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The Medical Device Control Office (MDCO) was established in July 2004. Our mission is to set up a risk-based and cost-effective regulation on the supply and use of medical devices with reference to harmonized standards and procedures recommended by the Global
Harmonization Task Force (GHTF).
The purpose of regulation is to ensure people in Hong Kong have timely access to medical devices that are safe, efficacious, and perform as intended on one hand, and to avoid unnecessary burden on the trade on the other.
To raise public awareness on the safe use of medical devices and enable traders to familiarise themselves with the future mandatory requirements, the government has launched a Medical Device Administrative Control System (MDACS) on 26 November 2004.
The listed medical devices are posted on our website for the public's reference .
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