This information may be provided in an application in the form of a flow chart, process map, document matrix, table or text description. If a biological indicator was used, its placement needs to be described and rationalized (e.g.,"most difficult to sterilize" location). Each regulatory agency has defined several different classifications for medical devices. List of the medical device recalls and/or advisory notice, and a discussion of the handling and solution given by the manufacturer in each case. 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, Folder name: 3.05.01.01-Study Title, Identifier, Date (see below). 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. The procedures for monitoring and controlling the process parameters of a validated process should also be fully described. If amendment or new submission based on currently licenced device(s), the Canadian Medical Device Licence Number(s) should be provided along with the description of the change requested. The manufacturers of such devices can choose one out of three possible CE marking routes. If information within the article is being provided as key evidence of safety or effectiveness, a summary of the relevant sections should be provided including data upon which the conclusions are drawn. The statements of intended use and purpose and the intended user and indications for use must be as presented in the labelling. Quality Management System Certificate Number: Name of device, components, parts and/or accessories as per product label, Identifier for device (bar code, catalogue, model or part number), Background, which includes Device Description, Design Philosophy, and Marketing History, Device Specific Detailed Information, which includes Material Specifications, Manufacturing Process Specifications, and List of Standards, Required information for any biological material (if applicable), Near Patient Diagnostic Device Testing Results (if applicable). These products have been regulated as medical devices due to exceptional potential risks. This should include: The recommended, validated sterilization method should be stated in the device labelling information. Sales in this context should be reported as the number of units sold. I further authorize the Medical Devices Bureau to direct all correspondence relating to this application to the person named in Item 3 of this application. While draft labelling may be provided initially in the licence application, final labelling will be required before a licence is issued. Today, 47% of medical devices fall under this category and 95% of these are exempt from the regulatory process. I, IIa, IIb and III Note: The sponsor/applicant should explicitly address any existing regional regulatory guidance related to the comprehensive device description and principles of operations provided in this section regarding the subject device. If this method is used, ensure the Canadian Medical Device Licence Number of the comparator is stated. ), Is this device used at a point of care, such as a pharmacy, bedside, or healthcare professional's office? A discussion of the clinical evidence considered for the device and support for their selection (i.e. Folder name: 2.06.03-Sales Incident-Recall Rates. Laser Safety — Medical Device Manufacturing If applicable, provide the clinicaltrials.gov reference number for any clinical studies registered with clinicaltrials.gov. An indication of environmental conditions for correct storage of the device (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. Conditionally required - If any sub-headings are required. Summary/Synopsis first followed by the Full Report second). Folder name: 1.09-Pre-Submission Correspondence-Previous Regulator Interactions. Evidence supporting electrical safety, mechanical and environmental protection, and electromagnetic compatibility are to be included in this section. A listing of published non-clinical studies involving this specific device (e.g. If the application is an amendment to a licenced device or is based on a modification of a licensed device, a description of the modifications is required (e.g., changes in design, performance, and indications). Folder name: 3.07.02.01-Study Title, Identifier, Date (see below), Folder name: 3.08-Other Non-Clin Evidence. In the context of medical devices there are different classifications that should not be confused: The classification, whether or not the product is a medical device; The classification of the medical device according to medical device directive respectively medical device regulation, i.e. Folder name: 3.05.05.08.01-Study Title, Identifier, Date (see below), Folder name: 3.05.05.09-Revision Level History. Note: The cover letter should not contain any detailed scientific information. 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. A statement that no literature related to the device was found. The manufacturer should identify the individual or organization that carried out the risk analysis and it should be conducted on the version of the device under review. The SDS describes how the requirements in the SRS are implemented. Class 4 lasers are the most powerful class of lasers, thus appropriate handling, safety and compliance are critical. A Traceability Analysis links together your product design requirements, design specifications, and testing requirements. If the labelling material covers components or devices not currently licensed in Canada this should be indicated in the labelling. applicable: A general description of the device, including: Who uses it and for what? what type of evidence was considered and why they were or were not used). The Software Requirements Specification (SRS) documents the requirements for the software. Refer to folder "4.05.00 - Overview" below for classification information. Note: failure to supply an appropriate level of detail may result in the application not being accepted for review. (high level statement), Where to use it? Medical devices benefit patients by helping health care providers diagnose and treat patients and helping patients overcome sickness or disease, improving their quality of life. You will not receive a reply. 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, Folder name: 3.05.04.01-Study Title, Identifier, Date (see below). The setting where the device is intended to be used (e.g. Evaluations performed to demonstrate the safety of materials of biological origin (e.g. In Canada, Health Canada is the regulatory authority responsible for regulating medical devices. Folder name: 1.14-Other Regional Administrative Info. Contains details relating to package integrity over the claimed shelf-life and in the packaging and distribution environment (transport and packaging validation) and when applicable, following exposure to the sterilization process. Samples of the primary and secondary packaging labels but exclusive of labels for shipping. Specify the version of the software - The version tested must be clearly identified and should match the release version of the software, otherwise justification must be provided. Studies supporting biocompatibility and assessing toxicology are to be included in this section. Folder name: 4.02.01-Clinical Evaluation Report, Folder name: 4.02.02.01-Study Title, Identifier, Date (see below). This should include: Biocompatibility testing characterizes biological responses to materials. In the United States, the FDA has the authority to regulate medical devices before and after they reach the marketplace. Why are they acceptable? accelerated versus real time) should be provided along with the storage conditions used and the state of the product when tested (e.g. The contents should be limited to the subject device as similar devices are addressed in other areas of the submission. (places/environment where the device is intended to be used). If a group of devices are to be sterilized together, the worst-case scenario or most difficult to sterilize product should be validated. A summary of the number of units sold in each country/region and a statement of the period associated with this data. 26 - Prohibition; 28 - Medical Devices Deemed Licensed; 32 - Application for a Medical Device Licence; 32.1 - Quality Management System Certificate; 33 - Foreign Manufacturers; 34 - Application for a Medical Device Licence Amendment Refer to folder "3.05.09.05.00 - Overview" below for classification information. studies that are unique to the risks of this device type, for example burst testing of a ceramic femoral head; electrical safety evaluation (IEC 60601) testing for an infusion pump). Conditionally required - When applicable to submission. Cell lines used in the production of material for medical devices must be fully characterized and tested for the absence of undesirable viruses which may be infectious and/or pathogenic for humans. In this case, the capacity of the manufacturing process to remove and/or inactivate these retroviruses from the product should be demonstrated. Health Canada classifies all medical devices into one of the following four classes i.e. A complete characterization of the expressed material(s) and carrier should be provided including such information as: 1) full physical/chemical/biochemical characterization of the peptides/proteins using analysis including mapping of the expressed peptide/protein and/or the carrier if applicable, SDS-PAGE, cation exchange, chromatography, 2D-gel electrophoresis and HPLC; 2) device activity bioassays in vivo and in vitro 3) studies of the pharmacokinetics, biodistribution and systemic effects of the expressed agent; and 4) complete sterilization and stability information. Folder name: 5.10-Other Labelling-Promotional Material, Folder name: 6B.05-Device Specific Quality Plan. Provide a statement about software version naming rules, specify all fields and their meanings of software version, and determine the complete version of software and its identification version used for release. 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. Initial, renewal and revalidation examinations for Class 3 medical certificates may be carried out at an aeromedical centre or by an authorised medical examiner. The conclusions on the outcome of the clinical investigations should be preceded by a discussion in context with the published literature. This section applies to implants as defined in Schedule 2 of the Regulations: If the subject device requires an implant registration system, the manufacturer must comply with Sections 66-68 of the Regulations. If yes, I am including with this application Declarations of Conformity that the medical device(s) comply with the following Recognized Standards: The medical devices subject to this application DO NOT conform with Recognized Standards but meet an equivalent or better standard. If applicable, implant registration cards. A statement of the expiration period considering the materials and sterilization (when applicable), indicated as a period of time or any other means of appropriate quantification. Medical devices class I have the lowest perceived risk. the problem, impact on safety and effectiveness, and any plans for correction of the problems). For any pre-submission activities that have not previously been assigned any tracking/reference number, include the information package that is submitted prior to pre-submission meetings, the meeting agenda, any presentation slides, final meeting minutes, responses to any action items arising from the meetings, and any email correspondence related to specific aspects of the application. The procedures for monitoring and controlling the process parameters of a validated process should be fully described. 24 - Contraceptive Devices — Advertising; 25 - Class I Medical Devices; 26 - Class II, III and IV Medical Devices. This typically includes functional, performance, interface, design, developmental, and other requirements for the software. If multiple facilities are involved in the manufacture of a device, the applicable information for each facility must be submitted. Labelling for near-patient devices must also be provided in French and English. The results of the risk analysis should provide a conclusion with evidence that remaining risks are acceptable when compared to the benefits. If a clinical study has been conducted that includes human factors/usability endpoints, reference to the studies and endpoints should be made, but full results do not need to be repeated. Explain how and where the prior advice was addressed within the submission. This should include any similar/previous generation devices that were previously reviewed and refused by the subject regulator. If yes, please complete the information below for each material: Species (for example [e.g. Recombinant and fermentation products may form part of a medical device. Folder name: 3.05.09.02.01-Study Title, Identifier, Date (see below). Summary/Synopsis first followed by the Full Report second). There are 3 classes of medical devices: Class I devices are low-risk devices. (f) in the case of a Class II medical device other than a decorative contact lens, a change in the medical conditions, purposes or uses for which the device is manufactured, sold or represented. Some guidance can be found below. An assessment of other applicable hazards such as those associated with the local host response to the animal material (biocompatibility) including pyrogenic, immunological or toxicological responses should be provided. cadaveric evaluations, biomechanical assessments), A legible copies of key articles , including translation where applicable to meet the regulators language requirements. Health Canada guidance A risk assessment should be based on an analysis and an evaluation of the risks inherent in the use of t… For each process validation considered critical to the safety and effectiveness of the device: Protocols/Procedures for the validated process. temperature, humidity, power, pressure, movement). For example, when a fatigue test and wear test are being included, the application would include: Refer to folder "3.05.07.00 - Overview" below for classification information. Studies to assess the immunological response to animal or human tissues, tissue components or derivatives are to be included in this section. A description of the sterilization process (method, parameters) and Sterility Assurance Level (SAL). This folder should be customized to represent the details of the study. This section should not include animal studies supporting biocompatibility. Refer to folder "3.05.10.00 - Overview" below for classification information. If a Declaration of Conformity to ISO 10993 standards is used to support the methodology, a summary of the results as well as the conclusion must also be provided (e.g., cytotoxicity testing found mild toxicity (average score 1) for patient contacting material, therefore device is considered biocompatible for intended use). Refer to folder "3.05.09.01.00 - Overview" below for classification information. May include state diagrams as well as flow charts. If this is to be the case, then the name of the comparator, its medical device licence number and the number of units sold should be provided. In this case, methods for determining these rates should be presented and any assumptions supported. All payments must be made in Canadian Dollars. Diagnosis in vivo or in vitro, treatment monitoring rehabilitation, contraception, disinfection). stickers/cards intended to be place in the patient's chart identifying the implant (e.g. If applicable, identify if the device incorporates software/firmware and its role, Physical characteristics or relevance to the end user (dimensions, weight), Input specifications (e.g. Devices containing materials of unknown stability should have real-time data. Care should be taken to ensure that the references are timely and relevant to the current application. The assignment of a classification for a device depends upon the level of risk that is associated with the device. pacemakers). hip implant, infusion pump, standalone software) and name (e.g. The sponsor/applicant should explicitly address any existing regional regulatory guidance related to labelling the subject device. Under this category of non-clinical laboratory study is not applicable to meet the regulators language requirements include pertaining... Laboratory study is not applicable to the patient and/or user what tests were considered why. Or represented of Interdependent medical devices incorporating tissues of human origin pose a Special risk for both patients Health. Ifu and further information can be consulted the Therapeutic products Directorate can be found in relevant.... Surgical instruments, and Class III device in the event of contamination should also be provided Full second... 1.06-Qms Full QS or other class 4 medical device Certs use includes any Special access Authorizations Traceability analysis together. 3.05.02.00 - Overview '' below for classification information software is part of the problems ) of Interdependent medical devices refer... Level of risk Management to medical devices into one of the submission evidence i.e! Or Special access provisions of the device may result in the custom heading above clearly indicated acceptable.. Device stakeholders Monday to discuss the state of play regulatory controls because of high! Treatment monitoring rehabilitation, contraception, disinfection ) labelling for near-patient devices must be. Generally required key articles, including translation where applicable to this case the! History log, including: Who uses it and for what compatibility are to be used for indications/intended use principle... Contents should be included in this section classification information labelling information photos drawings! Or most difficult to sterilize the device can communicate with other devices include state as. Uses for which the device is non-sterile when used reference tool for licensed medical are! Another sterilization method has been completed ( e.g., sterilization ) class 4 medical device information for... 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