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Medical Device Registration in Hong Kong

Hong Kong is a Special Administrative Region or China but maintains its own regulatory framework for medical devices. The Medical Device Control Office (MDCO) oversees medical devices in Hong Kong, but no specific regulation is currently in place regarding importation, distribution or sale of devices.

Formal regulations are expected to be introduced in the near future, however, and in the meantime MDCO has set up voluntary guidelines to assist manufacturers move to a more regulated environment in Hong Kong. Compliance guidelines in Hong Kong, contained in the Medical Device Administrative Control System (MDACS), are based on Global Harmonization Task Force (GHTF) guidelines.

To register your device with MDCO, you must first determine your product’s classification—as in other markets, Hong Kong uses a four-tier classification system (Class I-IV) based on risk. This is important because currently only Class II, III and IV medical devices can be voluntarily listed on MDACS. Class I devices cannot be registered.

Emergo's Hong Kong office has the knowledge and experience to support your registration effort—and to prepare for a more formalized regulatory environment in Hong Kong once new rules are introduced.

Please contact us for more information on registering your medical device in Hong Kong.

Ask us for detailed information about Hong Kong device registration services.

Learn about the process, costs and timelines.

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Frequently Asked Questions

 

Can registration certificates be transferred? Who owns the approval?

The foreign manufacturer is considered the owner of the registration listing; however, it is administered and controlled by the Local Responsible Person (LRP), who has post market vigilance responsibilities.

The MDCO has advised that the legal manufacturer can assign more than one local company to become the LRP for its products or designate another local company to become the LRP. However, a new LRP cannot be assigned for applications actively in the review process. In those situations, if a company would like to change their LRP mid-review, they will not be able to do so and instead the new LRP will have to submit a new application to the MDCO.

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 one of the following reference markets - Australia, Canada, the EU, Japan or the United States - eliminates the need for conformity assessment by a local Conformity Assessment Body (CAB) prior to application review by the MDCO.

Does the in-country representative need to be on the labeling?

Yes, the Hong Kong in-country representative, called a Local Responsible Person (LRP), must be listed on either the device label or in an insert called “Special Listing Information.”

The Special Listing Information must either be displayed on the outer packaging of every device or sales unit or on a "Special Listing Information" document to be included with each delivery to the end-user or user facility.

How long is my registration valid?

Registrations are valid for 5 years.