To apply for the Class I in vitro diagnostic (IVD) medical device MDL registration in Canada, certain conditions and requirements must be met to ensure compliance with Health Canada’s Medical Device Regulations (MDR). Here's a breakdown of the key conditions that need to be met:

1. Device Classification

• Class I Classification: The device must be classified as a Class I medical device, which is the lowest risk category of medical devices in Canada.
  • Class I devices are those that pose minimal risk to users and are typically used in diagnostic or monitoring applications, such as in vitro diagnostic (IVD) test kits or laboratory devices.
  • Class I devices do not require pre-market approval from Health Canada, but they must comply with the applicable regulations.

2. Compliance with Medical Device Regulations (MDR)

• The device must meet the requirements outlined in the Medical Device Regulations (MDR), specifically designed to ensure the safety and effectiveness of medical devices in Canada.
• Key MDR requirements include:
  • Safety and Effectiveness: The device must be designed and manufactured in a way that ensures its safety and effectiveness for its intended use.
  • Labeling Requirements: The device’s labeling must meet specific requirements for content, format, and language (e.g., including manufacturer details, intended use, warnings, and instructions for use).
  • Risk Management: Devices must be assessed for potential risks associated with their use, even though Class I devices are considered low risk.

3. Self-Declaration of Conformity

• Self-declaration of conformity is required, where the manufacturer (or the Canadian authorized representative) states that the device complies with the MDR.
  • This declaration confirms that the device adheres to the required safety, performance, and labeling standards.

4. Good Manufacturing Practices (GMP)

• While ISO 13485 certification or a formal quality management system (QMS) is not mandatory for Class I devices, it is still recommended to follow Good Manufacturing Practices (GMP).
  • A QMS ensures that devices are consistently produced and controlled according to quality standards.
  • Compliance with GMP helps ensure that the device consistently meets safety and performance standards.

5. Canadian Authorized Representative (If Applicable)

• If the device is manufactured outside of Canada, you must appoint a Canadian Authorized Representative to act as a liaison between your company and Health Canada.
  • This representative will handle regulatory communications and assist with the application process.

6. Device Labeling Compliance

• The device must be properly labeled according to Health Canada's guidelines. This includes the following:
  • Device name and description.
  • Intended use (e.g., diagnostic test kit or laboratory device).
  • Manufacturer details or the name of the Canadian Authorized Representative (if applicable).
  • Warnings, precautions, and any other information necessary for safe use.
  • Instructions for use and handling.

7. Risk Management Assessment (Optional but Recommended)

• While not required by law for Class I devices, conducting a risk management assessment is strongly recommended to identify potential hazards and ensure the device’s safety and performance.
  • This involves evaluating the risks associated with the device and taking steps to mitigate them.

8. Importation/Distribution Compliance (If Applicable)

• If you intend to import or distribute the device in Canada, you need to comply with regulations for importation and distribution.
• You will need to indicate that your business holds an MDEL for importing or distributing medical devices in Canada.
• If you are acting as a distributor or importer, you must also comply with the distribution rules set forth by Health Canada.

9. Payment of Fees

• Application Fee: There is a fee for applying for a Class I IVD device MDEL. The fee typically ranges from CAD $5,000 to CAD $10,000.
• Annual Maintenance Fee: After your MDEL is issued, you must pay an annual maintenance fee (typically ranging from CAD $2,000 to CAD $4,000).

Key Conditions for Class I IVD MDL Registration:

1. Device Classification: Ensure that your device is classified as Class I.
2. Compliance with MDR: The device must meet Health Canada’s Medical Device Regulations, including safety, effectiveness, and labeling requirements.
3. Self-Declaration of Conformity: You must submit a self-declaration of conformity confirming the device meets the MDR.
4. Good Manufacturing Practices (GMP): It is recommended to follow GMP or have a Quality Management System (QMS).
5. Canadian Authorized Representative: If the device is imported, a Canadian Authorized Representative must be appointed.
6. Proper Labeling: Ensure the device labeling complies with Health Canada's specific requirements.
7. Risk Management (Optional but Recommended): While not mandatory, providing a risk management assessment is a good practice.
8. Importation and Distribution: If you are importing or distributing, ensure compliance with regulations.
9. Payment of Fees: Pay the application fee and the annual maintenance fee.

By meeting these conditions, you will be eligible to apply for and obtain an MDEL for your Class I in vitro diagnostic medical device in Canada.

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