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- The application process for a Class III in vitro diagnostic medical device (IVD) Medical Device License (MDL) registration in Canada involves several detailed steps to ensure compliance with Health Canada’s regulatory requirements.
- Confirm Class III Classification: Verify that your device qualifies as Class III by assessing its intended use, risks, and features. This classification ensures you're meeting the appropriate regulatory requirements.
- Preparing the application, gathering all technical documentation, and ensuring compliance with regulatory requirements can take several weeks to a few months, depending on the readiness of the data and documentation.
- Determine Device Classification: Confirm that your device is classified as Class III according to Health Canada’s classification criteria. This involves assessing the intended use and risk factors associated with the device.
- Maintain compliance with the quality management system standard for medical devices, which includes requirements for documentation, record-keeping, and management reviews.
- Compliance with Medical Devices Regulations: Ensure ongoing adherence to the Medical Devices Regulations (SOR/98-282) under the Food and Drugs Act, which govern the manufacturing, labeling, and distribution of medical devices.
- Familiarize Yourself with Regulations: Review the Medical Devices Regulations (SOR/98-282) and relevant guidance documents from Health Canada to understand the requirements for Class III IVDs.
- Implement a post-market surveillance plan to monitor the device's performance in the real world. This includes collecting data on adverse events and user feedback.
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