To apply for Class I IVD (In Vitro Diagnostic) medical device registration under Hong Kong's Medical Device Administrative Control System (MDACS), the following procedures and steps must be followed. The process ensures that medical devices comply with local regulations for safety, quality, and performance before they can be marketed and sold in Hong Kong.

Steps for Applying for Class I IVD Medical Device Registration under Hong Kong MDACS

1. Determine Device Classification

First, confirm that the device qualifies as Class I IVD under Hong Kong's regulatory framework. Class I IVD devices are generally considered low risk and require minimal regulatory oversight compared to higher-risk devices.

Class I IVD devices include products like:

• Simple diagnostic tools.
• Devices with a minimal risk to the patient or user.
• Devices intended for professional or self-use, such as tests for glucose monitoring or pregnancy.

Ensure the device fits this classification by reviewing the Hong Kong medical device regulations or seeking professional advice.

2. Prepare the Required Documentation

You must gather the necessary documentation to support your application. Key documents for Class I IVD device registration include:

• Device Description: A detailed description of the device, including its intended use, design, and functionality.
• Conformity with Standards: Documentation proving compliance with international standards like ISO 13485 (for quality management systems) and ISO 14971 (for risk management).
• Risk Assessment: Evidence that the device's risks have been evaluated and managed according to ISO 14971.
• Clinical or Performance Data: If applicable, clinical or non-clinical performance data to support the device's safety and effectiveness.
• Labeling: Product labeling, including packaging, instructions for use (IFU), and safety warnings.
• Manufacturing Information: Information about the manufacturing processes and quality control measures.
• Authorized Representative: If the manufacturer is outside Hong Kong, an authorized representative in Hong Kong must be designated to handle the registration process.

3. Complete the Application Form

The next step is to complete the official MDACS registration form. This form can be downloaded from the Hong Kong Department of Health (DoH) website or accessed through the MDACS online portal.

The application form will require basic information about the manufacturer and the device, including:

• Manufacturer details (name, address, etc.).
• Device details (name, classification, intended use).
• Authorized representative details (if applicable).

Ensure all sections are filled out accurately and completely.

4. Submit the Application

Submit the completed application form and supporting documents to the Hong Kong Department of Health (DoH).

• Online Submission: If available, use the MDACS online submission portal to upload the application and supporting documentation.
• Paper Submission: Alternatively, submit the documents by mail or in person to the Department of Health, Hong Kong.

Along with the application form and supporting documents, you will need to pay the application fee, which is determined by the Department of Health.

5. Review by the Department of Health

Once the application is submitted, the Hong Kong Department of Health will conduct a regulatory review of the application and supporting documentation. This review process typically involves:

• Document Review: Ensuring that all required documents are submitted and complete.
• Compliance Check: Verifying that the device meets relevant safety, quality, and performance standards.
• Risk Management Review: Ensuring that the device has undergone proper risk assessments and risk management procedures in accordance with ISO 14971.
• Labeling and Instructions Review: Checking the device's labeling, including instructions for use (IFU), for compliance with regulatory requirements.

Review Time: The review process generally takes around 1 to 2 months. However, the exact time frame may vary depending on the completeness of the application and the complexity of the device.

6. Issuance of Registration Number

If the application meets all regulatory requirements, the Hong Kong Department of Health will approve the registration and issue a registration number for the device. This registration number must be displayed on the device labeling and any associated documents (e.g., instructions for use).

• Approved Registration: Once the device is registered, it is legally allowed to be marketed and sold in Hong Kong.
• Rejected or Pending Application: If additional information or corrections are needed, the Department of Health will request clarification, and the process will be delayed.

7. Post-Registration Requirements

Once the device is registered, there are ongoing obligations to maintain compliance with Hong Kong’s medical device regulations:

• Post-Market Surveillance: Monitor the safety and performance of the device once it’s on the market. Report any adverse events, device malfunctions, or safety issues to the Hong Kong Department of Health.
• Renewal: The registration for Class I IVD devices is valid for 5 years. Before the expiration of this period, the registration must be renewed by submitting updated documentation, confirming compliance, and paying the renewal fee.
• Changes to Device: Notify the Department of Health if there are any significant changes to the device, such as modifications to the design, intended use, or manufacturing process.

Summary of Key Steps in the Registration Process

1. Confirm Device Classification: Verify that the device is classified as Class I IVD.
2. Prepare Documents: Gather all required documentation, including device description, labeling, performance data, and risk assessment.
3. Complete the Application: Fill out the application form and submit it with the required documents.
4. Submit Application: Submit the application to the Hong Kong Department of Health either online or in paper form.
5. Review Process: The Department of Health reviews the application and supporting documents.
6. Receive Registration Number: If the application is approved, a registration number is issued, allowing the device to be marketed.
7. Post-Registration Compliance: Maintain compliance with post-market surveillance requirements and renew the registration every 5 years.

By following these steps, manufacturers can successfully register their Class I IVD medical devices under the Hong Kong MDACS and ensure compliance with local regulations.