Regular updates for Class II in vitro diagnostic (IVD) medical device registration in Hong Kong under the Medical Device Administrative Control System (MDACS) involve adherence to specific standards and processes to ensure ongoing compliance and safety. Here’s an overview of the key standards and processes for managing these updates:

Standards

1. ISO 13485:2016 - Quality Management Systems

   • Maintain and update your Quality Management System (QMS) to reflect changes in regulations, manufacturing processes, or device specifications.

2. ISO 14971:2019 - Risk Management

   • Continuously assess and update the risk management process to address new risks or changes in the device’s risk profile. Ensure that risk evaluations are documented and reviewed regularly.

3. ISO 18113 - In Vitro Diagnostic Medical Devices - Information Supplied by the Manufacturer

   • Ensure that all labeling and Instructions for Use (IFU) are updated in compliance with the latest standards and regulatory requirements.

4. IEC 62304 - Medical Device Software

   • If applicable, update software development processes to comply with software life cycle standards, ensuring that any software changes are validated.

Processes for Regular Updates

1. Periodic Review

   • Conduct regular reviews of all documentation, including the QMS, risk management files, and technical documentation, to ensure they reflect the current state of the device and regulatory requirements.

2. Monitoring Regulatory Changes

   • Stay informed about changes in local and international regulations that may impact your device. This includes updates from MDACS, the Hong Kong Department of Health, and relevant international standards organizations.

3. Implementation of Changes

   • Develop a process for implementing necessary changes, which may include:
     • Updating technical documentation
     • Revising labeling and IFUs
     • Modifying manufacturing processes or quality control measures
     • Adjusting the risk management plan based on new information or post-market surveillance data.

4. Internal Audits

   • Conduct internal audits of the QMS to ensure compliance with updated standards and regulations. Identify areas for improvement and document any findings.

5. Training and Competence

   • Provide ongoing training for staff involved in device management, ensuring they are aware of updates in standards and regulatory requirements.

6. Documentation of Changes

   • Keep detailed records of all updates made, including the rationale for changes, who authorized them, and when they were implemented. This documentation is crucial for regulatory inspections and audits.

7. Submission of Amendments

   • If significant changes occur (e.g., changes in manufacturing processes, intended use, or risk profile), submit the necessary amendments to the MDACS as required. Follow their guidelines for reporting changes to registered devices.

8. Post-Market Surveillance Feedback

   • Utilize feedback from post-market surveillance activities to identify trends or issues that may necessitate updates to the device or its documentation.

Summary

Regular updates for Class II IVD registration in Hong Kong involve adhering to standards such as ISO 13485 and ISO 14971, conducting periodic reviews, monitoring regulatory changes, and implementing necessary updates in documentation and processes. Internal audits, training, and thorough documentation of changes are essential to ensure ongoing compliance and safety. For significant modifications, submit the required amendments to the MDACS to maintain regulatory status.

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