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.