Additional Medical Device Labelling Requirements in Hong Kong: Understanding TR-005

Clarity and Compliance: Additional Medical Device Labelling in Hong Kong – Our Insights

From our perspective, clear and accurate labelling is super important for making sure medical devices are used safely and correctly. While the Essential Principles of Safety and Performance of Medical Devices (which TR-004 covers) give us a general idea of what information manufacturers should provide, Hong Kong's Medical Device Administrative Control System (MDACS) goes a step further with Additional Medical Device Labelling Requirements in Technical Reference TR-005. To our understanding, this document lays out very specific rules to ensure that users, patients, and even healthcare professionals in Hong Kong get all the necessary information in a way that's easy to read and understand. This is key for medical device compliance Hong Kong.

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What are the General Principles of Labelling? Simple Rules for Clear Information

TR-005 doesn't just jump into the extra rules; it also reminds us about the basic principles of good labelling. It emphasizes that information should always:

• Be communicated clearly and without any confusion.
• Show up either directly on the device, on its packaging (or as a little paper insert inside), or in the instructions for use (IFU).
• Be right for that particular device, what it's meant to do, and how much the person using it (or who is supposed to use it) knows and is trained.
• And here's a big one for Hong Kong: for critical information, it absolutely must be available in both English and Chinese. This helps ensure widespread medical device accessibility Hong Kong.

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Specific Extra Labelling Rules for Hong Kong: What's Unique Here?

Beyond just following international best practices, TR-005 outlines very specific information that must be on the labels for medical devices sold in Hong Kong. What are these unique Hong Kong medical device labelling requirements? Let's take a look:

1. MDACS Listing Number (HKMD No.): Your Device's Official ID

   • For any device that's been officially listed under MDACS, that unique HKMD number has to be clearly shown on the outer packaging of every single device or sales unit.
   • Why is this number important? To our understanding, it acts like a special ID badge, confirming that the device has gone through the official MDACS listing process. This helps with medical device traceability Hong Kong.

2. Local Responsible Person (LRP) Information: Your Local Contact

   • The contact details for the Local Responsible Person (LRP) are absolutely mandatory. This includes the LRP's full name, their address right here in Hong Kong, and their contact telephone/fax numbers.
   • Crucially, this information must be provided in both English and Chinese. Sometimes, even the type of font (like a specific Chinese font such as Kaishu) and how tall the characters are (e.g., no less than 2mm high) might be specified to make sure everyone can read it easily.
   • The LRP information should be either on the outer packaging or on a document that comes with the device. According to our experience, this ensures there's a clear local point of contact for any questions, problems (adverse events), or recalls.

3. Language Requirements for Instructions for Use (IFU): Double the Language, Double the Clarity

   • The IFU, any user manuals, and other super important instructions that come with the device must be in both Chinese and English. This is a non-negotiable for Hong Kong medical device import.
   • For other labelling information, like maintenance manuals, it's generally preferred to have both languages, but at least one of these two languages is acceptable.
   • What if your IFU is only in one language? To our understanding, you might need to include an extra statement telling the user that the instructions are only available in English or Chinese.

4. Format and Presentation: Making It Look Right

   • TR-005 might even specify particular ways for showing the listing number and LRP information, sometimes asking for a printed rectangular box around it.
   • The emphasis is always on consistent font size and ensuring everything is very readable.

5. Information for Traceability and Identification: Knowing Your Device

   • You need enough details so the user can easily figure out what the device is. If it's not obvious, you also need to clearly state its intended purpose and who it's for (e.g., pediatric patients, adults).
   • For devices where it matters (like sterile items, single-use disposables, or chemical reagents), you need a clear expiry date (year and month).
   • For reusable devices, you must provide information on how to properly clean, disinfect, package, and re-sterilize them, along with any limits on how many times they can be reused.

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The LRP's Vital Role in Labelling Compliance: Our Practical Experience

The Local Responsible Person (LRP), in our view, plays an absolutely critical role in making sure all medical devices sold in Hong Kong meet these extra labelling requirements. The LRP must put systems in place to ensure that whenever listed devices are supplied (whether they're given away for free or sold), a document containing this "Special Listing Information" (including the HKMD No. and LRP details) is given to the end-users or the facilities using them. According to our experience, this often means working very closely with manufacturers, importers, distributors, and even retailers.

What if you need to update your labels or instructions? Any changes or updates to the Instructions for Use (IFU) or other device labelling require an amendment application to be submitted to the MDD. The details for this are found in GN-10 (Guidance Notes on Changes for Listed Medical Devices), which is a separate but equally important document we often refer to.

By carefully following the specific rules in TR-005, manufacturers and LRPs significantly contribute to protecting consumers and staying compliant. From our perspective, this commitment is what truly helps foster a safe and transparent medical device market in Hong Kong.