The system for recordkeeping to allow traceability from sources to the finished device should be fully described. Folder name: 5.08-Patient File Stickers-Cards-Implant Registration Cards. This should include: If the product is subject to a shelf-life, shelf-life testing should be provided and the claimed shelf-life clearly stated. Today, 47% of medical devices fall under this category and 95% of these are exempt from the regulatory process. (Indicate () which documents listed below are included as attachments to this application. Critical analyses of the rates calculated (e.g. As you are aware, Health Canada is striving to add transparency to the medical device review process. Comparisons can be used to support the safety and effectiveness of the device if they are made to a currently licensed device in Canada. A medical device is used to diagnose, prevent, or treat a medical disease or condition without having any chemical action on any part of the body. (For a Class IV medical device intended to be used with another Class II, III, or IV device, provide a list of all medical devices that this device is intended to be used … Refer to folder "3.05.05.08.00 - Overview" below for classification information. Conditionally required - When a Master File is referenced, Conditionally required - When information is requested by the regulator (through guidance documents or other communication) but does not belong in any of the other headings of this Chapter. A Sterility Assurance Level (SAL) of 10-6 is generally required. Folder name: 3.07.01.01-Study Title, Identifier, Date (see below). Folder name: 3.05.03.01-Study Title, Identifier, Date (see below). Disease or medical condition that the device will diagnose, treat, prevent, mitigate, or cure, parameters to be monitored and other considerations related to indication for use. Typically, this would consist of arrangements for, or evidence of, revalidation of the packaging and sterilization processes. This section is specifically intended for studies performed to ensure the safety and/or effectiveness of the device that are not delineated in the rest of the Chapter 4. electronic storage system or built-in system, website). If a process challenge device was used to assess the sterilization process it must be shown to have comparative resistance or a greater challenge to sterilization than the biological indicators placed inside the product/packaging. Summary/Synopsis first followed by the Full Report second). If any of the study devices differ from the devices to be marketed, including competitors devices, a description of these differences and their impact on the validity of the evidence in terms of support for the application. Please note: The manufacturer will need to contact the Office of Controlled Substances to obtain a T.K. Folder name: 3.05.10.01-Study Title, Identifier, Date (see below), Folder name: 3.05.11-Usability-Human Factors. Heading for other information that may be important to the submission but that does not fit in any of the other headings of this chapter. Information and validation of manufacturer sterilization where the device is provided sterile. A summary of the specific study described in the custom heading above. Table 1 – Examples of Class II medical devices Devices Class Rule Anaesthesia breathing circuit II Rule 2 Device to warm or cool blood II Rule 3 Non-medicated impregnated gauze dressing II Rule 4 Intended Use: The statement of intended use should specify the therapeutic or diagnostic function provided by the device and may describe the medical procedure in which the device is to be used (e.g. Folder name: 3.05.05.07-Softw Life Cycle Process Desc. Folder name: 1.04-Application Form-Administrative Info. A statement of why this category of study is not applicable to this case. Devices containing materials of unknown stability should have real-time data. This information may be provided in an application in the form of a flow chart, process map, document matrix, table or text description. This should include: Note: The sponsor/applicant should explicitly address any existing regional regulatory guidance related to the non-clinical study results provided in this section regarding the subject device. The new medical device regulations (MDR) and IVD regulations (IVDR) were largely driven by the need to safeguard patient safety in response to technological progress. Refer to folder "3.07.02.00 - Overview" below for classification information. • New and Amendment Class 2, Class 3 and Class 4 medical device licence applications • All medical device Private Label licence applications • All Fax-back (Minor Change) applications • All Screening Deficiency, Clarification, and Additional Information Responses associated with those activities listed above • NOT . Labelling directed at the physician other than the package insert, such as the surgical manual. Bioburden determination, culture media used, time and temperature of incubation, controls, number of samples examined and frequency of testing should also be presented. This typically includes functional, performance, interface, design, developmental, and other requirements for the software. If applicable, labelled pictorial representation (diagrams, photos, drawings). The medical devices subject to this application conform with Recognized Standards as set out in the Guidance Document on Recognition and Use of Standards under the Medical Devices Regulations, which is available on the website. A wide variety of class 4 medical device options are available to you, such as quality certification, shelf life, and warranty. Manufacturing flow diagram should a description is required of the methods used in, and controls used for, the manufacture, processing, packaging, storage and, where appropriate, the installation of the device. Folder name: 2.04.03-History of Development. These products have been regulated as medical devices due to exceptional potential risks. Provide the Investigational Testing Authorization reference number for any clinical trials conducted under an Investigational Testing Authorization in Canada. The manufacturer should also demonstrate that they have a process in place to monitor bioburden levels on a regular basis to confirm that the sterilization method remains valid. A description of the sterilization process (method, parameters) and Sterility Assurance Level (SAL). The jurisdiction(s) associated with the incident should be clearly indicated. Conditionally required - Required when the purpose of the submission includes seeking a licence for a reprocessed single use device, A statement of the test environment and relation to the intended use environment. Note: The scope of this section is limited to the particular regulator to which the submission is being submitted (i.e. In this case, the capacity of the manufacturing process to remove and/or inactivate these retroviruses from the product should be demonstrated. In general ISO 10993 standards are taken as the gold standards for biocompatibility, use of other standards should be justified and compared against ISO 10993 methods. If a group of devices are to be sterilized together, the worst-case scenario or most difficult to sterilize product should be validated. For each of the markets listed in (a) above, and statement of the commercial names used in those markets OR a clear statement that the commercial names are the same in all jurisdictions. animal sourced, human sourced material) are to be included in this section. However, the manufacturer is required to registe… ALSO: Reference may be made to a product's proprietary information submission for this information. Where a standard is followed, identify the standard. Folder name: 4.02.03-Lit Review-Other Known Info, Note: The sponsor/applicant should explicitly address any existing regional regulatory guidance related to the clinical study and data provided in this section regarding the subject device, Folder name: 4.05-Other Clinical Evidence. This approach means that all medical devices are grouped into four classes with Class I devices presenting the lowest potential risk (e.g. If applicable, indication of biological material or derivate used in the medical device, including: origin (human, animal, recombinant or fermentation products or any other biological material), source (e.g. A description of the sterilization process (method, parameters). Please indicate your consent by completing this form and sending it with your application for a new medical device licence, or any time after a licence has been granted. Identify if the device is intended for single or multiple use. Summaries should cover the objectives, methodology and results presented in context, clearly and meaningfully. Process validation results should be included to substantiate that manufacturing procedures are in place to minimize biological risks in particular, with regard to viruses and other transmissible agents. In the case where the Medical Devices Bureau (MDB) has received requests concerning the status of the new licence application, amendment application, or fax-back application for (enter device name) from interested parties, In accordance with the Access to Information Act, confidential, third party information will not be disclosed without your expressed consent. Studies specifically assessing the instructions and/or device design in terms of impact of human behaviour, abilities, limitations, and other characteristics on the ability of the device to perform as intended should be included here. This HTML document is not a form. Detailed depiction of functional units and software modules. Refer to the Guidance Document: Recognition and Use of Standards under the Medical Devices Regulations and the current list of recognized standards for medical devices. If marketing history is presented for a previously licensed device, then the associated recalls, and incident reports for that device should also be summarized here. certificate of abattoir inspection). Certificates that support the safety of materials of biological origin (e.g. The SDS describes how the requirements in the SRS are implemented. A list of all materials in direct or indirect contact with the patient or user. If yes, please complete the information below for each material: Species (for example [e.g. Up to date indication of the markets (all countries or jurisdictions) where the device is approved for marketing, including any marketing under compassionate use regulations. Description on how the requirements detailed for the website have been met. Information regarding the packaging of the devices, including, when applicable, primary packaging, secondary and any other packaging associated; Specific packaging of accessories marketed together with the medical devices shall also be described; If the user needs to package the medical device or its accessories before they perform sterilization, information about the correct packaging (e.g. Discussion should address all of the different hardware configurations and, where applicable, operating systems identified in the labelling. Refer to folder "3.05.08.00 - Overview" below for classification information. Information and validation of manufacturer sterilization where the device and support for why this element is not expected be and! For correction of the clinical expert origin pose a Special risk for both patients and care... Not limited to the information as found on the form for viewing purposes only and... 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