Health canada medical device database

Health canada medical device database. To confirm if a particular UV radiation-emitting device meets the 2 years after the date the authorization holder first took possession, care or control of the device in Canada; At the same time, we have amended the Food and Drugs Regulations and the Natural Health Products Regulations to reduce the records retention period from 25 years to 15 years for clinical trials of drugs and natural health products. The choice of report type depends on whether all the required information is available within the appropriate report timeframe. The data set is updated on a monthly basis and currently covers the following time period: 1965 to 2024-04-30. With these amendments, we have implemented certain powers included in Vanessa's Law and additional measures to improve post-market In February 2024, the Public Health Agency of Canada and Health Canada jointly published an article in the Canada Communicable Disease Report on seasonal influenza vaccines distributed during the 2021/2022 influenza season. The database should not be used The Drug and Health Products Inspections Database (DHPID) supports open government and regulatory transparency. Selecting Search Active Licences takes you to the Medical Devices Active Licence Search window. This window is identical to the original MDALL search and displays the results as before. Canada Vigilance Online Adverse Reaction Database; review decisions, such as the: Regulatory Decision Summary (RDS) Summary Basis of Decision (SBD) Summary Safety Review (SSR) Drug Product Database. Health Canada Medical Device Licensing and MDEL registration FAQs. Purpose. This guidance is to be used in the preparation of medical device related regulatory transactions. Selecting the Active Licence Search link takes you to the Medical Devices Active Licence Search window. This guidance document is intended for any person in the medical device industry and it provides guidance on regulatory requirements in relation to Medical Device Establishment Licences (MDEL), including when and how to apply for an MDEL, and how to maintain an MDEL once issued. Reports are collected by the regional offices before being forwarded to the Canada Vigilance National Office for further a Nov 20, 2019 · Section 3 is mandatory if Section 4 (below) is not completed. FDA Medical Devices. Consultations. 5 Applicable fees. The Safety of Dental Amalgam [2002-08-12] Medical Devices Performance Reports Find recalls, advisories and safety alerts for various products and services in Canada, including health, food, transport, and consumer goods. An MDEL gives Health Canada assurance that: medical devices sold or imported into Canada meet the safety requirements set out in the Mar 13, 2019 · The move also brings Canada in line with the European Union's plans for greater transparency surrounding medical devices. When will I receive acknowledgement from Health Canada regarding my Medical Device Establishment Licence (MDEL) application? You will receive acknowledgement from Health Canada regarding your Medical Device Establishment Licence (MDEL) application as soon as it is received and screened for completeness. To find out if a medical device establishment has an active licence, visit the Medical devices establishment licence listing database Compliance and enforcement activities are a key element of safeguarding the drugs and health products to which Canadians have access. May 26, 2014 · 1. Information about human blood and blood components has been included in the database since September 1, 2015. Jan 27, 2023 · The FDA and Health Canada are conducting a joint pilot to test the use of a single eSTAR submitted to both the FDA and Health Canada. Health Canada will inspect your establishment to verify your attestation in section 6 and your establishment's compliance with the Medical Devices Regulations. Medical Device Single Audit Program; The results of these audits are not included in the database because they are not done by Health Canada. Feb 22, 2023 · Find out how Health Canada regulates medical devices in Canada and how they respond to COVID-19 related devices. ” In this case, I quickly found the license information I needed. You must also provide a search criterion for the selected option, in the 'Search for' field. Why we inspect. Search for licensed medical devices in Canada by licence number, device name or identifier. Health Canada monitors these reports in the interest of public health and patient safety. To determine which devices need a licence, all types of medical devices have been categorized based on the risk associated with their use. 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. MDALL contains product-specific information on all medical devices that are currently licensed for sale in Canada, or have been licensed in the past. For more information on how to obtain an authorization, please visit the overview page. 1 of the Medical Devices Regulations. mdall. Information about vaccines used for immunization has been included in the database since January 1, 2011. Drug and natural health products recall guide This guidance document is intended to facilitate the creation and submission to Health Canada of ToC-based medical device regulatory information. Health Canada intends to either develop a UDI database or modify the existing Medical Devices Active Latest advisories and recalls. 5 Abbreviations and acronyms HPFB Health Products & Food Branch IMDRF Canada's Food and Drugs Act and Regulations set out specific reporting requirements and timelines for mandatory reports. Aug 22, 2023 · Manufacturers of an existing medical device licence (MDL) and/or COVID-19 medical device authorizations wishing to make changes to a name or address must use our minor change form. Medical Device Incident Reports: Listing of Medical Device incidents reported to Health Canada. Class I medical devices do not require a medical device licence and are monitored by the Regulatory Operations and Regions Branch (Compliance and Enforcement) through Establishment Licensing. Searches can be conducted by manufacturer, medicinal ingredient, drug or device name, drug identification number, or device licence number. Aug 12, 2002 · Summary Basis of Decision documents are available, which outline the scientific and benefit/risk based decisions that factor into Health Canada's decision to grant market authorization for a drug or medical device. Health Product InfoWatch, August 2024 [2024-08-29]; Monthly Update to the Canada Vigilance adverse reaction online database [2024-08-09] Aug 2, 2024 · When a serious adverse drug reaction (ADR) or medical device incident (MDI) is documented in a hospital, the hospital must submit a report to Health Canada within 30 calendar days. Manufacturers should consider whether the clinical evidence provided to support these applications is objective and addresses all aspects of the indications for use. Continuous and significant technological advancement in the field of medical devices makes it necessary for Health Canada to implement a nomenclature designed to keep pace with medical devices innovations. The form contains more information on what’s required. Mar 7, 2023 · The Recalls and Safety Alerts Database provides easy access to a comprehensive list of recalls, advisories, and safety alerts. Use the Medical Device Recall Reporting Form - Final (FRM-0360) to complete your final recall report. Also search for a licensed device using the listing database. Report a medical Device Problem (For Health Care Professionals) Sep 18, 2015 · Access forms and guidance documents to help you apply for a medical device licence. Health Canada also targets to publish 5-7 Phase II SBDs per year for Class III or IV medical device applications with novel technology. Medical device incidents. 1. Information on drug and health products authorized by Health Canada. Health Canada’s Medical Devices Active Licence Listing (MDALL) MDALL contains product-specific information on all medical devices that are currently licensed for sale in Canada, or have been licensed in the past. You can also report them to Health Canada through the Canada Vigilance Program or by phone at 1-866-234-2345. Sponsors must apply to conduct a COVID-19 clinical trial in Canada through the Food and Drug Regulations or the interim order No. Search for advisories and recalls in the Recalls and Safety Alerts Database. Health Canada is adopting the Global Medical Device Nomenclature (GMDN) Health Canada is initiating the transition from its current medical device categorization method to the Global Medical Device Nomenclature (GMDN), in order to improve the availability, access to, and the quality of information available on medical devices in Canada. Access the latest updates, guidance, notices and consultations on medical devices. In Canada, certain devices must have a medical device licence before they can be sold. 3 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19). The current proposal involves requiring UDI labeling for all devices, with the exception of Class I low-risk devices. We are a federal institution that is part of the Health portfolio Apr 1, 2020 · About this document 1. You can access the RDS search function in the DHPR. You may search by one of the following search options only: company name or identifier, licence name or number, device name or identifier. MDALL is a database of all licensed Class II, III, and IV medical devices offered for sale in Canada. Search the Drug Product Database (DPD) to find drugs authorized for sale by Health Canada. : 613-957-299 Toll free: 1-866-225-0709 Fax: 613-941-5366 TTY: 1-800-465-7735. You can search by category, keyword, or date, and access detailed information on each recall. It: gives you access to information about each type of drug and health product inspection done by Health Canada, in Canada and abroad; covers all inspections done since 2012, in Canada and abroad The Medical Devices Directorate (MDD) is Canada's regulator of medical devices for human use. Health Canada’s decision to use the GMDN is in line with the recommendation of the International Medical Device Regulators Forum (IMDRF Health Canada encourages individuals to send in their complaints about health products to the Regulatory Operations and Enforcement Branch (ROEB). It can be searched by company name, licence name, device name, or device identifier. This database includes recalls from Health Canada, the Canadian Food Inspection Agency, and Transport Canada. Health products The Canada Vigilance Program is supported by seven Canada Vigilance Regional Offices who provide a regional point-of-contact for health professionals and consumers. Aug 29, 2012 · What Medical Device Establishment Licence (MDEL) holders need to know about annual licence review for 2024 [2023-11-15] COVID-19 Medical Device Establishment Licence (MDEL) supensions [Updated 2021-02-11] Guidance on Medical Device Establishment Licensing (GUI-0016) [Updated 2020-04-01] Every year, Health Canada authorizes approximately 900 clinical trials in patients. All UV radiation-emitting or ozone-generating devices registered by Health Canada are listed in the Pesticide Product Information Database. Jul 22, 2021 · Health Canada may consult the classification decisions of foreign regulatory authorities as a tool to assist in interpreting and applying the definitions of the F&DA. On this page. The data extract is a series of compressed ASCII text files of the full data set contained in the Canada Vigilance Adverse Reaction Online Database. Nov 4, 2019 · In the event that Health Canada's Medical Devices Licence Listing database is not updated within 20 days following receipt of a complete Annual Notification Package, a 25% credit will be reflected on the invoice issued to the manufacturer. These require regulated parties to report serious medical device incidents. The database includes: Health Canada's Action Plan on Medical Devices: Continuously Improving Safety, Effectiveness and Quality - Informing Canadians about medical device treatment options [2019-01-31] Scientific Advisory Committee on Health Products for Women: Nomination Call for Members and Terms of Reference [2019-01-30] Jun 28, 2021 · From: Health Canada Current status: Closed. All manufacturers holding medical device licences in Canada now participate in the program, which improves Health Canada's oversight of the medical devices sold in Canada, and ensures that the medical devices Canadians use meet higher quality standards. It is intended for users who are On February 22, 2023, Health Canada introduced the Regulations Amending the Medical Devices Regulations (Interim Order No. The database will be populated with information about each clinical trial after Health Canada issues its No-Objection-Letter (see terminology section for a definition). A search of all health products AND all adverse reactions terms is not possible. While Health Canada has provided information on medical device incidents by publishing trend reports, some Canadians still want to have access to a searchable database for individual reports. We want to ensure that Canadians remain up-to-date on current developments and issues pertaining to drugs and health products in Canada. Stay informed and protect yourself and your family from potential risks. Adverse reactions, medical device incidents and health product recalls in Canada: 2019 summary report; MedEffect Canada; Advisories, warnings and recalls; Adverse Reaction Database; Medical device incidents database; Medical devices establishment licence listing; Medical Device Active Licence Listing; Mandatory reporting requirements for hospitals What are health products at the drug-medical device interface? Health products at the drug-medical device interface are those that do not readily fall within the definition of "drug" or "device" in section 2 of the Food and Drugs Act (F&DA). This is Health Canada's first consultation on the UDI system for medical devices. Report a medical device problem (for health care professionals) Prescription Drug List; About . First Databank (FDB) is the leading provider of clinical and descriptive drug knowledge that’s integrated into healthcare information systems in Canada (including Epic, MEDITECH, Telus, QHR, Well Health, Maximus, and the majority of Provincial drug information systems), and the United States. 1 of the Medical Devices Regulations (MDR) Form F201 Change of a Manufacturer's Registration Status Health Canada is making regulatory changes to the Medical Devices Regulations to strengthen the lifecycle approach to the regulation of medical devices by increasing post-market surveillance authorities. Medical device licence. The consultation opened on June 28, 2021 and closed on September 30, 2021. This database includes data from 1965 to 2024-04-30. The Drug and Health Product Register (DHPR) is a multi-purpose database that contains product information and regulatory documentation such as Summary Basis of Decisions (SBDs). Drugs Apr 1, 2015 · RDSs for medical devices are available in the Drug and Health Product Register (DHPR). Nov 3, 2016 · Use the Medical Device Recall Reporting Form - Initial (FRM-0360) to complete your initial recall report. Sometimes people can assume that the Health Canada medical device class for their product(s) will be similar to that in the USA or Western Europe. Access various databases, such as Drug Product, Drug and Health Product register, Clinical Trials, and more. Find active and archived licences, application information, advisories and warnings, and contact details. 3. Email: publications@hc Health Canada vs. Submit a section 65 final report to your nearest Health Canada regional office as soon as possible after completing the recall. About the Drug and Health Product Register; Data and review decisions; Reported side effects - disclaimers; Medical Device Incidents - disclaimers; Prescription Drug List; Questions and Answers - Prescription Drug List; Feedback May 22, 2018 Our reference number: 18-104326-657. Mar 14, 2019 · Health Canada launched two public databases on Wednesday as the first step in making clinical information about the safety and effectiveness of drugs and medical devices publicly available. Sep 6, 2023 · This guidance document is intended for any person in the medical device industry and it provides guidance on regulatory requirements in relation to Medical Device Establishment Licences (MDEL), including when and how to apply for an MDEL, and how to maintain an MDEL once issued. Licensed Natural Health Products Database; Contact Drugs and Health Products Resources; What is available? Health Canada is committed to providing timely access to sound, evidence-based information. This window offers the capability to search the database using one of six available parameters: Company Name, Licence Name, Device Name, Company ID, Licence Number and Device Identifier. Adverse reactions are undesirable effects to health products. The database lists trials that were authorized by Health Canada starting April 1, 2013. This window offers the Stop illegal marketing of drugs and devices infographic ; Health Canada's Action Plan on Medical Devices ; Guide to reporting drug shortages and discontinuations ; Reporting adverse reactions to marketed health products – Guidance document for industry ; All related publications. Similar classification schemes are used by Health Canada for Class I, II, III, and IV Feb 28, 2024 · Notice: Transition to the Revised Version of ISO 13485 and its impact on the Compliance to the Quality Management System Requirements of the Canadian Medical Devices Regulations; List of Registrars Recognized by Health Canada under section 32. Publisher - Current Organization Name: Health Canada Jan 15, 2001 · Purchase of Licensed Medical Devices for Use in Health Care; Overview; Medical Devices Active Licence Listing (MDALL) Quality Systems ISO 13485; Standards; Fees for Medical Devices; Projects; What's new: Medical devices; Medical Devices Action Plan – stakeholder meetings and engagement activities; Medical device shortages: Overview; About The Bureau maintains a database of all licensed Class II, III, and IV medical devices offered for sale in Canada. ” I wasn’t sure who the manufacturer was for Surgiseal ™, so I used Health Canada’s Medical Device Active License Database and searched by “Device Name. An MDEL gives Health Canada assurance that: medical devices sold or imported into Canada meet the safety requirements set out in the MDALL contains product-specific information on all medical devices that are currently licensed for sale in Canada, or have been licensed in the past. About the Drug and Health Product Register; Data and review decisions; Reported side effects - disclaimers; Medical Device Incidents - disclaimers; Prescription Drug List; Questions and Answers - Prescription Drug List; Feedback The Recalls and Safety Alerts Database provides easy access to a comprehensive list of recalls, advisories, and safety alerts. These Regulations accelerate access to COVID-19 medical devices that have an urgent public health need in Canada. The DPD is updated nightly and includes: Selecting the Active Licence Search link takes you to the Medical Devices Active Licence Search window. Health Canada has also launched a separate database of adverse reactions Report a medical device problem (for health care professionals) Prescription Drug List; About . The Licence Number query was improved to return the exact number match only. . There is an urgent global need for COVID-19 diagnosis, treatment, mitigation or prevention options. 4 Policy statements. Dec 27, 2018 · Find information on drugs and medical devices authorized for sale in Canada, including safety, use, and side effects. Jun 12, 2015 · Medical Devices Annual Review Documents; Application for a Manufacturer's Certificate to Cover Export of Medical Devices (GUI-0097) Guidance on Medical Device Compliance and Enforcement (GUI-0073) [2015-06-12] Health Canada is now in Phase II of the SBD initiative. If "Select All Health Products" is chosen in Section 3, a keyword search must be done in Section 4 and if "Select All Adverse Reaction Terms" is chosen in Section 4, a keyword search would have to be done in Section 3. Summary of reports All reports submitted in Jun 17, 2019 · The Food and Drugs Act sets out the legislative framework under which medical devices are regulated in Canada. Health products include drugs, medical devices and natural health products. My device has FDA clearance – is there a fast track for devices sold in other major markets? Health Canada does not recognize approvals in other countries and they do not give you a Feb 29, 2024 · Drug Product Database; Medical Devices Active Licence Listing; Licensed Natural Health Products Database; The Drug and Health Product Portal; Drug Shortages Canada ; Medical Device Shortages; COVID-19 Vaccines and Treatments Portal; Suggestions? Your comments are important to us. 12. The DPD contains product-specific information on approximately 15,000 marketed health products approved for use in Canada. Information for medical device manufacturers, distributors and health professionals in relation to COVID-19. Health Canada will launch an accessible database that contains medical device incident reports in a user-friendly, searchable, online format. The intent of the e-learning course, Understanding How Medical Devices are Regulated in Canada – Medical Device Establishment Licensing and Post-market Regulation, is to help stakeholders understand Health Canada’s post-market regulatory requirements for medical devices, including topics such as Medical Device Establishment Licensing, Inspections and Compliance Verifications. Health Canada drafts Phase II SBDs for new drug submissions for new active substances and biosimilars (previously referred to as subsequent entry biologics). These results are updated regularly. 2 for clinical trials for medical devices and drugs related to COVID-19. Class I devices . The number of adverse reports in the Canada Vigilance Adverse Reaction Online Database should not be used as a basis for determining the incidence of a reaction or for estimating risk of a particular product, as neither the total number of reactions occurring, nor the number of patients exposed to the health product, is known. 2. Contact us for more information on our Health Canada medical device registration services. ca). Health Canada has proposed a UDI framework based closely on the international UDI guidance from the IMDRF. The incidents in this database represent the perspective of those who send Health Canada the reports. Nov 20, 2019 · Section 3 is mandatory if Section 4 (below) is not completed. Devices that are on this list are authorized under Part 1. 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. Another key component of FDA and Health Canada's duties is the regulation of medical equipment, which are classified by the FDA into different risk categories, ranging from Class I (low risk) to Class III (high risk). We inspect companies that manufacture, import or distribute medical devices for sale in Canada to make sure that they comply with the act and its regulations. Let us know what you think by reaching us at: Feb 18, 2016 · A searchable database of medical devices licensed in Canada can be found on the Health Canada website (www. Drug Product Database; About the Drug and Health Product Portal Report a Medical Device Health Canada Address Locator 0900C2, Ottawa, ON K1A 0K9 Tel. This approach means that all medical devices are grouped into 1 of 4 classes. Health Canada has successfully completed the transition to the Medical Device Single Audit Program (MDSAP). The Medical Device Keyword Index should also be used in conjunction with the guidance The Medical Device Active Licence Listing (MDALL) Database allows users to search and view information on approved medical device licences and licence holders. Unregistered or unauthorized devices, unless they are exempt, are prohibited and may be subject to compliance and enforcement action. Under the F&DA, three sets of regulations may apply to these products: The Food and Drug Regulations; You can report medical device incidents to your medical professional, to a hospital or to the company that made the product. Jan 13, 2015 · The competitor product I selected was “Surgiseal. As part of its regulatory responsibilities, Health Canada is responsible for compliance monitoring and enforcement activities related to health products in order to verify that regulatory requirements are being applied appropriately. each year, more suspected products are being reported in the medical device incidents sent to Health Canada from 6,544 devices in 2010 to 25,519 devices in 2019, a 4-fold increase; this may be due to improved reporting mechanisms and increased general awareness of the importance of reporting 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. Health Canada carries out post-market monitoring and assessment of medical devices. Feb 5, 2009 · Selecting Search Active Licences takes you to the Medical Devices Active Licence Search window. About the Drug and Health Product Register; Data and review decisions; Reported side effects - disclaimers; Medical Device Incidents - disclaimers; Prescription Drug List; Questions and Answers - Prescription Drug List; Feedback Jun 18, 2015 · Access the database. Find information on medical devices licensed by Health Canada, such as company name, licence name, device name and identifier. It ensures that high-quality health services are accessible, and works to reduce health risks. While Health Canada seeks to align device/drug classifications globally when feasible, a product would still need to meet the definitions in the F&DA and its regulations. The feasibility of using eSTAR will be determined by the Apr 23, 2015 · The Medical Devices Regulations (Regulations) utilize a risk-based approach to regulating products within its scope. ROEB manages health product complaints on a priority basis according to the risk to people's health and safety, with those considered high-risk receiving first priority. Health Canada is responsible for helping Canadians maintain and improve their health. Medical devices with cosmetic indications for use are subject to the same stringent Health Canada review as other devices to ensure the benefits outweigh the risks. Before authorizing the sale of a medical device in Canada, we verify that the device meets the safety, effectiveness and quality requirements of the Food and Drugs Act and its Regulations. 6 Risks and Benefits of the Requested Device The SAP requires a discussion of the risks and benefits related to the use of the requested device. How often we inspect Jan 10, 2013 · Adverse reactions, medical device incidents and health product recalls in Canada: 2019 summary report [2020-12-11] Product Recall Procedures; Health Products and Food Branch Inspectorate - Recall Policy (POL-0016) You may search by one of the following search options only: device name, licence number, or device identifier. More information on inspections conducted by Health Canada is found in How Health Canada inspects medical device establishments (GUI-0064). A medical device establishment licence (MDEL) is issued to Class I manufacturers as well as importers or distributors of all device classes to permit them to import or distribute a medical device in Canada. It allows healthcare professionals, patients, and other stakeholders to quickly verify the licensing and status of medical devices marketed in Canada. Related Non-compliant medical device inspections search results; Foreign site medical device inspections search results ; You can also do your own search for medical device inspections. What's new. Aug 1, 2023 · The Medical Device Active License Listing (MDALL) is a public database Health Canada maintains. Drugs include both prescription and nonprescription pharmaceuticals; biologically-derived products such as vaccines, serums, and blood derived products; cells, tissues and organs; disinfectants; and radiopharmaceuticals. Health Canada as the federal regulator of medical device safety and effectiveness, considers cybersecurity vulnerabilities in medical devices as a potential risk to patients that must be mitigated or eliminated by manufacturers of Health Canada holds the medical device manufacturers, importers, and distributors as accountable to correctly classify their medical devices as per Health Canada regulations. Search by one option only and provide a search criterion in the 'Search for' field. If you have witnessed or experienced a problem with a medical device, you should report it directly to the manufacturer of the device. bcjoe cxhpj nskxx uazy jngk jrlrd vvy ltj wlpgux jpitxkba