To apply for the Class I in vitro diagnostic (IVD) medical device MDL registration in Canada, the device must comply with Health Canada's Medical Device Regulations (MDR). The key requirements for applying for the registration (through the Medical Device Establishment License or MDEL) are as follows:

1. Verify Device Classification

• Confirm that the device is properly classified as Class I. Class I IVD devices are generally low-risk devices, such as diagnostic test kits. The classification is based on the device's intended use and associated risks. The Class I designation means that the device does not require pre-market approval but still must meet all regulatory requirements.

2. Designate a Canadian Authorized Representative (if applicable)

• Manufacturers located outside Canada must appoint a Canadian Authorized Representative. This representative will be responsible for regulatory communication with Health Canada.
• Canadian-based manufacturers do not need an authorized representative but must still comply with all regulatory requirements.

3. Prepare Device Information

• Device Labeling: The device must meet the labeling requirements set out by Health Canada. The labeling must include:
  • Name of the device and its intended use (e.g., intended to diagnose or monitor a medical condition).
  • Manufacturer details (or details of the Canadian Authorized Representative, if applicable).
  • Instructions for use, including handling, storage, and safety precautions.
  • Risk information, including any potential hazards associated with the device and instructions for safe use.
• Device Description: Provide detailed information on the device, including its intended purpose, components, and operation.

4. Ensure Compliance with the Medical Device Regulations (MDR)

• Medical Device Regulations (MDR): The device must comply with the Medical Device Regulations (MDR) under the Food and Drugs Act. For Class I IVD devices, the regulations focus on ensuring the safety and effectiveness of the device, appropriate labeling, and ensuring the manufacturer has implemented basic quality control measures.
• Risk Management: Although not as stringent as for higher-class devices, a risk management process should be in place to ensure the device is safe and performs as expected. The risk management plan should identify potential hazards, assess risks, and outline mitigation strategies.

5. Obtain a Medical Device Establishment License (MDEL)

• To legally sell or distribute Class I IVD devices in Canada, you must apply for an MDEL with Health Canada. This license is required for any manufacturer, importer, or distributor of medical devices.
• Application Process for MDEL:
  • Complete and submit an MDEL application through Health Canada's Medical Device Licensing System.
  • Provide necessary documentation about the device, such as labeling, device description, and your compliance with the Medical Device Regulations.
  • Submit the self-declaration of conformity stating that your device meets the MDR standards.

6. Maintain a Quality Management System (QMS) (Optional but Recommended)

• While a Quality Management System (QMS) is not mandatory for Class I devices, it is highly recommended to have a system in place. Implementing a QMS aligned with ISO 13485 (a standard for medical device quality management) can help ensure your device meets regulatory requirements and is continuously monitored for safety and performance.
• If you intend to move to a higher-class device in the future, implementing a QMS at the Class I stage may help streamline the process.

7. Submit the Required Documentation

• The following documentation must be submitted as part of your MDEL application:
  • Device labeling and instructions.
  • Device description and intended purpose.
  • Self-declaration of conformity to demonstrate that the device complies with Medical Device Regulations.
  • Manufacturing information, including details about how the device is made and the quality controls in place.
  • Importation or distribution details (if you are an importer or distributor).

8. Post-Market Surveillance Requirements

• Even for Class I devices, you must monitor the device after it is on the market. This includes:
  • Adverse event reporting: You must report any adverse events, device malfunctions, or safety issues to Health Canada.
  • Recall procedures: If a defect is found, you must have processes in place to recall the device, if necessary.

9. Ongoing Compliance

• After obtaining the MDEL and registering the device, you are required to ensure continuous compliance with the Medical Device Regulations throughout the lifecycle of the device.
• Record keeping: You must maintain detailed records of the device’s manufacturing, distribution, and any corrective actions taken in response to post-market feedback.

Summary of Key Requirements for Class I IVD MDL Registration in Canada:

1. Device Classification: Confirm that your device is a Class I IVD.
2. Canadian Authorized Representative: Appoint a representative if you are a foreign manufacturer.
3. Device Labeling: Ensure compliance with Health Canada's labeling requirements.
4. Self-declaration of Conformity: Declare that your device meets the Medical Device Regulations (MDR).
5. MDEL Application: Apply for a Medical Device Establishment License (MDEL) to sell or distribute the device.
6. Post-Market Surveillance: Implement procedures for reporting adverse events and device recalls.
7. Record Keeping: Maintain records of manufacturing and distribution activities.

By following these requirements, you can successfully register and market your Class I in vitro diagnostic device in Canada.

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