An overseas medical manufacturer desiring to sell their products in Hong Kong needs a local office or representative. If the foreign medical company does not have their own office in Hong Kong or does not want to use their distributor as their representative, then an independent third party based in Hong Kong can act as the Local Responsible Person (LRP).
What are the requirements to be a LRP?
- To be appointed as a LRP, the individual must be a legal or natural citizen with a business registration in Hong Kong.
What are the responsibilities of the LRP?
- Maintaining effective communication channels. The LRP is the primary source of communication between the users, manufacturer, importers, and the Hong Kong government, and must ensure quality service in a responsive and timely manner.
- Taking on the application process for the medical product and communicating with the Hong Kong government regarding the application.
- Maintaining distribution records, keeping an updated list of importers, and recording details of the medical product sold and distributed within Hong Kong.
- Maintaining the safety and quality of the medical products.
- Reporting any product modifications or recalls, as well as any adverse incidents in Hong Kong involving the medical product, to the Medical Device Control Office (MDCO).
- Handling complaints and providing maintenance and service arrangements through an established procedure.
- For high-risk products, enforcing a tracking system down to the individual patient level and submitting surveillance reports to the MDCO.
Pacific Bridge Medical has been helping international medical companies fulfill LRP regulatory requirements for more than two decades. We have our own office in Hong Kong and can act as your local agent or LRP to help you expand your company’s international footprint.
If you are interested in our LRP services, contact us for a free consultation with our expert regulatory consultants now.
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