The cost and time required to register Class II in vitro diagnostic (IVD) medical devices in Hong Kong under the Medical Device Administrative Control System (MDACS) can vary based on several factors. Here’s a general overview of the expected costs and timelines involved in the registration process:

Cost of Registration

1. Application Fee:

   • The registration fee for Class II medical devices is typically in the range of HKD 20,000 to HKD 30,000. However, the exact fee can vary based on the specifics of the device and the complexity of the application.
   • It’s important to check the MDACS website for the most current fee schedule, as fees can change and there may be additional costs for specific services.

2. Additional Costs:

   • Consulting Fees: If you choose to engage regulatory affairs consultants or legal advisors to assist with the application process, their fees will add to the overall cost.
   • Documentation Preparation: Costs associated with preparing necessary documentation, conducting clinical studies, and any translation services required if documents are not in English or Chinese.
   • Quality Management System (QMS) Certification: If your manufacturing facility needs to obtain or update QMS certifications (like ISO 13485), this can incur additional costs.

Time Required for Registration

1. Preparation Time:

   • The time required to prepare the necessary documentation can vary widely based on the complexity of the device and the thoroughness of your preparations. This may take anywhere from a few weeks to several months.

2. Review Process:

   • Once the application is submitted, the review and evaluation process by the Hong Kong Department of Health typically takes approximately 60 to 90 days. This duration can vary depending on:
     • The completeness of the application.
     • The need for any additional information or clarification requested by the regulatory authority.
     • The workload of the Department of Health at the time of submission.

3. Total Timeline:

   • Considering both the preparation and review phases, the entire process from initiation to receiving the registration certificate may take anywhere from 3 to 6 months or longer, depending on the factors mentioned above.

Summary

• Cost: Expect application fees around HKD 20,000 to HKD 30,000, plus potential additional costs for consulting and documentation preparation.
• Time: The total time from preparation to approval is generally 3 to 6 months, including both document preparation and the review process by the Department of Health.

Recommendations

• Plan Ahead: To ensure a smooth registration process, plan your timeline accordingly and start preparing documentation as early as possible.
• Stay Updated: Regularly check the MDACS website for updates on fees and guidelines, as regulatory requirements can change.

By considering these factors, you can better prepare for the registration of Class II IVDs in Hong Kong.