To register and apply for Class I IVD (In Vitro Diagnostic) medical device registration under the Hong Kong Medical Device Administrative Control System (MDACS), you need to follow a clear process. Below is a comprehensive guide on how to register and apply for a Class I IVD medical device under MDACS:

Steps to Register and Apply for Class I IVD Medical Device Registration under MDACS

1. Confirm the Device Classification

Before applying, ensure that your device qualifies as a Class I IVD medical device. Class I IVD devices are low-risk products that are intended for in vitro diagnostic purposes, such as glucose meters or simple diagnostic tests.

• Class I IVD devices are those that pose minimal risk to users and patients.
• Refer to the Hong Kong medical device classification guidelines or seek advice if you are unsure about the classification.

2. Prepare the Necessary Documentation

You need to prepare various documents to support your registration application. The required documentation for Class I IVD devices typically includes:

• Device Description: A detailed description of the device, its intended use, and its design.
• Compliance with Standards: Evidence that the device complies with relevant standards such as:
  • ISO 13485 for Quality Management Systems (QMS).
  • ISO 14971 for risk management.
• Performance Data: If applicable, clinical or non-clinical data showing that the device is safe and effective.
• Labeling: A copy of the device’s labeling, including:
  • Product name.
  • Intended use.
  • Instructions for use (IFU).
  • Warnings or precautions.
• Risk Management Documentation: Evidence of a risk assessment based on ISO 14971 to ensure that risks are controlled.
• Manufacturing Information: Details about the manufacturing process and quality control systems in place.
• Authorized Representative (if applicable): If the manufacturer is outside of Hong Kong, designate an authorized representative in Hong Kong to submit the application and serve as a liaison with the Hong Kong authorities.

3. Complete the Application Form

The next step is to complete the application form for Class I IVD device registration, which is available from the Hong Kong Department of Health (DoH). You can either:

• Download the form from the MDACS website or access it via the MDACS online submission system (if available).
• Fill out all required sections in the application form, providing information about the manufacturer, the device, and any other relevant details.

4. Submit the Application to the Department of Health

After completing the application form, submit it to the Hong Kong Department of Health for review. You can submit your application in two ways:

• Online Submission: If available, use the MDACS online portal to submit the application electronically along with the required documents.
• Paper Submission: If online submission is not available, you may submit your application and documents via mail or in person to the Department of Health.

Make sure to include the following:

• Completed application form.
• Required documents (device description, labeling, risk management documents, performance data, etc.).
• Application fee: Ensure the application fee is paid. The fee amount varies depending on the device and is specified on the Department of Health’s website.

5. Application Review Process

Once the application is submitted, the Hong Kong Department of Health will conduct a review of the application. The review process involves several steps:

• Document Review: The Department checks that all required documentation has been submitted and is complete.
• Compliance Assessment: The device will be assessed for compliance with safety, quality, and performance standards (e.g., ISO 13485, ISO 14971).
• Risk Management Review: The risk assessment will be reviewed to ensure that potential risks associated with the device have been adequately identified and controlled.
• Labeling and Instructions Review: The Department of Health will verify that the labeling and instructions for use (IFU) comply with regulatory requirements.

6. Registration Decision

After completing the review, the Department of Health will issue a decision:

• Approved Registration: If the device meets all the requirements, the Department will issue a registration number. This allows the device to be legally marketed and sold in Hong Kong.
• Further Clarifications: If any additional information or clarification is needed, the Department will request it. This may cause a delay in the approval process.

7. Receive the Registration Number

Once the application is approved, you will receive a registration number from the Hong Kong Department of Health. This number must be included in the labeling and any associated documentation for the device.

8. Post-Registration Obligations

After registration, the manufacturer must comply with several ongoing obligations, including:

• Post-market surveillance: The manufacturer must monitor the device’s performance and safety on the market. If there are any adverse events or issues, the Department of Health must be notified.
• Renewal: The registration is valid for 5 years, after which a renewal application must be submitted. The manufacturer should maintain all documentation and ensure continued compliance with relevant regulations.
• Changes to the Device: Any changes to the device, such as modifications in design, labeling, or manufacturing processes, must be reported to the Department of Health.

Summary of Key Steps in the Application Process

1. Confirm Classification: Ensure the device is a Class I IVD medical device.
2. Prepare Documentation: Gather all necessary documents, including device description, performance data, risk assessment, and labeling.
3. Complete the Application: Fill out the MDACS registration application form and provide all supporting documents.
4. Submit the Application: Submit the completed application form and documents either online or via paper submission to the Department of Health.
5. Review Process: The Department of Health reviews the application for completeness, compliance with standards, and risk management.
6. Receive Registration Number: If approved, receive the registration number and begin marketing the device in Hong Kong.
7. Post-Registration Compliance: Ensure ongoing compliance with regulatory requirements, including post-market surveillance and device renewal every 5 years.

By following these steps, manufacturers can successfully apply for and register their Class I IVD medical device under the Hong Kong MDACS. It’s important to maintain all necessary documentation and ensure compliance with local regulations throughout the life cycle of the device.