Navigating Medical Device Regulations in Hong Kong: The MDACS Framework

Understanding the Medical Device Administrative Control System (MDACS) in Hong Kong

Hong Kong currently operates a unique regulatory landscape for medical devices, primarily through the Medical Device Administrative Control System (MDACS). Launched in November 2004 by the Department of Health (DH) and administered by its Medical Device Division (MDD), MDACS is a risk-based framework designed to ensure the safety, quality, and performance of medical devices supplied in the region. While it remains largely voluntary, the system aligns with international best practices, drawing principles from the International Medical Device Regulators Forum (IMDRF), formerly the Global Harmonization Task Force (GHTF). The MDACS is seen as a transitional arrangement, paving the way for a future statutory regulatory framework.

Device Classification and Risk Categories

Under MDACS, medical devices are classified into four risk-based categories:

• Class I: Low risk
• Class II: Low-moderate risk
• Class III: Moderate-high risk
• Class IV: High risk

Similarly, in vitro diagnostic (IVD) medical devices are categorized into Classes A, B, C, and D, from lowest to highest risk. This classification is crucial as the level of regulatory scrutiny increases with the device's risk profile. The MDD provides technical references (e.g., TR-003 for general medical devices and TR-006 for IVD devices) to guide manufacturers in determining the correct classification based on factors such as intended use, duration of contact with the body, invasiveness, and potential harm.

The Voluntary Listing System: A Key Component

A cornerstone of the MDACS is its voluntary listing system for medium- to high-risk medical devices (Class II, III, IV, and IVD Classes B, C, D). While not yet mandatory for all devices to be on the market, listing under MDACS offers significant advantages. Public hospitals and procurement bodies increasingly prefer, and in some cases, require MDACS-listed devices. This growing emphasis makes voluntary listing a de facto necessity for effective market access in Hong Kong. A listed device's approval is typically valid for five years, requiring timely renewal applications.

The Crucial Role of the Local Responsible Person (LRP)

For foreign manufacturers wishing to supply medical devices in Hong Kong, designating a Local Responsible Person (LRP) is a mandatory requirement. The LRP acts as a vital liaison between the manufacturer, importers, distributors, users, and the Medical Device Division. Their responsibilities are extensive, including:

• Managing applications for device listing.
• Maintaining communication channels.
• Handling complaints and managing traceability.
• Reporting changes to listed devices.
• Crucially, reporting adverse events to the MDD. The Adverse Event Reporting System is integral to MDACS, ensuring that incidents are reported and investigated to prevent recurrence and enhance public health protection.

The Listing Application Process

The general steps for obtaining a voluntary device listing involve:

1. Device Classification: Accurately determining the device's risk class.
2. LRP Appointment: Appointing a qualified LRP in Hong Kong.
3. Dossier Compilation: Preparing a comprehensive application dossier with supporting documents, often aligning with GHTF/IMDRF submission guidelines.
4. Submission and Review: The LRP submits the application to the MDD for assessment. The MDD may request additional information during this review.
5. Listing Approval: Upon favorable review, the MDD issues a listing number and adds the device to its online database.

Manufacturers with approvals from recognized "reference countries" (such as the US, EU, Canada, Japan, Australia, Korea, or mainland China) may benefit from an abridged or expedited review pathway.

Market Access and the Greater Bay Area (GBA)

MDACS listing is becoming increasingly important not only for the Hong Kong market but also as a gateway to the Guangdong-Hong Kong-Macao Greater Bay Area (GBA). Initiatives like the GBA Connected Scheme allow Hong Kong-registered medical devices to be utilized in approved healthcare institutions within the GBA, offering a significant expansion opportunity for manufacturers.

Future Outlook

While MDACS currently operates as an administrative control system, Hong Kong has been considering transitioning to a mandatory statutory framework for medical devices. This potential shift underscores the ongoing commitment to strengthening regulatory oversight and ensuring the highest standards of medical device safety and quality in the region. Manufacturers and LRPs are encouraged to stay updated with the latest guidelines and any legislative developments to ensure continued compliance and market access.