Subject to subrule (2), all non-invasive devices that are intended to come into contact with injured skin are classified as Class II. Repeal. Guidance documents also provide assistance to staff on how Health Canada mandates and objectives should be implemented in a manner that is fair, consistent and effective. Classification rules: Yes Classification rules details: Classification depends on the intended use of a medical device. The manufacturer is responsible for classifying their device based on its characteristics and intended purposes. Once confirmed, the classification rules should be applied to determine its proper risk classification. restoring, modifying or correcting the body structure of human beings or animals or the functioning of any part of the bodies of human beings or animals. Class I devices do not require a medical device license; however, manufacturers, distributors and importers of Class I devices are required to obtain an establishment license. A device described in subrule (1) that accomplishes the modification by centrifugation, gravity filtration or the exchange of gas or heat is classified as Class II. The final classification of the device, however, will be determined by the rule which assigns the higher risk. These calibrators and testers must be employed to calibrate or test a medical device prior to (or during every use) in order to ensure the proper functioning of the device. Classification must be consistent with the claims that appear on the label of the device, including brochures, operating manuals, and the directions for use. It classifies devices described in Rule 10(1) that are intended to be used to monitor, assess or diagnose a disease, a disorder, an abnormal physical state, or a pregnancy, where erroneous readings could result in immediate danger, as Class III. 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. The Medical Devices Regulations (Regulations) utilize a risk-based approach to regulating products within its scope. A preamendments device is one that was in commercial distribution before May 28, 1976, the date the Medical Device Amendments to the Federal Food, Drug, and … A device that administers energy to the body is not invasive if only energy penetrates the body and not the device itself. The Medical Device regulations require Class II, III and IV medical devices to be manufactured (Class II) or designed and manufactured (Class III and IV) under CAN/CSA ISO 13485:2003. If registration is exempted, the manufacturer must register their establishment with the FDA and comply with the applicable Quality System Regulation (QS… This can be a large opening, such as a surgical incision, or a pinprick opening created by a needle. Subject to subrules (2) and (3), an active therapeutic device, including any dedicated software, intended to be used to administer or withdraw energy to or from the body is classified as Class II. Certain stem cell separators and ex vivo photodynamic cell processors are Class IV by this corollary. A device which comes into contact with the surface of the eye, or which penetrates inside the body (in whole or in part), either through a body orifice or through the surface of the body, is an invasive device. There are four device classifications--Class I, II, III and IV--using a set of 16 rules found in Schedule 1, Part 1 of the Canadian Medical Devices Regulations (CMDR) SOR/98-282. An MDEL is issued by the Inspectorate based on an establishment certifying that they meet certain requirements and are then inspected for compliance. Companies with a medical device establishment licence (MDEL) can import and distribute medical gowns. A device described in subrule (1) that is intended to be placed in the oral or nasal cavities as far as the pharynx or in the ear canal up to the ear drum is classified as Class I. These are good examples of when the "highest classification possible" rule applies. Jul 7, 2005 #1. CLASSIFICATION SYSTEM: Medical devices are classified according to a risk-based model. Rule 1: (1) Subject to subrules (2) and (3), all surgically invasive devices are classified as Class II. You can begin to evaluate if obtaining Canadian approval is worth your effort by understanding how these differences are likely to impact your organization. The name, address and contact details of the organisation making the application. In some cases, devices covered under this rule are simple gravity-activated delivery devices. 8 - Application; 9 - Manufacturer’s Obligations; 10 - Safety and Effectiveness Requirements; 21 - Labelling Requirements; 24 - Contraceptive Devices — Advertising; 25 - Class I Medical Devices; 26 - Class II, III and IV Medical Devices. The following indicators of risk posed by a given device were used to create the Canadian classification rules: degree of invasiveness, duration of contact, body system affected, and local versus systemic effects. A device that meets the criteria set out in Rule 9(2) and that is also intended to control the treatment of a patient's condition through a closed-loop system is classified as Class IV. There may be cases where either a device cannot be classified by the existing rules because of an unusual characteristic, or where the resulting classification does not reflect known hazards associated with the use of the device. A device described in subrule (1) that is intended to be used in radiographic mode is classified as Class II. preventing conception in human beings or animals; A surgically created stoma is considered, for classification purposes, to be a body orifice. Health Canada holds the medical device manufacturers, importers, and distributors as accountable to correctly classify their medical devices as per Health Canada … Only calibrators, testers and quality control support devices offered for sale as part of medical device systems or as medical devices themselves fall under this category. Classification of Medical Devices •To determine the classification of a device, you must apply all of the rules in Schedule 1 of the Medical Devices Regulations. Examples of devices that are Class II by this rule are: The second corollary to this rule states that all surgical or dental instruments are classified as Class I. The risk classification system takes into consideration the duration of use of a medical device. Many of the rules and interpretations of terms are either the same as, or similar to, those proposed by the European Union in the supporting documentation to the Council Directive. If a physician uses a device in a manner not intended by the manufacturer, this does not change the classification of the device. Please note, however, that even if a particular device type is provided as an example, this does not mean that the classification indicated by the example applies to all such devices. 14 •You must consider the labelled indications for use, or claims made for the device; this includes any marketing material. Risk Classification Process for Health Canada Device Licensing Posted by Rob Packard on September 18, 2013. Q&R ensures that the firm has a valid Establishment License and also prepares the required documents including the standard operating procedures for the activities such as mandatory problem reporting, complaint handling, recall, distribution records, and corrective/preventative actions etc. There are two exceptions to this interpretation: Rule 1 starts by classifying all surgically invasive devices as Class II. As a corollary to the above, it is equally important to note that Health Canada reserves the right to request information or material, or define conditions not specifically described in this document, in order to allow the Department to adequately assess the safety, efficacy or quality of a therapeutic product. Again, it is important to check all rules. Long term, portable ECG recorder (holter monitor), Nitrous-oxide gas analyser (gaseous phase), Ultrasonic/doppler neonatal blood pressure monitor, Cardiac monitor (including cardiotachometer and rate alarm). In order to be allowed to import or market its medical device in Canada, the manufacturer shall submit the appropriate application form, containing the following information: The name of the device in question, The class of the device in accordance with the risk-based classification, The indication of the identifier of the device, Examples of devices that are classified under Rule 7(2)(a) are: The second corollary to this rule states that if a device described in Rule 7(1) is intended to be connected to an active device that is classified as Class II or higher, then it becomes a Class II device. There are four European and Canadian medical device classifications. The Medical Devices Regulations (Regulations) utilize a risk-based approach to regulating products within its scope. Such a device is classified in the class that applies to the finished medical device. Energy, as such, is not a device and therefore cannot be classified. A body orifice may be either a natural opening or a permanent artificial opening in the body. Typically, devices addressed by this rule are used in transfusion, infusion, extracorporeal circulation, and the delivery of anaesthetic gases and oxygen. The classification of the medical device is based on the application of the risk classification rules outlined in the Medical Device Regulations. Subject to subrule (2), all other non-invasive devices are classified as Class I. Rule 4 classifies non-invasive devices that come into contact with injured skin, where they are intended to be used only as mechanical barriers, for compression or for absorption of exudations, as Class I. REGULATORY AUTHORITY: Medical devices are regulated by Health Canada. Devices covered under Rule 5 may be considered indirectly invasive, meaning that they are generally attached to an invasive device (e.g. The Health Products and Food Branch's mandate is to take an integrated approach to the management of the risks and benefits to health related products and food by: © Minister of Public Works and Government Services Canada 2015, Également disponible en français sous le titre : Ligne directrice : Orientation sur le système de classification fondé sur le risque des instruments autres que les instruments diagnostiques in vitro (IDIV). The manufacturer should first determine that their product meets the definition of a medical device as defined in the Regulations. Continuous use is understood to be uninterrupted use for the intended purpose. Promoting conditions that enable Canadians to make healthy choices and providing information so that they can make informed decisions about their health. Examples of devices that are classified under this rule are: The first corollary to this rule states that should the administration or withdrawal by such a device be potentially hazardous, taking into consideration the nature of the administration or withdrawal, the nature of the substance involved and the part of the body concerned, the device is classified as Class III. Class I devices are approximately 40% of approved devices. A Medical Device Establishment Licence is separate from a Medical Device Licence and is issued for the activities of importing and selling medical devices for human use in Canada. Transcutaneous electrical nerve stimulator for pain relief, High energy DC defibrillator (including paddles; non-closed loop), Automatic implantable cardioverter defibrillator, Implanted vagus nerve epilepsy stimulator. A device described in subrule (1) that is normally intended to remain in the body or in contact with the surface of the eye for at least 30 consecutive days is classified as Class III. Alternate approaches should be discussed in advance with the relevant program area to avoid the possible finding that applicable statutory or regulatory requirements have not been met. For example, intravenous administration sets rely on gravity for the flow of IV fluids and are therefore, not active devices. Examples of devices that are Class I by this rule are: Non-invasive devices with any other intended mechanism of action or indication (e.g., promote healing, provide relief of pain, provide a moist wound healing environment), and which come into contact with injured skin, are Class II. all latex condoms are classified as Class II. The device classification for Canada must be based on the risk-based classification approach specified by Health Canada. Examples of devices that are Class IV by Rule 14(1)(a) or 14(1)(b) are: However, a device described in Rule 14(1) that is intended to only come into contact with intact skin is classified as Class I. If the administration or withdrawal by a device described in subrule (1) is potentially hazardous, taking into account the nature of the administration or withdrawal, the intensity of the energy and the part of the body concerned, the device is classified as Class III. Medical devices are classified according to Health Canada's risk-based system. This guidance document is intended to clarify the application of the risk classification rules set out in the Regulations for non-in vitro diagnostic devices. Diagnostic dental radiographic unit (x‑ray). Our team at Q&R will handle the medical device submission preparation and on-going contact with the Medical Devices Bureau. Minimizing health risk factors to Canadians while maximizing the safety provided by the regulatory system for health products and food; and. (1-3) The following report will present eight conclusions I have reached, in the form of comparisons of the U.S. regulatory system with the corresponding systems in Europe, Canada… Automatic delivery peritoneal dialysis system, Water purification/reverse osmosis system, Cardiopulmonary bypass cardiotomy suction line blood filter. 02/03. Only the device generating or administering the energy can be classified. Coming into Force. Federal laws of canada. It is the manufacturer's intended use of the device that primarily determines the device's classification. Q&R Canada Inc. performs medical device classification and registration of Class II, Class III and Class IV with Health Canada. If the intended use is not specified on the label of the device, then the intended use will be deemed to be that accepted in general medical practice. Federal laws of canada. Note: Health Canada Class 1 Medical Devices do not require a license. These devices may, however, be connected to the patient by means of a catheter or other tubing. Examples of such devices are: Rule 3 overrides Rules 1 and 2 and is a "special" rule for invasive devices. IVDs are also classified as Class I through IV using a set of 9 rules, which can be found in Schedule 1, Part 2 of the CMDR.Device classification dictates the type of license required for your product, as well as qu… All the medical devices are classified into four main categories: Class I represents the lowest risk and Class IV the highest. Examples of devices which fall under this rule are: However, there is also a corollary to Rule 10 which is similar to that of Rule 9. The manufacturer, however, may request a reconsideration of this decision. The classification of combination products is addressed in separate policy documents, "Policy on Drug/Medical Device Combination Products - Decisions" and "Drug/Medical Device Combination Products", which can be found on the Health Canada website. Examples of such devices are: Similar to Rule 1, Rule 2 states that all devices that penetrate the body through a body orifice or that come into contact with the surface of the eye are Class II. Examples of devices that are classified as Class III by Rule 11(2) are: If a device meets the criteria set out in the first corollary and is intended to control the treatment of a patient's condition through a closed-loop system, it is classified as Class IV by Rule 11(3). A device that is intended to disinfect or sterilize another medical device is classified as Class II by Rule 13(b). Again a chart mentions concrete examples. Author reviews considerations of the risk classification process for Health Canada device licensing, including a review of Health Canada guidance documents. Similar to Rule 7 for non-invasive devices, rule 12 acts as a fall-back rule for active devices. It is intended to be used to perform one of the following actions: cutting, drilling, sawing, scraping, clamping, hammering, puncturing, dilating, retracting or clipping. Rule 11(1) states that an active device, including any dedicated software, intended to administer or withdraw drugs, body fluids or other substances to or from the body is classified as Class II. Some of the most significant differences between FDA and Health Canada requirements for medical device approval surround device classification, ISO, and reviewer discretion. There are four levels of medical device classifications in Canada: 1. to be connected to an active device that is classified as Class II, III or IV. Rule 6(1) states that non-invasive devices intended to modify the biological or chemical composition of blood or other body fluids, or liquids, for the purpose of introduction into the body by means of infusion or other means of administration are Class III. 96 [Repeal]. The rules developed for the Canadian classification system borrow significantly from those which appear in the European Union's Council Directive 93/42/EEC. Examples of other devices that fall under this rule are: An "active device" requires a source of energy (other than the energy generated by the human body or gravity) to work. Medical Devices: Class I, Class II, Class III and Class IV. Examples of devices which are Class III by Rule 10(2) are: There are instances when a device is classified as both a Class III by Rule 10(2) and Class IV by Rule 1(2). A device whose function depends on gravity or energy provided by a human is not considered to be an active device. HPRA Guide to Classification of a Medical Device 7.1 Administrative information . Guidance documents are meant to provide assistance to industry and health care professionals on how to comply with governing statutes and regulations. There are no regulatory quality system requirements for Class 1 medical devices. A device described in subrule (2) that is intended to control the treatment of a patient's condition through a closed loop system is Class IV. Medical Device Regulations, 6. In order for a medical device to be considered a "surgical or dental instrument" and, therefore, be classified as a Class I device, it must meet all of the following criteria: Examples of reusable and manual instruments that fall under this corollary are: An instrument that is intended for surgical or dental use that does not meet all of the criteria indicated above would, most likely, be Class II by either Rule 1(1) or 2(1). Class II 3. A "closed-loop system" refers to a device that is capable of sensing, interpreting and treating a patient without human interference at any point in the procedure. Examples of devices that are Class I by Rule 12 are: Although a device may be Class I by Rule 12, other applicable rules may move the device to a higher classification. In 2002 Health Canada authorized amendments to 650 licences for class IV, 1,950 for class III, and 3,700 for class II devices. diagnosing pregnancy in human beings or animals, caring for human beings or animals during pregnancy or at or after the birth of the offspring, including caring for the offspring, or. By the rule which assigns the higher risk for medical devices do not require a.... One of few certification bodies offering diverse medical device is not invasive if only energy penetrates the body not... Provided they are supported by adequate justification servicing and maintenance of a medical device establishment (. 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