Hong Kong Medical Device Regulatory Update 2024

The Hong Kong government has been updating its regulatory framework for medical devices, with a number of key changes that seek to enhance safety, efficacy, and compliance.

Compulsory Procurement Registration

On June 21, 2023, the Hong Kong Department of Health (DOH) launched a policy requiring all medical equipment purchased by the DOH to be registered on the voluntary list under the Medical Device Administrative Control System (MDACS). The shift to 100% on the voluntary list for government procurement is a significant increase from the current 20%. This change was driven by an adverse event associated with a medical device – a mounted examination lamp that led to injuries similar to an unreported problem that occurred in the US. The incident demonstrated the dangers of using unregistered devices and prompted the authorities to limit purchases only to those devices that are registered and on the voluntary list.

This new approach to procurement is expected to encourage more device manufacturers to register their products if they want to supply the DOH. The DOH is the largest purchaser of medical equipment in Hong Kong into registering their products. This also sets the stage for anticipated future mandatory device registration.

Updates on Change Notifications in Medical Device Regulation

Further tightening the regulatory framework, on December 22, 2023, Hong Kong updated its guidelines (GN-10) regarding registered medical devices and change notifications. These changes require the local responsible person (LRP) to notify the Medical Device Division (MDD) within 12 weeks for major changes and 24 weeks for minor changes from the expected date of implementation. The rapid two-week notification process aims to maintain up-to-date records and ensure that all registered devices continue to meet the necessary safety and performance standards. Please note if a change notification is rejected, the existing device registration may become invalid.

Introduction of Technical Document TR – 007 for Software in Medical Devices

The Medical Device Department also released Technical Reference TR – 007, a new guidance document that delineates the categorization and regulatory expectations for Software in a Medical Device (SiMD) and Software as a Medical Device (SaMD). This document is part of Hong Kong’s efforts to adapt to the evolving landscape of medical technology, particularly the increasing use of software-driven devices. The guidelines specify that both SiMD and SaMD must adhere to the stringent requirements outlined in earlier technical references, including those for quality management systems and cybersecurity, reflecting global best practices such as ISO 27032 and ISO/IEC 27001.

Implications and Future Directions

These regulatory enhancements demonstrate Hong Kong’s commitment to aligning its medical device market with international standards and improving patient safety. For device manufacturers, these changes mean stricter compliance requirements and potentially higher costs associated with maintaining registrations and managing product changes. However, these regulations also promise more transparent pathways for marketing medical devices in Hong Kong.