The process for Class D medical device registration under the Hong Kong Medical Device Administrative Control System (MDACS) involves several structured steps. Class D devices are classified as high-risk medical devices, and the registration process is designed to ensure their safety, efficacy, and compliance with regulatory standards. Here’s an outline of the key steps involved in the registration process:

Step-by-Step Process for Class D Medical Device Registration

1. Pre-Application Preparations

• Understand Regulatory Framework: Familiarize yourself with the Medical Device Ordinance (Cap. 594) and relevant guidelines from the Hong Kong Department of Health.
• Determine Classification: Confirm that your device meets the criteria for Class D classification based on its intended use and risk level.
• Quality Management System (QMS): Ensure that your organization has implemented a QMS compliant with ISO 13485.

2. Gather Required Documentation

• Technical Documentation: Compile comprehensive technical documentation, including:
  • Product description and specifications.
  • Design and manufacturing information.
  • Risk management documentation (ISO 14971).
  • Clinical evaluation report (CER) based on available clinical data.
• Labeling and Instructions for Use (IFU): Prepare labeling materials that comply with ISO 15223, including symbols and necessary information for users.

3. Application Submission

• Complete Application Form: Fill out the Application Form (MD-14), which requires details about the device, manufacturer, and Local Responsible Person (LRP) if applicable.
• Submit Application: Submit the completed application form along with the required technical documentation and any supporting documents to the Medical Device Division (MDD) of the Hong Kong Department of Health. This can typically be done via an online portal or by mail.

4. Payment of Fees

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

5. Review by Regulatory Authorities

• Initial Review: The MDD will conduct an initial review to ensure that all necessary documents are submitted and meet the required standards.
• Detailed Evaluation: A more detailed evaluation will follow, where the MDD assesses the technical documentation, clinical data, and compliance with applicable standards.
• Requests for Additional Information: Be prepared to respond promptly to any queries or requests for additional information from the MDD during their evaluation process.

6. Approval and Registration

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

7. Post-Market Obligations

• Post-Market Surveillance: Implement a post-market surveillance plan to monitor the device’s safety and effectiveness once it is on the market.
• Adverse Event Reporting: Establish a system for reporting any adverse events or incidents related to the device to the MDD as required.

8. Renewal of Registration

• Monitor Registration Validity: Class D device registrations are typically valid for five years. Monitor the expiration date and prepare for the renewal process well in advance.
• Submit Renewal Application: Renew the registration by submitting an updated application with any required documents and fees before the registration expires.

Summary

In summary, the process for Class D medical device registration under the Hong Kong MDACS consists of the following steps:

1. Pre-Application Preparations: Understand regulations and confirm device classification.
2. Gather Required Documentation: Compile technical documentation and labeling materials.
3. Application Submission: Complete and submit the application form along with supporting documents.
4. Payment of Fees: Pay the required application fees.
5. Review by Regulatory Authorities: Undergo initial and detailed evaluations by the MDD.
6. Approval and Registration: Receive approval and registration for the device.
7. Post-Market Obligations: Implement post-market surveillance and reporting mechanisms.
8. Renewal of Registration: Monitor and prepare for the renewal process as needed.

Following these steps will help ensure a successful registration process for Class D medical devices in Hong Kong.

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