Listing Procedures for Medical Device Importers in Hong Kong: A Guide to GN-07

Listing as a Medical Device Importer in Hong Kong: Our Insights from GN-07

From our perspective, Hong Kong's Medical Device Administrative Control System (MDACS) isn't just about listing medical devices themselves; it also keeps a close eye on all the players in the supply chain. For companies that bring medical devices into Hong Kong, the "Guidance Notes for Listing of Importers of Medical Devices" (GN-07) clearly lays out the steps and requirements for getting voluntarily listed under this system. While it's not compulsory right now, choosing to be listed, in our experience, shows a strong commitment to quality and following the rules in the Hong Kong medical device market. It's a key step for any medical device importer Hong Kong.

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What is the definition of a medical device in Hong Kong?

When we talk about "medical devices" in Hong Kong, what exactly does the Department of Health's Medical Device Division (MDD) consider to be one? According to their guidelines, a medical device is essentially any instrument, apparatus, machine, appliance, implant, software, material, or similar item. It's important that the manufacturer intends it to be used, either alone or with other things, for specific medical purposes in humans.

These purposes include:

• Diagnosing, preventing, monitoring, treating, or easing diseases.
• Diagnosing, monitoring, treating, easing, or compensating for an injury.
• Investigating, replacing, modifying, or supporting the body's structure or how it works.
• Supporting or sustaining life.
• Controlling conception (like contraception).
• Disinfecting other medical devices.
• Providing medical information by examining samples from the human body (this is what IVDMs do!).

Crucially, a medical device does not achieve its main effect in or on the body through drugs, immune responses, or metabolism. However, it might be helped in its function by such means. So, it's pretty broad, covering everything from a simple bandage to complex diagnostic software!

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Who is an "Importer" in the MDACS Context?

So, what is an "Importer" in the world of MDACS, specifically for medical devices? Generally speaking, an "Importer" is a company or organization (a "legal entity") that either brings, or arranges to bring, any medical devices covered by MDACS into Hong Kong for sale or supply here. From our understanding, this definition usually doesn't include individuals who simply import devices for their own personal use. This distinction is vital for medical device regulation Hong Kong.

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Why Should an Importer Get Listed? (Eligibility and Benefits)

Any legal company with a properly staffed office in Hong Kong that handles the import of medical device(s) can apply to be included in "The List of Importers." According to our experience, the voluntary listing of importers offers several clear advantages:

• Boosted Trust & Reputation: Being listed shows that an importer is serious about meeting MDACS standards. From our perspective, this builds significant trust with manufacturers, Local Responsible Persons (LRPs), distributors, and healthcare providers. It truly enhances your importer reputation in Hong Kong.
• Smoother Business Dealings: While it's not a legal requirement for all imports, we've observed that being a listed importer can make business dealings and purchasing processes much easier. This is especially true when working with public healthcare institutions, which are increasingly preferring to collaborate with MDACS-listed companies for their medical device supply chain Hong Kong needs.
• Safer Supply Chain: By having a recognized list of importers, the Medical Device Division (MDD) helps create a safer and more accountable medical device supply chain for Hong Kong, which ultimately protects public health.

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Key Requirements for Listed Importers: What We Look For

To get listed under MDACS, an importer needs to set up, follow, and keep up-to-date a set of written procedures. What's the big picture here? These procedures are absolutely vital for properly controlling and managing imported medical devices, ensuring their safety and quality from arrival to distribution. They should cover important areas like:

• Keeping Track of Records: What kind of records do you need? You'll need to keep detailed and current records of all imported medical devices. This includes information that allows for tracing them all the way back to their origin. According to our experience, these records must be readily available for the MDD to check within a set time (for example, often within two weeks).
• Handling, Storing, and Delivering Devices: You need clear, written steps for properly handling, storing, and delivering medical devices. Why is this crucial? To make sure their safety and performance aren't harmed by things like extreme temperatures or humidity during transport or storage.
• Managing Recalls and Safety Notices: You should have clear procedures for effectively handling product recalls (when devices need to be taken back from the market) and "field safety notices" (when manufacturers alert users about potential safety issues). This includes telling the MDD quickly and working closely with manufacturers/LRPs to address the situation.
• Dealing with Reportable Incidents: You need written procedures for finding, managing, and, if necessary, reporting any adverse incidents (problems) to the LRP (or directly to the MDD if there's no LRP for that specific incident). This is part of your post-market vigilance.
• Handling Complaints: You should have a robust system in place for receiving, checking, investigating, and responding to any complaints about the imported medical devices you distribute.
• Reporting Changes: You'll need steps for informing the MDD about any big changes to your company's information or any details related to the listed medical devices you import. Our understanding is this should generally be done very quickly, often within 10 calendar days.

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The Application Process: Our Step-by-Step Guide

Ready to apply? The process for getting listed as a medical device importer in Hong Kong typically involves these steps, based on our guidance to clients:

1. Submitting the Application Form: You'll need to send in the special application form (often called MD-IP+D, which sometimes covers both importers and distributors) through the online Medical Device Information System (MDIS). Why is MDIS preferred? Because, in our experience, using MDIS is the most efficient and preferred way to submit your application, streamlining the medical device registration Hong Kong process.
2. Providing Supporting Documents: You'll need to provide all the necessary supporting papers. What should you prepare? This usually includes:
   • A valid Business Registration Certificate for your Hong Kong office.
   • Details about your properly staffed office in Hong Kong.
   • Copies of all the written procedures we talked about above.
   • Any other information the MDD feels is necessary for their assessment.
3. MDD Review: The MDD will carefully go over your submitted application and all your documents to make sure everything meets GN-07 and other MDACS requirements. What happens during this stage? The MDD might ask for more information or clarification, and our experience tells us that prompt and thorough responses are key to avoiding delays.
4. Approval and Listing: If everything checks out and the MDD is satisfied, your company will be added to "The List of Importers," which is available for everyone to see on the MDD website. You'll also receive an official listing certificate, marking your successful medical device importer listing.

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Ongoing Compliance: A Continuous Commitment

Getting listed as a medical device importer isn't a one-time event; it's an ongoing commitment. According to our experience, listed importers are expected to continuously keep their written procedures in place and follow them, keep their records updated, and quickly tell the MDD about any important changes or incidents. This continuous dedication is really important for keeping the medical device supply chain reliable and ensuring public health protection here in Hong Kong. It's about maintaining trust and safety in the Hong Kong healthcare market for the long run.