Automatic delivery peritoneal dialysis system, Water purification/reverse osmosis system, Cardiopulmonary bypass cardiotomy suction line blood filter. 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. Class I medical devices do not require a license. The following key terms are found within the risk classification rules. Subject to subrule (2), all other non-invasive devices are classified as Class I. Examples of devices that fulfill both these corollaries are: Rule 10(1) classifies all active diagnostic devices, including any dedicated software, that supply energy for the purpose of imaging or monitoring physiological processes, as Class II. This rule also does not include equipment used for periodic servicing and maintenance of a device. For example, a general rule (invasive/non-invasive) that is not specific to active devices may, nonetheless, apply to an active device. The Medical Devices Regulations (Regulations) utilize a risk-based approach to regulating products within its scope. Such an electrode is a Class II medical device under Rule 7(2)(b). The final classification of the device, however, will be determined by the rule which assigns the higher risk. In Canada, all medical gowns (Isolation and Surgical) are classified as Class I medical devices and are subject to the Medical Devices Regulations. There are four levels of medical device classifications in Canada: 1. Subject to subrules (2) and (3), an active device intended to emit ionizing radiation, including any device or software intended to control or monitor such a device or directly influence its performance, is classified as Class III. all latex condoms are classified as Class II. Jul 7, 2005 #1. These devices may, however, be connected to the patient by means of a catheter or other tubing. 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. Medical devices are classified according to Health Canada's risk-based system. If a physician uses a device in a manner not intended by the manufacturer, this does not change the classification of the device. However, mammographic x‑ray systems, although used in radiographic mode, are still Class III. The manufacturer is responsible for classifying their device based on its characteristics and intended purposes. For example, intravenous administration sets rely on gravity for the flow of IV fluids and are therefore, not active devices. Rely on Q&R Canada as your trusted partner for Canadian Regulatory Compliance. Examples of devices that fall under this corollary are: The third corollary to Rule 2 states that if the device is intended to prevent the transmission of infectious agents during sexual activities (or to reduce the risk thereof), it is a Class III device. 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. In these situations, the final classification will be determined by the rule which assigns the higher risk. 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. However, given that Rule 1(2) assigns the higher risk, the final classification of such a device is Class IV. diagnosing, treating, mitigating or preventing a disease, disorder or abnormal physical state, or any of their symptoms, in human beings or animals. 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. Tissue expanders for breast reconstruction and augmentation. In the event of a discrepancy between the manufacturer and Health Canada regarding the classification of a medical device, the final decision rests with Health Canada. It does not necessarily hold true, however, that a medical device classified in one class according to the European Union's classification system will be classified in the same class based on the Canadian classification system. Class I 2. 6 - Classification of Medical Devices; 8 - PART 1 - General. 01. A device that is intended to disinfect or sterilize another medical device is classified as Class II by Rule 13(b). 14 •You must consider the labelled indications for use, or claims made for the device; this includes any marketing material. Classification must be consistent with the claims that appear on the label of the device, including brochures, operating manuals, and the directions for use. 25 - Class I Medical Devices; 26 - Class II, III and IV Medical Devices. The classification of the medical device is based on the application of the risk classification rules outlined in the Medical Device Regulations. Another example is an ECG machine intended only to be used in a doctor's office for routine check-ups versus an ECG machine intended to be used in critical care settings. Medical device regulations follow a risk-based classification system—Canada and the EU group products in four different classes; the US, three. 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. 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 are two exceptions to this interpretation: Rule 1 starts by classifying all surgically invasive devices as Class II. 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. Devices introduced into such an opening are surgically invasive. The first states that should the device act as a calibrator, tester or quality control support to another medical device, it is classified as Class II. Subject to subrules (2) and (3), an active device, including any dedicated software, intended to administer drugs, body fluids or other substances to the body or withdraw them from the body is classified as Class II. Most class I (and also a few class II) medical devices are exempt from registration requirements as specified in the CFR Parts 862–892. Intrauterine contraceptive device (IUD) and introducer, Dental/oral barrier dam (intended for use during sexual activities). SCHEDULE 1 (Section 6) Classification Rules for Medical Devices PART 1 Medical Devices other than in Vitro Diagnostic Devices Invasive Devices. The Canadian classification rules are located on pages 54-57 of the Canadian Medical Device Regulations (http://bit.ly/FindCMDR). 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. 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. All such devices, together with any software intended to control, monitor or directly influence the performance of such devices, are classified as Class III unless they are used only in radiographic mode, in which case, they are classified as Class II. 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. 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. Risk Classification Process for Health Canada Device Licensing Posted by Rob Packard on September 18, 2013. 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. 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. Similar to Rule 7 for non-invasive devices, rule 12 acts as a fall-back rule for active devices. A graphical depiction of the rules is included in the Appendices. There will be situations where a device is both non-invasive and active, or invasive and active, and it is not unusual for more than one rule to apply to any given device. Typically, devices addressed by this rule are used in transfusion, infusion, extracorporeal circulation, and the delivery of anaesthetic gases and oxygen. Q&R Canada Inc. performs medical device classification and registration of Class II, Class III and Class IV with Health Canada. 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. Therefore, surgical gloves and needles used with syringes are surgically invasive. The former is Class II by Rule 10(1), and the latter is Class III by Rule 10(2). All the medical devices are classified into four main categories: Class I represents the lowest risk and Class IV the highest. The first corollary to this rule addresses those devices which, during the modification process, may introduce into the body a foreign substance that is potentially hazardous, taking into account the nature and quantity of the substance. There are two corollaries to Rule 7. The name, address and contact details of the organisation making the application. 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). Examples of devices which are Class I by Rule 7(1) are: Devices covered under this rule have either no physical contact with the patient or only come into contact with intact skin. A device described in subrule (1) is classified as Class II if it is intended: to act as a calibrator, tester or quality control support to another medical device; or. Our mission is to help the people of Canada maintain and improve their health. This document applies only to the classification of non-in vitro diagnostic devices (non-IVDDs). From Health Canada. While most software is incorporated into the medical device itself, some is not. By Caroline Henrie, David Yi and Jordana Sanft on January 21, 2020 Posted in Life sciences and healthcare, Pharmaceuticals and life sciences On December 18, 2019, Health Canada published a new Guidance Document Software as a Medical Device (SaMD): Definition and Classification (Guidance Document). Examples of such Class IV devices are: The second corollary to Rule 1 is that a surgically invasive device that is intended to be absorbed by the body, or that is normally intended to remain in the body for at least 30 consecutive days, is Class III. There are four European and Canadian medical device classifications. In contrast, a surgically created opening to allow access to the circulatory system is not considered to be a body orifice. 04/05. This rule is intended to catch all active medical devices not addressed by Rules 8 through 11, and classifies them as Class I. A body orifice may be either a natural opening or a permanent artificial opening in the body. 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