ANSWERED ON THIS PAGE:
- What are the requirements for a Local Responsible Person (LRP) in Hong Kong?
- What is the role of an LRP?
- What is a Listed Importer?
Foreign medical device manufacturers who choose to list their products in Hong Kong need an in-country regulatory representative known as a Local Responsible Person (LRP). Emergo maintains an office in Hong Kong, and has the capability and expertise to serve as your Local Responsible Person for Hong Kong medical device registration.
In-country representation requirements for medical device companies in Hong Kong
Your Hong Kong Local Responsible Person must have a valid business registration and a legal residence in Hong Kong. Once appointed, your Local Responsible Person interacts with the Medical Device Control Office (MDCO), Hong Kong’s medical device market regulator, to manage your device registration process. The LRP must be empowered by a Letter of Designation from the manufacturer, and acts as liaison between the manufacturer and health authorities, as well as the public.
Emergo can act as your Local Responsible Person (LRP) in Hong Kong
We represent more than 1,000 medical device companies worldwide as an in-country representative. With a presence in Hong Kong, we can perform all the duties of a Hong Kong Local Responsible Person, including:
- Serving as your communication liaison with the MDCO
- Submitting your medical device approval application
- Maintaining required documentation
- Providing support for adverse event reports and corrective actions.
Having an independent, professional representative is important to meet and manage your regulatory obligations in Hong Kong.
Common Local Responsible Person questions
Can we select a distributor as our Local Responsible Person?
Yes. However, using a distributor as your Hong Kong LRP comes with risks because the LRP is responsible for corresponding with the MDCO. Distributors may not have the expertise or experience to fulfill this role as your regulatory liaison. Additionally, the LRP must have access to technical documentation, which you may not wish to share.
What is a Listed Importer?
In addition to the requirements for an LRP, medical device importers are subject to voluntary listing in the MDCO List of Importers. Importers must be a legal or natural person with proof of Hong Kong residency, incorporation, or business registration. Listed Importers are subject to a number of regulatory obligations, including record keeping, post-market vigilance, and other post-market activities.