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.