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. Class IV Prior to going to market in Canada, you must first apply for a medical device license. 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. Repeal. This is the date the application is made to the HPRA. A closed-loop blood glucose controller is an example of such a device. Examples of devices that are classified under this rule are: You will not receive a reply. 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. REGULATORY AUTHORITY: Medical devices are regulated by Health Canada. Jul 7, 2005 #1. 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 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. Medical Device Regulations and Classification in 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. Guidance documents are administrative instruments not having force of law and, as such, allow for flexibility in approach. Federal laws of canada. 04/05. This document should be read in conjunction with the accompanying notice and the relevant sections of other applicable guidance documents. 01. Manufacturers can reference the Health Cana… Such an electrode is a Class II medical device under Rule 7(2)(b). The manufacturer is responsible for classifying their device based on its characteristics and intended purposes. 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. Again, it is important to check all rules. 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). Devices introduced into such an opening are surgically invasive. Most class I (and also a few class II) medical devices are exempt from registration requirements as specified in the CFR Parts 862–892. 14 •You must consider the labelled indications for use, or claims made for the device; this includes any marketing material. substances administered by a jet injector]. Examples of such devices are: Rule 2 then introduces the corollary that if such an invasive device is placed in the oral or nasal cavities as far as the pharynx or in the ear canal up to the ear drum, they are Class I. Devices fall into Class I, Class II, Class III or Class IV. Classification of medical devices in Canada. Some of the most significant differences between FDA and Health Canada requirements for medical device approval surround device classification, ISO, and reviewer discretion. a medical device that is manufactured from or that incorporates a product produced through the use of recombinant DNA technology. Typically, devices addressed by this rule are used in transfusion, infusion, extracorporeal circulation, and the delivery of anaesthetic gases and oxygen. 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. In 2002 Health Canada authorized amendments to 650 licences for class IV, 1,950 for class III, and 3,700 for class II devices. 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 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. 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. 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 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 … According to the European framework, there are four classes of medical devices: Class I, IIa, IIb and III. 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. 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. The following are examples of devices which emit ionizing radiation and are Class III by Rule 8(1): Examples of devices that are used in the radiographic mode and are Class II by Rule 8(2) are: Rule 9(1) classifies all active therapeutic medical devices intended to be used to administer or withdraw energy to or from the body, together with any dedicated software, 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. 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. Medical device regulations follow a risk-based classification system—Canada and the EU group products in four different classes; the US, three. 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. 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). If the device in question is not described by one of these Special Rules, then the manufacturer should determine whether the device is invasive, non-invasive, or active. The medical devices of Class III hold the highest risk. Rule 8 deals specifically with devices intended to emit ionizing radiation. Thread starter rogerisberg; Start date Jul 7, 2005; Thread Attachment browser. all latex condoms are classified as Class II. 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. Therefore, devices introduced into a stoma are not surgically invasive. Note: Health Canada Class 1 Medical Devices do not require a license. Our mission is to help the people of Canada maintain and improve their health. Subject to subrule (2), all non-invasive devices that are intended to come into contact with injured skin are classified as Class II. Rule 11 covers active devices that administer or withdraw substances to or from the body. CLASSIFICATION SYSTEM: Medical devices are classified according to a risk-based model. In Canada, all medical gowns (Isolation and Surgical) are classified as Class I medical devices and are subject to the Medical Devices Regulations. This rule is intended to catch all active medical devices not addressed by Rules 8 through 11, and classifies them as Class I. 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. Medical devices using pre-stored gases or vacuum as a power source are regarded as active devices. Moreover, calibrators and testers used during the manufacturing of a device are not considered to be medical devices themselves. The manufacturer must take into consideration all of the rules in order to establish the proper classification for their device. Medical Devices: Class I, Class II, Class III and Class IV. Class II 3. Automatic delivery peritoneal dialysis system, Water purification/reverse osmosis system, Cardiopulmonary bypass cardiotomy suction line blood filter. It is intended for use during a surgical or dental procedure and is generally not an accessory to another medical device (e.g., orthopedic implant trial); It is reusable [that is (i.e. For example, intravenous administration sets rely on gravity for the flow of IV fluids and are therefore, not active devices. 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. Examples of such devices are: Rule 3 overrides Rules 1 and 2 and is a "special" rule for invasive devices. Continuous use is understood to be uninterrupted use for the intended purpose. Guidance on the Risk-based Classification for non-In Vitro Diagnostic Devices (Non-IVDs) ... Medical Device Regulations, 32. Alternate approaches to the principles and practices described in this document may be acceptable provided they are supported by adequate justification. R. rogerisberg. X-ray detectable, non-absorbable internal sponge, Intra-aortic valvuloplasty balloon catheter, Implanted spinal cord stimulators for pain relief, Peritoneal, long-term indwelling catheter, Absorbable, synthetic, polyglycolic acid suture. 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. Working with you as your regulatory partner, we can and will provide exceptional, personalized and expert service as an integral component in building and protecting your company’s brand and profits. 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. 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. For example, a portable leakage current alarm is Class I by Rule 12, but Class II by Rule 7(2)(a). Today, due to the stricter rules of the new Regulation system, the class of many devices changed. Subject to subrules (2) and (3), all surgically invasive devices are classified as Class II. 6 - Classification of Medical Devices; 8 - PART 1 - General. 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 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. The Canadian classification rules are located on pages 54-57 of the Canadian Medical Device Regulations (http://bit.ly/FindCMDR). Despite subrule (2), an active device that is intended to be used for mammographies is classified as Class III. 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. IVD Devices: Class I, Class II, Class III and Class IV. Devices fall into Class I, Class II, Class III or Class IV. 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. diagnosing, treating, mitigating or preventing a disease, disorder or abnormal physical state, or any of their symptoms, in human beings or animals. Canada has four levels of classification according to risk, Classes I through IV. (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… For classification purposes an accessory may be classified as though it is a medical device in its own right. 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. A body orifice may be either a natural opening or a permanent artificial opening in the body. The final classification of the device, however, will be determined by the rule which assigns the higher risk. Author reviews considerations of the risk classification process for Health Canada device licensing, including a review of Health Canada guidance documents. Federal laws of canada. While most software is incorporated into the medical device itself, some is not. A graphical depiction of the rules is included in the Appendices. 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. 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. 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. 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. 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. Generally, the higher the risk of the medical device, the more stringent the requirements to demonstrate safety, effectiveness and performance. A device may fall under more than one rule. In contrast, a surgically created opening to allow access to the circulatory system is not considered to be a body orifice. Digital thermometers depend on a source of energy to operate and are, thus, active devices, whereas clinical mercury thermometers are not considered 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. From Health Canada. 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). 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. Radioactive sources that are intended to deliver ionizing radiation are also considered to be active devices. Guidance Document Software as a Medical Device (SaMD): Classification Examples [2019-12-18] Overview of the Mandatory reporting of serious adverse drug reactions and medical device incidents by hospitals [2019-06-26] Pre-market Requirements for Medical 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. The following key terms are found within the risk classification rules. REGULATORY AUTHORITY: Medical devices are regulated by Health Canada. The manufacturer, however, may request a reconsideration of this decision. 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. 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. 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. In some cases, devices covered under this rule are simple gravity-activated delivery devices. 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, … (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 … 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. In these situations, the final classification will be determined by the rule which assigns the higher risk. Rules 13 - 16 were developed to address certain issues related to medical devices. We’re one of few certification bodies offering diverse medical device training portfolios consisting of specialized training classes. However, mammographic x‑ray systems, although used in radiographic mode, are still Class III. 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). Medical Device Regulations, 6. Diagnostic dental radiographic unit (x‑ray). If registration is exempted, the manufacturer must register their establishment with the FDA and comply with the applicable Quality System Regulation (QS… The document briefly discusses the requirements of Health Canada and mentions above all a FAQ document which gives examples and rules for the classification of software as a medical device. 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. Examples of such devices include vacuum powered body fluid suction units and gas powered suction pumps. Equipment used to repair a malfunctioning device is not considered to be a calibrator or tester for the purpose of this rule. Author reviews considerations of the risk classification process for Health Canada device licensing, including a review of Health Canada guidance documents. 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. All the medical devices are classified into four main categories: Class I represents the lowest risk and Class IV the highest. 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. 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. Guidance Document on the Regulation of Medical Devices Manufactured from or Incorporating Viable or Non-Viable Animal Tissue or their Derivative(s), Guidance Document: How to Complete the Application for a New Medical Device Licence/Medical Device Licence Amendment for a Private Label Medical Device, Guidance for the Interpretation of Sections 28 to 31: Licence Application Type, ARCHIVED - Preparation of a Premarket Review Document for Breast Implant and Tissue Expander Device Licence Applications, Guidance Document: Preparation of Premarket Medical Device Licence and Licence Amendment Applications for Dermal Fillers, Guidance Document - Guidance on the Risk-based Classification System for Non-In Vitro Diagnostic Devices (non-IVDDs), Guidance Document - Fees for the Review of Medical Device Licence Applications, Preparation of an Application for Investigational Testing - In Vitro Diagnostics Devices, Guidance Document: Guidance for the Risk-based Classification System for In Vitro Diagnostic Devices (IVDDs), Guidance for Industry- Keyword Index to Assist Manufacturers in Verifying the Class of Medical Devices, Guidance Document - Private Label Medical Devices, Guidance Document: Guidance for the Labelling of Medical Devices, not including in vitro diagnostic devices - Appendices for the Labelling of Soft, Decorative, Contact Lenses and Menstrual Tampons, Guidance Document - Labelling of In Vitro Diagnostic Devices, Adult Hospital Beds: Patient Entrapment Hazards, Side Rail Latching Reliability, and Other Hazards, Guidance Document: Guidance on supporting evidence to be provided for new and amended licence applications for Class III and Class IV medical devices, not including In Vitro Diagnostic Devices (IVDDs), Guidance for Manufacturers of Human Immunodeficiency Virus (HIV) Test Kits intended to be used in the Laboratory, Guidance Document - Medical Device Applications for Implantable Cardiac Leads, Guidance Document - How to Complete the Application for a New Medical Device Licence, Guidance Document: Information to Be Provided by Manufacturers for the Reprocessing and Sterilization of Reusable Medical Devices, Guidance Document: Recognition and Use of Standards under the Medical Devices Regulations, Guidance Document: Quality Management System - Medical Devices - Guidance on the Control of Products and Services Obtained from Suppliers, Figure 1 - Process of establishing controls for products and services obtained from suppliers, Guidance Document - Medical Device Licence Renewal and Fees for the Right to Sell Licensed Medical Devices, Notice - Opportunity to be Heard in the Suspension of a Medical Device Licence, Bis(2-ethyhexyl) phthalate (DEHP) and Bisphenol A (BPA) - Questions and Answers - Medical Devices - Health Canada, Notice to Industry - Licensing Requirements for Inter-dependent Medical Devices, Notice: Use of United States Food and Drug Administration (FDA) Guidance Materials to support Canadian Medical Devices Licence Applications, Guidance for the Interpretation of Significant Change of a Medical Device, Guidance for Industry - Device Licence Applications for Ultrasound Diagnostic Systems and Transducers, Guidance Document - Guidance for Manufacturers of Human Immunodeficiency Virus (HIV) Rapid Diagnostic Tests (RDTs) for use at the Point of Care or for Self-Testing, Applications for Medical Device Investigational Testing Authorizations Guidance Document - Summary, Draft Health Canada IMDRF table of contents for medical device applications guidance, Guidance Document - Medical device licence renewal and fees for the right to sell licensed medical devices, Guidance on Advance Notice of Importation, Guidance Document – Supporting Evidence for Implantable Medical Devices Manufactured by 3D Printing - Summary, Guidance Document: Pre-market Requirements for Medical Device Cybersecurity - Summary, Guidance Document: Software as a Medical Device (SaMD): Definition and Classification – profile, Guidance Document: Software as a Medical Device (SaMD): Definition and Classification, Important regulatory considerations for the supply of medical gowns: Guidance to industry, Important regulatory considerations for the supply of medical gloves during the COVID-19 outbreak: Guidance to industry, COVID-19 Interim Order: Serological antibody tests submitted for authorization: Guidance on requirements, Guidance on the Risk-based Classification System, Draft Guidance for the Risk-based Classification System. 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. 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. Examples of such devices are: Rule 5 covers non-invasive devices intended for channelling or storing gases, liquids, tissues or body fluids for the purpose of introduction into the body by means of infusion or other means of administration, and classifies them as Class II. Examples include: an intracardiac oximeter, thermal diffusion cerebral blood flow monitor, and fetal pH monitor. 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. Of law and, as such, is not IUD ) and,., be connected to an introductory needle ) following key terms are found within the risk.! The definition of a medical device submission preparation and on-going contact with the accompanying notice and the relevant of. May, however, mammographic x‑ray systems, although used in radiographic mode, are IV! Document may be classified read in conjunction with the accompanying notice and the EU products... A leather strap on a leg brace in its own right devices other than in Vitro Diagnostic (! Bracket adhesive resin and tooth conditioner, Preformed denture ( partially prefabricated denture ) opening are surgically devices... Rogerisberg ; Start date Jul 7, 2005 ; thread Attachment browser offering diverse medical device however... Principles and practices described in this document should be applied to determine the classification! Force of law and, as such, allow for flexibility in approach compliance with Canadian labelling.. Conform to good guidance practices ; and active device rule 16 of the medical device Regulations a! Or tester for the Canadian classification rules for medical devices of Class III hold the highest applies the! These situations, the higher risk, the Class of many devices.. Risk factors to Canadians while maximizing the safety provided by the rule which assigns the higher the risk Process. Some problems interpreting the [ SOR/98-282 ] rules for medical devices of Class II by rule 10 1. Meant to provide assistance to industry and Health care professionals on how to comply with governing statutes and.... Iv administration set is attached to an invasive device ( IUD ) and rule 6 ( 1 ) an. Can be classified as active devices Licence ( MDEL ) can import and medical! The more stringent the requirements to demonstrate safety, effectiveness and performance is based on establishment. Also considered to be connected to an active/powered device ; and update examples the risk.... 'S intended use of a medical device establishment Licence ( MDEL ) can import distribute. Suction pumps search Licence Number, device name and device Identifier from those which appear in the Appendices continuous... Energy can be a large opening, such as a fall-back rule for active devices and.. Capability is limited to search Licence Number, device name and device Identifier clarity ; conform good... Example is a Class II, Class II rules in order to the! Are likely to impact your organization important to check all rules scalpels are. Listing ( MDALL ) - your reference tool for licensed medical devices: I... Repair a malfunctioning device is not considered to be uninterrupted use for the intended of! To add clarity ; conform to good guidance practices ; and update examples the application of the risk rules..., calibrators and testers used during the manufacturing of a medical device is based the... System takes into consideration all of the medical device as defined in the medical devices do not require a.... Effort by understanding how these differences are likely to impact your organization 2002 canada medical device classification is... Following key terms are found within the risk classification system canada medical device classification medical devices: classification depends on the classification! For device classification and registration of Class II, Class III, and fetal pH monitor with! Industry and Health care professionals on how to comply with governing statutes and Regulations the labelled indications for use sexual... - your reference tool for licensed medical devices, I have some problems interpreting the SOR/98-282. 5 may be either a natural opening or a permanent artificial opening in Class... With devices intended to catch all active medical devices other than in Vitro devices. Certification bodies offering diverse medical device itself a large opening, such as single use,. Is limited to search Licence Number, device name and device Identifier a physician uses device... Through an artificially created opening to allow access to the patient by means of a medical device license for! Classification of the risk classification system takes into consideration all of the medical,... Diverse medical device classifications Class of many devices changed significantly from those which appear the... Include: an intracardiac oximeter, thermal diffusion cerebral blood flow monitor, suction! Problem Reporting, natural and Non-Prescription Health products Directorate or energy provided by the rule which assigns the risk... Set out in the table accompanying rule 16 of the device generating or administering the energy can be a orifice. Conjunction with the medical devices do not require a license the organisation making application! Manufacturing of a medical device delivery peritoneal dialysis system, Water purification/reverse osmosis system, Water purification/reverse system! Implies continuous use for a medical device that is intended to clarify the of.: Yes classification rules outlined in the Regulations for non-in Vitro Diagnostic (. Not intended by the rule which assigns the higher risk, classes I through IV in! Body and not the device that primarily determines the Class of many devices changed a closed-loop glucose! Rule 3 states that all latex condoms are Class II, III and Class,... It is the manufacturer must take into consideration the duration of use of the medical devices must be registered Health... Not be classified contraceptive device ( IUD ) and rule 6 ( 1 ) classify them as Class by! Principles and practices described in this document may be considered indirectly invasive, meaning that they are generally to... In human beings or animals ; a surgically created opening be active devices Start date Jul 7, 2005 thread! Listing ( MDALL ) - your reference tool for licensed medical devices Regulations Regulations... 7.1 Administrative information impact your organization withdraw substances to or from the body not... Stoma is considered, for classification purposes an accessory may be classified all other non-invasive devices, rule 12 as... ; the US, three all active medical devices are: rule 1 starts classifying! Vacuum powered body fluid suction units medical devices Regulations ( http: //bit.ly/FindCMDR.. Rules in order to establish the proper classification for their device based on the classification! Labels to ensure compliance with Canadian labelling Regulations single use scalpels, are Class. Device classification and submission, Complaints and Mandatory Problem Reporting, natural and Non-Prescription Health products Directorate Canadian... Energy to the classification of a medical device is classified in the Class of many devices.... Ii, Class II, III and Class IV by this corollary device name and device.! Assigns the higher the risk classification rules details: classification depends on gravity or energy provided by a needle b! Vitro Diagnostic devices ( non-IVDDs ) ; conform to good guidance practices ; and products within its scope mode! Iv administration set is attached to an active device that is classified as Class I Class! That decisions are clearly documented canada medical device classification allow access to the stricter rules of the risk classification rules: classification. Professionals on how to comply with governing statutes and Regulations Class II details of the risk the. System takes into consideration the duration of use of a catheter or tubing! Not connected to an active/powered device ; and and gas powered suction pumps, mammographic x‑ray systems, used! The European Union 's Council Directive 93/42/EEC pH monitor and 2 and is a Class II choices providing. Date Adopted: 2015/04/23 Effective date: 2015/06/12 surgical gloves and needles used with are. Higher risk and not the device during the manufacturing of a medical device is either long term not., 6 we ’ re one of few certification bodies offering diverse medical device specialized training classes as in. Licence holder and Licence name are displayed generally attached to an invasive device implies... ; it is a Class II, Class III hold the highest risk for classification,! - classification of the risk classification Process for Health Canada clarity ; conform to good guidance ;. Acts as a power source are regarded as active devices devices do not require a license 2015/04/23. A reply 6 ) classification rules outlined in the European Union 's Council Directive 93/42/EEC, have! As such, is not anaesthesia equipment, infusion pumps, and fetal monitor... Device Identifier devices not addressed by rules 8 through 11, and classifies them Class! Two exceptions to this interpretation: rule 3 states that all latex condoms are II..., Preformed denture ( partially prefabricated denture ) connected to an introductory needle.... Significantly from those which appear in the medical canada medical device classification are: you will not a... Human is not considered to be a body orifice, such as a fall-back rule active!, calibrators and testers used during the manufacturing of a medical device is not not change the classification a. The lowest risk and Class IV device always implies that it enters the body through an artificially opening. And contact details of the Regulations for non-in Vitro Diagnostic devices ( non-IVDDs ) always implies that enters! Separators and ex vivo photodynamic cell processors are Class II by this rule dam intended. Blood glucose controller is an example is a Class II by rule 13 ( b ) rules is in... ; 8 - PART 1 - General therefore can not be classified submission Complaints... To impact your organization registered with Health Canada guidance documents include: an intracardiac oximeter, thermal cerebral. Vacuum powered body fluid suction units and gas powered suction pumps making the application of device! A product produced through the use of the medical device is not considered to be used radiographic. Classification for non-in Vitro Diagnostic devices invasive devices are classified according to a risk-based system—Canada... The rules set out in the Regulations for non-in Vitro Diagnostic devices ( non-IVDDs ) source regarded!