MDD Hong Kong Medical Device Registration
Hong Kong, with its population of over 7 million, has become a strategic operational hub for medical device companies looking to expand in the region. Its voluntary registration system for certain classes of medical devices and IVD products positions it as a unique market within the global healthcare landscape.
Navigating Regulatory Requirements in Hong Kong
Regulatory Authority
Pure Global can assist with Hong Kong medical device registration, ensuring MDD approval to sell in the European market.
Classification
Medical devices are classified from Class A - Class D. Understanding the classification of your medical devices is crucial for determining the appropriate regulatory pathway in Hong Kong.
The Department of Health will give preference to all medical devices to be listed under the Medical Device Administrative Control System (MDACS). The voluntary registration system applies to Class 2 or higher medical devices and Class D IVD products and are encouraged to apply as soon as possible.
Key Requirements
Manufacturers without a registered business in Hong Kong must appoint a Local Responsible Person (LRP) to:
- Register their products with the MDD.
- Fulfill post-market surveillance responsibilities.
Tailored Support for Market Entry
Our services are designed to streamline your regulatory compliance process in Hong Kong:
Assistance with product classification and identification of the regulatory pathway.
Preparation and compilation of the technical dossier for product registration.
Acting as your Local Responsible Person (LRP), handling product registration with the MDD and managing post-market requirements.
Frequently
Asked Questions
What is the regulatory authority for medical device registration in Hong Kong?
The Department of Health is the regulatory authority overseeing medical device registration in Hong Kong. They manage the Medical Device Administrative Control System (MDACS), which is the framework for voluntary Hong Kong medical device registration of certain classes of medical devices and in vitro diagnostic (IVD) products.
How are medical devices classified in Hong Kong?
Medical devices in Hong Kong are classified from Class A to Class D under the MDD medical device classification system. Understanding the classification of your device is essential for determining the appropriate regulatory pathway. The voluntary registration system specifically targets Class 2 or higher medical devices and Class D IVD products.
Is it mandatory for all medical devices to be registered in Hong Kong?
No, the registration system for medical devices in Hong Kong is voluntary, particularly under the Medical Device Administrative Control System (MDACS). However, the Department of Health encourages the registration of Class 2 or higher medical devices and Class D IVD products as soon as possible under Hong Kong medical device regulations.
What are the requirements for manufacturers without a registered business in Hong Kong?
Manufacturers without a registered business in Hong Kong must appoint a Local Responsible Person (LRP). The LRP is responsible for registering the products with the Medical Device Division (MDD Hong Kong) and fulfilling post-market surveillance responsibilities.
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Whether looking for more information or ready to partner with us, we're here to guide you through every step of the regulatory process.