Members of the public will soon be able to obtain updated information of more medical devices in a thematic website designed to help them to make informed choice.
A spokesman for DH said the voluntary listing system, which enabled manufacturers to list their products in 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.
"Starting from today (November 14), it will be extended to cover also 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 make reference to the list when making purchases," he said.
Relevant traders are encouraged to apply for listing of 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 harmonized requirements recommended by an international organization called Global Harmonized Task Force (GHTF).
It avoids unnecessary burden to the trade on one hand, and allows local consumers to have access to medical devices that are safe, efficacious, performing as intended and of the latest technology.
To tie in with 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 organized to familiarize the traders with the System.
Under the MDACS, each listed device would have a Local Responsible Person, who would keep track of the distribution and report 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 for the listing of medical devices accordingly.