Code of Practice for Local Responsible Persons (LRPs) in Hong Kong: A Guide to COP-01

The Pivotal Role of Local Responsible Persons (LRPs) in Hong Kong's MDACS: A Guide to COP-01 – Our Insights

From what we've observed, the Local Responsible Person (LRP) in Hong Kong's Medical Device Administrative Control System (MDACS) isn't just another role; they're a truly critical go-between. Their main job is to ensure accountability and compliance for medical devices sold in the market. The "Code of Practice for Local Responsible Persons" (COP-01) gives us a comprehensive roadmap on what LRPs actually do, their responsibilities, and their duties. To our understanding, COP-01 is the very backbone of how Hong Kong manages post-market vigilance and ensures regulatory adherence. This is absolutely key for medical device regulation Hong Kong.

According to our experience, the main goal of COP-01 is to set clear expectations for LRPs. This helps make sure they effectively handle both the "pre-market" (before selling) and "post-market" (after selling) aspects of listed medical devices, ultimately safeguarding public health.

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Who is a Local Responsible Person (LRP)? Let's Break It Down.

So, what exactly is an LRP? And do you always need one?

An LRP is essentially a company or a person legally registered in Hong Kong. They are officially appointed by a medical device manufacturer to act on their behalf within the MDACS framework. From our perspective, for foreign manufacturers who don't have a physical presence here, appointing an LRP is absolutely mandatory if they want to list their medical devices in Hong Kong. Even local manufacturers might choose to appoint an LRP, or they can take on this important role themselves. This ensures someone is always accountable locally for LRP Hong Kong requirements.

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Core Functions and Responsibilities of an LRP (as per COP-01): What Do They Actually Do?

According to our experience, COP-01 lays out a wide range of responsibilities for LRPs. It really highlights their role as the main point of contact, connecting the manufacturer, users, importers, distributors, the public, and the Medical Device Division (MDD) of the Department of Health. What are these key responsibilities? Let's go through them:

1. Application for Device Listing: Getting Your Device Approved

How does an LRP help get your device listed?

• They are the ones preparing and submitting applications for listing medical devices (specifically Class II, III, IV general medical devices and Class B, C, D IVDMDs) with the MDD.
• To our understanding, they ensure that all the submitted paperwork (like the Summary Technical Documentation (STED) as per TR-002, and the Essential Principles Conformity Checklist) clearly shows that your device meets the Essential Principles of Safety and Performance (TR-004) and additional labelling requirements (TR-005). This is a crucial step for medical device listing Hong Kong.

2. Maintaining Communication Channels: Keeping Everyone in the Loop

Why is communication so vital for an LRP?

• According to our experience, the LRP acts as the central hub for all communication regarding your listed devices, both before and after they're on the market. This means they'll be responding to questions from the public, healthcare professionals, and of course, the MDD.

3. Keeping of Records: Documentation is Key!

What kind of records does an LRP need to keep, and why is it so important?

• Transaction Records: They maintain complete and up-to-date records of all medical devices supplied in Hong Kong. This includes details of importers, distributors, and transaction data, ensuring everything is fully traceable. We've seen that these records must be readily available for inspection by the MDD, typically within a short timeframe (e.g., two weeks). This is a cornerstone of medical device compliance Hong Kong.
• Documentation: They also keep all your technical documentation, quality management system certifications, and all correspondence related to your listed devices.

4. Management of Product Recalls and Field Safety Corrective Actions: When Things Go Wrong

What happens if there's a safety issue with a device already on the market?

• To our understanding, LRPs must have strong procedures in place for managing product recalls and any "field safety notices" (like warnings or updates about device issues). This involves keeping a close watch, quickly informing the MDD, working with distributors/importers, and making sure affected devices are effectively retrieved or corrected. (You can find more details in GN-03). This is a critical part of post-market surveillance Hong Kong.

5. Handling of Reportable Adverse Incidents: Reporting Problems

What if a device causes harm or a serious problem?

• LRPs are responsible for setting up procedures to identify, evaluate, and report any adverse incidents concerning medical devices to the MDD. This includes thoroughly investigating incidents and submitting detailed reports. (Again, more details are in GN-03). This is key for adverse event reporting Hong Kong.

6. Complaints Handling: Listening to Feedback

How does an LRP deal with complaints from users or patients?

• They establish a systematic way to receive, document, investigate, and respond to any complaints related to the safety, quality, or performance of the listed medical devices.

7. Reporting Changes to Listed Devices: Keeping It Current

What if you make a change to your device after it's listed?

• LRPs must quickly tell the MDD about any changes to listed medical devices. They need to know the difference between "major" and "minor" changes and follow the procedures and timelines laid out in GN-10. According to our experience, this ensures that your device's listing remains valid and compliant.

8. Post-Market Surveillance (PMS): The Ongoing Watch

Is PMS a separate task?

• While not explicitly listed as a separate point in COP-01, to our understanding, PMS is an overarching responsibility that ties together many of the duties we've just discussed (like adverse event reporting, recalls, and complaints). It's all about continuously monitoring the safety and performance of devices once they're actually being used. This continuous monitoring is paramount for medical device compliance Hong Kong.

9. Maintenance and Service Arrangements (if applicable): Keeping Devices Running

What if the LRP is involved in device maintenance?

• If the LRP or others they designate provide maintenance or service for the devices, there must be documented procedures for these activities.

10. Temperature Requirements for IVDMDs (if applicable): Keeping IVDs Stable

Are there special storage rules for certain devices?

• For IVDMDs (In Vitro Diagnostic Medical Devices), LRPs must ensure there are documented procedures to maintain proper temperature conditions during storage and transportation.

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Importance for Regulatory Compliance: Why the LRP is Indispensable

From our perspective, the role of the LRP, as spelled out in COP-01, is absolutely fundamental to the integrity and effectiveness of the MDACS. By diligently carrying out these responsibilities, LRPs do more than just ensure medical devices comply with Hong Kong's regulatory framework; they play a vital part in protecting public health. What's our final piece of advice for manufacturers? You must carefully choose and empower your LRP to effectively manage these critical functions. A well-functioning LRP Hong Kong is your key to success in the Hong Kong medical device market.