A device that is intended to disinfect or sterilize another medical device is classified as Class II by Rule 13(b). Health Canada is committed to ensuring that such requests are justifiable and that decisions are clearly documented. 26 - Prohibition; 28 - Medical Devices Deemed Licensed; 32 - Application for a Medical Device Licence; 32.1 - Quality Management System Certificate; 33 - Foreign Manufacturers; 34 - Application for a Medical Device Licence Amendment; 35 - Additional Information and … Rule 8 deals specifically with devices intended to emit ionizing radiation. Federal laws of canada. Examples of devices that are classified under this rule are: You will not receive a reply. a medical device that is manufactured from or that incorporates a product produced through the use of recombinant DNA technology. 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). (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 … 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. Thread starter rogerisberg; Start date Jul 7, 2005; Thread Attachment browser. 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. 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. Minimizing health risk factors to Canadians while maximizing the safety provided by the regulatory system for health products and food; and. Coming into Force. 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. Certain stem cell separators and ex vivo photodynamic cell processors are Class IV by this corollary. Q&R Canada Inc. performs medical device classification and registration of Class II, Class III and Class IV with Health Canada. Their definitions are the same as those in the Medical Devices Regulations unless otherwise indicated. For classification purposes an accessory may be classified as though it is a medical device in its own right. 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. 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. It is acknowledged that any rule system has limitations and cannot accommodate all devices. Our team at Q&R will handle the medical device submission preparation and on-going contact with the Medical Devices Bureau. IVD Devices: Class I, Class II, Class III and Class IV. 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. 6 - Classification of Medical Devices; 8 - PART 1 - General. Medical Devices: Class I, Class II, Class III and Class IV. 01. We’re one of few certification bodies offering diverse medical device training portfolios consisting of specialized training classes. There are four European and Canadian medical device classifications. 96 [Repeal]. Canada has four levels of classification according to risk, Classes I through IV. A graphical depiction of the rules is included in the Appendices. IVD Devices: Class I, Class II, Class III and Class IV. Therefore, surgical gloves and needles used with syringes are surgically invasive. Therefore, devices introduced into a stoma are not surgically invasive. The risk classification scheme was developed to categorize medical devices according to the hazard a particular device presents and not the probability that harm will occur. Medical Device Regulations and Classification in Canada. Hi all, I have some problems interpreting the [SOR/98-282] rules for medical devices. Some of the most significant differences between FDA and Health Canada requirements for medical device approval surround device classification, ISO, and reviewer discretion. 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. This can be a large opening, such as a surgical incision, or a pinprick opening created by a needle. The manufacturer should first determine that their product meets the definition of a medical device as defined in the Regulations. 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. This is the date the application is made to the HPRA. The classification of the medical device is based on the application of the risk classification rules outlined in the Medical Device Regulations. We can also handle any review of product labels to ensure compliance with Canadian labelling regulations. 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. The name, address and contact details of the organisation making the application. Medical Devices: Class I, Class II, Class III and Class IV. 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. Each section begins with general principles, followed by a reproduction of the rules as they are presented in the Regulations, and a detailed explanation with examples when applicable. 25 - Class I Medical Devices; 26 - Class II, III and IV Medical Devices. 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. 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. 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 guidance document for device classification is published by Health Canada. In these cases, the device may be listed in the table accompanying Rule 16 of the Regulations. 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). However, mammographic x‑ray systems, although used in radiographic mode, are still Class III. Tissue expanders for breast reconstruction and augmentation. 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. The Medical Devices Regulations (Regulations) utilize a risk-based approach to regulating products within its scope. 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. 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, … 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. Classification must be consistent with the claims that appear on the label of the device, including brochures, operating manuals, and the directions for use. 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. 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. From Health Canada. There are two exceptions to this interpretation: Rule 1 starts by classifying all surgically invasive devices as Class II. Intrauterine contraceptive device (IUD) and introducer, Dental/oral barrier dam (intended for use during sexual activities). Guidance on the Risk-based Classification for non-In Vitro Diagnostic Devices (Non-IVDs) ... Medical Device Regulations, 32. If registration is exempted, the manufacturer must register their establishment with the FDA and comply with the applicable Quality System Regulation (QS… The third corollary to Rule 3 states that all latex condoms are Class II. There are two corollaries to Rule 7. 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). 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. A device described in subrule (1) that is intended to be used in radiographic mode is classified as Class II. Examples of such devices are: The second corollary to Rule 2 states that when a device is invasive via a body orifice, or that is in contact with the surface of the eye, and remains so for 30 consecutive days or longer, it is a Class III device. Note: Health Canada Class 1 Medical Devices do not require a license. An example is a leather strap on a leg brace. Examples of devices that are classified under this rule are: Many devices involved in dialysis and hemoperfusion are also covered under Rule 11(2). 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. 97 (1) Subject to subsections (2) to (5), these Regulations come into force on July 1, 1998. Medical device regulations follow a risk-based classification system—Canada and the EU group products in four different classes; the US, three. 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. Class I devices are approximately 40% of approved devices. 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. Examples of such devices are: Rule 3 overrides Rules 1 and 2 and is a "special" rule for invasive devices. 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. The safety and effectiveness evidence required to support a medical device licence application is proportional to the risk of the device, which is determined by applying the Classification Rules for Medical Devices detailed in Schedule 1 of the Regulations. 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. 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. 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. Once confirmed, the classification rules should be applied to determine its proper risk classification. Class II, III, and IV Jul 7, 2005 #1. This document applies only to the classification of non-in vitro diagnostic devices (non-IVDDs). A closed-loop blood glucose controller is an example of such a device. 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. Subject to subrule (2), the following medical devices are classified as Class IV: a medical device that is manufactured from or that incorporates human or animal cells or tissues or their derivatives; and. 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. 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 nature of the substance involved and the part of the body concerned, the device is classified as Class III. The device classification for Canada must be based on the risk-based classification approach specified by Health Canada. Author reviews considerations of the risk classification process for Health Canada device licensing, including a review of Health Canada guidance documents. 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. There are four levels of medical device classifications in Canada: 1. I have recently written three reports on the U.S. Food and Drug Administration's regulation of medical devices that summarize and provide documentation for the views I hold regarding the U.S. regulatory system. 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 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). The former is Class II by Rule 10(1), and the latter is Class III by Rule 10(2). 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… 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. Rules 13 - 16 were developed to address certain issues related to medical devices. 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. 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. substances administered by a jet injector]. Subject to subrule (2), an active diagnostic device, including any dedicated software, that supplies energy for the purpose of imaging or monitoring physiological processes is classified as Class II. Examples include: an intracardiac oximeter, thermal diffusion cerebral blood flow monitor, and fetal pH monitor. 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. Such a device is classified in the class that applies to the finished medical device. 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