Simplifying Medical Device Regulation Compliance

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.

Device Classification and Regulatory Pathways

Navigating Regulatory Requirements in Hong Kong

Regulatory Authority

The Medical Device Division (MDD) oversees the Medical Device Administrative Control System (MDACS), facilitating a pathway towards establishing a statutory regulatory framework for medical devices. While regulatory revisions are anticipated, currently, the registration of Class 2 or higher medical devices and Class D IVD products remains voluntary.

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.
How We Can Help

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.

We Provide Access To 28+ Markets Worldwide

Our team of experts and local representatives, supported by partnerships with hundreds of clinical labs and the extensive GRIP database for over 100 countries, accelerates product launches and ensures compliance across 28 countries.

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