Health canada medical device database. 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. Drug Product Database; About the Drug and Health Product Portal Report a Medical Device 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. 1 of the Medical Devices Regulations (MDR) Form F201 Change of a Manufacturer's Registration Status Apr 1, 2015 · RDSs for medical devices are available in the Drug and Health Product Register (DHPR). In the post-market setting, severe symptomatic hypocalcemia (resulting in hospitalization, life-threatening events and fatal cases) has been reported, particularly in patients with severe renal impairment, receiving dialysis or treatment with other calcium-lowering drugs. Search the Drug Product Database (DPD) to find drugs authorized for sale by Health Canada. Apr 23, 2015 · The Medical Devices Regulations (Regulations) utilize a risk-based approach to regulating products within its scope. On this page. If you have witnessed or experienced a problem with a medical device, you should report it directly to the manufacturer of the device. 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 issue notices when there is an advisory, safety review or new safety information on a medical device; maintain a medical device incident database, which contains medical device incident reports and recall information; Inspection, compliance and enforcement. Health Canada encourages individuals to send in their complaints about health products to the Regulatory Operations and Enforcement Branch (ROEB). The DPD is updated nightly and includes: The Bureau maintains a database of all licensed Class II, III, and IV medical devices offered for sale in Canada. 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. You can report medical device incidents to your medical professional, to a hospital or to the company that made the product. ” In this case, I quickly found the license information I needed. Find out which companies are licensed by Health Canada to import or distribute medical devices in Canada. 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. 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. 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. Submit a Final Incident Report to Health Canada justifying any corrective or preventative actions you have taken, including any investigation results. Publisher - Current Organization Name: Health Canada 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. Search for licensed medical devices in Canada by licence number, device name or identifier. For more information on how to obtain an authorization, please visit the overview page. You can also report them to Health Canada through the Canada Vigilance Program or by phone at 1-866-234-2345. Why we inspect. Health Canada is taking steps to further promote the safety, effectiveness and quality of the medical devices used by Canadians. Health Canada has proposed a UDI framework based closely on the international UDI guidance from the IMDRF. Searches can be conducted by manufacturer, medicinal ingredient, drug or device name, drug identification number, or device licence number. To find out if a medical device establishment has an active licence, visit the Medical devices establishment licence listing database Use this page to search the Government of Canada database of recalls and safety alerts for consumer products, vehicles, food and health products Jan 13, 2015 · The competitor product I selected was “Surgiseal. 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. Health Canada monitors these reports in the interest of public health and patient safety. 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. The Recalls and Safety Alerts Database provides easy access to a comprehensive list of recalls, advisories, and safety alerts. The DPD contains product-specific information on approximately 15,000 marketed health products approved for use in Canada. 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. Search by product name, manufacturer, classification or date. Reports are collected by the regional offices before being forwarded to the Canada Vigilance National Office for further a 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] Jun 28, 2021 · From: Health Canada Current status: Closed. This is Health Canada's first consultation on the UDI system for medical devices. Health products Report a medical device problem (for health care professionals) Prescription Drug List; About . Jun 18, 2015 · Access the database. Ultimate consumer: Information on drug and health products authorized by Health Canada. More information on inspections conducted by Health Canada is found in How Health Canada inspects medical device establishments (GUI-0064). 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. Medical device incidents. Find information on medical devices authorized by Health Canada, including active license listing, incident reports, regulatory decisions and safety reviews. Access various databases, such as Drug Product, Drug and Health Product register, Clinical Trials, and more. Health Canada intends to either develop a UDI database or modify the existing Medical Devices Active Sep 6, 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. Summary of reports All reports submitted in 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. Find active and archived licences, application information, advisories and warnings, and contact details. The Canada Vigilance Program is supported by seven Canada Vigilance Regional Offices who provide a regional point-of-contact for health professionals and consumers. Information for medical device manufacturers, distributors and health professionals in relation to COVID-19. 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). These results are updated regularly. 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. Aug 16, 2016 · Health Canada has successfully completed the transition to the Medical Device Single Audit Program (MDSAP). Distribute a corrective action notification to consumers if approved by Health Canada. 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) Aug 1, 2023 · The Medical Device Active License Listing (MDALL) is a public database Health Canada maintains. As such, Health Canada has been studying the feasibility of introducing a Unique Device Identifier (UDI) system for medical devices in Canada. Health Canada will launch an accessible database that contains medical device incident reports in a user-friendly, searchable, online format. 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 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. Let us know what you think by reaching us at: Feb 22, 2023 · 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 Cybersecurity [2019-06-26] Draft Health Canada IMDRF table of contents for medical device applications guidance [2019-02-28] Jan 25, 2024 · Key messages for healthcare professionals: Footnote 2 Hypocalcemia. Also search for a licensed device using the listing database. 1 of the Medical Devices Regulations. Find information on medical devices licensed by Health Canada, such as company name, licence name, device name and identifier. How often we inspect Health Canada will inspect your establishment to verify your attestation in section 6 and your establishment's compliance with the Medical Devices Regulations. The database should not be used The Medical Devices Directorate (MDD) is Canada's regulator of medical devices for human use. Jan 27, 2023 · UPDATE – January 27, 2023: Health Canada and the FDA launch eSTAR pilot Health Canada and U. Nov 26, 2020 · The title of this database seems to imply that any Medical Device listed therein is somehow uniquely blessed by Health Canada for use against COVID. Mar 13, 2019 · The move also brings Canada in line with the European Union's plans for greater transparency surrounding medical devices. This would include certain personal protective equipment, such as masks, or certain testing/diagnostic devices, such as IR thermometers. The consultation opened on June 28, 2021 and closed on September 30, 2021. Health Canada inspects companies that sell, distribute and import devices. 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 Feb 5, 2009 · Selecting Search Active Licences takes you to the Medical Devices Active Licence Search window. The Drug and Health Products Inspections Database (DHPID) supports open government and regulatory transparency. When necessary, the OoS also provides advice on the classification of other products that are regulated by Health Canada. It can be searched by company name, licence name, device name, or device identifier. e. This database includes data from 1965 to 2024-05-31. Nov 20, 2019 · Section 3 is mandatory if Section 4 (below) is not completed. 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. Dec 27, 2018 · Find information on drugs and medical devices authorized for sale in Canada, including safety, use, and side effects. Devices that are on this list are authorized under Part 1. You can access the RDS search function in the DHPR. Search by licence number, company ID, company name, activity, country or province/state. Report a medical device problem (for health care professionals) Prescription Drug List; About . , pharmaceutical, biologic, or natural health products), medical devices, or drug-medical device combinations. The database includes: Provides consumers, patients, and health professionals with health product safety information, including prescription drugs, over-the-counter medicines, natural health products and medical devices; importance of and options for reporting adverse reactions (side effects) Submit a Preliminary Report to Health Canada detailing the incident and corrective action strategy. Access forms and guidance documents to help you apply for a medical device licence. Access the latest updates, guidance, notices and consultations on medical devices. It allows healthcare professionals, patients, and other stakeholders to quickly verify the licensing and status of medical devices marketed in Canada. MDALL is a database of all licensed Class II, III, and IV medical devices offered for sale in Canada. A search of all health products AND all adverse reactions terms is not possible. 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] 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 Every year, Health Canada authorizes approximately 900 clinical trials in patients. A copy of this letter must be sent with the shipment to allow timely entry of the drug or medical device into 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 MDALL contains product-specific information on all medical devices that are currently licensed for sale in Canada, or have been licensed in the past. ” 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. Health Canada has also launched a separate database of adverse reactions Jun 23, 2021 · The choice of report type depends on whether all the required information is available within the appropriate report timeframe. . CDRH Databases: a listing of databases for such topics as advisory committees, regulations, good practices, medical devices, Premarket Approval (PMA) and Notification (510(k)), product codes 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. Selecting the Active Licence Search link 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 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 The OoS primarily provides recommendations on the classification of products as drugs (i. Search by one option only and provide a search criterion in the 'Search for' field. Information about human blood and blood components has been included in the database since September 1, 2015. The current proposal involves requiring UDI labeling for all devices, with the exception of Class I low-risk devices. 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 . . The Medical Device Keyword Index should also be used in conjunction with the guidance 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. This window is identical to the original MDALL search and displays the results as before. An MDEL gives Health Canada assurance that: medical devices sold or imported into Canada meet the safety requirements set out in the Medical Device Single Audit Program; The results of these audits are not included in the database because they are not done by Health Canada. 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. The Licence Number query was improved to return the exact number match only. 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. This database includes recalls from Health Canada, the Canadian Food Inspection Agency, and Transport Canada. Food and Drug Administration’s joint eSTAR pilot has reached its total of 9 participants. If warranted, Health Canada will provide a letter of authorization to the health care provider. 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. Information about vaccines used for immunization has been included in the database since January 1, 2011. S. Nov 17, 2016 · Health Canada decides whether to allow access to these devices based on the details of each case. The database lists trials that were authorized by Health Canada starting April 1, 2013. Feb 22, 2023 · Find out how Health Canada regulates medical devices in Canada and how they respond to COVID-19 related devices. Health Canada’s decision to use the GMDN is in line with the recommendation of the International Medical Device Regulators Forum (IMDRF Report a medical device problem (for health care professionals) Prescription Drug List; About . xjmdh rhnjwgg fdmab ipxi yes dxzm tmvbqey qfn jyjixnvi ocxp