The time frame for applying for Class C medical device registration under the Hong Kong Medical Device Administrative Control System (MDACS) can vary depending on the complexity of the device, the completeness of the application, and the response time to any additional information requests by the Medical Device Control Office (MDCO). Generally, the registration process can take anywhere from 6 to 12 months, although it may take longer if issues arise during the review.

Stages of the Review Process and Time Frame

Here’s a breakdown of the key stages involved in the review process and the estimated time frame at each stage:

1. Pre-Submission Stage: Preparation of Application

Time Frame: Varies depending on the readiness of documentation, usually 1-3 months.

Key Activities:

• Classification Confirmation: Confirm that the device falls under Class C.
• Document Compilation: Prepare all the necessary technical documentation, including device description, risk management report, clinical evidence, labeling, and quality management system (QMS) certificates (e.g., ISO 13485).
• Local Authorized Representative (LAR): Appoint an LAR if the manufacturer is outside Hong Kong.
• Consultation with MDCO (Optional): You may consult with MDCO to clarify requirements and ensure that the submission is complete.

2. Submission Stage: Application Submission to MDCO

Time Frame: 1-2 weeks for submission process (depending on the mode of submission).

Key Activities:

• Application Form: Complete the Class C medical device registration application form and submit it to MDCO.
• Documentation Submission: Submit all the required documents, including the technical file, risk management report, clinical evidence, and ISO 13485 certification.
• Fee Payment: Pay the applicable registration fee.

3. Preliminary Review by MDCO

Time Frame: 1-2 months (depending on the backlog and complexity of the device).

Key Activities:

• Initial Screening: MDCO conducts a preliminary review to check the completeness of the application and documentation.
• Request for Additional Information (if needed): If there are any missing or unclear elements in the application, MDCO will request additional information or clarification. This could include clinical data, risk management information, or labeling updates.

4. In-Depth Technical Review

Time Frame: 3-6 months, depending on the complexity of the device and the need for supplementary data.

Key Activities:

• Conformity Assessment: MDCO conducts a thorough technical review to ensure the device complies with the Essential Principles of Safety and Performance and international standards (e.g., ISO 13485, ISO 14971 for risk management, and relevant IEC standards).
• Clinical Evidence Review: If the device is novel or high-risk, MDCO will carefully evaluate the clinical evidence to ensure the device has been adequately tested and is safe and effective for its intended use.
• Risk Management: Review of the risk management documentation in accordance with ISO 14971 to ensure that all risks have been identified and mitigated.

5. Review of Post-Market Surveillance (PMS) Plan

Time Frame: Usually overlaps with the technical review, 1-2 months.

Key Activities:

• PMS Plan Evaluation: MDCO reviews the post-market surveillance plan to ensure that there are mechanisms in place to monitor the safety and effectiveness of the device once it is on the market.
• Adverse Event Reporting Mechanism: MDCO checks that there is a clear and efficient process for reporting adverse events related to the device.

6. Decision-Making and Issuance of Registration

Time Frame: 1-2 months after the completion of the technical review.

Key Activities:

• Final Decision: Once MDCO is satisfied that all safety and performance requirements have been met, a decision is made to either approve or reject the application.
• Issuance of Registration: If approved, the device will be officially registered, and a certificate of registration will be issued.
• Notification of Outcome: MDCO will notify the applicant (or LAR) about the approval or rejection, with reasons provided for any rejection.

7. Post-Registration Activities

• Post-Market Surveillance (PMS): After registration, you must implement the post-market surveillance plan and report any adverse events to MDCO as required.
• Renewal: The registration is valid for 5 years, after which renewal must be applied for before expiration.

Total Estimated Time Frame for Class C Registration: 6 to 12 months (may vary based on the device complexity and response times).

Key Factors that Affect the Time Frame

• Completeness of Application: Submitting a complete and accurate application with all required documents and clinical data can speed up the review process. Missing documents or incomplete information will result in delays due to requests for additional information.
• Device Complexity: Devices that are more complex, novel, or high-risk (e.g., implantable devices) may require a more in-depth review, including detailed analysis of clinical data and risk management measures.
• MDCO Backlog: The number of applications being processed by MDCO at the time of submission can also affect the time frame.
• Additional Information Requests: If MDCO requests additional information, the applicant’s ability to respond quickly and comprehensively will affect the overall processing time.