Applying for Class D medical device registration under the Hong Kong Medical Device Administrative Control System (MDACS) involves a systematic approach to ensure compliance with regulatory requirements. Below is a detailed guide on how to apply:

Step-by-Step Guide to Apply for Class D Medical Device Registration

1. Determine Device Classification

• Confirm Classification: Ensure that your device is classified as Class D. This classification applies to high-risk medical devices that require stringent regulation. Review the guidelines provided by the Hong Kong Department of Health to confirm the classification.

2. Pre-Application Preparations

• Understand Regulatory Requirements: Familiarize yourself with the Medical Device Ordinance (Cap. 594) and relevant guidelines from the Hong Kong Department of Health.
• Quality Management System (QMS): Establish a QMS compliant with ISO 13485 to ensure the device meets safety and quality standards.

3. Gather Required Documentation

• Technical Documentation: Compile the following essential documents:
  • Device Description: Comprehensive details about the device, including intended use and specifications.
  • Manufacturing Information: Details of the manufacturing process and quality control measures.
  • Clinical Evaluation Report (CER): Document clinical evidence supporting the device's safety and effectiveness, including data from clinical studies or literature.
  • Risk Management File: Documentation demonstrating compliance with ISO 14971, including risk analysis, evaluation, and mitigation strategies.
• Labeling Requirements: Prepare product labeling and Instructions for Use (IFU) that comply with ISO 15223 and include necessary symbols and safety information.

4. Complete Application Form

• Application Form (MD-14): Fill out the Application Form (MD-14) provided by the Hong Kong Department of Health. This includes:
  • Basic information about the device and manufacturer.
  • Details about the Local Responsible Person (LRP) if applicable.

5. Submit Application

• Submission of Documents: Submit the completed application form along with all supporting documents to the Medical Device Division (MDD) of the Hong Kong Department of Health. You can typically do this via an online portal or by postal mail.
• Verify Completeness: Double-check that all required documents are included and formatted correctly to avoid processing delays.

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 specific circumstances. Confirm the exact fee amount on the official website or relevant documentation.

7. Review Process by MDD

• Initial Review: The MDD will conduct an initial review to ensure the application is complete. This typically takes 2 to 4 weeks.
• Detailed Evaluation: Following the initial review, the MDD will perform a detailed assessment of the technical documentation, clinical data, and risk management files. This stage can take 3 to 6 months.
• Requests for Additional Information: Be prepared to respond promptly to any requests for additional information or clarification from the MDD.

8. Approval Notification

• Issuance of Registration Certificate: If the application is approved, the MDD will issue a registration certificate for the device.
• Registration Number: The device will be assigned a unique registration number, which must be included in all related documentation and labeling.

9. Post-Market Surveillance

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

10. Renewal of Registration

• Monitor Registration Validity: Class D device registrations are typically valid for five years. Prepare for renewal by updating any necessary documentation and resubmitting as required.

Summary of Key Steps

1. Determine Device Classification: Confirm the device is Class D.
2. Pre-Application Preparations: Understand regulations and establish a 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. Submit Application: Submit the application and documentation to the MDD.
6. Payment of Fees: Pay the required application fees.
7. Review Process by MDD: Undergo the initial and detailed evaluation by the MDD.
8. Approval Notification: Receive the registration certificate and registration number.
9. Post-Market Surveillance: Implement PMS and reporting procedures.
10. Renewal of Registration: Prepare for renewal every five years.

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

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