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Members of the public will soon be able to obtain updated information on more medical devices on a website designed to help them to make informed choices.
A spokesman for the Department of Health said the voluntary listing system, which enabled manufacturers to list their products on an official website for users' and consumers' reference, would be extended to cover more medical devices.
"When the voluntary listing under the Medical Device Administrative Control System (MDACS) was introduced last November, it only covered high-risk devices," the spokesman said.
"Starting from today (November 14), it will be extended to cover medium-risk medical devices used in healthcare facilities as well as those sold to consumers such as insulin pens, hearing aids and electronic thermometers.
"The listing arrangement allows users and consumers to refer to the list when making purchases," he said.
Relevant traders are encouraged to apply to list medium-risk medical devices under the MDACS. Their listed medical devices will be posted on the Medical Device Control Office website (www.mdco.gov.hk) for reference by members of the public.
The MDACS is built on the principle of a risk-based framework with reference to requirements recommended by an international organisation called Global Harmonized Task Force (GHTF).
It avoids unnecessary burden for the trade, and allows local consumers to have access to medical devices that are safe, perform as intended and harness the latest technology.
To tie in with the listing of medium-risk medical devices, a new document GN-05: Guidance Notes for Listing Class II/III Medical Devices specifying the detailed requirements has been posted on the Medical Device Control Office website. Workshops will also be organised to familiarise traders with the system.
Under the MDACS, each listed device has a Local Responsible Person, who keeps track of the distribution and reports any adverse incidents related to the device. Manufacturers or their local representatives can assume the role of Local Responsible Persons. Traders are encouraged to apply to list their medical devices.
Ends/Monday, November 14, 2005
Issued at HKT 17:30
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