Class D medical device registration under the Hong Kong Medical Device Administrative Control System (MDACS) refers to the process of listing and obtaining approval for high-risk medical devices (Class D) to be sold or distributed in Hong Kong. The MDACS is a voluntary system overseen by the Medical Device Division (MDD) of the Department of Health in Hong Kong to ensure the safety, quality, and performance of medical devices.

What is a Class D Medical Device?

Class D medical devices are considered high-risk devices, typically those that:

• Sustain or support life,
• Are implanted in the body,
• Are used for critical or high-risk medical treatments.

Examples of Class D devices include:

• Pacemakers
• Implantable defibrillators
• Heart valves
• Dialysis equipment
• Ventilators

Purpose of Registration under MDACS

The goal of registering under MDACS is to ensure that medical devices meet internationally recognized safety and quality standards before they are marketed or used in Hong Kong. While MDACS is voluntary, it is often required by hospitals and healthcare providers as part of their procurement process.

How to Apply for Class D Medical Device Registration under MDACS

Step 1: Understand Device Classification

Ensure that your device is classified correctly as a Class D medical device. This is based on its intended use, risk to patients, and the level of regulatory oversight required.

Step 2: Prepare Required Documentation

You will need to compile various documents to demonstrate the safety, performance, and regulatory compliance of the device. Key documents include:

• Application Form MD-14: The official form for listing medical devices under MDACS.
• Declaration of Conformity: A statement from the manufacturer declaring that the device complies with recognized standards.
• Certificate of Free Sale: Evidence that the device is legally sold in other markets, typically from countries with equivalent regulatory standards.
• Quality Management System (QMS) Certification: Proof that the manufacturer operates under an ISO 13485 (or equivalent) certified QMS.
• Clinical Data: Supporting evidence that the device is safe and performs as intended in real-world use.
• Product Description: Detailed description of the device, its components, and how it operates.
• Risk Analysis Report: A document that outlines the potential risks of using the device and how these risks are mitigated.
• Instructions for Use (IFU) and Labeling: Sample labels and instructions that come with the device.
• Post-Market Surveillance (PMS) Plan: A plan for monitoring the device’s performance once it is on the market.

Step 3: Appoint a Local Responsible Person (LRP)

If you are a foreign manufacturer, you will need to appoint an LRP who is a registered entity in Hong Kong. The LRP will be responsible for:

• Submitting the application on behalf of the manufacturer.
• Liaising with the MDD.
• Handling post-market obligations such as adverse event reporting and recalls.

Step 4: Submit the Application

Submit the completed MD-14 form along with all supporting documents and the appropriate application fee to the Medical Device Division of the Hong Kong Department of Health.

• Submission can be done electronically or in hard copy to the MDD office.

Step 5: Pay the Application Fee

Ensure the payment of the non-refundable application fee for Class D medical devices. The fee is required to process your application.

Step 6: Assessment by the MDD

The Medical Device Division (MDD) will review the application and supporting documentation. This may include:

• Verification of technical documentation.
• Additional clarifications or audits.
• Assessment of clinical data and safety evidence.

Step 7: Approval and Listing

If the MDD is satisfied with the application and documentation, your Class D device will be approved and listed on the MDACS database. This listing typically lasts for five years, after which you must renew the registration.

Step 8: Maintain Post-Market Compliance

After registration, manufacturers must comply with ongoing obligations, including:

• Post-market surveillance.
• Adverse event reporting.
• Managing product recalls.
• Keeping the MDD updated with any significant changes to the device.

Conclusion

The Class D medical device registration process ensures that high-risk medical devices meet Hong Kong’s safety and performance standards. While voluntary, registration under MDACS enhances the credibility of the device and helps with market acceptance in Hong Kong.

If you need further assistance or guidance with specific steps, feel free to ask!