Health Canada Device Classification

Obtaining an MDL is comparable to the US FDA 510 k process. You must consider the labelled indications for use or claims made for the device.

Software As Medical Device Samd Classification And Definitions

In vitro diagnostic devices IVDDs are also classified as Class I through IV using a set of 9.

Health canada device classification. There are four device risk classifications in Canada. There are four device classifications Class I II III and IV which are classified using a set 16 rules. Degree of invasiveness duration of contact body system affected and local versus systemic effects.

Class IV medical devices eg a pacemaker pose the highest risk. The classification of combination products is addressed in separate policy documents Policy on DrugMedical Device Combination Products - Decisions and DrugMedical Device Combination Products which can be found on the Health Canada website. The classification procedures in Canada and the EU are quite similarmanufacturers must classify their medical devices according to the rules and criteria set out in the relevant medical device regulations Canada and directives EU as indicated in Table 1.

Health Canada Medical Device License MDL A Canadian Medical Device License MDL is required for companies selling Class II - IV medical devices in Canada. This includes any marketing material. Other classification rules may be used as SaMD technology progresses.

This document explains that additional rules outlined in Part 2 of Schedule 1 of the Regulations will also be used to classify SaMD. The following indicators of risk posed by a given device were used to create the Canadian classification rules. The term Medical Devices as defined in the Food and Drugs Act covers a wide range of health or medical instruments used in the treatment mitigation diagnosis or prevention of a disease or abnormal physical condition.

If your device is Class I then you can work with a distributor in Canada that has an establishment license. There are four European and Canadian medical device classifications. In Canada medical devices are grouped into 4 classes based on the expected level of risk to a persons health and safety.

The Canadian classification rules are located on pages 54-57 of the Canadian Medical Device Regulations httpbitlyFindCMDR. Class I IIa IIb and III are the European classifications while Class I II III and IV are the Canadian classifications. The purpose of the Medical Device Keyword Index is to assist manufacturers in verifying the classification of medical device products after application of the Classification Rules for Medical Devices set out in Schedule 1 of the Medical Devices Regulations.

The MDL is a product approval while a MDEL is a permit for the companydistributorimporter itself. The Medical Device Keyword Index should also be used in conjunction with the guidance document titled Guidance for the Risk-based Classification. Manufacturers must apply the rules set out in Schedule 1 of the Regulations to determine the appropriate classification for their device in Canada.

The guidance document titled Classification of Products at the Medical Device-Drug Interface describes the factors considered by Health Canada in the classification of health products as either devices or drugs. As such Health Canada utilized classification Rules 10 1 10 2 and 12 in Part 1 of Schedule 1 of the Regulations to classify SaMD. While Health Canada seeks to align devicedrug classifications globally when feasible a product still needs to meet the definitions in the Act and its regulations.

Health Canada may consult the classification decisions of foreign regulatory authorities as a tool to assist in interpreting and applying the definitions of the Act. Updated guidance on classification for Device or Drug products Health Canada has issued updated guidance on how it classifies healthcare products that do not readily fall within the definition of a medical device or a drug to reflect legislative changes and provide more clarity on the classification. Class I medical devices eg a thermometer pose the lowest risk to users.

2-5 In the US the classifications and ancillary information relating to medical device. 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. Draft Health Canada IMDRF table of contents for medical device applications guidance 2019-02-28 Implementation of Advance Notice of Importation Process for Medical Devices 2019-02-12 Guidance on Advance Notice of Importation under section 211 of the Medical Devices Regulations MDR and section 31 of the Radiation Emitting Devices Regulations REDR 2019-02-12.

I II III and IV. Additional information on how medical devices are approved and authorized in Canada is available on the fact sheet Safe Medical Devices in Canada. Medical devices are classified according to Health Canadas risk-based system.

Procedures to classify medical devices.

What Is A Medical Device Official Definition For Eu Usa China Brazil Medical Medical Device Medical Equipment

Does An Fda Class 1 Medical Device List Exist

Medical Devices We Stand For Quality Reliability And Flexibility We Focus On Producing High Quality Medical Equipment Medical Device Healthcare Technology

Clinical Trials Medical Device Trials Genesis Research Services

Mdr Ivdr Update

Applications For Medical Device Investigational Testing Authorizations Guidance Document Canada Ca

Frequently Asked Questions Medical Device Establishment Licensing And Fees Canada Ca

Medical Device White Papers

Guidance For Industry Keyword Index To Assist Manufacturers In Verifying The Class Of Medical Devices Medical Device Medical Manufacturing

Software As Medical Device Samd Classification And Definitions

Emergo

How To Write A Declaration Of Conformity Mdr And Ivdr Declaration Regulatory Affairs Conformity

Software As Medical Device Samd Classification And Definitions

Usability Engineering And Human Factors Testing For Devices Medical Device Academy

Complete Guide To Bringing A Medical Device To Market

What Is A Medical Device Quality Management System Qms

Guidance Document Guidance For The Risk Based Classification System For In Vitro Diagnostic Devices Ivdds Canada Ca

Clinical Trials Medical Device Trials Genesis Research Services

How To Place A Custom Made Medical Device On The Market Medical Medical Device Regulatory Affairs