If multiple facilities are involved in the manufacture of a device, the applicable information for each facility must be submitted. Prior to selling a device in Canada, manufacturers of Class II, III and IV devices must obtain a Medical Device Licence. Identify if the device is intended for single or multiple use. 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 procedures for monitoring and controlling the process parameters of a validated process should also be fully described. The detailed information expected for each material depends on the type of biological material and the particular risks inherent in that particular material. For example, but not limited to: If the device can communicate with other devices. Conditionally required - If demonstrating that device complies with standards. It can also record an electrocardiogram (ECG) in 30 seconds “anytime and anywhere,” according to Apple. 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. ): 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. A key specification comparison, preferably in a table, between the references (similar and/or previous generation) considered and the device. It also provides a means of tying together identified hazards with the implementation and testing of the mitigations. If appropriate, for the validation report, see Chapter 3 – Non-Clinical Studies. If applicable, provide the clinicaltrials.gov reference number for any clinical studies registered with clinicaltrials.gov. This may be provided in a table format. Evidence to support the interoperability should be provided. Further, as described in the Health Canada Adapted Assembly and Technical Guide for IMDRF Table of Contents Submissions for each additional custom folder created, the final digit of the heading number should be incremented by 1. A statement of why this category of non-clinical laboratory study is not applicable to this case. Class I Medical Devices. The procedures for monitoring and controlling the process parameters of a validated process should be fully described. If more than one device is included, the information should be provided for each device. cadaveric evaluations, biomechanical assessments), A legible copies of key articles , including translation where applicable to meet the regulators language requirements. Conditionally required - When relevant to the amendment. Affirmatively state there has been no prior submissions and/or pre-submission interactions for the specific device that is the subject of the current submission. 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. Please note: The manufacturer will need to contact the Office of Controlled Substances to obtain a T.K. A summary of the risks identified during the risk analysis process and how these risks have been controlled to an acceptable level. ). No other information would be supplied. This blog will be a guide A listing of published non-clinical studies involving this specific device (e.g. A general description of the device, including: Who uses it and for what? In this case, methods for determining these rates should be presented and any assumptions supported. A quality plan should specify "which processes, procedures and associated resources will be applied by whom and when to meet the requirements of a specific project, product, process or contract…". The European Union's Medical Device Coordinating Group met with medical device stakeholders Monday to discuss the state of play. The assignment of a classification for a device depends upon the level of risk that is associated with the device. 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. Note: No files or content should be included at this level. The classifications are, for the most part or as a general rule, related to the perceived risk of the product type. Does this device consist of recombinant material? Contain the information on the testing for sterilant residues, where the device is supplied sterile and sterilized using a method susceptible to residues. If a clinical study has been conducted that includes usability/human factors endpoints, reference to the studies and endpoints should be made, but full results do not need to be repeated and should be included in Chapter 4 – Clinical Evidence. stickers/cards intended to be place in the patient's chart identifying the implant (e.g. Conditionally required - If any sub-headings are required. A description of the sterilization process (method, parameters) and Sterility Assurance Level (SAL). 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. 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. Class III medical devices are under the most severe regulatory controls because of their high risk nature. 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. This folder should be customized to represent the details of the study. A complete curriculum vitae, or similar documentation, to justify the manufacturer's choice of the clinical expert. Cybersecurity vulnerabilities and risks analysis, Traceability matrix linking cybersecurity controls to the cybersecurity vulnerabilities and risks. A summary of the number of units sold in each country/region and a statement of the period associated with this data. Folder name: 3.05.05.08.01-Study Title, Identifier, Date (see below), Folder name: 3.05.05.09-Revision Level History. If yes, provide the authorization number or the device identification number: (include an identifier for each device or medical device group listed and indicate (by a check mark) if it contains ≥ 0.1% w/w of Di (2-Ethyl hexyl) Pthalate [DEHP] or is manufactured from raw materials containing or derived from bisphenol A [BPA]), (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 or function with, including their medical device licence number. This should include, Folder name: 3.08.01-Study Title, Identifier, Date (see below), Folder name: 4.02-Overall Clinical Evidence Summary. Detailed depiction of functional units and software modules. Multiple options can be indicated. 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. Examples include bandages, handheld surgical instruments, and nonelectric wheelchairs. (high level statement), Where to use it? Devices containing materials of unknown stability should have real-time data. 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. Folder name: 3.05.09.05.01-Study Title, Identifier, Date (see below). 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. It is recognized that some cell lines, especially those from rodents, used for the manufacture of products will contain endogenous retroviruses, retrovirus particles or retrovirus-like particles. 2. The manufacturers of such devices can choose one out of three possible CE marking routes. Additional classification guidance can be sought through the Medical Devices Bureau. If the drug does not have a DIN or NPN, please provide the Drug Establishment Licence (DEL) number of the company from where the drug is sourced. Copies of the articles should also be provided. Contains information on the validation of cleaning and disinfection instructions for reusable devices. Folder name: 3.07.02.01-Study Title, Identifier, Date (see below), Folder name: 3.08-Other Non-Clin Evidence. Refer to folder "3.05.09.04.00 - Overview" below for classification information. Class 3 medical certificates are valid for 24 months until the age of 40, and for 12 months thereafter. Folder name: 1.09-Pre-Submission Correspondence-Previous Regulator Interactions. 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. A clinical evaluation considers available, relevant clinical data from published sources, or device-related investigations. Conditionally required - When software is part of the device. Folder name: 3.05.07.01-Study Title, Identifier, Date (see below). This should include: Folder name: 3.05.02.01-Study Title, Identifier, Date (see below). 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. Medical devices incorporating tissues of human origin pose a special risk for both patients and health care providers. Devices sold in non-sterile condition, but intended to be used sterilized, must specify the recommended sterilization process in the labelling. Refer to folder "3.05.08.00 - Overview" below for classification information. The rationale (and limitations) of selecting the particular animal model should be discussed. A summary describing the software development life cycle and the processes that are in place to manage the various life cycle activities. what tests were considered and why they were or were not performed). When required, full details to support how these specifications are met are to be provided in CH3.5.02 – Chemical/Material Characterization. This should include: Folder name: 3.05.11.01-Study Title, Identifier, Date (see below). Incidents should include any Canadian incidents through SAP or other previous Canadian applications, if known. 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. Authority to regulate medical devices it can also record an electrocardiogram ( ECG ) in 30 seconds “ and... 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