The process of applying for Class D medical device registration under the Hong Kong Medical Device Administrative Control System (MDACS) requires adherence to specific procedures, submission of various required documents, and awareness of key regulatory considerations. Class D devices are considered high-risk and include life-sustaining or implantable devices. Below is a detailed guide on the procedures, required documents, and key considerations.

1. Procedures for Applying for Class D Medical Device Registration

Step 1: Device Classification

• Confirm that your device falls under Class D based on the MDACS classification system. Class D devices are typically the highest-risk devices, such as pacemakers, heart valves, and defibrillators.
• Consult the MDACS classification guidelines to ensure accurate classification.

Step 2: Appoint a Local Responsible Person (LRP)

• If the manufacturer is not based in Hong Kong, a Local Responsible Person (LRP) must be appointed. The LRP is responsible for submitting the application, handling post-market obligations, and acting as the point of contact for the Medical Device Division (MDD).
• The LRP must be a registered legal entity in Hong Kong.

Step 3: Prepare the Required Documentation

• The required documents should be compiled following MDACS requirements (see below for a full list of documents).

Step 4: Submit the Application

• Submit the completed application form (MD-14) along with all supporting documentation to the Medical Device Division (MDD) of the Hong Kong Department of Health.
• The application can be submitted in person, by mail, or possibly electronically. You can reach out to the MDD to confirm if electronic submission is applicable.

Step 5: Pay the Application Fee

• An application fee must be paid, which is non-refundable. The fee for Class D devices typically ranges from HKD 25,000 to HKD 50,000 or more, depending on the specifics of the device.
• Payment must accompany the submission.

Step 6: Application Review

• The MDD will review the submission for completeness and regulatory compliance. They may request additional documents or clarifications.
• The review process may take 6 to 12 months or more depending on the complexity of the device and the completeness of the submission.

Step 7: Approval and Listing

• Once the application is approved, the device will be listed in the MDACS database, and it will be legal to market the device in Hong Kong.
• The listing is typically valid for five years, after which it must be renewed.

Step 8: Post-Market Obligations

• After the device is listed, ongoing post-market surveillance (PMS), adverse event reporting, and recall procedures must be followed as per MDACS requirements.

2. Required Documents for Class D Medical Device Registration

The application requires the submission of several documents to demonstrate compliance with safety and performance standards. These include:

1. Application Form (MD-14)

• This is the official form for Class D device listing under MDACS. It must be completed and signed by the manufacturer or the LRP.

2. Proof of Regulatory Approval/Certificate of Free Sale

• Submit a Certificate of Free Sale or equivalent document that proves the device is legally marketed in a jurisdiction with equivalent regulatory standards (e.g., the US, EU, or Australia).
• Alternatively, provide documentation that the device complies with internationally recognized standards.

3. Declaration of Conformity

• A Declaration of Conformity from the manufacturer, confirming that the device complies with relevant international standards, such as ISO 13485 (Quality Management Systems for medical devices).
• The declaration should include the standards the device conforms to and be signed by an authorized representative.

4. Quality Management System (QMS) Certification

• Submit certification for the manufacturer’s Quality Management System (QMS). Typically, this would be an ISO 13485 certificate issued by an accredited body.

5. Risk Analysis and Management Report

• A comprehensive Risk Management Report based on ISO 14971 (the international standard for risk management in medical devices), detailing potential risks associated with the device and the steps taken to mitigate them.

6. Clinical Evidence and Data

• Submit clinical evidence demonstrating the safety and performance of the device. This may include clinical trials, real-world evidence, or post-market surveillance data, particularly for high-risk devices.
• Include summaries of clinical studies, if available.

7. Product Description

• Provide a detailed description of the device, including its:
  • Design and technical specifications.
  • Intended use and indication for use.
  • Components, materials, and accessories (especially important for implantable devices).
  • Diagrams or images, if necessary, to illustrate the device.

8. Labeling and Instructions for Use (IFU)

• Submit samples of the device labeling and packaging, along with Instructions for Use (IFU). This documentation must be in English or Chinese and should include:
  • Device name and classification.
  • Manufacturer and LRP contact details.
  • Instructions for use, warnings, precautions, and contraindications.

9. Post-Market Surveillance (PMS) Plan

• A PMS plan outlining how the manufacturer will monitor the device once it is marketed. This plan should include procedures for tracking adverse events, handling product complaints, and implementing corrective actions or recalls if necessary.

10. Technical Documentation

• A complete set of technical documents supporting the safety, performance, and design of the device. This may include:
  • Design and manufacturing information.
  • Verification and validation data (including software validation, if applicable).
  • Sterilization validation for devices supplied sterile.

11. Adverse Event Reporting and Recall Procedures

• Procedures for adverse event reporting and product recalls must be established and documented. These procedures must comply with Hong Kong’s MDACS requirements.

12. Payment of Application Fee

• Proof of payment of the application fee, which is required to initiate the review process.

3. Key Considerations for Class D Medical Device Registration

1. Device Classification

• Ensure the device is correctly classified as Class D, which includes the highest-risk devices. Incorrect classification could result in delays or rejection of the application.

2. Compliance with International Standards

• The device must comply with internationally recognized safety and performance standards, such as ISO 13485 for Quality Management Systems, ISO 14971 for risk management, and any relevant product-specific standards (e.g., IEC 60601 for electrical safety in medical devices).
• You must demonstrate this compliance through certificates and technical documentation.

3. Clinical Evidence

• Due to the high-risk nature of Class D devices, strong clinical evidence is critical. If clinical trials have been conducted, include the results, and be prepared to provide comprehensive safety and performance data.

4. Local Responsible Person (LRP)

• Appointing a reliable and compliant LRP is essential. The LRP will be the point of contact for the MDD, handle post-market obligations, and manage adverse event reporting and recalls.

5. Post-Market Surveillance and Reporting

• Post-market surveillance (PMS) is a significant obligation for Class D devices. Manufacturers must have a plan in place to continuously monitor the device’s safety and performance once it is in use. This plan should align with the requirements of MDACS.
• Additionally, prompt reporting of adverse events and the ability to handle recalls efficiently is crucial for maintaining compliance.

6. Timeline and Cost

• Be aware that the review process for Class D devices typically takes between 6 to 12 months or more. Plan for the costs, including the non-refundable application fee, LRP fees, and any costs associated with clinical trials or post-market surveillance activities.

7. Renewal of Registration

• The registration is valid for five years, after which the device listing must be renewed. Be prepared to submit updated documentation and pay renewal fees before the expiration of the registration.

By following these procedures, preparing the required documents, and considering the key regulatory and post-market obligations, you can ensure a smoother application process for Class D medical device registration under the Hong Kong MDACS.

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