How does Health Canada classify medical devices in Canada?
Medical devices are classified into 4 categories based on the risk of use, with Class I being the least risky, and Class 4 being the riskiest. The type of medical device licence depends on the class of your device.
- Class I medical devices require a Medical Device Establishment Licence (MDEL)
- Class II devices require a Medical Device Licence (MDL), and an attestation that your device meets the regulatory requirements for your device, however you must be able to demonstrate that you can meet the requirements you attested to during an inspection by Health Canada.
- Class III and IV devices require a Medical Device Licence (MDL), and a submission of safety and efficacy data to Health Canada.
How does the US FDA (United States Federal Drug Administration) classify medical devices in the United States?
Medical devices are classified into 3 categories based on the risk of use, with Class I being the least risky, and Class III being the most. For this reason, regulatory control increases with each class.
- Class I: Most Class I medical devices are exempt from the 510(k) submission requirement and can be self-registered.
- Class II: Most Class II medical devices require a 510(k) submission.
- Class III: Most Class III medical devices require a Pre-Market Approval (PMA) submission however some Class III medical devices are exempt from needing a PMA and only require a 510(k) submission.
- Evaluate your medical device and determine the proper classification within its intended jurisdiction
- Determine which predicate devices already have clearance and which regulatory pathway was used to expedite your own submission
- Review testing requirements, applicable guidance documents, and required standards
- Provide a technical comparison of your medical device to other predicate devices with approvals
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