To apply for Class I IVD medical device registration under Hong Kong’s Medical Device Administrative Control System (MDACS), the process involves several key steps. Below is a detailed guide on how to apply:

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

1. Confirm Classification

Before applying, confirm that the device qualifies as a Class I IVD medical device under Hong Kong’s regulations. This class typically includes devices that are low-risk and have minimal regulatory requirements.

2. Prepare the Required Documentation

To apply for registration, you must prepare the necessary documents to support your application. These include:

• Device Description: Provide a detailed description of the device, including its intended use, design, and functionality.
• Performance Data: Include clinical or non-clinical data that demonstrates the device’s safety, effectiveness, and accuracy (if applicable).
• Risk Assessment: A document demonstrating that a risk assessment has been conducted in line with ISO 14971 (risk management for medical devices).
• Labeling and Instructions for Use (IFU): A copy of the device’s labeling, including packaging and instructions for use.
• Quality Management System (QMS): Proof that the manufacturer complies with ISO 13485 or an equivalent quality management system standard.
• Manufacturing Information: Information about the device’s manufacturer and manufacturing processes. If the manufacturer is outside of Hong Kong, an authorized representative in Hong Kong must be designated.
• Authorized Representative: If the device is manufactured outside Hong Kong, you must appoint an authorized representative in Hong Kong to submit the application on your behalf.

3. Complete the Application Form

The application for Class I IVD medical device registration must be submitted to the Hong Kong Department of Health (DoH). The following steps are involved:

• Complete the Application Form: The application form can be found on the Hong Kong Department of Health’s website or through the MDACS online portal. Ensure all sections are filled out accurately.
• Submit Supporting Documents: Along with the completed application form, submit the required documents (device description, performance data, labeling, etc.).
• Fee Payment: Pay the required application fee, which is set by the Department of Health. The fee can be paid online or as instructed during the application process.

4. Submit the Application

After preparing the application form and necessary documents, submit them to the Hong Kong Department of Health either:

• Online Submission: If available, use the MDACS online portal to submit the application electronically.
• Paper Submission: Alternatively, the application and documents can be submitted in hard copy. Ensure the documents are complete and signed by the authorized representative (if applicable).

5. Application Review by the Department of Health

Once the application is submitted, the Hong Kong Department of Health will:

• Verify Completeness: Review the submitted documents to ensure all necessary information is provided and that the device meets regulatory requirements.
• Compliance Check: Check that the device complies with relevant safety, quality, and performance standards (e.g., ISO 13485, ISO 14971).
• Risk Assessment: Assess the risk management documentation to ensure potential risks are identified and controlled according to regulatory standards.

6. Notification of Registration Decision

After the Department of Health reviews the application, they will issue a decision on whether the device is approved for registration. The review process typically takes 1 to 2 months.

• Approved Registration: If the device is approved, the Department will issue a registration number.
• Further Clarifications: If the application is incomplete or if further information is needed, the Department may request clarification or additional documentation. The applicant will be notified, and the process will be delayed accordingly.

7. Issuance of Registration Number

Once the application is approved, the device will be registered, and the manufacturer will receive a registration number. This number must be displayed on the device labeling and any associated documentation (e.g., instructions for use).

8. Post-Registration Obligations

After registration, manufacturers must:

• Ensure Compliance: Ensure that the device continues to meet all regulatory requirements, including maintaining compliance with safety standards and risk management practices.
• Post-Market Surveillance: Manufacturers must monitor the safety and performance of the device once it’s on the market. Report any adverse events or incidents as required.
• Renewal: The registration is valid for 5 years. A renewal application must be submitted before the expiration date to maintain market access.

Additional Considerations

• Authorized Representative: If the manufacturer is based outside of Hong Kong, they must appoint a local authorized representative in Hong Kong. This representative will handle the submission of the application and communication with the Department of Health.
• Regulatory Compliance: Be aware of other regulations such as ISO 13485 for quality management systems and ISO 14971 for risk management, which are necessary for demonstrating compliance in the application process.

Summary of Key Steps:

1. Confirm Device Classification: Ensure the device qualifies as Class I IVD.
2. Prepare Documentation: Compile the necessary documents, including device description, labeling, performance data, and risk assessment.
3. Complete the Application Form: Fill out the official application form and gather required documents.
4. Submit the Application: Submit the completed application form and supporting documents to the Hong Kong Department of Health.
5. Review Process: The Department of Health will review the application for completeness and regulatory compliance.
6. Receive Registration Number: If the application is approved, you will receive a registration number for the device.
7. Post-Registration Compliance: Monitor the device’s safety, renew the registration every 5 years, and comply with ongoing regulatory requirements.

By following these steps, manufacturers can successfully register a Class I IVD medical device under Hong Kong’s MDACS and maintain ongoing compliance with regulatory standards.