Medical Device Registration in Hong Kong
ANSWERED ON THIS PAGE:
- How are medical devices regulated in Hong Kong?
- How can we start selling our medical device in Hong Kong?
- How do Hong Kong regulators classify medical devices?
Hong Kong is a Special Administrative Region of China that maintains its own regulatory framework for medical devices. The Medical Device Control Office (MDCO) oversees medical devices in Hong Kong and has a voluntary listing system for certain device classifications. With a presence in Hong Kong, we can help you obtain medical device market access.
Hong Kong medical device registration requirements
Companies who plan to register under the voluntary system must prove conformance with the Medical Device Administrative Control System (MDACS), which will be reviewed by the MDCO. Once the application has been approved, the MDCO will issue a listing number and add the device to the List of Medical Devices.
While device registration is voluntary, it is often expected for purchasing. Both private and government hospitals may request the MDCO listing number to show your device is approved. Additionally, the voluntary system is not intended as a free-pass, but as a phase-in for eventual mandatory registration.
Medical device classification in Hong Kong
You must first determine your product’s classification in order to register your device with the MDCO. As in other markets, Hong Kong uses a four-tier classification system (Classes I–IV) based on increasing risk. Only Class II, III, and IV medical devices can be voluntarily listed through the MDACS. Class I devices cannot be registered. Only Class D IVDs can be registered.
Hong Kong in-country representation for foreign device manufacturers
Companies without a presence in Hong Kong should appoint a Local Responsible Person (LRP). The LRP must be “a legal person incorporated in Hong Kong, or a natural or legal person with a business registration in Hong Kong.” The LRP applies for the device listing and is identified in the registration. The LRP also has post-market responsibilities that include adverse incident reporting, complaint handling, and recalls.
Emergo can help you access Hong Kong’s medical device market
Emergo's Hong Kong office has the expertise to support your registration effort in Hong Kong. Here’s how we can help:
- Assist with device classification per Hong Kong’s classification rules.
- Prepare and submit your MDCAS device application.
- Communicate with the MDCO on your behalf.
- Assist with device renewals and post-market compliance.
Emergo is qualified to help you prepare for a more formalized regulatory environment in Hong Kong once new rules are introduced. Your success in Hong Kong is our goal.
Common Hong Kong registration questions
Is ISO 13485 required?
Yes, the MDCO requests the ISO 13485 certificate as a part of the medical device application process.
Is home country approval required?
No, but approval in a reference market—Australia, Canada, the EU, Japan or the United States—eliminates the need for conformity assessment by a local Conformity Assessment Body (CAB).
Does the in-country representative need to be on the labeling?
Yes, the LRP information, as well as the listing number, must either be displayed on the outer packaging of every device or sales unit or on a document to be included with the device or with each delivery to the end-user or user facility.
How long is my registration valid?
Registrations are valid for 5 years.