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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 Global Harmonization Task Force. 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 Control Office, 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 incident reporting system, through which the manufacturers,
importers, users, and the general public could report adverse
incidents to the Department of Health for evaluation to reduce
the likelihood of, or to prevent repetition of adverse incidents,
or alleviate consequences of such repetition.
Details of the Medical Device Administrative Control System are
available at the following links:
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