The bureau maintains a database of all licensed class ii, iii, and iv medical devices offered for sale in canada. Medical devices active licence listing mdall mdall contains productspecific information on all medical devices that are currently licensed for sale in canada, or have been licensed in the past. In late 2018, a series of news articles took aim at canada s regulation of medical devices, alleging that health canada s medical device approval and adverse event monitoring systems were severely lacking. Learn to comply with health canadas medical device adverse event reporting requirements. The capability is limited to search licence number, device name and device identifier. The mdl is a product approval, while a mdel is a permit for the companydistributorimporter itself. The mandatory medical device problem reporting form for industry can be used to report preliminary, updates, final, or preliminary and final reports to canada vigilance medical device problem reporting program. If a software patch is required, consult health canada s guidance for the interpretation of significant change of a medical device. How to use the imdd international medical devices database.
Medical devices, medical information technology, medical software and health informatics. With that in mind, health canada is asking canadians who use medical devices to report any incident they experience to health canada and their healthcare provider. Alerts and recalls for drugs and medical devices 153 alerts for field safety notice. Canada s sor 98282, sections 57 through 61, give instructions for complaint handling. Regulatory provisions all devices offered for sale in canada must comply with the food and drugs act.
On december 18, 2019, health canada published a new guidance document software as a medical device samd. Medical devices active licence listing mdall canada. Canadian healthcare market regulator health canada is developing new requirements for certain hospitals to report serious medical device incidents and adverse drug reactions to better protect public health. Japans requirements for reporting medical device adverse events. This section contains information about the reporter, who is submitting the report to canada vigilance medical devices problem reporting program cvmd to fulfil their obligations under sections 59, 60, 61 and 61. Link to and information on health canadas canada vigilance adverse. Medical device reporting mdr is one of the postmarket surveillance tools the fda uses to monitor device performance, detect potential devicerelated safety issues, and contribute to benefitrisk. Selecting the active licence search link takes you to the medical devices active licence search window. The process of securing an mdl is usually faster than that a 510 k. Guidance documents medical devices guidance documents have been prepared to assist in the interpretation of policies and governing statutes and regulations. For example, treatment planning software that supplies information used in a linear accelerator is software as a medical device. If you are an industry representative, looking to file a complaint about a competitors medical device or report a problem not covered by mandatory reporting requirements, access this online form.
The choice of report type depends on whether all the required information is available within the appropriate report timeframe. Medical device reporting questions and answers, rockville, md, fda, center for devices and radiological health cdrh, february 1988. For medical devices if you are a consumer looking to report a problem with a medical device, access this online form. This article will provide an update regarding steps health canada has now taken to tighten up regulation of medical devices.
Canada vigilance medical device problem reporting program. To learn more about the medical device inspections we conduct, visit about medical device inspections or browse these inspection results. Mandatory medical device problem reporting form for. Given that there are nearly 5,000 individual classes of medical devices, tens of thousands of medical device suppliers, and millions of healthcare providers around the world, device related problems are bound to happen. Weve helped thousands of medical device companies with. Submission of a report does not constitute an admission that. The licence number query was improved to return the exact number match only. Health canada provides guidance on regulation of software. We do not provide medical advice on the use of the products identified in this listing. Obtained from adverse reaction and medical device incident report. The device licence number is issued by health canada but does not normally appear on the label. The classification of samd is based on the intended use and on the existing classifications in canada s medical device regulations, ranging from lowrisk class i to highrisk class iv.
Medical devices safety therapeutic goods administration. Health canada considers that software is a medical device when. Health canada proposing regulatory requirements for software as a medical device samd. From health canada you may search either by a licence number, b company id, c any combination of company name, activity, country and provincestate. Medical devices regulation and safety latest documents. Class i medical devices do not require a medical device licence and are monitored by the health products and food branch inspectorate compliance and. Obtaining an mdl is comparable to the us fda 510 k process. Report any medical device incidents brought to your attention to health canada by calling tollfree at 18002679675, or by reporting online. Chapter 2health canadaregulation of medical devices. 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. Canadian medical device licensing is generally a simpler process than the 510k submission process for the us fda and the european ce marking process. This is blog post 1 of 4 in our series on medical device complaint handling. Software with a medical purpose that operates on a general purpose.
Health canada will generally consider software as having a medical purpose where it is intended to. Medical device incidents search page drug and health. A canadian medical device license mdl is required for companies selling class ii iv medical devices in canada. Additionally, some medical devices do not require a device licence. How to determine if your product is a medical device fda. Selecting the archived licence search link takes you to the new medical devices licence history archive search window. The device name is usually found on the label and may include a brand or trade name. Canada releases final guidance on software as a medical device. Health canada has finalized guidance on software as a medical device samd that clarifies how it fits into the agencys regulatory framework and how devicemakers can comply. Medical purposes are set out in the definition of device in the act. Cybersecurity vulnerabilities associated with some medical. Canadas scientific advisory panel on software as a medical device.
To ensure the inspectorate is made aware of the following to protect the canadian. Submission of inadequate mandatory problem reports by reporters, for which canada vigilance medical device problem reporting program is consistently required to request additional information, will result in the forwarding of this information to the health products and food branch inspectorate, to determine regulatory compliance. We are not suggesting or implying that any companies or other entities included in the international medical devices database engaged in unlawful conduct or otherwise acted improperly. Guidance document for mandatory problem reporting for medical. Once the report has been received and entered into our database, a letter confirming receipt of the report.
Health canada medical device establishment licence mdel inspections, audits and compliance june 2009. Report a serious adverse drug reaction for hospitals report a medical device problem for health care professionals prescription drug list. 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 name that includes this word. Proposed health canada regulations for samd based on international medical device regulators forum imdrf guidelines. Mandatory problem reporting forms for health canada. Weve combined all four posts into one easy to read white paper. For those outside the industry, the term complaint handling conjures visions of angry customers arguing with tonedeaf service representatives. Health canada on tuesday opened up a consultation on changes to the countrys food and drug regulations and medical devices regulations that would make it mandatory for certain health care institutions to report serious adverse drug reactions adrs and medical device incidents mdis. This database contains medical device recalls classified since november 2002. The last licence holder and licence name are displayed.
If you already know the basics, skip to the second post on reportable incidents. Intent of the medical device establishment licensing requirements in the medical devices regulations 1. This window is identical to the original mdall search and displays the results as before. Health canada encourages canadians to report incidents. Health canada opens consultation on mandatory adverse drug. The same device may have different names in different countries. Preparing new mdl or amendment for private label medical devices. New canadian medical device incident reporting rules proposed. Health canada samd regulations would exclude products such as electronic health records and wellness apps. It also includes details about the manufacturer and importer of the medical device that are responsible to submit the report to cvmd. Guidance document for mandatory problem reporting for.
The device name is usually found on label and may include a brand or trade name. The medical device regulations outline specific requirements for mandatory problem reporting to health canada and require that you have written procedures to address these requirements. Health canada medical device adverse event reporting. The medical device reporting mdr regulation 21 cfr part 803 contains mandatory requirements for manufacturers, importers, and device user facilities to report certain device related adverse.
Health canada looks at serious adverse drug reaction and medical device incident reports as an. Submit a preliminary report to health canada detailing the incident and corrective action strategy. Canada vigilance medical device problem reporting program marketed health products directorate health canada address locator 1908c 200 tunneys. The iris insite program works closely with health facilities to improve awareness about medical device adverse event reporting. A new health canada consultation paper provides updates on the regulators effort to establish new incident reporting rules as authorized. This article explains the process for obtaining a health canada medical device license through a hypothetical case study. Health canada publishes draft software as a medical device.
Health canada medical device establishment licence mdel. Exploiting globally available safety information on medical devices. The reporting of incidents involving medical devices allows health canada to more quickly identify, communicate and act on new or increased medical device safety concerns. Medical devices active licence listing mdall health canada is the federal regulator of therapeutic products, including medical devices. Use of united states food and drug administration fda guidance materials to support canadian medical devices licence applications canada. The guidance document explains what products would be regulated as samd under the food and drugs act act and the medical devices regulations regulations as well as information on classification of samd. Reference canada s medical device regulations, sor98282, and guidance document for mandatory problem reporting for medical devices for the correct reporting timeline, which will depend on the severity of the incident. Health canada uses the definition developed by the international medical device regulators forum imdrf as provided in section 1. Software is changing how clinicians practice medicine, how consumers manage their own health, and how patients and providers interact. Health canada is the federal department responsible for medical devices through its. Mandatory problem reporting forms for health canada canada s sor 98282 thread starter susan07. Health canada currently requires mandatory reporting of medical device incident. Cannot advertise or represent by label a treatment for a schedule a disease or disorder section 3 cannot sell or advertise a device that may cause harm cannot sell or advertise a device in a misleading or deceptive way all medical devices those used on human beings must also comply.
As a result of the gaps in its medical devices program, health canada does not. Medical device problem reporting for the betterment of. One revolutionary development in digital health technology is software that can perform complex medical functions software as a medical device samd. Medical devices help to diagnose, prevent and treat many injuries and diseases. The status is updated if the fda identifies a violation and classifies the. The iris is responsible for the management of all reports of adverse events or problems associated with medical devices that are reported to the tga.
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