To apply for Class D medical device registration under the Hong Kong Medical Device Administrative Control System (MDACS), you need to follow a structured process that ensures compliance with the relevant regulations. Here’s a step-by-step guide on how to apply:

Step-by-Step Application Process

1. Determine Device Classification

• Confirm Classification: Ensure that your device is classified as Class D based on its intended use and risk level. Class D devices are typically those that pose the highest risk to patients and users.

2. Pre-Application Preparations

• Regulatory Understanding: Familiarize yourself with the Medical Device Ordinance (Cap. 594) and relevant guidelines issued by the Hong Kong Department of Health.
• Quality Management System: Establish and maintain a Quality Management System (QMS) compliant with ISO 13485.

3. Gather Required Documentation

• Technical Documentation: Compile comprehensive technical documentation, including:
  • Device description and specifications.
  • Design and manufacturing processes.
  • Risk management documentation (following ISO 14971).
  • Clinical evaluation report (CER) supported by clinical data.
• Labeling and Instructions for Use (IFU): Prepare labeling materials that comply with relevant standards (e.g., ISO 15223).

4. Complete Application Form

• Application Form (MD-14): Fill out the Application Form (MD-14), which includes:
  • Basic information about the device.
  • Manufacturer details.
  • Information about the Local Responsible Person (LRP), if applicable.

5. Submission of Application

• Submit Documents: Send the completed application form along with all supporting technical documentation to the Medical Device Division (MDD) of the Hong Kong Department of Health. This can typically be done via an online portal or through hard copy submission.
• Check for Completeness: Ensure all documents are complete and properly formatted to avoid delays in processing.

6. Payment of Fees

• Application Fees: Pay the required application fee, which usually ranges from HKD 25,000 to HKD 50,000 for Class D devices, depending on specifics.

7. Review by Regulatory Authorities

• Initial Review: The MDD will conduct an initial review to check if the application is complete and meets submission standards.
• Detailed Evaluation: Following the initial review, the MDD will perform a detailed evaluation of the technical documentation, risk management, and clinical data.
• Requests for Additional Information: Be prepared to respond to any queries or requests for additional information from the MDD.

8. Approval and Registration

• Approval Notification: If the application is approved, the MDD will issue a registration certificate.
• Registration Number: The device will be assigned a unique registration number, which should be used in all relevant documentation and labeling.

9. Post-Market Surveillance and Obligations

• Implement PMS Plan: Establish a post-market surveillance (PMS) plan to monitor the safety and effectiveness of the device once it is on the market.
• Adverse Event Reporting: Set up procedures for reporting adverse events or incidents related to the device.

10. Renewal of Registration

• Monitor Registration Validity: Class D device registrations are typically valid for five years. Prepare for the renewal process well in advance.

Summary of Key Steps

1. Determine Device Classification: Confirm it as Class D.
2. Pre-Application Preparations: Understand regulations and set up QMS.
3. Gather Required Documentation: Compile all necessary technical documents and labeling materials.
4. Complete Application Form: Fill out the MD-14 application form.
5. Submission of Application: Submit documents to the MDD.
6. Payment of Fees: Pay applicable application fees.
7. Review by Regulatory Authorities: Go through the initial and detailed evaluation.
8. Approval and Registration: Receive the registration certificate and number.
9. Post-Market Surveillance: Implement PMS and reporting mechanisms.
10. Renewal of Registration: Prepare for renewal every five years.

By following these steps, you can effectively navigate the application process for Class D medical device registration under the Hong Kong MDACS.

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