The cost and time required to apply for Class D medical device registration under the Hong Kong Medical Device Administrative Control System (MDACS) depend on several factors, including the complexity of the application, the completeness of the documentation, and the review process conducted by the Medical Device Division (MDD). Below are the details:

1. Cost of Class D Medical Device Registration

The cost primarily involves the application fee that must be paid to the MDD for processing the registration. The fee for Class D devices is generally higher than for lower-class devices due to the higher risk associated with these products. The exact fee structure is as follows:

• Application Fee for Class D Medical Devices: Approximately HKD 25,000 to HKD 50,000 (or more), depending on specific factors such as additional documentation requirements, the complexity of the review process, and possible amendments during the review.

• • The fee is non-refundable, meaning it must be paid at the time of submission regardless of the outcome of the review.

Additional potential costs may include:

• Appointment of a Local Responsible Person (LRP): If the manufacturer is based outside of Hong Kong, you may need to pay a fee for the services of a Local Responsible Person (LRP), who will handle the application process on your behalf. Fees for an LRP vary depending on the service provider but could range from HKD 10,000 to HKD 50,000 or more annually.
• Document Translation Fees: If the documentation is not in English or Chinese, translation costs will be incurred for official documents (e.g., labeling, Instructions for Use).
• Post-Market Surveillance Costs: After the device is approved and listed, there are ongoing costs related to post-market surveillance, reporting, and compliance.

2. Time Required for Class D Medical Device Registration

The time required for the registration process varies depending on several factors, such as the completeness of the submission, the need for additional information, and the complexity of the device. On average, the timeline for Class D registration is:

• Initial Application Review:

  • The MDD typically begins the initial review of the application within 1-3 months after submission. During this time, the MDD checks the completeness of the submission and may request additional information or clarification.

• Total Review Time:

  • The total time for the complete review and approval process can take between 6 to 12 months or more, depending on the complexity of the device, the quality of the submission, and the need for additional documentation or clinical data.
  • For high-risk Class D devices, which may require more in-depth review (e.g., clinical trials or extensive risk analysis), the review time may extend beyond 12 months.

Factors That May Affect Time and Cost:

1. Quality and Completeness of the Application: Delays can occur if the submitted documentation is incomplete or requires clarification. Ensuring all required documents (e.g., clinical data, risk analysis reports, and regulatory approvals) are correctly compiled and submitted will help avoid delays.

2. Device Complexity: More complex or novel Class D devices may require a longer review period. If the device involves new technologies or higher risks, the MDD may take more time to thoroughly assess the clinical data and safety profile.

3. Requests for Additional Information: If the MDD requests further clarification, additional clinical data, or further testing results, the timeline may be extended.

4. Post-Market Obligations: After approval, you must comply with post-market surveillance requirements, which may incur additional time and costs related to adverse event reporting and ongoing compliance monitoring.

Summary of Costs and Time:

• Cost:
  • Application Fee: Around HKD 25,000 to HKD 50,000 (non-refundable).
  • Additional costs for the Local Responsible Person (LRP), translation services, and post-market obligations.
• Time:
  • Initial review: 1-3 months.
  • Total process time: Typically 6 to 12 months or more, depending on the complexity of the device and the submission quality.

By preparing a comprehensive and complete application with all required documentation, you can help streamline the process and reduce potential delays.