Medical device manufacturers seeking to register their products in Hong Kong must appoint an in-country regulatory representative known as a Local Responsible Person. This is mandatory if you have no local office 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. Emergo maintains an office in Hong Kong, and has the capability and expertise to serve as your Local Responsible Person.
Hong Kong Local Responsible Person Duties
In Hong Kong, as with many Asian markets, it is important that you have someone local you can trust to act in your best interest. Having an independent, professional representative is important to ensure that your regulatory obligations are being met. We represent more than 1,000 medical device companies worldwide as an in-country regulatory liaison and take this role very seriously. We perform all duties a Hong Kong Local Responsible Person is required to fulfill, including:
- Serving as your communication liaison with Hong Kong regulators
- Managing your medical device approval application
- Maintaining duplicate records of all pertinent documents
- Tracking your medical devices being sold on the Hong Kong market
- Managing complaint handling related to your device
- Tracking product alerts, modifications and recalls
- Managing reportable adverse events related to your device
Please contact us for more information on our Hong Kong Local Responsible Person representation service.