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Medical Device Database Health Canada

Health Canada Medical Device License MDL A Canadian Medical Device License MDL is required for companies selling Class II - IV medical devices in Canada. Report a serious adverse drug reaction for hospitals Report a medical device problem for health care professionals Prescription Drug List.


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Only products which appear in this database listing may be offered for general marketing.

Medical device database health canada. Establishment Licensing EL fees Health Canada inspects establishments to assess whether they comply with regulatory requirements to conduct regulated activities related to drugs and medical devices. Before a drug or medical device is authorized for sale in Canada Health Canada reviews it to assess its safety efficacy and quality. 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 - Your reference tool for licensed medical devices in Canada. Copy the Medical Device Keyword Index PDF file to your computer. Obtaining an MDL is comparable to the US FDA 510 k process.

Enter the keyword PNC or description you are searching for in the Find field. Health Canadas drug and medical device databases are intended to increase transparency and to make information accessible to stakeholders and the general public. 25 years market expertise.

An MDEL provides Health Canada assurance that medical devices sold or imported into Canada meet the safety requirements set out in the Medical Devices. Medical devices help to diagnose prevent and treat many injuries and diseases. 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.

About the Drug and Health Product Register. Over the last 10 years. To search for a medical device group within the PDF file go to EditFind.

We manage the entire application process for Health Canada Medical Device Establishment License MDEL for Class I II III or IV medical or surgical devices IVD. The same device may have different names in different countries. Medical devices establishment licence listing.

Devices that measure blood sugar such as glucose meters and glucose monitoring systems are some of the most frequently used medical devices in Canada. This window is identical to the original MDALL search and. Regulatory Provisions All devices offered for sale in Canada must comply with the Food and Drugs Act.

Selecting the Active Licence Search link takes you to the Medical Devices Active Licence Search window. The MDL is a product approval while a MDEL is a permit for the companydistributorimporter itself. Report a side effect.

Medical devices help to diagnose prevent and treat many injuries and diseases. CMDCAS is the Canadian Medical Device Conformity Assessment System httpbitlyCMDCAS-Certification-Part2. Class I II III IV Health Canada MDEL applications.

Data and review decisions. Dear visitor We have reorganized our Web site. Class I medical devices do not require a medical device licence and are monitored by the Health Products and Food Branch Inspectorate Compliance and Enforcement through Establishment Licensing.

7949 345 medical device incidents reported to Health Canada were of a serious nature. The Quality System Auditor from the registrar will look for additional requirements specific to the CMDR but all of these requirements are identified in GD210another guidance document from Health Canada. It must be noted that the class assigned to a medical device groupPNC is only indicative of the.

A Medical Device Establishment Licence MDEL is a licence 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. The same device may have different names in different countries. Although some information on drugs and medical devices can be accessed via alternate channels Health Canada encourages stakeholders to use the databases as a primary means of accessing information.

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. 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. This is not unexpected.


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