To apply for Class D medical device registration under the Hong Kong Medical Device Administrative Control System (MDACS), you must meet specific documentation, regulatory, and procedural requirements. Class D devices are considered high-risk devices, and the registration process requires comprehensive evidence of safety, performance, and compliance with international standards.

Key Requirements for Class D Medical Device Registration under MDACS:

1. Appoint a Local Responsible Person (LRP)

• If you are a manufacturer located outside of Hong Kong, you must appoint an LRP who is legally registered in Hong Kong. The LRP acts as your representative and is responsible for liaising with the Medical Device Division (MDD) and fulfilling post-market obligations.
• The LRP is responsible for:
  • Submitting the application.
  • Reporting adverse events.
  • Managing product recalls or corrective actions.

2. Completed Application Form (MD-14)

• The MD-14 form is the official application form for listing a medical device under the MDACS. It must be completed in full and submitted as part of the registration process.
• The form requires detailed information about the device, the manufacturer, and the Local Responsible Person (LRP).

3. Proof of Regulatory Approval/Certificate of Free Sale

• You must provide evidence that the device is already legally sold or approved for use in a country with similar or equivalent regulatory standards (such as the US FDA, EU CE marking, or Australian TGA approval).
• This can be demonstrated with a Certificate of Free Sale or equivalent regulatory documentation.

4. Declaration of Conformity

• A Declaration of Conformity from the manufacturer is required. This document asserts that the device conforms to applicable international safety and performance standards, such as ISO 13485 or other recognized regulatory frameworks.
• The declaration should be signed by an authorized representative of the manufacturer.

5. Quality Management System (QMS) Certification

• The manufacturer must have a certified Quality Management System (QMS) in place. The QMS should be compliant with ISO 13485, which is the international standard for medical devices.
• A valid ISO 13485 certificate issued by an accredited certification body must be included in the application.

6. Risk Analysis and Management Report

• A Risk Analysis Report that identifies the potential risks associated with the device and details the risk management strategies in place is required.
• This report should be based on ISO 14971, the international standard for risk management in medical devices.

7. Clinical Evidence and Data

• You must provide clinical data to demonstrate the safety and performance of the device. Clinical studies or real-world evidence of the device’s use should be included, especially for high-risk Class D devices.
• If the device has undergone clinical trials, the results and conclusions should be submitted as part of the supporting documentation.

8. Product Information and Description

• Detailed information about the device, including its:
  • Design,
  • Intended use,
  • Technical specifications,
  • Components,
  • Accessories,
  • Variations (if applicable),
  • Materials used (especially if it involves patient contact or is implantable).
• You should also provide diagrams or images, if necessary, to illustrate the product.

9. Labeling and Instructions for Use (IFU)

• Provide examples of the device labels and Instructions for Use (IFU). This documentation must be in English and/or Chinese and should include:
  • Device name and classification.
  • Manufacturer and LRP contact details.
  • Instructions for correct use of the device.
  • Warnings, contraindications, and any potential hazards.
  • Sterilization information, if applicable.
• The labeling must comply with Hong Kong’s local regulatory requirements and international standards.

10. Post-Market Surveillance (PMS) Plan

• A Post-Market Surveillance (PMS) Plan is required to outline how the manufacturer will monitor the device’s performance after it is placed on the market.
• The PMS plan should include:
  • Procedures for collecting and reviewing data related to device performance.
  • Methods for handling complaints and addressing adverse events.
  • Processes for implementing corrective actions or recalls if necessary.

11. Technical Documentation

• A complete set of technical documentation must be provided to demonstrate compliance with safety and performance standards. This may include:
  • Design and manufacturing information.
  • Verification and validation data.
  • Software validation (if applicable).
  • Sterilization validation (if applicable).

12. Adverse Event Reporting and Recall Procedures

• The manufacturer (via the LRP) must have procedures in place for adverse event reporting and managing product recalls.
• These procedures should be described in the PMS plan and must comply with the adverse event reporting obligations set out by the MDACS.

13. Payment of Application Fee

• An application fee must be paid for the Class D medical device registration process. The fee is non-refundable and covers the administrative costs of the review by the MDD.
• The fee amount for Class D devices is typically higher than for lower-class devices due to the higher risk associated with these products.

14. Additional Specific Requirements (if applicable)

• Sterilization Validation: For devices that are supplied sterile, evidence of the sterilization method and validation process must be provided.
• Biocompatibility Testing: If the device comes into contact with human tissues or fluids, biocompatibility testing results based on international standards (e.g., ISO 10993) must be submitted.
• Software Validation: If the device contains software or is software as a medical device (SaMD), software validation and verification documents are required, following standards like IEC 62304.

Summary of Key Requirements:

1. Local Responsible Person (LRP): A Hong Kong entity to represent the manufacturer.
2. Application Form MD-14: Fully completed with detailed device information.
3. Regulatory Approval/Certificate of Free Sale: Proof of approval in other jurisdictions.
4. Declaration of Conformity: Stating compliance with international standards.
5. Quality Management System (QMS): Certification, usually ISO 13485.
6. Risk Analysis Report: Based on ISO 14971 for risk management.
7. Clinical Data: Evidence supporting device safety and performance.
8. Product Description: Detailed device information, including diagrams.
9. Labeling and IFU: Samples of labels and instructions in English and/or Chinese.
10. Post-Market Surveillance (PMS) Plan: Strategy for monitoring the device post-market.
11. Technical Documentation: Comprehensive set of technical files supporting safety and compliance.
12. Adverse Event and Recall Procedures: Must be defined and in place.
13. Application Fee: Non-refundable fee payable at the time of submission.
14. Specific Testing (if applicable): Sterilization, biocompatibility, or software validation documents.

Once all these requirements are met and the application is submitted, the Medical Device Division (MDD) will review the application and may request additional information or clarification before approving the device for listing in the MDACS database.