Canadian licence process for medical devices a step by. New medical device manufacturing license application instructions a separate application is required for each place of business. Class 1 are exempt from requiring a medical device license. All class ii, iii and iv medical device applica onsare submi ed to. Class iv mdl applications are comparable to a us pma application. In canada, you are required to obtain a medical device establishment license mdel if you intend to market your class i device, or a medical device license mdl for your class ii, iii or iv device. To access the portable document format pdf version you must have a. The licence number query was improved to return the exact number match only. The future of the medical device market looks good with opportunities in hospital and homecare sector.
Risk classification process for health canada medical. Bsimdchina canadian regulationstewartbrainpresentationuken. Canadian medical device license information new service. Health canada increasingly regulates drugs and medical devices from a life cycle approach. One of the major issues for companies developing and producing medical devices is to be updated on the regulatory requirements and implement them in the process.
As of december 31, 2018, health canada has terminated the canadian medical device conformity assessment system cmdcas program. This report explores the role of industry, government, health system stakeholders and canadian. Action plan despite the strong foundation of canadas existing regulations, more can be done to improve the safety and effectiveness of medical devices and to optimize health outcomes for patients. Mdsap includes compliance with the qms requirements of the canadian medical devices regulations cmdr. This flowchart has been prepared by medtech europe as a highlevel overview of the requirements of the medical devices regulation. This document outlines the strategy and provides guidance for the medical device industry on health canadas compliance and enforcement activities. Canada medical device registration pathway and regulatory. Regulations are current to 20200116 and last amended on 20191216. They are intended to assist in preparing the various device licence applications required when seeking an authorization to sell a medical device product in canada. Manufacturers of class ii, iii, or iv medical devices must apply for a medical device license mdl. Medical device and diagnostic pricing and reimbursement in canada.
Office of pharmaceuticals management strategies, health canada. Draft new class ii medical device licence application form notice to the reader. Health canada recently developed strategies to increase cooperation at the. Transforming canada into a global centre for medical device. Include the appropriate fee for each application as indicated in the fee schedule and make payable to. The therapeutic products directorate tpd and, more specifically, the medical devices bureau regulates medical devices in canada ensuring their quality, safety and efficacy.
Regulations since no sale of a medical device is taking place. The medical device milestone map clinical validation is obtained after a device has been used successfully in a pilot trial in which all clinical endpoints were achieved. To do this, they must obtain an establishment license and, if necessary, a device license. The sample size of a pilot trial is usually equal to the minimal number of patients necessary for the results to hold statistical significance. Class ii iv medical device investigational testing in. Definitions of the term international medical graduate vary but the medical council of canada defines an img to be a graduate of a medical school outside of canada or the united states, with the exception of us. Implementation of the regulatory changes outlined here began in 2016 and will be completed around 2020. Health canada now only accepts mdsap certificates for the purpose of medical device license application or maintenance. This document provides guidance on regulatory requirements in relation to medical device establishment licence mdel, such as when and how to apply for an mdel, as well as how to maintain it once it is issued. In canada, sponsors or manufacturers should submit an investigational testing application ita to use unapproved class ii, iii, and iv devices in clinical trials to the device evaluation division of the medical devices office of health canada. Canada licence before selling or advertising class ii, iii and iv devices. Medical device manufacturers should develop partnerships with canadian distributors to sell their products.
As a service to all members, darryl mackie selfcare home health products has summarized some of the more important points coming out of the roadshow. Companies selling class i medical devices in canada are required to have a medical device establishment licence. To ensure the inspectorate is made aware of the following to protect the canadian consumer. If you intend to distribute licensed medical devices into canada, you will require a mdel. A person outside of canada selling medical devices into canada is also considered to be a distributor. Medical device market by application, function, end use. This action plan lays out a threepart strategy, which will be achieved through improving how devices get on. However, if the asp has purchased a medical device with which the asp is providing a service, the manufacturer of the device is still required to comply with the requirements of the medical devices regulations and obtain the appropriate licence prior to the sale to the asp. This document describes the entry of new medical devices into the canadian.
Medical devices active licence listing mdall canada. Health canada medical device establishment license mdel a number of hmeda members attended the recent health canada medical devices roadshow held recently in coquitlam. A canadian medical device license mdl is required for companies selling class ii iv medical devices in canada. As in most other markets, a manufacturers regulatory requirements in canada depend on its device s classification. Guidance on medical device compliance and enforcement gui. Note that search strings are not case sensitive, and that you may use a partial criterion for the company name medical will return any company. The last licence holder and licence name are displayed. Class i devices present the least risk and require no medical device licence but products in the three higherrisk categories do require licences before being sold in canada. This publication is available for free download from the ihe website at. This thesis examines the regulatory requirements for medical devices in argentina. This report examines the medical device industry in canada and identifies the value of the medical device industry as a strategy for strengthening the sustainability of canadas public health care systems. An example of a class 1 medical device is a thermometer.
Class ii, iii and iv medical devices must have a medical device licence to be sold in canada. You may search either by a licence number, b company id, c any combination of company name, activity, country and provincestate. As the device class increases, so does the level of premarket regulatory scrutiny. Canada medical device licensing quality smart solutions. Health canada regulatory approval process for medical devices. Identifying new changes posted by rob packard on june 5, 2012. Roughly speaking, class i devices constitute approximately 40% of devices on the canadian market, 40% class ii, 15% class iii, and 5% class iv. Draft new class ii medical device licence application form. A primer on canadian medical device regulations mddi online. Us food and drug administration, center for devices and radiological health cdrh.
Manufacturers of medical devices classified as class ii, iii, and iv must demonstrate compliance with iso 485 under mdsap. Importers or distributors of medical devices into canada for human use. While medtech europe considers the information herein to be reliable it makes no warranty or representation as to its accuracy, completeness or correctness. Please complete andor amend this application as is most appropriate to your facility.
Article number ean, assigned to a medical device by the manufacturer. Canadian cmdr consulting for health canada medical device. Devices are regulated by health canada and classified according to a riskbased system. Class ii, iii and iv devices require a medical device licence from health canada before they can be imported, sold or adver sedfor sale. Guidance on medical device establishment licensing gui. The organizational, process, and mindset changes required for medical device regulatory compliance are substantial. Certification of your mdsapcompliant quality system by a health canada and mdsapaccredited auditing organization. Last week, i was visiting a client who was told that their device is a higher risk device classification i. Although it is not a requirement of health canada that your medical device be labeled with an electrical safety mark, a health canada issued medical device licence does not imply exemption from canadian electrical requirements, which are mandated by provincial and territorial electrical safety authorities, and not by health canada.
The mdl is a product approval, while a mdel is a permit for the companydistributorimporter itself. Draft new class ii medical device licence application form health canada. Access forms and guidance documents to help you apply for a medical device licence. Yes, application forms for private label medical devices and a guidance for. Intent of the medical device establishment licensing requirements in the. Selecting the active licence search link takes you to the medical devices active licence search window. The capability is limited to search licence number, device name and device identifier. Medical devices that are imported or sold in canada except class i medical devices must be licensed before being imported or sold in canada. Also search for a licensed device using the listing database. This version of the document includes updated web links and the incorporation of changes to the establishment licensing provisions which recently occurred due to the cost recovery initiative.
Also, health canada in a recent announcement laid out the timeframe for which they will terminate their canadian medical device conformity assessment system cmdcas program and utilize mdsap as the means by which manufacturers will obtain a medical device license for distribution of medical devices. For class ii, iii, and iv devices, apply for a canadian medical device license mdl application for your device. Medical devices regulation flowchart medtech europe. Importer a person, other than the manufacturer of a device, who causes the medical device to be brought into canada for sale. Managing the complexity of medical device regulatory changes. Number of medical device licences renewed annually by health canada. This window is identical to the original mdall search and displays the results as before. Health canada medical device license mdl a canadian medical device license mdl is required for companies selling class ii iv medical devices in canada. The medical devices bureau bureau of the therapeutic products directorate, health canada is the canadian federal regulator responsible for licensing medical devices in accordance with the food and drugs act and regulations and the medical devices regulations. Class iii medical device licence amendment application form. Imgs, and often their health care manager sponsors, face a complex, multistep process to gain a canadian medical license.
Private label manufacturers must apply for and obtain a medical device licence in order to sell their class ii, iii or iv private label medical devices in canada a crossreferenced private label device licence application must include a letter signed by a senior official of the original manufacturer on the original. Imported medical devices are subject to canadian safety. No person can import or sell a class ii, iii, or iv medical device unless the manufacturer holds a license for that device. The bureau maintains a database of all licensed class ii, iii, and iv medical. The proposed regulations would apply to medical device licence holders for class ii, iii. Guidance documents have been prepared to assist in the interpretation of policies and governing statutes and regulations.
Inspectorate document, inspection strategy for medical device companies, which was. Pdf fillablesaveable 297 k 20160620 doc version 1 k declaration of conformity 20060911 investigators agreement in accordance with subsection 81 k of the medical devices regulations 20030110 licence amendment faxback form guidance for changes to the name of. Health canada cmdcas, mdsap and iso 485 qms compliance. Search for medical devices that have an active licence.
Canadas medical device market is one of the most robust markets in the world. Obtaining an mdl is comparable to the us fda 510k process. Medical devices are becoming more important in the health care sector. Class i devices are exempt from licensing and do not need to obtain health. Brief history of the canadian medical device regulatory. Th erefore, as discussed below, the regulatory schemes. Compared to a us 510k application, mdl applications are simpler for class ii devices and about the same for class iii devices. Market authorization granted by health canada takes the form of a medical device license. Selecting the archived licence search link takes you to the new medical devices licence history archive search window. This flowchart is intended for informational purpose.
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