The following key terms are found within the risk classification rules. These are good examples of when the "highest classification possible" rule applies. 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. 6 - Classification of Medical Devices; 8 - PART 1 - General. 04/05. Rule 15 covers any medical device that is a material intended to be sold to a healthcare professional or dispenser for configuration or arrangement into a mould or shape to meet an individual's needs. 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. From Health Canada. However, if a drug delivery system depends upon manual winding to preload a spring, which is subsequently released to deliver a substance, then the device incorporating the spring is considered to be an active device. Jul 7, 2005 #1. In Canada, a medical device includes an instrument, apparatus, contrivance or other similar article, or an in vitro reagent, including a component, part or accessory of any of them, that is manufactured, sold or represented for use in diagnosing, tre… Medical device regulations follow a risk-based classification system—Canada and the EU group products in four different classes; the US, three. A device described in subrule (1) whose characteristics are such that the modification process may introduce a foreign substance into the body that is potentially hazardous, taking into account the nature and quantity of the substance, is classified as Class IV. A device whose function depends on gravity or energy provided by a human is not considered to be an active device. The manufacturer is responsible for classifying their device based on its characteristics and intended purposes. Examples of such devices include vacuum powered body fluid suction units and gas powered suction pumps. Medical Devices: Class I, Class II, Class III and Class IV. 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. Jul 7, 2005 #1. Medical Device Regulations, 6. Canada has four levels of classification according to risk, Classes I through IV. 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. IVD Devices: Class I, Class II, Class III and Class IV. 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. It is the manufacturer's intended use of the device that primarily determines the device's classification. Rule 1: (1) Subject to subrules (2) and (3), all surgically invasive devices are classified as Class II. Diagnostic dental radiographic unit (x‑ray). 02/03. Provided The second corollary identifies those devices that accomplish the intended modification through centrifugation, gravity filtration or the exchange of gas or heat as Class II. Automatic delivery peritoneal dialysis system, Water purification/reverse osmosis system, Cardiopulmonary bypass cardiotomy suction line blood filter. Class I devices are approximately 40% of approved devices. substances administered by a jet injector]. The rules developed for the Canadian classification system borrow significantly from those which appear in the European Union's Council Directive 93/42/EEC. 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. 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). Examples of devices that are classified under this rule are: You will not receive a reply. 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. Therefore, devices introduced into a stoma are not surgically invasive. Rule 11 covers active devices that administer or withdraw substances to or from the body. Our mission is to help the people of Canada maintain and improve their health. Examples include therapeutic intense pulsed light (IPL) or laser (Class 3B or Class 4 as per IEC 60825-1) devices intended for photocoagulation of vascular lesions and hair removal. Other examples are: Rule 1 then introduces the corollary that if the device is intended to diagnose, monitor, control or correct a defect of the central cardiovascular system or the central nervous system or of a fetus in utero, it is a Class IV device. Class IV Prior to going to market in Canada, you must first apply for a medical device license. If a physician uses a device in a manner not intended by the manufacturer, this does not change the classification of the device. (2) Section 32, except paragraphs (2)(f), (3)(j) and (4)(p), comes into force (a) in the case of a medical device referred to in section 94 or 95, on September 1, 1998; (b) in the case of any other medical device, on … The first corollary places denture materials and orthodontic appliances, and their accessories, in Class II. Subject to subrules (2) to (4), all invasive devices that penetrate the body through a body orifice or that come into contact with the surface of the eye are classified as Class II. Determine the classification of your medical device according to Schedule 1, Part 1 of the Canadian Medical Devices Regulations (CMDR) SOR/98-282 as published by Health Canada. A graphical depiction of the rules is included in the Appendices. The manufacturer, however, may request a reconsideration of this decision. Coming into Force. In contrast, a surgically created opening to allow access to the circulatory system is not considered to be a body orifice. Devices fall into Class I, Class II, Class III or Class IV. Hi all, I have some problems interpreting the [SOR/98-282] rules for medical devices. Examples of devices of this nature are: Rule 7(1) is a fallback rule intended to cover all other non-invasive devices not addressed by a more specific rule. There are no regulatory quality system requirements for Class 1 medical devices. Intrauterine contraceptive device (IUD) and introducer, Dental/oral barrier dam (intended for use during sexual activities). 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. 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. ), not disposable/single use]; It is not connected to an active/powered device; and. IVD Devices: Class I, Class II, Class III and Class IV. Federal laws of canada. Examples of devices that fall under this rule are: Rule 14(1) states that a medical device that is manufactured from (or that incorporates) animal or human cells or tissues or their derivatives, or is manufactured from (or that incorporates) a product produced through the use of recombinant DNA technology, is classified as Class IV. Class III 4. Typically, devices addressed by this rule are used in transfusion, infusion, extracorporeal circulation, and the delivery of anaesthetic gases and oxygen. 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. an IV administration set is attached to an introductory needle). 14 •You must consider the labelled indications for use, or claims made for the device; this includes any marketing material. ... A guidance document for device classification is published by Health Canada. The classification of the medical device is based on the application of the risk classification rules outlined in the Medical Device Regulations. Author reviews considerations of the risk classification process for Health Canada device licensing, including a review of Health Canada guidance documents. 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). device to enable that medical device to achieve its intended purpose, should be subject to all MDACS documents as apply to the medical device itself. Long term use implies continuous use for a period of 30 or more days. 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. 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. In these cases, the device may be listed in the table accompanying Rule 16 of the Regulations. 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 … Subject to subrules (2) and (3), a non-invasive device intended for modifying 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 is classified as Class III. Rely on Q&R Canada as your trusted partner for Canadian Regulatory Compliance. 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. Classification of Medical Devices. 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. Rewritten to add clarity; conform to Good Guidance Practices; and update examples. 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. Examples include: an intracardiac oximeter, thermal diffusion cerebral blood flow monitor, and fetal pH monitor. For enquiries, contact us. 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. Risk Classification Process for Health Canada Device Licensing Posted by Rob Packard on September 18, 2013. You can begin to evaluate if obtaining Canadian approval is worth your effort by understanding how these differences are likely to impact your organization. Promoting conditions that enable Canadians to make healthy choices and providing information so that they can make informed decisions about their health. The manufacturer should first determine that their product meets the definition of a medical device as defined in the Regulations. Health Canada is committed to ensuring that such requests are justifiable and that decisions are clearly documented. 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. Moreover, calibrators and testers used during the manufacturing of a device are not considered to be medical devices themselves. 6 Medical devices are classified into one of Classes I to IV by means of the classification rules set out in Schedule 1, where Class I represents the lowest risk and Class IV represents the highest risk.. 7 If a medical device can be classified into more than one class, the class representing the higher risk applies. 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. A device that is intended to disinfect or sterilize another medical device is classified as Class II by Rule 13(b). However, if a device administers a substance, whether this substance is a medicine or a medical device, such a substance must be assessed in its own right [for example (e.g.) Rule 13(a) states that a device that is intended to disinfect or sterilize blood, tissues or organs that are intended for transfusion or transplantation, is classified as Class IV. Such devices include: the ventricular assist device, the laser coronary angioplasty device, and the intra-aortic and control balloon system. Guidance on the Risk-based Classification for non-In Vitro Diagnostic Devices (Non-IVDs) ... Medical Device Regulations, 32. 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. Equipment used to repair a malfunctioning device is not considered to be a calibrator or tester for the purpose of this rule. Despite subrule (2), an active device that is intended to be used for mammographies is classified as Class III. Similar to Rule 7 for non-invasive devices, rule 12 acts as a fall-back rule for active devices. 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. Once confirmed, the classification rules should be applied to determine its proper risk classification. 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. 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. Energy, as such, is not a device and therefore cannot be classified. 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. CLASSIFICATION SYSTEM: Medical devices are classified according to a risk-based model. Class III medical devices consist of higher-risk devices such as pacemakers or implants and constitute just 10% of the devices regulated by the US FDA. Such a device is classified in the class that applies to the finished medical device. The classification of the medical device is based on the application of the risk classification rules outlined in the Medical Device Regulations. Risk Classification Process for Health Canada Device Licensing Posted by Rob Packard on September 18, 2013. For instance, an electrode for a transcutaneous electrical nerve stimulator (TENS) is not an active device but, rather is connected to an active Class II device (i.e., TENS unit). The rules for non-IVDD medical devices can be grouped into four sets: The first step in determining the risk classification of a device is to review Special Rules 13 to 16. Health Canada holds the medical device manufacturers, importers, and distributors as accountable to correctly classify their medical devices as per Health Canada … Medical devices in Canada are regulated federally by Health Canada’s Medical Devices Bureau of the Therapeutic Products Directorate and governed by Canada’s Food and Drugs Act (Act) and Medical Device Regulations (Regulations). There are four levels of medical device classifications in Canada: 1. For instance, a syringe which relies on energy generated by human muscle to depress the plunger (thus causing a substance to be delivered to the patient) is not an active device. Radioactive sources that are intended to deliver ionizing radiation are also considered to be active devices. 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. 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). 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). Digital thermometers depend on a source of energy to operate and are, thus, active devices, whereas clinical mercury thermometers are not considered active devices. 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. Medical devices are classified according to Health Canada's risk-based system. Only the device generating or administering the energy can be classified. For example, an oximeter intended by the manufacturer to be used to obtain a spot-check or single measurement of arterial oxygen saturation as part of a routine examination is Class II by Rule 10(1), while a pulse oximeter intended to be used in the operating room to continuously monitor arterial oxygen saturation is Class III by Rule 10(2), and an intracardiac oximeter is Class IV by Rule 1(2). 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. 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. There are two corollaries to Rule 7. Medical Devices Active Licence Listing (MDALL) - Your reference tool for licensed medical devices in Canada. According to the European framework, there are four classes of medical devices: Class I, IIa, IIb and III. Examples of devices that are classified under this rule are: Many devices involved in dialysis and hemoperfusion are also covered under Rule 11(2). Tissue expanders for breast reconstruction and augmentation. This is the date the application is made to the HPRA. This document applies only to the classification of non-in vitro diagnostic devices (non-IVDDs). 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. 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. Devices classified under this rule must be considered separately from devices covered under Rule 7, which have either no physical contact with the patient or only come into contact with intact skin. The third corollary to Rule 3 states that all latex condoms are Class II. Guidance documents are administrative instruments not having force of law and, as such, allow for flexibility in approach. Alternate approaches to the principles and practices described in this document may be acceptable provided they are supported by adequate justification. The Canadian classification rules are located on pages 54-57 of the Canadian Medical Device Regulations (http://bit.ly/FindCMDR). REGULATORY AUTHORITY: Medical devices are regulated by Health Canada. We can also handle any review of product labels to ensure compliance with Canadian labelling regulations. 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 represented as preventing the transmission of infectious agents during sexual activities or reducing the risk thereof is classified as Class III. 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, (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… The use of a medical device is either long term or not. 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. The application of energy from the human body does not make a device active unless that energy is stored within the device for subsequent release. 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 classified as Class III. 1.1 Policy Objective 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. If registration is exempted, the manufacturer must register their establishment with the FDA and comply with the applicable Quality System Regulation (QS… The medical devices of Class III hold the highest risk. REGULATORY AUTHORITY: Medical devices are regulated by Health Canada. Examples of other devices which are Class III by Rule 9(2) are: There are devices that fall under both Rule 9(2) as Class III, and Rule 1(2) as Class IV. Semi-automatic peritoneal dialysate delivery system, disinfecting or sterilizing blood, tissues or organs that are intended for transfusion or transplantation is classified as Class IV; and. 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. In these situations, the final classification will be determined by the rule which assigns the higher risk. There are two exceptions to this interpretation: Rule 1 starts by classifying all surgically invasive devices as Class II. Q&R Canada Inc. performs medical device classification and registration of Class II, Class III and Class IV with Health Canada. 25 - Class I Medical Devices; 26 - Class II, III and IV Medical Devices. A device described in subrule (1) that is intended to be used to monitor, assess or diagnose a disease, a disorder, an abnormal physical state or a pregnancy, if erroneous readings could result in immediate danger, is classified as Class III. Federal laws of canada. 97 (1) Subject to subsections (2) to (5), these Regulations come into force on July 1, 1998. 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. 96 [Repeal]. 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. Classification must be consistent with the claims that appear on the label of the device, including brochures, operating manuals, and the directions for use. HPRA Guide to Classification of a Medical Device 7.1 Administrative information . As per section 6 of the Regulations, medical devices are classified into one of four classes where Class I represents the lowest risk and Class IV the highest. 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… Determine the classification of your medical device according to Schedule 1, Part 1 of the Canadian Medical Devices Regulations (CMDR) SOR/98-282 as published by Health Canada. A surgically invasive device that is intended to diagnose, monitor, control or correct a defect of the central cardiovascular system or the central nervous system or of a fetus. 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. 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. 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. However, mammographic x‑ray systems, although used in radiographic mode, are still Class III. all denture materials and orthodontic appliances, and their accessories, are classified as Class II; all surgical or dental instruments are classified as Class I; and. A body orifice may be either a natural opening or a permanent artificial opening in the body. All risk II, III, and IV medical devices must be registered with Health Canada prior to their sale in 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. Subject to subrules (2) and (3), all surgically invasive devices are classified as Class II. A surgically invasive device always implies that it enters the body through an artificially created opening. Medical Device Regulations and Classification in Canada. Examples of such devices are drug delivery systems, anaesthesia equipment, infusion pumps, and suction units. A device means an instrument, apparatus, contrivance or other similar article, or an in vitro reagent, including a component, part or accessory of any of them, that is manufactured, sold or represented for use in (a) diagnosing, treating, mitigating or preventing a disease, disorder or abnormal physical state, or any of their symptoms, in human beings or animals, (b) restoring, … There are four European and Canadian medical device classifications. Generally, the higher the risk of the medical device, the more stringent the requirements to demonstrate safety, effectiveness and performance. Examples of devices that fall under Rule 5 are: Rule 6 covers the more sophisticated elements of extracorporeal circulation sets, dialysis systems and autotransfusion systems, as well as devices for extracorporeal treatment of body fluids which may not be reintroduced immediately into the body. preventing conception in human beings or animals; A surgically created stoma is considered, for classification purposes, to be a body orifice. 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. 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. 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