Navigating the Medical Device Regulatory Landscape in Hong Kong

Understanding Hong Kong's Medical Device Regulation: What We've Learned

From our perspective, the way medical devices are regulated in Hong Kong currently operates under a voluntary system known as the Medical Device Administrative Control System (MDACS). The Department of Health set this up, and its core purpose, as we understand it, is to protect public health by making sure medical devices are safe, high-quality, and work as they should. It's built on principles recommended by the International Medical Device Regulators Forum (IMDRF), which is a global benchmark.

While the system is voluntary, it's worth noting that the Hospital Authority, a major buyer of medical devices for public hospitals, significantly prefers products listed under MDACS. In our experience, this often makes listing a commercial must-have for many suppliers aiming to succeed in this market.

Device Classification: Our Understanding of the Risks

When it comes to MDACS, medical devices are grouped based on how much risk they might pose to patients and users. This risk-based approach, from what we've seen, really shapes the level of regulatory checks they'll need.

General Medical Devices:

Class I (Low risk): These are devices with minimal risk. Think of simple, everyday items like tongue depressors, bandages, or walking aids.
Class II (Low to medium risk): These devices carry a bit more risk. Examples we commonly encounter include contact lenses, hearing aids, and surgical scalpels.
Class III (Medium to high risk): These are higher-risk devices. This category includes more complex items like ventilators, hip implants, and diagnostic ultrasound equipment.
Class IV (High risk): These are the most critical devices, where a malfunction could have very serious consequences. Our experience shows this class includes vital devices such as pacemakers, heart valves, and implantable defibrillators.

In-Vitro Diagnostic (IVD) Medical Devices:

Class A (Low risk): These are usually straightforward lab materials, like common reagents or general culture media.
Class B (Moderate risk): These include tests for things like pregnancy or determining cholesterol levels.
Class C (High risk): This group covers more critical tests, such as devices for blood glucose self-testing or detecting infectious agents like chlamydia.
Class D (Highest risk): These are the most vital IVDs, often used for critical public health screenings. Based on our knowledge, this covers tests for detecting transmissible agents in blood donations (e.g., HIV, Hepatitis C) or for blood grouping.

The Listing Process: Steps We Guide Clients Through

For manufacturers and importers looking to supply Class II/B, III/C, or IV/D medical devices in Hong Kong, getting their products listed under the MDACS is, in our view, an absolutely essential step.

Here are the key steps involved, as we understand and typically assist with:

Appoint a Local Responsible Person (LRP): If a manufacturer is based outside of Hong Kong, they absolutely need to appoint an LRP. From our experience, the LRP must be a locally incorporated entity, and they serve as the primary point of contact with the Department of Health. This person or entity takes on the significant responsibility of handling the application, coordinating closely with the manufacturer, and fulfilling all ongoing responsibilities after the product is on the market.
Prepare the Application Dossier: This involves putting together a comprehensive technical dossier. We've found this includes the application form, solid evidence of a certified Quality Management System (like ISO 13485, which demonstrates robust quality control), detailed information about the device itself, and technical documentation that clearly shows it meets the "Essential Principles of Safety and Performance." According to our experience, having marketing approval from at least one recognized regulatory authority (like the US FDA, EU Notified Bodies, or Health Canada) can significantly streamline and accelerate the review process.
Submission and Review: The LRP submits the application to the Medical Device Division (MDD). The MDD then conducts a thorough review of the dossier. If they find anything missing or needing clarification, the MDD will issue a request for additional information. From our perspective, responding to these queries promptly and comprehensively is crucial to avoid delays.
Listing and Post-Market Responsibilities: Once the review is successful, the device gets added to the MDACS list, and a unique listing number is issued. It's important to remember that the LRP's responsibilities continue well after the product is listed. This includes setting up a system for traceability, promptly reporting any adverse incidents, and managing any necessary recalls or field safety corrective actions, as we've seen happen in the market.

The Importance of GN-02: Our Key Reference

The "Guidance Notes for Listing Class II/III/IV Medical Devices" (GN-02) is, from our vantage point, the definitive guide for this entire process. It provides very granular detail on application requirements, the various conformity assessment pathways (including those for devices with and without prior reference country approval), precise documentation needs, labeling specifics, and the exact format for the Essential Principles Conformity Checklist. In our professional opinion, a thorough understanding of GN-02 isn't just helpful; it's absolutely critical for a successful application.

Future Developments: What We Anticipate

The Hong Kong government is actively working towards establishing a more comprehensive and, eventually, mandatory legislative framework for medical devices. What we understand is that a key part of this strategy is the establishment of the Hong Kong Centre for Medical Products Regulation (CMPR). The ultimate goal is to move away from solely relying on reference country approvals towards a "primary evaluation" approach for new and innovative medical technologies. From our insights, the current voluntary MDACS is an important transitional phase, allowing the industry to align with these proposed regulatory requirements before they become mandatory.

Do you have any specific devices or classifications in mind that we could discuss further based on these procedures?

Important Disclaimer

The information provided in this article is for general informational and educational purposes only and should not be considered as professional, legal, or regulatory advice. While we strive to keep the information accurate and up-to-date, pharmaceutical regulations and requirements may change frequently. Always consult with qualified regulatory professionals, legal advisors, or relevant authorities for specific guidance related to your situation. ElendiLabs Limited disclaims any liability for decisions made based on this information.

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