The costs and time involved in obtaining MDACS (Medical Device Administrative Control System) registration for Class IV in vitro diagnostic (IVD) medical devices in Hong Kong can vary based on several factors. Here’s an overview of what to expect:

Costs

1. Application Fees:

   • The specific application fees for MDACS registration can vary depending on the type of device and the complexity of the application. As of the latest information, the fee structure for Class IV devices is generally higher than for lower-risk classifications.
   • You can check the exact fees on the Medical Device Control Office (MDCO) website or contact them directly for the most current fee schedule.

2. Consultation and Professional Fees:

   • If you engage regulatory consultants or legal professionals to assist with the application process, these fees can add to the total cost. Consulting fees can vary widely based on the consultant's expertise and the complexity of your device.

3. Documentation Preparation Costs:

   • Costs associated with preparing technical documentation, clinical data, and other required materials can also be significant, especially if you need to conduct clinical studies or hire external testing services.

4. Quality Management System (QMS) Implementation:

   • If your organization does not already have an ISO 13485-compliant QMS in place, costs for establishing and maintaining such a system should be considered.

Time Involved

1. Preparation Time:

   • Document Compilation: Gathering all necessary documentation can take anywhere from several weeks to months, depending on the complexity of the device and the availability of data.
   • Quality Management System: If you need to implement or update your QMS, this process can also take additional time.

2. Review and Evaluation:

   • Once the application is submitted, the MDCO typically takes around 60 to 90 days for the initial review and evaluation. This timeframe can vary based on the volume of applications they are processing and the complexity of your submission.

3. Response to Queries:

   • If the MDCO requires additional information or clarifications, the time taken to respond and resubmit documents can extend the overall timeline. The length of this additional review will depend on the responsiveness of the applicant and the complexity of the issues raised.

4. Overall Timeline:

   • From the start of document preparation to receiving final approval, the entire process can take several months to over a year, depending on the factors mentioned above.

Summary

• Costs: Application fees, consultation fees, documentation preparation costs, and potential QMS implementation costs.
• Time: Document preparation (weeks to months), review and evaluation (60 to 90 days), plus additional time if queries arise, leading to an overall process that can last several months to over a year.

Useful Tips

• To manage costs and time effectively, start preparing your documentation as early as possible and ensure compliance with all regulatory requirements.
• Consult the MDCO website or contact them directly for the latest information on fees and processing times.

By understanding these costs and timeframes, you can better plan for the MDACS registration process for your Class IV IVD device.

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