The cost and time required for B-class medical device registration under the Medical Device Administrative Control System (MDACS) in Hong Kong can vary based on several factors, including the complexity of the device, the completeness of the application, and the specific regulatory requirements. Here’s a general overview:

1. Registration Costs

• Application Fees:
  • The registration fees for B-class medical devices are usually in the range of HKD 10,000 to HKD 30,000 (approximately USD 1,300 to USD 3,800). The exact fee can vary, so it's best to consult the Medical Device Control Office (MDCO) or refer to their official fee schedule for the most current rates.
• Additional Costs:
  • Additional costs may arise for:
    • Consultancy Services: If you hire regulatory affairs consultants to assist with the application process, their fees can vary widely based on the services provided.
    • Quality Management System Certification: If your facility needs ISO 13485 certification or similar, this can also incur costs.
    • Clinical Studies: If clinical data is required, conducting clinical trials can be expensive and time-consuming.

2. Timeframe for Registration

• Application Preparation:
  • Preparing the application and documentation can take anywhere from a few weeks to several months, depending on the complexity of the device and the availability of required data.
• MDCO Review Process:
  • The review process by the MDCO typically takes about 4 to 8 weeks, but this can vary based on the workload of the MDCO, the completeness of the application, and whether additional information is requested.
• Total Time Estimate:
  • Overall, from preparation to approval, the entire process may take 3 to 6 months, but it could be longer if additional data or clarifications are needed or if there are complications during the review process.

3. Considerations

• Preparation Quality: Ensuring that all documentation is thorough and complete can help reduce the time required for review and minimize the chances of needing to submit additional information.
• Regulatory Guidance: Consulting with regulatory experts can help streamline the process and ensure compliance with all requirements, potentially saving time in the long run.

Summary

The costs for B-class medical device registration under MDACS in Hong Kong generally range from HKD 10,000 to HKD 30,000, while the total time required can span from 3 to 6 months, depending on various factors. It's advisable to check with the MDCO for the most accurate and updated information regarding fees and timelines.