Medical Device Administrative Control System

Currently, there is no specific legislative control over the importation and sale of medical devices in Hong Kong.

To safeguard public health, a risk-based framework for regulating the supply of medical devices was proposed in the Consultation Document entitled "Regulation of Medical Devices" in July 2003. The proposed framework is largely in line with that recommended by the International Medical Device Regulators Forum (IMDRF) (previously Global Harmonization Task Force (GHTF)). It incorporates internationally accepted best practices relating to safety, quality and risk management and at the same time provides for the flexibility and capability to regulate the rapidly advancing medical technology.

Pending the enactment of legislation, an administrative control system called Medical Device Administrative Control System has been set up to facilitate the transition to the long-term statutory control. The Medical Device Division, an office under the Department of Health, is responsible for the running of the Medical Device Administrative Control System.

The Medical Device Administrative Control System has the following features:

• a listing system for medical devices, under which manufacturers and importers of medical devices could voluntarily list their medical devices with the Department of Health; and
• an adverse event reporting system, through which the manufacturers, importers, users, and the general public could report medical device adverse events to the Department of Health for evaluation to reduce the likelihood of, or to prevent repetition of adverse events, or alleviate consequences of such repetition.

Details of the Medical Device Administrative Control System are available at the following links:

• Scope
• Implementation Progress
• Issued Documents
• Listing Application
• New Procurement Requirement of the Department of Health for Medical Devices
• Classified Examples of Medical Devices
• Medical Device Classification Program
• Report Medical Device Adverse Events
• Application for Inclusion into Mailing List
• Search Database