Periodic updates for MDACS (Medical Device Administrative Control System) registration of Class IV in vitro diagnostic (IVD) medical devices in Hong Kong are essential to maintain compliance with regulatory requirements and ensure the continued safety and effectiveness of the devices. The process for periodic updates involves adhering to specific standards and following a structured approach. Here’s an overview of the standards and processes involved:

Standards for Periodic Updates

1. Medical Device Ordinance (Cap. 663):

   • This is the primary legislation that governs the registration and regulation of medical devices in Hong Kong. It establishes the legal framework for periodic updates, compliance, and reporting obligations.

2. ISO 13485:2016 - Quality Management Systems:

   • Compliance with this standard is essential for manufacturers to maintain a quality management system that includes processes for managing periodic updates, changes, and improvements.

3. ISO 14971:2019 - Application of Risk Management to Medical Devices:

   • This standard outlines the requirements for risk management throughout the device's lifecycle, including the assessment of risks related to changes and updates.

4. MDCO Guidance Notes:

   • The Medical Device Control Office provides guidance notes that detail the requirements and procedures for periodic updates, including information on the types of changes that must be reported.

Processes for Periodic Updates

1. Review of Current Registration:

   • Conduct a thorough review of the current registration details, including the scope of the registration, labeling, indications for use, and performance data.

2. Identify Changes:

   • Identify any changes that may have occurred since the last registration or update. This can include:
     • Modifications to device design or components.
     • Changes in manufacturing processes.
     • Updates to clinical data or performance specifications.
     • Any alterations in intended use or labeling.

3. Conduct Risk Assessments:

   • Evaluate the potential impact of the identified changes on the safety and effectiveness of the device.
   • Conduct risk assessments in accordance with ISO 14971 to ensure that any new risks are identified and mitigated.

4. Prepare Updated Documentation:

   • Gather and prepare updated technical documentation, which may include:
     • Revised device description and specifications.
     • Updated clinical evaluation data.
     • Modifications to labeling and instructions for use.
     • Quality management system documentation reflecting any changes.

5. Submission of Update Application:

   • Submit the application for periodic update to the MDCO, including all required documentation and any relevant fees.
   • Ensure that the submission is complete and complies with the guidance notes provided by the MDCO.

6. MDCO Review and Feedback:

   • Upon submission, the MDCO will review the updates to ensure they comply with regulatory requirements.
   • Be prepared to respond to any queries or requests for additional information from the MDCO during the review process.

7. Approval and Implementation:

   • Once the MDCO approves the periodic update, implement the changes across all relevant areas, including production, labeling, and marketing.
   • Update internal records to reflect the changes made to the registration.

8. Ongoing Monitoring:

   • Continue to monitor the device's performance and safety, maintaining post-market surveillance activities.
   • Stay informed about any further regulatory changes or requirements that may necessitate additional updates in the future.

Summary

In summary, the periodic update of MDACS registration for Class IV in vitro diagnostic medical devices involves adhering to relevant standards and following a structured process to ensure compliance and safety. By systematically reviewing, identifying changes, conducting risk assessments, and submitting updates, manufacturers can maintain their registration and ensure that their devices meet ongoing regulatory requirements.

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