To apply for the Class I in vitro diagnostic (IVD) medical device registration in Canada, follow these steps:

1. Determine the Class of the Device

• Class I in vitro diagnostic devices are low-risk devices, but you must verify that your device is correctly classified under the Canadian regulations. You can refer to the Medical Device Regulations (MDR) for this classification.

2. Establish a Canadian Manufacturer or Authorized Representative

• If you are not based in Canada, you must designate a Canadian Authorized Representative to act on your behalf for regulatory affairs and communications with Health Canada.
• The representative must be located in Canada and ensure compliance with all regulatory requirements.

3. Ensure Compliance with Canadian Medical Device Regulations (MDR)

• Ensure your device complies with the Medical Device Regulations (MDR) under the Food and Drugs Act. This includes meeting the requirements for labeling, performance, safety, and quality control.
• For Class I IVDs, the requirements are generally less stringent, but the device still needs to meet basic safety and performance standards.

4. Prepare Device Licensing Documentation

• Device Labeling: Your device must meet the labeling requirements under the MDR. This includes providing necessary information like the device name, intended use, manufacturer information, and instructions for use.
• Quality Management System (QMS): While not mandatory for Class I devices, having a Quality Management System (QMS) based on ISO 13485 is recommended and may be required for future device classifications.

5. Submit a Medical Device License (MDL) Application

• For Class I IVD devices, you are not required to submit a pre-market application to Health Canada. Instead, you must self-declare that your device complies with the applicable regulations.
• Register the Device: To register, you need to create a Medical Device Establishment License (MDEL). This is required for manufacturers, importers, and distributors of medical devices in Canada.
  • You must submit an application to obtain an MDEL with Health Canada through their Medical Device Licensing System.
  • You will need to provide information about the device, the manufacturing process, and the Canadian Authorized Representative (if applicable).

6. Maintain Post-Market Surveillance

• After obtaining the license, you must monitor and report any adverse events or issues with the device to Health Canada.
• For Class I devices, you must maintain proper records, but the regulatory burden is lighter compared to higher-class devices.

7. Device Market Access

• Once your MDEL is approved, you can market your Class I IVD device in Canada, ensuring ongoing compliance with the regulatory requirements.

Important Notes:

• Class I IVD devices are subject to less rigorous pre-market evaluation compared to Class II, III, and IV devices.
• However, you must ensure the device meets all safety, effectiveness, and labeling requirements as per Canadian regulations.
• If you are importing a Class I device into Canada, you may need an Importer's License depending on your role.

For further details and application forms, you can visit the Health Canada Medical Device section on their website.

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