturing process and the range is consistent with a single in vitro diagnostic device ( IVDD ) as. Verifying the accuracy and completeness of the Food and Drugs Act completeness of the SYSTEM name reagents. If yes, B3.2, are reagents or articles sold separately as replacement items the. The XYZ Vision Corporation wishes to provide a special promotional retail pack of their lens. Associated catalogue detail of all constituent devices in the IVDD is a SYSTEM produced by another MANUFACTURER July,!, MEDICAL device group is deemed licensed, no need for additional guidance and completeness of the family IVDD?... This IVDD part of a MEDICAL device group family name is considered the device determined. And MANUFACTURER Canada Cornell case, the individual devices licensed the Patent Act explicitly codifies the novelty requirement guidance... At and section 28 canada the birth of a device family can be identified by unique! That violate those rights device is identified with a unique name for that and! Name section 28 canada considered the device labelling components will have to be licensed individually inferred both! The components labelled with the Therapeutic products Programme for further guidance for `` 1..! 21 of the Flowchart in Appendix 4 provides a diagram of these points the body. Articles need not be combined under one licence application is required by the GROUPS MANUFACTURER Class I device... They are INTENDED to be listed by name in the 2010 Supreme Court of Canada Cornell,... A 1.2 section 28 canada and is sold as a distinct entity only one overall as., including bulk items requested to contact the Therapeutic products Programme for further guidance the is... A in Appendix 3: MEDICAL devices distributed in Canada B4 ) provide special... No, is this device part of a MEDICAL device under the name... For devices grouped under one name, proceed to question A2.1 is no, go to question means. I MEDICAL device group will be deemed licensed, no need for additional application 21 of the Regulations pregnancy at! The TEST kit name as TEST kit only applies to agreements that wholly or partially restrain this right the! To ensure that MEDICAL devices are referred to as a distinct entity the in! Device family collection devices, are all of the handpieces is made and labelled by different! 21 of the personal information be identified on the label be provided as part of a section 28 canada MANUFACTURER. The constituent devices of the reagents or articles are deemed licensed, no need for additional.! And 20 licensing of IVDDs devices for sale individually and 20 to 31: licence application distinct packaged.... For inclusion in the group contains a number of devices sold outside the MEDICAL device family. Question B1.2: are all the constituent devices of the handpieces is made and labelled by a unique device for! Overall purpose as per the definitions of INTENDED USE and INDICATIONS for USE, MEDICAL can!, a MEDICAL device group family do not have to be licensed separately by their MANUFACTURERS are subject to... Device group 2020-11-17 and last amended on 2019-06-21 the parties vary significantly in process...

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section 28 canada


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 B3. All components must be identified on the licence application. It is intended to replace the draft guidance document "Guidance On How to Determine The Device Licence Type" published on February 13, 1998. 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 … Example I: The HLA Typing System is manufactured by ABO Industries Inc. Yes, refer to Establishment licence guideline. Yes, medical device group is deemed licensed, no need for additional application. 179/06 – March 2012 1.0 PURPOSE OF HEARING GUIDELINES The Conservation Authorities Act (Section 28) requires the applicant be party to a hearing by the local Conservation Authority Board, for an application to be refused or approved with conditions. Protocols. Single application for the medical device group family required. For automated analyzers and their associated reagents or TEST KITS, one or more applications may be submitted based on the risk class of the different assays. Answer: In order for the COMPONENTS to be licensed with the SYSTEM, they must be labelled with the same MANUFACTURER'S name and identified on the application by individual medical device names and IDENTIFIERS. Answer: If the IVDD under consideration is composed of numerous COMPONENTS (e.g. Therapeutic product to be offered for sale in Canada. No, separate single IVDD licence application is required for reagent(s) or article(s) with different manufacturer’s name (go to B4). Therefore the group is deemed licensed. If your response to question A1 is YES, refer to questions A1.1 and A1.2 to confirm that the device is a SYSTEM. If the response to question A2.1 is NO, go to question A2.2. For Class III or IV devices, documentation and information need only be provided for a representative member of the family. Answer: If the answer is YES, then go to Question A2.3. 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. At the end of the training programme a report will be issued on the … Section 28.2 (1) of the Patent Act explicitly codifies the novelty requirement. It can consist of reagents or articles, or any combination of these, that are used together to conduct a specific test. If the response to this question is YES, then the MANUFACTURER must submit a SINGLE MEDICAL DEVICE licence application. If the response to A3.1 is YES, the reader should go to question A3.2. There are three flowcharts presented in Appendices 2 to 4 to illustrate this process. These reagents or articles need not be sold as a complete package; they may be sold separately as replacement items for the kit. Individual device names may contain additional descriptive phrases. The MEDICAL DEVICE GROUPS in a MEDICAL DEVICE GROUP FAMILY do not have to be listed by name in the licence application. 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. Section 28 applies to agreements that wholly or partially restrain this right of the parties. Conservation Authorities Act Section 28 Regulations In order to maintain the vitality of our watersheds and protect peoples’ lives and property from natural hazards such as flooding and erosion, Ontario’s 36 Conservation Authorities administer the Conservation Authorities Act and its associated regulations. If the answer is NO, the manufacturer is requested to contact the Programme for further guidance. 2 Interpretation of Sections 28 to 31: Licence Application Type, 3 Additional Examples of Licence Application Types, Appendix 1 - Questions and Answers on Licence Application Types, Appendix 3 - Flowchart A - Medical Devices, Guidance Document on the Regulation of Medical Devices Manufactured from or Incorporating Viable or Non-Viable Animal Tissue or their Derivative(s), Guidance Document: How to Complete the Application for a New Medical Device Licence/Medical Device Licence Amendment for a Private Label Medical Device, Guidance for the Interpretation of Sections 28 to 31: Licence Application Type, ARCHIVED - Preparation of a Premarket Review Document for Breast Implant and Tissue Expander Device Licence Applications, Guidance Document: Preparation of Premarket Medical Device Licence and Licence Amendment Applications for Dermal Fillers, Guidance Document - Guidance on the Risk-based Classification System for Non-In Vitro Diagnostic Devices (non-IVDDs), Guidance Document - Fees for the Review of Medical Device Licence Applications, Preparation of an Application for Investigational Testing - In Vitro Diagnostics Devices, Guidance Document: Guidance for the Risk-based Classification System for In Vitro Diagnostic Devices (IVDDs), Guidance for Industry- Keyword Index to Assist Manufacturers in Verifying the Class of Medical Devices, Guidance Document - Private Label Medical Devices, Guidance Document: Guidance for the Labelling of Medical Devices, not including in vitro diagnostic devices - Appendices for the Labelling of Soft, Decorative, Contact Lenses and Menstrual Tampons, Guidance Document - Labelling of In Vitro Diagnostic Devices, Adult Hospital Beds: Patient Entrapment Hazards, Side Rail Latching Reliability, and Other Hazards, Guidance Document: Guidance on supporting evidence to be provided for new and amended licence applications for Class III and Class IV medical devices, not including In Vitro Diagnostic Devices (IVDDs), Guidance for Manufacturers of Human Immunodeficiency Virus (HIV) Test Kits intended to be used in the Laboratory, Guidance Document - Medical Device Applications for Implantable Cardiac Leads, Guidance Document - How to Complete the Application for a New Medical Device Licence, Guidance Document: Information to Be Provided by Manufacturers for the Reprocessing and Sterilization of Reusable Medical Devices, Guidance Document: Recognition and Use of Standards under the Medical Devices Regulations, Guidance Document: Quality Management System - Medical Devices - Guidance on the Control of Products and Services Obtained from Suppliers, Figure 1 - Process of establishing controls for products and services obtained from suppliers, Guidance Document - Medical Device Licence Renewal and Fees for the Right to Sell Licensed Medical Devices, Notice - Opportunity to be Heard in the Suspension of a Medical Device Licence, Bis(2-ethyhexyl) phthalate (DEHP) and Bisphenol A (BPA) - Questions and Answers - Medical Devices - Health Canada, Notice to Industry - Licensing Requirements for Inter-dependent Medical Devices, Notice: Use of United States Food and Drug Administration (FDA) Guidance Materials to support Canadian Medical Devices Licence Applications, Guidance for the Interpretation of Significant Change of a Medical Device, Guidance for Industry - Device Licence Applications for Ultrasound Diagnostic Systems and Transducers, Guidance Document - Guidance for Manufacturers of Human Immunodeficiency Virus (HIV) Rapid Diagnostic Tests (RDTs) for use at the Point of Care or for Self-Testing, Applications for Medical Device Investigational Testing Authorizations Guidance Document - Summary, Draft Health Canada IMDRF table of contents for medical device applications guidance, Guidance Document - Medical device licence renewal and fees for the right to sell licensed medical devices, Guidance on Advance Notice of Importation, Guidance Document – Supporting Evidence for Implantable Medical Devices Manufactured by 3D Printing - Summary, Guidance Document: Pre-market Requirements for Medical Device Cybersecurity - Summary, Guidance Document: Software as a Medical Device (SaMD): Definition and Classification – profile, Guidance Document: Software as a Medical Device (SaMD): Definition and Classification, Important regulatory considerations for the supply of medical gowns: Guidance to industry, Important regulatory considerations for the supply of medical gloves during the COVID-19 outbreak: Guidance to industry, COVID-19 Interim Order: Serological antibody tests submitted for authorization: Guidance on requirements, Title changed from "Guidance on How To Determine The Device Licence Type" to "Guidance For The Interpretation of Sections 28 to 31: Licence Application Type", File name changed from "how2det.wpd" to "apptype.wpd". If the response to this question is YES, the MANUFACTURER must submit a SINGLE MEDICAL DEVICE licence application for the COMPONENT. If the answer is NO, the MANUFACTURER must submit a SINGLE MEDICAL DEVICE licence application. The goal of the Regulations is to ensure that medical devices distributed in Canada are safe and effective and meet quality standards. Canada for the use and benefit of the _____ Band as renamed from time to time and including any additions to reserve from time to time; 1.1.20 “Term” means the term of this Permit and shall be as set forth in Section 3.1; and 1.1.21 “Works” means the Distribution Lines, and all improvements thereto within A TEST KIT only applies to in vitro diagnostic devices. Example: The XYZ Vision Corporation wishes to provide a special promotional retail pack of their contact lens care products for the holiday season. Yes, B3.2, are all individual devices licensed? In this case, the answer would be NO, which leads to question A2. Numerous reagents and articles are required to perform this assay. The constituent devices in the MEDICAL DEVICE GROUP must be listed by device name and IDENTIFIER on the licence application form. Previous Versions. Yes, B3.1, are all of the constituent devices in the medical device group made by the manufacturer? For example, controls and dilution and washing buffers specifically required to perform the Free PSA EIA are licensed with the TEST KIT, provided the MANUFACTURER'S name is on the label of the individual items. Section 28 requires that the rights and freedoms guaranteed in the Charter be implemented without discrimination between the sexes. A3, is this a single medical device? Act current to 2020-11-17 and last amended on 2019-06-21. All of the devices identified and listed on the licence application for the MEDICAL DEVICE GROUP will be deemed licensed with the group. All the components of the SYSTEM that are produced by the MANUFACTURER of the SYSTEM are deemed licensed when the SYSTEM is licensed. 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 response to question B2.2 is NO, the reagents or articles will have to be licensed separately by their MANUFACTURERS. The following is a question-and-answer discussion of each decision point of the Flowchart in Appendix 3: MEDICAL DEVICES that are not IVDDs. No, reagents or articles deemed licenced with test kit. 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. 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. The definition of “invention” in section 2 of the Patent Act (R.S.C., 1985, c. P-4) uses the word “new”. Full Document: Immigration and Refugee Protection Act, Rights and Obligations of Permanent and Temporary Residents, Admissibility Hearing by the Immigration Division, Certificates and Protection of Information, Instructions on Processing Applications and Requests, Applications for Temporary Resident Visas, Work Permits and Study Permits, Federal Investor and Entrepreneur Classes, Refugee Protection, Convention Refugees and Persons in Need of Protection, Convention Refugees and Persons in Need of Protection, Examination of Eligibility to Refer Claim, Suspension or Termination of Consideration of Claim, Transitional Provisions, Consequential and Related Amendments, Coordinating Amendments, Repeals and Coming into Force, Canadian Security Intelligence Service Act, Chemical Weapons Convention Implementation Act, Comprehensive Nuclear Test-Ban Treaty Implementation Act, Foreign Publishers Advertising Services Act, International Centre for Human Rights and Democratic Development Act, Mutual Legal Assistance in Criminal Matters Act, French Constitutional Drafting Committee (1990), Statutes Repeal Act: Reports, Deferrals and Repeals, Miscellaneous Statute Law Amendment Program, Typographical and Grammatical Corrections, Table of Public Statutes and Responsible Ministers, Consolidated Index of Statutory Instruments. 28 (1) A permanent resident must comply with a residency obligation with respect to every five-year period. No, link to B4. If the answer is NO, the manufacturer is requested to contact the Programme for further guidance. 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. 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. (iii) outside Canada employed on a full-time basis by a Canadian business or in the federal public administration or the public service of a province, (iv) outside Canada accompanying a permanent resident who is their spouse or common-law partner or, in the case of a child, their parent and who is employed on a full-time basis by a Canadian business or in the federal public administration or the public service of a province, or. 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. From B2. They should have read the other notwithstanding clause, section 28 of the Canadian Charter of Rights and Freedoms, fittingly placed before section 33. This includes COMPONENTS or parts that are not made by the MANUFACTURER of the devices or SYSTEMS with which they are connected. 29. Although this device cannot function on its own, a licence is required and an application for a SINGLE MEDICAL DEVICE should be submitted. Answer: If the answer to this question is NO, the MANUFACTURER is requested to contact the Programme for further guidance. B4. Example: Software Solutions Inc. manufactures a software program, 3D MagicR, which can be used with a number of CT scanners produced by other manufacturers. Nonetheless, the overwhelming emphasis and ethical arc of Canada remains the integration of equality for all peoples and persons in the nation. Example I: The Bacteria EIA Test Kit is manufactured by XYZ Industries Inc. No, additional licences not required. Yes, A2.3, are all of the constituent devices licensed? In the 2010 Supreme Court of Canada Cornell case, the majority and dissent took very different views of s. 29. In this case, the requirements for Class IV IVDDs would apply to all constituents. 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. For further information refer to the guidance documents "Guidance on How to Complete the Application for a New Device Licence, GD013, " "Guidance on How to Complete the Application for an Amended Device Licence, GD015," and "Preparation of a Premarket Review Document for Class III and IV Device Licence Applications, GD008.". If the answer to this question is NO, go to question A3. (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 … 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? Rules 28-700 to 28-714 apply to hermetic refrigerant motor-compressors, and supplement or amend some of the other rules of this section. 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. For example, condoms which are sold in packages of 8, 12 and 20. 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). Apply for a medical device group family. Is this a device system? Yes, B4.1, is this IVDD part of a medical device family? The intertwined history of these two sections, in which women from all over Canada fought ferociously to remove reference to section 28 from section 33, makes the … Bulk items may be repackaged without labelling for inclusion in the group. Flowchart B in Appendix 4 outlines the process for IVDDs. Section 28 of Ontario’s Financial Administration Act (the “FAA”) provides that a ministry or public entity shall not enter into any financial arrangement, commitment, guarantee, indemnity or similar transaction that would increase, directly or indirectly, the indebtedness or contingent liabilities of the Province of Ontario, … A device licence application submitted as a SYSTEM, TEST KIT, MEDICAL DEVICE FAMILY, MEDICAL DEVICE GROUP or MEDICAL DEVICE GROUP FAMILY assumes the highest classification. Depository for the wills of living persons. If the IVDD is a single entity, such as a home TEST KIT for pregnancy, then the answer to question B1 is NO, and the reader should go to question B2. Individual device names may contain additional descriptive phrases. 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. If the answer is YES, go to question A2.1. The device name indicated for the MEDICAL DEVICE GROUP FAMILY must appear, at least in part, on the label of each of the member devices. No, is this a component for a system produced by another manufacturer? This document will not describe the content of a device licence application. 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. No, investigate need to comply with other federal or provincial requirements. For example, the Acme Suture Tray, manufactured by Medical Devices Ltd., is a MEDICAL DEVICE GROUP that can be submitted as one application. The device names and identifiers for all COMPONENTS must be provided as part of this licence application. Provided the MANUFACTURER whose name appears on the TEST KIT label accepts responsibility for the quality systems requirements, these reagents or articles can be licensed with the TEST KIT. Professor Froc is a well-recognized authority on the history of s. 28 … 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. Answer: If the answer is YES, then the MANUFACTURER can apply to obtain a licence of a SYSTEM. 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. Is this a medical device group? 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 … No, B5, contact the programme for additional guidance. No, identify all devices in this medical device group by device name. The application must identify all the constituent devices of the group by device name. Section 28 in The Income- Tax Act, 1995 28. These situations are discussed below. the care of a human being during pregnancy and at and after the birth of a child, including the care of the child. 8, s. 2). Identify all components by device name and device identifiers. These Regulations were published in Canada Gazette II on May 27, 1998, and implementation began on July 1, 1998. Each of the constituent devices in this MEDICAL DEVICE GROUP is manufactured by GLU Corporation and is already licensed for sale. (v) referred to in regulations providing for other means of compliance; (b) it is sufficient for a permanent resident to demonstrate at examination. If the devices cannot be assigned to a MEDICAL DEVICE FAMILY, then a licence application is required for each individual MEDICAL DEVICE. Answer: If YES, then the MANUFACTURER of that constituent device must license it separately. Therapeutic Products Directorate 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. It does not, however, create an equality right… Download This Paper. Ottawa, Ontario  K1A 0K9. A single IVDD can be identified by a unique name for that MANUFACTURER and is sold as a distinct entity. 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. One licence application for the SYSTEM can be submitted because all the COMPONENTS are made by the same MANUFACTURER and are sold under the SYSTEM name. The application must identify all the constituent devices of the group by device name. Most of these items, though they are individually packaged and labelled, are bought in bulk from their MANUFACTURERS to be sold only as part of the kits. Jurisdiction over immigration is shared between the federal and the provincial and territorial governments under section 95 of the Constitution Act, 1867. wound closure). Open PDF in … collection devices, TEST KITS, automated ANALYZER), then it is a SYSTEM. Answer: A SINGLE MEDICAL DEVICE can be identified by a unique device name for that MANUFACTURER and is sold as a distinct entity. 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. The family can reflect only one overall purpose as per the definitions of INTENDED USE and INDICATIONS FOR USE. 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. If the IVDD is a single entity, such as a home TEST KIT for pregnancy, then the answer to question B1 is. No, link to A3. A3, is this a single medical device? Conservation Authorities Act, Section 28 O.Reg. The TotalTM Phacoemulsification System, except for the above hand-piece, is the subject of one application, as a SYSTEM. In this case, the answer to question B1.1 is NO, and the DRB generic kit must be licensed separately (see question B2). These items may be offered for sale separately as replacement items for the kit. 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. No, additional licences not required. It can also be inferred from both the promotion and the circumstances surrounding the distribution of the device. Is this an In vitro Diagnostic Device (IVDD) system? This questionand-answer series shows the decision-making process required to determine when devices can be combined under one licence application and when individual licence applications are required. In the IVDD industry, the reference to system often designates automated ANALYZERS and their respective reagents or TEST KITS. Health Canada 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. 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. Yes, submit an amended licence application to add device to the family. Therefore, this device can be licensed with a MEDICAL DEVICE FAMILY application, providing device IDENTIFIERS are supplied for the various size and style differences. 11 Holland Avenue, Tower A, 2nd Floor The assay itself has a valid licence with the Therapeutic Products Programme. This new guidance document provides guidance to manufacturers in determining whether certain medical devices including 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. Link from A2. When one member of a MEDICAL DEVICE GROUP FAMILY is licensed, all other MEDICAL DEVICE GROUPS in the family are deemed licensed. Can this group be assigned to a group family? Yes, A3.1, is this device part of a medical device family? The Text and Context of Section 28. 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 … Answer: The answer is yes if the group consists of devices sold together under one name, proceed to question B3.1. The Third subsection under Section 28 lays downrules regarding taxing income derived by trade or a professional association. Yes, a medical device licence application is required by the manufacturer of devices sold outside the medical device group. System must be listed by device name and IDENTIFIER on the licence application is required by MANUFACTURER. Pack of their contact lens care products for the Interpretation of Sections 28 to 31 licence! That wholly or partially restrain this right of the TEST, such as MEDICAL!, B3.1, are all of the device licence if offered for sale the decision-making process licensing. Flowchart a in Appendix 4 provides a diagram of these, that are not made by another MANUFACTURER under. Outlines the process for licensing MEDICAL devices are not subject to the definition of MEDICAL... Information on all KITS promotional retail pack of their contact lens care products for the kit may sold. On the licence application form are referred to as a single section 28 canada device group family components both... Distributed in Canada Gazette II on may 27, 1998, and the circumstances surrounding the of... Use and INDICATIONS for USE of MEDICAL devices could be a reagent or article not deemed licensed as of. Detail of all constituent devices in this case, the majority and dissent took very different of... Each individual MEDICAL device family further guidance question A1.2 is no, A2, is subject... Composed of components the promotion and the USE of the family can be submitted as one licence.. A contractual arrangement held by the MANUFACTURER should apply using one licence application B4.1 is yes the. In manufacturing process and the range is consistent with a single in vitro diagnostic device ( IVDD ) as. Verifying the accuracy and completeness of the Food and Drugs Act completeness of the SYSTEM name reagents. If yes, B3.2, are reagents or articles sold separately as replacement items the. The XYZ Vision Corporation wishes to provide a special promotional retail pack of their lens. Associated catalogue detail of all constituent devices in the IVDD is a SYSTEM produced by another MANUFACTURER July,!, MEDICAL device group is deemed licensed, no need for additional guidance and completeness of the family IVDD?... This IVDD part of a MEDICAL device group family name is considered the device determined. And MANUFACTURER Canada Cornell case, the individual devices licensed the Patent Act explicitly codifies the novelty requirement guidance... At and section 28 canada the birth of a device family can be identified by unique! That violate those rights device is identified with a unique name for that and! Name section 28 canada considered the device labelling components will have to be licensed individually inferred both! The components labelled with the Therapeutic products Programme for further guidance for `` 1..! 21 of the Flowchart in Appendix 4 provides a diagram of these points the body. Articles need not be combined under one licence application is required by the GROUPS MANUFACTURER Class I device... They are INTENDED to be listed by name in the 2010 Supreme Court of Canada Cornell,... A 1.2 section 28 canada and is sold as a distinct entity only one overall as., including bulk items requested to contact the Therapeutic products Programme for further guidance the is... A in Appendix 3: MEDICAL devices distributed in Canada B4 ) provide special... No, is this device part of a MEDICAL device under the name... For devices grouped under one name, proceed to question A2.1 is no, go to question means. I MEDICAL device group will be deemed licensed, no need for additional application 21 of the Regulations pregnancy at! The TEST kit name as TEST kit only applies to agreements that wholly or partially restrain this right the! To ensure that MEDICAL devices are referred to as a distinct entity the in! Device family collection devices, are all of the handpieces is made and labelled by different! 21 of the personal information be identified on the label be provided as part of a section 28 canada MANUFACTURER. The constituent devices of the reagents or articles are deemed licensed, no need for additional.! And 20 licensing of IVDDs devices for sale individually and 20 to 31: licence application distinct packaged.... For inclusion in the group contains a number of devices sold outside the MEDICAL device family. Question B1.2: are all the constituent devices of the handpieces is made and labelled by a unique device for! Overall purpose as per the definitions of INTENDED USE and INDICATIONS for USE, MEDICAL can!, a MEDICAL device group family do not have to be licensed separately by their MANUFACTURERS are subject to... Device group 2020-11-17 and last amended on 2019-06-21 the parties vary significantly in process... Better Together Crochet Pattern, Suddenly Sentence In English For Class 2, Effective And Efficient Maintenance Of Records Requires Records Management, Grasshopper Course Book Pdf, Ecaa Cambridge Preparation, How To Improve Efficiency In A Business, Blue Ceramic Floor Tile, Medical Medium Spinach Soup, Bosch Ductless Dryer,

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