The timeline for Class III medical device MDACS registration in Hong Kong involves several stages, each with specific timeframes. Here's an overview of the process:

🗓️ 1. Application Submission

• Preparation Time: Applicants should allocate sufficient time to gather and prepare all necessary documentation, including technical files, clinical data, and quality management system certifications.

• Submission: Applications must be submitted through the Medical Device Information System (MDIS), the Department of Health's online platform. Paper-based submissions are no longer accepted as of 31 December 2024. mdd.gov.hk+2mdd.gov.hk+2mdd.gov.hk+2

📨 2. Acknowledgment of Receipt

• Timeline: Upon receiving an application, the Medical Device Division (MDD) will acknowledge receipt via email and assign an application number within 2 weeks. mdd.gov.hk+3mdd.gov.hk+3mdd.gov.hk+3

🔍 3. Application Review

• Standard Processing Time: The MDD typically requires approximately 12 weeks to review a Class III medical device application. This period may vary depending on the complexity of the device and the completeness of the submitted documentation.mdd.gov.hk

• Expedited Approval: Under certain conditions, such as the device being approved by two or more recognized regulatory agencies and having no reported deaths or serious injuries associated with it, an expedited approval process may be available. Applicants must respond to any issues within 2 weeks after receiving notice from the MDD. mdd.gov.hk

✅ 4. Decision Notification

• Outcome: After reviewing the application, the MDD will notify the applicant of the decision. If approved, a listing certificate will be issued.mdd.gov.hk+11mdd.gov.hk+11mdd.gov.hk+11

🔄 5. Post-Approval Compliance

• Ongoing Obligations: Once listed, the device is subject to post-market surveillance requirements, including reporting adverse events and implementing corrective actions as necessary.

🔁 6. Registration Renewal

• Validity Period: The registration for a Class III medical device is typically valid for 5 years.

• Renewal Process: Before the expiration date, a renewal application must be submitted, which may require updated documentation and information.

📌 Additional Considerations

• Authorized Representative: If the manufacturer is based outside Hong Kong, appointing a Local Responsible Person (LRP) in Hong Kong is mandatory. The LRP must be a legal entity or individual with a registered place of business in Hong Kong. mdd.gov.hk+5mdd.gov.hk+5mdd.gov.hk+5

• Documentation: Ensure all required documents are complete and accurate to avoid delays in the review process.

• Regulatory Updates: Stay informed about any changes to the MDACS regulations to ensure ongoing compliance.

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