The procedures for applying for Class D medical device registration under the Hong Kong Medical Device Administrative Control System (MDACS) involve several organized steps to ensure that the device meets safety, efficacy, and regulatory compliance. Here’s a detailed breakdown of the procedures:

Detailed Procedures for Class D Medical Device Registration

1. Device Classification Verification

• Confirm Classification: Determine that the medical device qualifies as Class D, which indicates it is high-risk and requires rigorous evaluation. Refer to the Hong Kong guidelines for classification criteria.

2. Preparation of Documentation

• Technical Documentation: Compile comprehensive technical documents, which include:
  • Device Description: Details about the device, including specifications and intended use.
  • Manufacturing Information: Description of the manufacturing process and quality control measures.
  • Clinical Evaluation Report (CER): Documentation of clinical evidence supporting the device’s safety and effectiveness.
  • Risk Management Documentation: Evidence that complies with ISO 14971, addressing risk analysis and mitigation strategies.
• Labeling Requirements: Prepare product labeling and Instructions for Use (IFU) that comply with ISO 15223. Ensure that labeling includes necessary symbols and safety information.

3. Application Form Completion

• Fill Out Application Form (MD-14): Complete the Application Form (MD-14) provided by the Hong Kong Department of Health. This includes:
  • Information about the manufacturer.
  • Device details and classification.
  • Details of the Local Responsible Person (LRP) if applicable.

4. Submission of Application

• Submit Application: Submit the completed application form along with all supporting documents to the Medical Device Division (MDD) of the Hong Kong Department of Health.
  • Submission can often be done through an online portal or by mail.
• Verification of Completeness: Ensure all required documentation is included to facilitate a smooth review process.

5. Payment of Application Fees

• Fee Payment: Pay the application fee, which generally ranges from HKD 25,000 to HKD 50,000 for Class D devices. Check the latest fee structure for specifics.

6. Initial Review by MDD

• Completeness Check: The MDD will conduct an initial review to confirm that the application is complete and adheres to submission standards. This typically takes 2 to 4 weeks.

7. Detailed Evaluation

• In-Depth Review: The MDD will perform a thorough evaluation of the technical documentation, clinical data, and risk management files. This process usually takes 3 to 6 months.
• Queries and Clarifications: Be prepared to respond to any requests for additional information or clarification from the MDD during this evaluation phase.

8. Approval Notification

• Decision on Application: After the detailed evaluation, if the application is approved, the MDD will issue a registration certificate.
• Issuance of Registration Number: A unique registration number will be assigned to the device, which must be included in all relevant documentation and labeling.

9. Post-Market Surveillance (PMS)

• Implementation of PMS Plan: Develop and implement a post-market surveillance plan to monitor the device’s safety and effectiveness in the market.
• Adverse Event Reporting: Establish procedures for reporting any adverse events or incidents related to the device to the MDD.

10. Renewal of Registration

• Monitoring Registration Validity: Registrations for Class D medical devices are typically valid for five years. Prepare for renewal by updating any necessary documentation and resubmitting as required.

Summary of Key Procedures

1. Device Classification Verification: Confirm the device is Class D.
2. Preparation of Documentation: Compile technical documents and labeling materials.
3. Application Form Completion: Fill out the MD-14 application form.
4. Submission of Application: Submit the application and documentation to the MDD.
5. Payment of Application Fees: Pay the required fees.
6. Initial Review by MDD: Undergo completeness check by MDD.
7. Detailed Evaluation: Complete a thorough review 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.