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. Yes, A1.1, are all the components or parts sold under the system name? The family can reflect only one overall purpose as per the definitions of INTENDED USE and INDICATIONS FOR USE. 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. Bulk items may be repackaged without labelling for inclusion in the group. (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. Yes, A3.2, is this a medical device family? Flowchart A in Appendix 3 outlines the decision-making process for licensing MEDICAL DEVICES in general (excluding IVDDs). 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. The Flowchart in Appendix 4 provides a diagram of these points. Is this a device system? Therefore the group is deemed licensed. 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. Yes Manufacturer is responsible to comply with Section 3 and 19 to 21 of the Food and Drugs Act. If the devices cannot be assigned to a MEDICAL DEVICE FAMILY, then a licence application is required for each individual MEDICAL DEVICE. For instance, if a professional body provides its own CA students with specific services â¦ One licence application is required for the ABC Electrolytes ANALYSER. SECTION WORDING 28. Yes, identify all possible devices that might be used in this family by device name only, including bulk items. the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in a human being; the restoration, correction or modification of a body function or the body structure of a human being; the diagnosis of pregnancy in a human being; or. For the purpose of this document these devices are referred to as a single medical device. Example I: The FUNGITM Sensitivity disc, manufactured by ACME Inc., is a SINGLE MEDICAL DEVICE available in a number of different sizes, antibiotics and concentrations. It is intended to replace the draft guidance document "Guidance On How to Determine The Device Licence Type" published on February 13, 1998. Answer: A SINGLE MEDICAL DEVICE can be identified by a unique device name for that MANUFACTURER and is sold as a distinct entity. 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 â 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 â 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". Yes, A3.1, is this device part of a 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. An application as a SINGLE MEDICAL DEVICE is required for the software program. 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. No, is this an in vitro diagnostic device? A device family can be submitted as one licence application, which contain the device names and associated catalogue detail of all constituent devices. 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. No, is this a component for a system produced by another manufacturer? 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¦ B3. Example II: The INFECTION EIA random access ANALYZER (closed) and six TEST KITS (CMV, Rubella, Toxo-M, Chlamydia, HCV and HIV) are manufactured by XYZ Industries. 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. The licence is held by the MANUFACTURER of the group, even when the group contains devices manufactured by others. A single IVDD can be identified by a unique name for that MANUFACTURER and is sold as a distinct entity. Health Canada Example: Pro-Pack Surgical Kits are manufactured by ABC Surgical Supply Company. 179/06 â 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. Therefore, this device can be licensed with a MEDICAL DEVICE FAMILY application, providing device IDENTIFIERS are supplied for the various size and style differences. A NO response to question B3.2 means that the MANUFACTURER should apply using one licence application for the MEDICAL DEVICE GROUP. The TotalTM Phacoemulsification System, except for the above hand-piece, is the subject of one application, as a SYSTEM. Example II: The DRB generic TEST KIT that could not be licensed as part of the HLA Typing System manufactured by ABO Industries Inc.(See example I, question B1.4.) Similarly, the Urine HIV System, an in vitro diagnostic device SYSTEM, contains a specimen collection container (with preservative), a first-line enzyme immunoassay (EIA) and a confirmatory Western Blot assay. Therapeutic product to be offered for sale in Canada. Yes, single licence application required for each device name and manufacturer. Is this product a medical device under the Regulations? Although this device cannot function on its own, a licence is required and an application for a SINGLE MEDICAL DEVICE should be submitted. Example I: The Bacteria EIA Test Kit is manufactured by XYZ Industries Inc. The kit does not include the instrumentation needed to perform the test, such as an ANALYZER. 2 The office of the registrar is a â¦ Effective July 2, 2013, primary responsibility for Passport Canada and the administration of the Canadian Passport Order and the Order Respecting the Issuance of Diplomatic and â¦ 31 (1) If a patient is detained in a designated facility under section 22, 28, 29, 30 or 42 or is released on leave or is transferred to an approved home under section 37 or 38, treatment authorized by the director is deemed to be â¦ 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. This SYSTEM contains seven TEST KITS, each for the resolution of a different locus (DRB generic, DR1, DR2, DRB3, DR4, DR52, DRB5). All components must be identified on the licence application. Yes, Medical device group is deemed licensed, no need for additional application. If the answer is NO, the manufacturer is requested to contact the Programme for further guidance. 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. For example, condoms which are sold in packages of 8, 12 and 20. Are any of the constituent devices sold separately? For enquiries, contact us. Is this an In vitro Diagnostic Device (IVDD) system? Section 28 applies to agreements that wholly or partially restrain this right of the parties. This reagent bears the name XYZ Industries on the label. (1) Where a person who is authorized to execute a warrant to arrest believes, in good faith and on reasonable grounds, that the person whom he arrests is the person named in the warrant, he is protected from criminal responsibility in respect thereof to the same extent as if that person were the â¦ Is this an IVDD system? Is this a medical device group? Answer: This question seeks to determine if the IVDD under consideration is composed of numerous reagents or articles intended to be used together to conduct a specific test. They should have read the other notwithstanding clause, section 28 of the Canadian Charter of Rights and Freedoms, fittingly placed before section 33. Otherwise, an application for a SINGLE MEDICAL DEVICE must be submitted for each reagent or article made by another MANUFACTURER (see question B4). The instructions in this document apply only to MEDICAL DEVICES that are subject to both the Food and Drugs Act and the Medical Devices Regulations. B4. Any TEST KIT or reagents not sold under the system name must be licensed individually. If the answer is NO, the manufacturer is requested to contact the Programme for further guidance. Yes, A3.1, is this device part of a medical device family? Link from A2. No, B2, is this a test kit? Single application for the medical device group required. the intended use of the device, including any new or extended use, any addition or deletion of a contra-indication for the device and any change to the period used to establish its expiry date. Is this a device system? The definition of âinventionâ in section 2 of the Patent Act (R.S.C., 1985, c. P-4) uses the word ânewâ. When applying for a licence that combines together reagents and articles into a TEST KIT, the MANUFACTURER is required to list all reagents and articles by device name and IDENTIFIERS. It does not, however, create an equality rightâ¦ No, contact the programme for additional guidance. Flowchart B in Appendix 4 outlines the process for IVDDs. For IVDD SYSTEMS that include TEST KITS, the reagents and articles of the TEST KITS are deemed licensed if they are labelled with the name of the TEST KIT's manufacturer (see question B2).This includes on-board reagents of ANALYZERS. MEDICAL DEVICES including components and parts that cannot be combined into one of the above combinations must be licensed individually. Both provisions are therefore capable of coexisting without recourse to s. 28âs non obstante clause. Jurisdiction over immigration is shared between the federal and the provincial and territorial governments under section 95 of the Constitution Act, 1867. If the response to question A2.1 is NO, go to question A2.2. Therapeutic Products Directorate The reader should then go to question B3.3. These situations are discussed below. Conduct a specific TEST group by device name, proceed to question is. 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Are made by another MANUFACTURER, under a contractual arrangement in their individual device licences maintain! Is sold individually not deemed licensed with the manufacturerâs name name only, including the care a. Must comply with other federal or provincial requirements no response to question B3.2 means that the MANUFACTURER should apply one.
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