These documents should be consulted for additional guidance with regard to device labelling. Bioburden determination, culture media used, time and temperature of incubation, controls, number of samples examined and frequency of testing should also be presented. Marketing history of a Health Canada licensed, previous version of the device can sometimes be used in support of safety or effectiveness of the subject device. Copies of the articles should also be provided. 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. For details regarding content and format, you are requested to consult the Guidance Document -Preparation of a Premarket Review Document for Class III and Class IV Device Licence Applications (which is available on the website.). If partial compliance, a list the sections of standard that, Are not applicable to the device, and/or, were deviated from for other reasons – discussion to accompany, Conditionally required - If demonstrating that device complies with standards. ): Tissue Type (e.g., bone, heart valve, skin and hair): Derivative (e.g., collagen, gelatin, hyaluronic acid, stearate): Species (e.g., human, bovine, ovine etc. 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 Evidence to support the cybersecurity should be provided here. Note: It is acknowledged that the definition of recall may vary from one jurisdiction to another; hence this heading is labelled as regionally focused (RF). This folder should be customized to represent the details of the study. Labelling directed at the physician other than the package insert, such as the surgical manual. A brief summary of process validation should be included to substantiate that manufacturing and screening procedures are in place to minimize biological risks, in particular, with regard to viruses and other transmissible agents. Conditionally required - Required if declaration of conformity is being made relating to standards relevant to the amendment. A general description of the device, including: Who uses it and for what? Class II, III and IV devices require a medical device licence from Health Canada before they can be im-ported, sold or adver sedfor sale. Refer to folder "3.05.09.05.00 - Overview" below for classification information. Summaries should cover the tests conducted, standards applied, test methodology; pass fail criteria chosen with justification, and a summary of the results and conclusions drawn. This should include: If the device requires special packaging (e.g., considerations related to sterility, humidity, light sensitivity, pressure or oxidative reaction under irradiation), evidence should be provided that this has been addressed. list of references) of all relevant published literature dealing with the use, safety and effectiveness and the indications for use of the subject device in question. ), instructions of use, advertising, or promotional material] must be consistent with the official statement. This should include: Biocompatibility testing characterizes biological responses to materials. A bibliography may not be necessary if the device or its technology is well known with a long history of use. An evaluation of clinical evidence is necessary to help establish the clinical safety and effectiveness of a medical device for each claimed indication for use. 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. temperature, pressure, humidity, luminosity). Refer to folder "3.05.09.01.00 - Overview" below for classification information. Folder name: 3.07.01.01-Study Title, Identifier, Date (see below). For a complete list of licensed medical devices, refer to: MDALL - Your reference tool for licensed medical devices in Canada. This should be a brief (1-2 page) summary of the available clinical evidence being presented in support of the submission. It is the intention to move these to the CTO regulatory regime in the future. EtO, gamma irradiation, dry heat) or an affirmative statement that the device is non-sterile when used. The detailed information expected for each material depends on the type of biological material and the particular risks inherent in that particular material. Certificates that support the safety of materials of biological origin (e.g. 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. Folder name: 2.06.02-Global Incident Reports-Recalls. Labelling directed the technical users and operators of medical devices focusing on the proper use and maintenance of the device. Class 3 medical certificates are valid for 24 months until the age of 40, and for 12 months thereafter. How do they break down in terms of incidents? Verathon issued an Urgent - Safety Alert and Medical Device Recall letter, dated May 10, 2013, to all affected customers The letter identified the affected product, problem and actions to be taken. Detailed depiction of functional units and software modules. Health Canada will only accept quality system certificates that have been issued by special third party auditing organizations recognized by the Minister in accordance with Section 32.1 of the Medical Devices Regulations. Clinical evidence in the form of device-specific clinical investigations conducted in Canada or other countries should be summarized. A clinical evaluation report reviewed and signed by an expert in the relevant field that contains an objective critical evaluation of all of the clinical data submitted in relation to the device. Each regulatory agency has defined several different classifications for medical devices. Its purpose is to display the information as found on the form for viewing purposes only. Conditionally required - When applicable to submission. If a device includes software, a description of that software and its impact on the safety and effectiveness of the device should be provided. Labels will be reviewed against the requirements of sections 21, 22 and 23 of the Regulations. Typically, this would consist of arrangements for, or evidence of, revalidation of the packaging and sterilization processes. They un- Health Canada does not need pre-submission information relating to interactions with ANVISA). The letter advises customers to discontinue the use of the specific serial numbers listed in the letter and asked that the affected product be returned to Verathon for replacement. (In Vitro Diagnostic Devices [IVDD] ONLY). If the labelling material covers components or devices not currently licensed in Canada this should be indicated in the labelling. Process validation data should include test data and methods, information on controls, number of samples examined, frequency of testing, and why process validation was used (e.g., routine end product tests have insufficient sensitivity, reliability of a changed process is unknown, etc.). Is this an IVDD Test Kit containing a controlled substance? In effect, this document describes what the Software Device is supposed to do. The corrigendum "is on the way," Manfred Beeres, director of communication and media relations at BVMed, the German Medical Technology Association, told MedTech Dive. Folder name: 1.04-Application Form-Administrative Info. As medical devices and IVDs become increasingly advanced and therefore complex, there is usually a higher risk to the patient. The onus is on manufacturers of radiation emitting medical devices to ensure that their devices meet all of the necessary national or provincial regulations applicable to their product. Identify if the device is intended for single or multiple use. If the device contains a drug and is not an IVDD, indicate the Drug Identification Number (DIN) or the Natural Product Number (NPN) and complete the information listed below. new, amendment, change of existing application, renewal); if amendment/supplement, the reason of the amendment/supplement; if a change to existing approval, description of the change requested (e.g., changes in design, performance, indications, changes to manufacturing processes, manufacturing facilities, suppliers); any high-level background information or unusual details that the manufacturer wishes to highlight in relation to the device, its history or relation to other approved devices or previous submissions (provides context to submission). Apple claims that the device can detect falls and arrhythmias. A wide variety of class 4 medical device options are available to you, such as quality certification, shelf life, and warranty. design, labelling, specifications) from those approved or marketed in other jurisdiction, the differences should be described. 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. The Medical Device Regulation (MDR), just like the Medical Device Directive (MDD), splits medical devices into classes 1, 2a, 2b and 3.The classes are often written using Roman numerals (class I, IIa, IIb and III). The assignment of a classification for a device depends upon the level of risk that is associated with the device. A definition of minimally manipulated can be found in the Safety of Human Cells, Tissues and Organs for Transplantation Regulations (CTO Regulations). The month and year of market approval in each country or jurisdiction where the device is marketed. The Apple watch series 4 received FDA approval as a class II medical device. Examples of medical devices against MDR Classifications. Process validation related to sterilization or shelf life should be captured under separate headings of sterilization or shelf life and need not be included in this section. Discussion to support why the evidence presented is sufficient to support the application. In this case, methods for determining these rates should be presented and any assumptions supported. Tests that describe the chemical or structural composition of the device and its components are to be included in this section. 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. range and type of energy delivered, resolution of images). The European Union's Medical Device Coordinating Group met with medical device stakeholders Monday to discuss the state of play. If the subject device is different in any way (e.g. Disinfection/decontamination procedures in the event of contamination should also be outlined along with appropriate validation. Health Canada guidance A risk assessment should be based on an analysis and an evaluation of the risks inherent in the use of t… If applicable, labelled pictorial representation (diagrams, photos, drawings). For example, when a pilot study and a controlled pivotal study are being presented, the application would include: A custom folder named "4.02.02.01- EU Pilot Study, CT4203, 2010-10-10" containing: and a custom folder named "3.5.01.02-NA RCT Study, CT4584, 2011-01-23" containing: Per IMDRF content guidance, the synopsis should contain: Note: The sponsor/applicant should explicitly address any existing regional regulatory guidance related to the components of the clinical trial synopsis. 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. Both statistical and clinical significance should be considered and critically analyzed. 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. It may also include information pertaining to Proprietary Information Submission. ALSO: Reference may be made to a product's proprietary information submission for this information. This should include: This section is applicable to all medical devices which are manufactured from or incorporate biological material from human, animal or microbial origin. To inform special/additional data that do not fit on previous headings. Medical device class (MDC) is a regulatory category defined by the United States Food and Drug Administration (FDA). If the only biological materials are heparin or tallow derivatives (e.g., glycerol) this in itself does not change the classification of the device to class IV. Folder name: 2.04.02-Description of Device Packaging. This should include: A medical device licence issued by the Medical Devices Bureau does not mean that the licenced device has been assessed to meet all relevant regulations – only that the device has been deemed to meet the requirements of the Medical Device Regulations. Please note: The manufacturer will need to contact the Office of Controlled Substances to obtain a T.K. All class II, III and IV medical device applica onsare submi ©ed to the Medical Devices Bureau at the TPD. Class I devices are seen as the lowest risk whereas Class III are deemed high-risk devices. I, as a senior official of the manufacturer named in Item 2 of this application, hereby attest that I have direct knowledge of the items checked above and declare that these identified statements are true and that the information provided in this application and in any attached documentation is accurate and complete. Labelling materials should include, as appropriate, recommended disposal techniques, the nature of combustion products, the risk of explosion, etc. Determining what device falls into what class, and what steps need to be taken afterwards to introduce the device to the European market can be difficult. If a device falls into a generic category of exempted Class I devices, a premarket notification application and FDA clearance is not required before marketing the device in the U.S. Note: Human factors testing that include patients should be included here. "The key issue is a transitional period that will be introduced for class l devices … If the submission is unsolicited information (where accepted), this should be stated and any related reference number(s) provided. Sufficient detail must be provided to enable the judgement of the appropriateness of the controls in place. No other information would be supplied. A quality plan specific for the subject device should link device requirements to the processes, resources and projects used by the manufacturer in producing that device. Folder name: 2.07-Other Submission Context Info. Laser Safety — Medical Device Manufacturing Policy on Drug/Medical Device Combination Products - Decisions and Drug/Medical Device Combination Products). If approved by the regulator, provide the approval number and identification for each component or accessory. Initial, renewal and revalidation examinations for Class 3 medical certificates may be carried out at an aeromedical centre or by an authorised medical examiner. Should include history of the marketing of the device by any other entity in as much detail as possible, acknowledging that detailed information may not be available in all cases. This section should include, as appropriate: Folder name: 2.05.02-Intended Environment-Setting. Draft Health Canada IMDRF table of contents for medical device applications guidance, 1.04 - Application Form/Administrative Information, 1.06 - Quality Management System, Full Quality System or Other Regulatory Certificates, 1.09 - Pre-Submission Correspondence and Previous Regulator Interactions, 1.12 - Letters of Reference for Master Files, 1.14 - Other Regional Administrative Information, 2.04.01 - Comprehensive Device Description and Principle of Operation, 2.04.02 - Description of Device Packaging, 2.04.04 - Reference and Comparison to Similar and/or Previous Generations of the Device, 2.05 - Indications for Use and/or Intended Use and Contraindications, 2.05.01 - Intended Use; Intended Purpose; Intended User; Indications for Use, 2.05.02 - Intended Environment/Setting for use, 2.06.02 - Global Incident Reports and Recalls, 2.06.03 - Sales, Incident and Recall Rates, 2.07 - Other Submission Context Information, 3.04.02 - Declaration and/or Certification of Conformity, 3.05.01 - Physical and Mechanical Characterization, 3.05.02 - Chemical/Material Characterization, 3.05.03 - Electrical Systems: Safety, Mechanical and Environmental Protection, and Electromagnetic Compatibility, 3.05.05.01 - Software/Firmware Description, 3.05.05.03 - Software Requirement Specification, 3.05.05.05 - Software Design Specification, 3.05.05.07 - Software Development Environment Description, 3.05.05.08 - Software Verification and Validation, 3.05.05.10 - Unresolved Anomalies (Bugs or Defects), 3.05.06 - Biocompatibility and Toxicology Evaluation, 3.05.07 - Non-Material-Mediated Pyrogenicity, 3.05.08 - Safety of Materials of Biological Origin (human/animal), 3.05.09.04 - Cleaning and Disinfection Validation, 3.05.09.05 - Reprocessing of Single Use Devices Validation Data, 3.07 - Expiration Period and Package Validation, 4.02 - Overall Clinical Evidence Summary, 4.02.02 - Device Specific Clinical Trials, 4.02.03 - Clinical Literature Review and Other Reasonable Known Information, 5.03 - Package Insert/Instructions for Use, 5.08 - Patient File Stickers/Cards and Implant Registration Cards, 5.10 - Other Labelling and Promotional Material, 6B - Quality Management System Device Specific Information, 6B.06.03 - Production and service controls information, 6B.08 - Other Device Specific Quality Management System Information, Health Canada Application and Fee Forms for the application, Guidance Document - How to Complete the Application for a New Medical Device Licence, Policy on Drug/Medical Device Combination Products - Decisions, Drug/Medical Device Combination Products, Guidance Document: Recognition and Use of Standards under the Medical Devices Regulations, Safety of Human Cells, Tissues and Organs for Transplantation Regulations (CTO Regulations). 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Submitted to Health Canada classifies all medical devices for details only one, of the sterilization process in the being! Number ( s ) associated with the MDR classifications reflect the potential risk of product. Of environmental conditions that can affect the device is of Class II, and any related number! As quality certification, shelf life, and if Full or partial compliance and compliance critical! The immunological response to animal or class 4 medical device sourced material name, proprietary name ), this consist. ) or an affirmative statement that no subpopulations exist for the software,!