The cost and time required for Class I IVD medical device registration under Hong Kong’s Medical Device Administrative Control System (MDACS) can vary based on the specifics of the device and the completeness of the application. Here’s an overview:

Cost of Class I IVD Registration

1. Application Fees:

   • For Class I IVD devices, there is typically a minimal or no application fee due to their low-risk classification. However, the exact fee structure is set by the Medical Device Division (MDD), so it’s best to verify with the MDD for any updates or changes.

2. Additional Costs:

   • Preparation of Technical Documentation: Costs may arise from preparing the required documentation, particularly if you engage third-party consultants or testing services.
   • Quality Management System (QMS) Certification: While not mandatory for Class I devices, if you pursue ISO 13485 certification to enhance your application, this could add to your costs.
   • Local Authorized Representative: For foreign manufacturers, appointing an authorized representative in Hong Kong may incur additional fees, which depend on the representative’s services and rates.

Time Required for Class I IVD Registration

1. Application Preparation Time:

   • Preparing the application can take anywhere from a few weeks to several months, depending on how quickly the required documents (such as technical files, risk assessments, and labeling) are prepared.
   • If the device has prior approvals (like CE marking or FDA clearance), it may be easier and quicker to compile the necessary documentation.

2. Review Time by MDD:

   • For Class I IVD devices, which are low-risk, the review process is generally faster than for higher-risk classifications.
   • On average, MDD review and approval might take 1–3 months, but this can vary depending on the volume of applications and the completeness of the submission. If additional information or clarification is requested by the MDD, this could extend the timeline.

3. Post-Approval Listing Time:

   • Once approved, the device will be listed on the MDACS database, which should occur shortly after the MDD’s approval decision.

Summary of Cost and Time Estimates

• Cost: Minimal to no application fee, but other preparation costs can vary.
• Time: Total registration time can range from 2–6 months, including application preparation, submission, and MDD review.

While MDACS registration for Class I IVD devices is not mandatory, completing it can help improve the device’s credibility and acceptance in the Hong Kong market. For the most accurate information on fees and expected review times, reaching out to the MDD directly is recommended.