The time cycle for applying for B-class medical device registration under the Medical Device Administrative Control System (MDACS) in Hong Kong can vary based on several factors, including the complexity of the device, the completeness of the application, and the responsiveness of the applicant. Here’s a general overview of the timeline and the steps involved in the review process:

Time Cycle for B-Class Medical Device MDACS Registration

1. Preparation Phase:

   • Duration: This phase can take anywhere from 1 to 6 months, depending on the complexity of the device and how quickly you can gather the necessary documentation.
   • Activities: Preparing the technical documentation, conducting risk assessments, and compiling labeling and instructions for use (IFU).

2. Application Submission:

   • Once all documents are ready, the application is submitted to the Medical Device Control Office (MDCO).

3. Review Phase:

   • Duration: The review process typically takes about 2 to 3 months, but this can vary. Factors that can affect the timeline include:
     • The number of applications being processed by the MDCO at the time.
     • The completeness of the submitted application. If the MDCO finds missing information, they may request additional details, extending the review time.
   • Activities: During this phase, the MDCO evaluates the application to ensure compliance with regulatory requirements.

4. Post-Review and Approval:

   • Duration: If approved, you will receive your registration certificate. If additional information is needed, this can lead to further delays.
   • Activities: The MDCO may issue a registration certificate once the application is approved, allowing the device to be marketed in Hong Kong.

Steps in the Review Process

1. Initial Application Screening:

   • Purpose: To verify that all required documents are included in the submission.
   • Outcome: If documents are missing or incomplete, the application may be returned to the applicant for correction.

2. Technical Evaluation:

   • Purpose: The MDCO assesses the technical documentation to ensure the device meets the Essential Principles of Safety and Performance and complies with applicable standards (e.g., ISO 13485, ISO 14971).
   • Outcome: The evaluation will identify any concerns regarding safety, efficacy, or quality.

3. Risk Assessment Review:

   • Purpose: To review the risk management process and evaluate the identified risks and their mitigations.
   • Outcome: Confirmation that the device's risks have been appropriately managed according to established guidelines.

4. Clinical Data Review (if applicable):

   • Purpose: To assess any clinical data provided in the application, ensuring it supports the device's safety and performance claims.
   • Outcome: An evaluation of the adequacy of clinical evidence presented.

5. Labeling and IFU Evaluation:

   • Purpose: To ensure that labeling and instructions for use are clear, comprehensive, and compliant with regulatory requirements.
   • Outcome: Feedback on any required changes or improvements to the labeling or IFU.

6. Final Decision:

   • Purpose: The MDCO makes a final decision based on the evaluations conducted during the review process.
   • Outcome: Either approval of the registration with issuance of a certificate or request for additional information or modifications.

7. Notification of Results:

   • Purpose: To communicate the outcome of the review to the applicant.
   • Outcome: Notification of approval or further requirements needed for compliance.

Summary of Time Cycle and Review Steps

• Total Time: The overall cycle for B-class medical device registration can range from 3 to 9 months, depending on preparation time, application completeness, and MDCO review duration.
• Review Steps:
  1. Initial Application Screening
  2. Technical Evaluation
  3. Risk Assessment Review
  4. Clinical Data Review (if applicable)
  5. Labeling and IFU Evaluation
  6. Final Decision
  7. Notification of Results

Being well-prepared and ensuring all documentation is complete and compliant can help expedite the registration process.

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