The Medical Device License is a legal document that is required for the manufacture, sale, and distribution of medical devices. A medical device license is a type of intellectual property (IP) license that is issued by the FDA to authorize a manufacturer to sell its medical device in the United States. The MDL is the most comprehensive and stringent of these licenses.
There are three types of Medical Device Licenses: MDL MDEL and SAMD. The first type, the MDL – or “full” medical device license – is the most comprehensive and stringent of these licenses.
It is important to know the difference between MDEL and SAMD licenses because they are not interchangeable, and they are both required for different purposes.
Differences between MDL, MDEL & SAMD:
The MDL is a license that is required for medical devices. It enables the manufacture, distribution, and sale of medical devices in the United States. This article will explain what the MDL is and what it does.
The MDEL is an FDA regulatory classification for medical device products. It was created to provide a more accurate description of a product’s risk profile to help FDA staff determine how to handle the device’s regulation. We can also operate as your MDEL Import Agent to ensure your products are successfully imported into Canada.
SAMDs are Medical Device Submissions submitted by manufacturers of Class II or III devices to comply with FDA regulations.
Let’s know more about each of them in detail while particularly focusing on the key differences.
Medical Device License (MDL) – Common License
It is a license that is required for a company to manufacture, import, distribute and sell medical devices in Canada.
A medical Device License (MDL) is a permit or license to sell medical devices. It is issued by Health Canada, and it is a requirement for all medical device manufacturers.
The MDL is a regulatory classification for class I, II, and III devices in the US and Canada. It is not a classification of the device itself but instead of the FDA’s regulatory authority over the device. The MDL was created in 1976 and updated in 1990 to include class III devices.
– A Class I device is defined as a device that does not require premarket approval from FDA, while Class II devices are those that require premarket notification to FDA before marketing.
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– Class III devices are those for which there is insufficient information about their safety and effectiveness to permit them to be marketed without premarket approval from FDA.
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Medical Device Establishment License (MDEL)
Medical Device Establishment License (MDEL) is the document that provides evidence of compliance with the Medical Devices Regulations. The Medical Device Establishment License (MDEL) is an authorization issued by Health Canada under the authority of the Food and Drugs Act, which authorizes an establishment to manufacture or import a medical device.
The MDEL Health Canada SAMD is an authorization issued by Health Canada under the authority of the Medical Devices Regulations, which authorizes an establishment to manufacture or import software that performs medical functions. Medical devices are regulated by the FDA and Health Canada. The FDA regulates devices that are marketed in the United States, while Health Canada regulates devices that are marketed in Canada.
Software as a Medical Device (SAMD)
Software as a Medical Device (SAMD) is software that monitors or treats human health. It is not regulated by the FDA and does not require any type of licensing. The FDA has no jurisdiction over software as a medical device.
Software as a Medical Device (SAMD) is a software that has been demonstrated to meet the regulatory requirements of Health Canada’s Medical Devices Program. It can be used in lieu of an MDL, but not in addition to an MDL.
Software as a medical device (SAMD) is a regulatory term used in Canada to describe the approval process for the software that performs medical functions. The term SAMD is also used for an electronic device that offers healthcare services. SaMD’s can be used for diagnosis, treatment, or prevention of illness or injury.
MDL vs MDEL vs SAMD Under The Microscope
In order to import medical devices into Canada, the device must be approved by Health Canada. This approval is done through an MDEL license.
There are different types of licenses for medical devices:
MDL: Designated medical device license (MDL) for importing designated medical devices into Canada
MDEL: Medical device establishment license (MDEL) for manufacturing or importing medical devices in Canada
SAMD: Software as a designated medical device license
The software license is an MDEL Health Canada SAMD, while the MDL and the MDEL are specific subsets of this type of license.
MDEL is an abbreviated name for Medical Device Establishment License. This is a license issued by the Canadian government to authorize a medical device establishment to put their devices into commercial distribution. MDEL is mainly required when releasing new devices or when adding new technologies to existing devices.
Medical Device License Health Canada:
In Canada, there are two versions of the MDEL: SAMD and MDEL-H. The latter enables companies with established facilities to add new technologies without having to start from scratch with a whole new facility and provides easier access for small enterprises while still maintaining strict regulations. A company can have both types of licenses at the same time, but they will differ in what they cover or what kind of work can be done under each license.
A medical device can be licensed by Health Canada and Health Canada will then assign a Medical Device Establishment License (MDEL) to the company. The MDEL is given to the company to be able to import, wholesale, or lease devices for use in Canada.
The US FDA classifies software as a device. A Software as a Medical Device (SAMD) is considered similar to MDEL which requires certification from the FDA.
We hope that you have now clearly grasped the idea of all three terms (MDL, MDEL & SAMD). If you still have questions, feel free to ask the experts now.
If you need FDA Medical Device compliance assistance we can help with that as well!
How Quality Smart Solutions can help
Our experts at Quality Smart Solutions are here to help and offer medical device-related regulatory advice and support on successfully securing your medical device license. We can help you by responding to potential information requests, keeping your license updated, and reviewing your device labels.
Contact us today to learn more about how we can support your compliance needs during and after licensing! Please find our contact information here: