Medical Device Adverse Event Reporting in Hong Kong: A Guide for LRPs

The Importance of Adverse Event Reporting in Hong Kong

The Medical Device Administrative Control System (MDACS) in Hong Kong places significant emphasis on post-market surveillance, with adverse event reporting being a cornerstone. The primary objective of the Adverse Event Reporting System, as detailed in guidance notes such as GN-03-E, is to improve the protection of public health and safety. This is achieved by collecting and disseminating information that can help reduce the likelihood of, or prevent the repetition of, adverse events associated with medical devices.

While the MDACS is currently an administrative system, the robust adverse event reporting mechanism ensures that potential risks are identified, investigated, and addressed, thereby safeguarding users and patients.

Who is Responsible for Reporting? The Local Responsible Person (LRP)

Under the MDACS, the Local Responsible Person (LRP) bears the primary responsibility for reporting and managing adverse events that occur in Hong Kong concerning their listed medical devices. This reinforces the LRP's crucial role as the key point of contact between the manufacturer, the Medical Device Division (MDD) of the Department of Health, and other stakeholders.

What Constitutes a Reportable Adverse Event?

A reportable adverse event generally refers to any incident involving a medical device that has led to, or might lead to, certain outcomes. While the precise definitions are detailed in official guidance, they typically include events that result in:

• Death of a patient, user, or other person.
• Serious injury to a patient, user, or other person.
• An event that, had it recurred, might have led to death or serious injury.

This also extends to situations where the LRP or manufacturer notes a significant change in trend or pattern of an issue that could potentially lead to serious harm, or when corrective actions are initiated to prevent such harm.

Reporting Timeframes

Timeliness is critical in adverse event reporting to ensure swift investigation and appropriate action. The MDACS sets specific timeframes for reporting these events to the MDD, which typically vary based on the severity and nature of the incident:

• Expedited reports (e.g., within 2 or 10 calendar days) are required for events leading to death or serious injury, or those representing a serious public health threat.
• Follow-up reports are necessary to provide additional information as the investigation progresses.
• Final reports are submitted upon the completion of the investigation, detailing findings and any corrective and preventive actions (CAPA) taken.

The Adverse Event Investigation Process

Upon receiving an adverse event report, the MDD may require the LRP to conduct a thorough investigation into the incident. The LRP is responsible for this investigation, often in conjunction with, or with assistance from, the device manufacturer or other relevant parties. The investigation aims to determine the cause of the event, identify contributing factors, and implement necessary corrective actions to prevent recurrence. The LRP must submit a detailed report of their findings and recommendations to the MDD. The MDD also reserves the right to conduct its own independent investigation if deemed necessary.

Importance of Comprehensive Documentation and Post-Market Surveillance

Effective adverse event reporting relies on robust post-market surveillance systems maintained by manufacturers and LRPs. This includes:

• Establishing documented procedures for identifying, evaluating, and reporting adverse events.
• Maintaining comprehensive records of complaints, investigations, and corrective actions.
• Ensuring traceability of devices to facilitate effective recalls if necessary.

Staying informed about the latest guidance notes and regulatory updates issued by the MDD is essential for continued compliance and contributes significantly to the overall safety and quality of medical devices in the Hong Kong market.